The Pharmacy Order 2010

Statutory Instruments

2010 No. 231

Health Care And Associated Professions

The Pharmacy Order 2010

Made

10th February 2010

Coming into force in accordance with article 1

At the Court at Buckingham Palace, the 10th day of February 2010

Present,

The Queen’s Most Excellent Majesty in Council

This Order in Council is made in exercise of the powers conferred by sections 60 and 62(4) and (4A) of, and Schedule 3 to, the Health Act 1999(1) as read with paragraph 1A of Schedule 2 to the European Communities Act 1972(2).

This Order makes provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to Her Majesty, with the advice of Her Privy Council, that it is necessary for the reference to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications(3) to be construed as a reference to that Directive as amended from time to time.

The Secretary of State and the Scottish Ministers published a draft Order and invited representations as required by paragraph 9(1) and (3) of Schedule 3 to the Health Act 1999.

The period of three months mentioned in paragraph 9(4) of that Schedule expired before a draft of this Order in Council was laid before Parliament and the Scottish Parliament.

A draft of this Order in Council has been approved by resolution of each House of Parliament and the Scottish Parliament in accordance with section 62(10) of the Health Act 1999.

Accordingly, Her Majesty is pleased, by and with the advice of Her Privy Council, to make the following Order in Council:

PART 1 E+W+S Preliminary

Citation and commencement E+W+S

1.—(1) This Order may be cited as the Pharmacy Order 2010.

(2) The following provisions come into force on the day after the day on which this Order is made—

(a) this article;

(b) articles 2, 3, 4(1), (2), (3)(b), (5) and (8) and 7 and Schedule 1; and

(c) articles 65, 66, 69(1) to (4) and 70 and Schedules 5 and 6.

(3) Except as provided for by paragraph (2), the provisions of this Order which confer powers enabling rules or orders to be made, or which enable standards or requirements to be set by the Council, come into force on the making of this Order, but for the purpose only of the exercise of those powers.

(4) Rules under article 7(1) and (4) are not to come into force before the end of the period of two years beginning with the day on which this Order is made.

(5) Except as provided for by paragraphs (2) and (3), this Order comes into force on such day as the Privy Council may by order appoint.

(6) Different days may be appointed by an order under paragraph (5) for different provisions or different purposes.

Commencement Information

I1 Art. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I2 Art. 1 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(a)

Extent E+W+S

2.—(1) Subject to paragraph (2), this Order extends to England and Wales and Scotland.

(2) The extent of any amendment, revocation, repeal or saving of any enactment set out in Schedules 4 and 6 is the same as that of the enactment amended, revoked, repealed or saved.

Commencement Information

I3 Art. 2 in force at 10.2.2010 for specified purposes, see art. 1(3)

I4 Art. 2 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Interpretation E+W+S

3.—(1) In this Order—

“the 2007 Order” means the Pharmacists and Pharmacy Technicians Order 2007(4);

“annotation” means an annotation in the Register;

“assessment team” means an assessment team appointed under rules made under article 55;

“competent authority” means any authority or body of a relevant European State designated by that State for the purposes of the Directive as competent, in connection with practice as a pharmacist or pharmacy technician—

(a)

to receive or issue evidence of qualifications or other information or documents; and

(b)

to receive applications and take the decisions referred to in the Directive;

“controlled drugs” has the meaning given in section 2(1)(a) of the Misuse of Drugs Act 1971(5) (controlled drugs and their classification);

“the Council” means the General Pharmaceutical Council established by article 4;

“the Directive” means Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications(6), and references in this Order to the Directive, or to any provision of the Directive, are references to the Directive, or to that provision, as amended from time to time;

“electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act 2000(7) (general interpretation);

“enactment” means an enactment contained in, or in an instrument made under—

(a)

an Act of Parliament;

(b)

an Act of the Scottish Parliament; or

(c)

a measure or Act of the National Assembly for Wales;

“European mutual recognition area” means the territory of the EEA States(8) and Switzerland;

“exempt person” means—

(a)

a national of a relevant European State other than the United Kingdom;

(b)

a national of the United Kingdom who is seeking access to, or is pursuing, the profession of pharmacist or pharmacy technician by virtue of an enforceable [F1 EU] right; or

(c)

a person who is not a national of a relevant European State but who is, by virtue of an enforceable [F1 EU] right, entitled to be treated, for the purposes of access to and pursuit of the profession of pharmacist or pharmacy technician, no less favourably than a national of a relevant European State;

“General Systems Regulations” means the European Communities (Recognition of Professional Qualifications) Regulations 2007(9);

“improvement notice” means a notice served on any person under article 13;

“individual assessor” means an individual assessor appointed under rules made under article 55;

“inspector” means an inspector appointed by the Council under article 8(1);

“medical device” has the meaning given in regulation 2(2) of the Medical Devices Regulations 2002(10);

“medicinal product” has the same meaning as it has in the Medicines Act 1968 by virtue of section 130 of that Act(11) (meaning of “medicinal product” and related expressions);

“medicinal product on a general sale list” means a medicinal product of a description, or falling within a class, specified in an order which is for the time being in force under section 51 of the Medicines Act 1968 (12)(general sale lists);

“the Pharmacy Acts” means the Pharmacy Act 1852(13), the Pharmacy Act 1868(14), the Pharmacy Act 1908(15), the Pharmacy and Poisons Act 1933(16) and the Pharmacy Act 1954(17);

“the Poisons Rules” means rules made by the Secretary of State under section 7 of the Poisons Act 1972(18) (poisons rules);

“prescribed” means prescribed by rules made by the Council;

“the Register” means the register established and maintained under article 19;

“registered pharmacist” means a person who is entered in Part 1 or 4 of the Register;

“registered pharmacy technician” means a person who is entered in Part 2 or 5 of the Register;

“registered pharmacy” means premises that are entered in Part 3 of the Register;

“registrant” means a registered pharmacist or a registered pharmacy technician;

“Registrar”, except where used in the expression “Registrar General”, is to be construed in accordance with article 18(1) and (6);

“Registrar General” means—

(a)

the Registrar General for England and Wales appointed under section 1 of the Registration Service Act 1953(19) (Registrar General); or

(b)

the Registrar General for Scotland appointed under section 1(1) of the Registration of Births, Deaths and Marriages (Scotland) Act 1965(20) (the Registrar General);

“regulatory body” means a regulatory body which has the function of authorising persons to practise as a member of a health or social care profession;

“relevant European State” means an EEA State or Switzerland;

“retail pharmacy business” has the meaning given in section 132 of the Medicines Act 1968(21) (general interpretation provisions);

“retail sale” is to be construed in accordance with section 131(3) of the Medicines Act 1968(22) (meaning of “wholesale dealing”, “retail sale” and related expressions);

“the Society” means the Royal Pharmaceutical Society of Great Britain;

“statutory committees” means the Committees of the Council listed in article 4(6);

“superintendent pharmacist” means a pharmacist who is a superintendent for the purposes of section 71(1) of the Medicines Act 1968(23) (business carried on by body corporate); and

“supply in circumstances corresponding to retail sale” is to be construed in accordance with section 131(4) of the Medicines Act 1968.

(2) For the purposes of this Order, a person practises as a pharmacist or a pharmacy technician if, whilst acting in the capacity of or purporting to be a pharmacist or a pharmacy technician, that person undertakes any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of healthcare.

(3) For the purposes of articles 34 and 35, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004(24) (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.

Textual Amendments

F1 Words in Order substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 3-6

Commencement Information

I5 Art. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I6 Art. 3 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

PART 2 E+W+S The Council and its Committees

The Council and its Committees E+W+S

4.—(1) There is to be a body corporate known as the General Pharmaceutical Council (“the Council”).

(2) The Council is to be constituted as provided for by an order of the Privy Council made under this article subject to the provisions of Schedule 1 to this Order.

(3) The principal functions of the Council are—

(a) to establish and maintain a register of pharmacists, pharmacy technicians and premises at which a retail pharmacy business is, or is to be, carried on;

(b) to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies;

(c) to set requirements by reference to which registrants must demonstrate that their fitness to practise is not impaired;

(d) to promote the safe and effective practice of pharmacy by registrants (including, for example, by reference to any code of conduct for, and ethics relating to, pharmacy);

(e) to set standards and requirements in respect of the education, training, acquisition of experience and continuing professional development that it is necessary for pharmacists and pharmacy technicians to achieve in order to be entered in the Register or to receive an annotation in the Register and to maintain competence; and

(f) to ensure the continued fitness to practise of registrants.

(4) The Council has the functions conferred on it by this Order and such other functions as may be conferred on it by the Privy Council by order.

(5) Before making an order under paragraph (4), the Privy Council must consult the Council.

(6) The Council must have the following committees—

(a) the Investigating Committee;

(b) the Fitness to Practise Committee; and

(c) the Appeals Committee,

and each of those committees has the functions assigned to it by or under this Order.

(7) The Council may establish such other committees as it considers appropriate in connection with the discharge of its functions and may delegate any of its functions to them, except any power to make rules.

(8) Schedule 1 makes further provision about the Council, its committees, its staff, its publications and its accounts.

Commencement Information

I7 Art. 4(1)(2)(3)(b)(5)(8) in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

I8 Art. 4 in force at 10.2.2010 for specified purposes, see art. 1(3)

I9 Art. 4(3)(a), (c)-(f), (4)(6)(7) in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Standards and requirements: consultation and review E+W+S

5.—(1) Before setting any standards or requirements under this Order, the Council must consult such persons as it considers appropriate including, where it considers appropriate, persons appearing to it to represent—

(a) registrants;

(b) employers of registrants;

(c) professional bodies or organisations appearing to the Council to represent registrants;

(d) users of the services of registrants;

(e) persons or bodies commissioning or funding the services provided by registrants or at registered pharmacies;

(f) persons carrying on a retail pharmacy business at a registered pharmacy; and

(g) persons or bodies providing, assessing, regulating or funding education and training for registrants or prospective registrants.

(2) The Council must keep the standards and requirements set under this Order under review and may vary or withdraw any of those standards and requirements whenever it considers it appropriate to do so.

(3) Paragraph (1) applies to the variation or withdrawal of standards or requirements as it applies to the setting of standards or requirements.

Commencement Information

I10 Art. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I11 Art. 5 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

The Council’s general duties E+W+S

6.—(1) The main objective of the Council (including its staff and committees) in exercising such of its functions as affect the health, safety or well-being of members of the public is to protect, promote and maintain the health, safety and well-being of members of the public, and in particular of those members of the public who use or need the services of registrants, or the services provided at a registered pharmacy, by ensuring that registrants, and those persons carrying on a retail pharmacy business at a registered pharmacy, adhere to such standards as the Council considers necessary for the safe and effective practice of pharmacy.

(2) In exercising its functions, the Council (including its staff and committees) must—

(a) have proper regard to—

(i) the interests of persons using or needing the services of registrants in Great Britain,

(ii) the interests of all registrants and prospective registrants, and any differing interests of registered pharmacists and registered pharmacy technicians or groups within those professions, and

(iii) the interests of persons carrying on a retail pharmacy business at a registered pharmacy; and

(b) co-operate, in so far as is appropriate and reasonably practicable, with persons concerned with—

(i) the employment (whether or not that employment is under a contract of service) of registrants,

(ii) the education or training of registrants, prospective registrants or other health or social care professionals,

(iii) the regulation of, or the co-ordination of the regulation of, other health or social care professionals,

(iv) the regulation of health services, and

(v) the provision, supervision or management of health services.

(3) In carrying out its duty to co-operate under paragraph (2)(b), the Council must have regard to any differing considerations relating to practising as a pharmacist or as a pharmacy technician which apply in England, Scotland or Wales.

(4) In paragraph (2), “other health care professionals” means persons regulated by a body, other than the Council, mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002(25).

Commencement Information

I12 Art. 6 in force at 10.2.2010 for specified purposes, see art. 1(3)

I13 Art. 6 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 3 E+W+S Registered Pharmacies: Standards in retail pharmacies

Standards: general E+W+S

7.—(1) In the exercise of its functions under article 4(3)(b), the Council must make provision in rules about the standards that are to be met in connection with the carrying on of a retail pharmacy business at a registered pharmacy.

(2) Those standards may relate to requirements that are to be met—

(a) by the person carrying on the retail pharmacy business; or

(b) by a superintendent pharmacist.

(3) The standards may, in particular, relate to—

(a) record keeping;

(b) standard operating procedures;

(c) the training of staff;

(d) incident reporting mechanisms;

(e) arrangements for the obtaining, keeping, handling, use and security of medicinal products or medical devices;

(f) the conditions in which medicinal products (including controlled drugs) are to be stored;

(g) the condition of the premises (including the physical state, safety and security of the premises);

(h) the availability or condition of facilities or equipment at the premises used to carry out certain activities (including the conducting of clinical procedures (such as the taking of blood), the undertaking of consultations with patients and the carrying on of activities to which section 10 of the Medicines Act 1968(26) (exemptions for pharmacists) applies);

(i) the management of waste (including the adequate procedures for the safe destruction and disposal of medicinal products kept on the premises); and

(j) the use of the premises as a training establishment.

(4) The Council must also make provision in rules—

(a) requiring any person carrying on a retail pharmacy business to provide information to the Council;

(b) for such information to be provided—

(i) at the request of the Council, or

(ii) on such dates or at such intervals as the Council may determine, either generally or in relation to particular persons carrying on a retail pharmacy business or such persons of a particular description; and

(c) in respect of—

(i) the form and manner in which such information is to be provided to the Council, and

(ii) the time within which such information is to be provided to the Council pursuant to a request under sub-paragraph (b)(i).

(5) Rules under paragraph (4) must, in particular, enable the Council to obtain the following information—

(a) details of the person carrying on the retail pharmacy business including—

(i) where the business is carried on by an individual, details of the home address in the Register of that individual,

(ii) where the business is carried on by a partnership, details of the address of the principal office of the partnership and of the names and home addresses of the partners in the partnership,

(iii) where the business is carried on by a body corporate, details of the address of the registered or principal office of the body corporate and of the names and home addresses of its directors;

(b) a list of all premises at which the retail pharmacy business is carried on;

(c) where medicinal products, other than medicinal products on a general sale list, are sold by retail at any premises at which a retail pharmacy business is carried on, or are supplied in circumstances corresponding to retail sale, and the retail pharmacy business is owned by a body corporate, the name of the superintendent pharmacist under whose management the business is carried on;

(d) details of the type or types of activities undertaken at the premises at which the retail pharmacy business is carried on; and

(e) details of any relevant offence or relevant investigation.

(6) For the purposes of paragraph (5)(e)—

(a) a relevant offence is—

(i) where the retail pharmacy business is carried on by an individual, a criminal offence with which that individual has been charged,

(ii) where the retail pharmacy business is carried on by a partnership, a criminal offence with which any partner in the partnership has been charged,

(iii) where the retail pharmacy business is carried on by a body corporate, a criminal offence with which the body corporate or any of its directors has been charged,

and a criminal offence is a relevant offence whether or not the charge has resulted in a caution or conviction;

(b) a relevant investigation is an investigation by a licensing, regulatory or other body into the conduct of—

(i) where the retail pharmacy business is carried on by an individual, that individual,

(ii) where the retail pharmacy business is carried on by a partnership, any partner in the partnership,

(iii) where the retail pharmacy business is carried on by a body corporate, that body corporate or any director of it,

and the reference to details of a relevant investigation includes details of the outcome of that investigation.

(7) Rules under paragraph (4) must also enable the provision to the Council of a statement which confirms that the standards that are provided for in rules made under paragraph (1) are met in connection with the carrying on of the retail pharmacy business at the registered pharmacies at which it is carried on and which is signed—

(a) where the retail pharmacy business is carried on by an individual, by that individual;

(b) where the retail pharmacy business is carried on by a partnership, by a partner in the partnership;

(c) where the retail pharmacy business is carried on by a body corporate, by a director of that body corporate.

Commencement Information

I14 Art. 7 in force at 10.2.2010 for specified purposes, see art. 1(3)

I15 Art. 7 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

The Inspectorate E+W+S

8.—(1) The Council must establish an inspectorate which is to consist of inspectors appointed by the Council under this paragraph.

(2) An inspector appointed by the Council under paragraph (1) has the following functions—

(a) in connection with the Council’s functions under article 4(3)(b), to enforce such standards as may be provided for by rules under article 7(1);

(b) to assist the Council in its investigation of matters to which Part 6 of this Order applies;

(c) to secure compliance by registrants and by persons carrying on a retail pharmacy business at a registered pharmacy with the provisions of Parts 3 and 4 of the Medicines Act 1968(27) (which contain provisions about dealings with medicinal products and about pharmacies) in so far as they relate to the sale and supply of medicinal products;

(d) to secure compliance by registered pharmacists and persons carrying on a retail pharmacy business with the provisions of the Poisons Act 1972(28) and the Poisons Rules;

(e) to enforce—

(i) article 38 of this Order, and

(ii) any other provisions of this Order and of rules made under this Order.

(3) An inspector is to hold and vacate office in accordance with the terms of the inspector’s appointment.

(4) The Council may pay to an inspector such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine.

Commencement Information

I16 Art. 8 in force at 10.2.2010 for specified purposes, see art. 1(3)

I17 Art. 8 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Inspection and enforcement E+W+S

9.—(1) The Council must make provision in rules relating to—

(a) the intervals at which inspectors may conduct routine inspections of registered pharmacies; and

(b) the circumstances in which inspectors may conduct special inspections of, and other visits to, registered pharmacies.

(2) Rules under paragraph (1) are not to limit an inspector’s power of entry under article 10.

Commencement Information

I18 Art. 9 in force at 10.2.2010 for specified purposes, see art. 1(3)

I19 Art. 9 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Power of entry E+W+S

10.—(1) An inspector, on producing (if required)—

(a) evidence of the inspector’s identity; and

(b) evidence of the inspector’s appointment,

may, for the purposes of the exercise of a function conferred on the inspector by article 8(2)(a), (b) or (e) enter any registered pharmacy or other premises at any reasonable hour.

(2) In the case of any premises which are or form part of a private dwelling house, an inspector may enter the premises by virtue of paragraph (1) only if 24 hours notice of the intended entry has been given to the occupier.

(3) If a justice of the peace, on sworn information in writing from an inspector, is satisfied that entry to a registered pharmacy or other premises is required for the purposes of the exercise of a function conferred on the inspector by article 8(2)(a), (b) or (e) and is also satisfied that—

(a) admission has been refused, or a refusal is expected, and (in either case) that notice to apply for a warrant has been given to the occupier;

(b) asking for admission, or the giving of such notice, would defeat the object of entry;

(c) the case is one of urgency; or

(d) the premises are unoccupied or the occupier is temporarily absent,

the justice may by signed warrant authorise the inspector to enter the premises, if need be by reasonable force.

(4) A warrant issued by a justice of the peace under paragraph (3) is valid for the period of one month beginning with the day on which the warrant is issued.

(5) An inspector who is authorised to enter any premises by a warrant issued by a justice of the peace under paragraph (3) must, on entering the premises, produce the warrant to any person at the premises appearing to the inspector to be in charge of, or responsible for, the premises or, if the premises are unoccupied, leave a copy of the warrant at the premises.

(6) An inspector entering premises by virtue of this article—

(a) may be accompanied by a police constable or by such other persons as the inspector considers necessary;

(b) may bring into the premises such equipment as the inspector considers necessary.

(7) If an inspector enters any unoccupied premises by virtue of this article, the inspector must leave the premises as effectively secured against unauthorised entry as the premises were found.

(8) In the application of this article to Scotland, a reference to a justice of the peace includes a reference to the sheriff and to a magistrate.

Commencement Information

I20 Art. 10 in force at 10.2.2010 for specified purposes, see art. 1(3)

I21 Art. 10 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Powers of an inspector E+W+S

11.—(1) An inspector may, upon entering any premises by virtue of article 10 —

(a) inspect the premises and any plant, machinery or equipment at the premises;

(b) search the premises;

(c) inspect and remove from the premises any substance, article or product (whether or not appearing to the inspector to be a medicinal product);

(d) take and remove from the premises samples of any substance, article or product;

(e) carry out any examinations and tests and make any enquiries (including such enquiries of any person as the inspector considers it appropriate to make relating to the fitness to practise of a registrant who is or has been employed on the premises to provide pharmaceutical services);

(f) require any person holding or accountable for any documents or records (whether or not kept at the premises being inspected) to produce them for inspection at the premises.

(2) The power conferred by paragraph (1)(f) includes power to require any documents or records that are kept by means of a computer or other electronic device to be produced in a form in which they are legible and may be taken away.

(3) If an inspector requires documents or records to be produced for inspection by virtue of the power conferred by paragraph (1)(f), the inspector may—

(a) take copies of or extracts from such documents or records;

(b) take possession of the documents or records or of the computer or other electronic device in which the documents or records are stored and retain them for as long as the inspector considers necessary;

(c) require access to any computer or other electronic device or to any associated apparatus or material that is or has been used in connection with the documents or records and inspect and check the operation of the computer, electronic device, apparatus or material.

(4) The power conferred by paragraph (3)(c) includes power to require any person having charge of, or otherwise concerned with the operation of, the computer, device, apparatus or material to afford such assistance as the inspector may reasonably require.

(5) An inspector also has power to do anything which is calculated to facilitate the discharge of the inspector’s functions or which is incidental or conducive to the discharge of those functions.

Commencement Information

I22 Art. 11 in force at 10.2.2010 for specified purposes, see art. 1(3)

I23 Art. 11 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Obstruction: offences E+W+S

12.  Any person who—

(a) intentionally obstructs an inspector exercising functions under article 10 or 11;

(b) without reasonable cause, fails to give an inspector exercising any functions under this Order any assistance or information that the inspector may reasonably require from that person for the performance of those functions;

(c) furnishes to an inspector exercising any functions under this Order any information that the person knows to be false or misleading; or

(d) fails to produce a document or record when required to do so by an inspector exercising any functions under this Order,

commits an offence and is liable, on summary conviction, to a fine not exceeding level 3 on the standard scale.

Commencement Information

I24 Art. 12 in force at 10.2.2010 for specified purposes, see art. 1(3)

I25 Art. 12 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Improvement notices E+W+S

13.—(1) If an inspector has reasonable grounds for believing that there is—

(a) a failure in connection with the carrying on of a retail pharmacy business at a registered pharmacy entered in the Register under section 74A of the Medicines Act 1968 (registration or premises: Great Britain) to meet the standards that are provided for in rules made under article 7(1); or

(b) a failure to comply with conditions to which the entry of a registered pharmacy entered in the Register under section 74A of the Medicines Act 1968 is subject by virtue of section 74D(1)(29) of that Act (conditional registration: Great Britain),

the inspector may serve a notice on the person carrying on the retail pharmacy business at the registered pharmacy (in this Order referred to as an “improvement notice”).

(2) An improvement notice must—

(a) state the inspector’s grounds for believing that there is a failure referred to in paragraph (1)(a) or (b);

(b) specify the measures that the person to whom the notice is addressed must take in order to rectify that failure;

(c) require that person to take those measures, or measures that the inspector agrees are at least equivalent to them, within the period specified in the notice which may not be less than 28 days beginning with the day on which the notice is served; and

(d) state—

(i) that there is a right of appeal to a magistrates’ court or to the sheriff under article 16, and

(ii) the period within which such an appeal may be brought.

(3) An improvement notice is served by an inspector—

(a) on an individual—

(i) if it is delivered to that individual personally,

(ii) if it is left at that individual’s proper address, or

(iii) if it is sent by first class post or otherwise delivered to that individual at that individual’s proper address;

(b) on a partnership—

(i) if it is delivered personally to a partner in the partnership,

(ii) if it is delivered personally to a person having control or management of the partnership business, or

(iii) if it is sent by first class post or otherwise delivered to the partnership’s proper address;

(c) on a body corporate—

(i) if it is delivered personally to the secretary or clerk of that body,

(ii) if it is sent by first class post or otherwise delivered to that body’s proper address.

(4) For the purposes of paragraph (3), and of section 7 of the Interpretation Act 1978(30) (which defines “service by post”) in its application to that paragraph, the proper address of a person is—

(a) in the case of an individual, to that individual’s home address in the Register;

(b) in the case of a partnership, the address of the principal office of the partnership;

(c) in the case of a body corporate, the address of the registered or principal office of the body.

(5) An improvement notice is treated as having been served, where the notice is sent by post, at the time at which the notice would be delivered in the ordinary course of post or, where the notice has been left at an address, it is treated as having been served on the next working day following the day on which it was left at that address.

(6) The Council may make rules providing for an improvement notice which is required to be served on any person under this article to be served by an electronic communication.

(7) Rules under paragraph (6) must secure that—

(a) an improvement notice cannot be served by an electronic communication unless the person consents in writing to the receipt of notices from the Council by electronic communication and the communication is sent to the number or address specified by that person when giving consent;

(b) an electronic communication received outside of a person’s normal business hours is to be taken to have been served on the next working day.

(8) In this article “working day” means a day which is not a Saturday or Sunday, Christmas Day, Good Friday or a day which is a bank holiday under the Banking and Financial Dealings Act 1971(31) in the part of Great Britain in which the premises to which the notice relates are located.

Commencement Information

I26 Art. 13 in force at 10.2.2010 for specified purposes, see art. 1(3)

I27 Art. 13 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Non-compliance with improvement notices E+W+S

14.—(1) A person carrying on a retail pharmacy business at a registered pharmacy who fails to comply with the terms of an improvement notice served under article 13 commits an offence and is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(2) Where an inspector is reasonably satisfied that a person carrying on a retail pharmacy business at a registered pharmacy has failed to comply with the terms of an improvement notice served under article 13, the inspector must give notice of that fact in writing to the Registrar.

(3) The obligation imposed by paragraph (2) applies whether or not proceedings are to be brought against the person for an offence under paragraph (1).

(4) Upon receipt of a notice given under paragraph (2), the Registrar may—

(a) remove the entry of the registered pharmacy from the Register; or

(b) suspend that entry pending compliance by the person with such requirements or conditions as the Registrar considers it necessary to impose.

(5) Where under paragraph (4) the Registrar removes or suspends the entry of a registered pharmacy, the Registrar must send to the person carrying on the retail pharmacy business a statement in writing giving that person notice of the removal or suspension and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(6) The notice under paragraph (5) must be sent—

(a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the Register;

(b) where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office;

(c) where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered address or principal office.

(7) Proceedings for an offence under this article may be begun—

(a) in England and Wales, at any time within the period of 6 months beginning with the date on which evidence sufficient in the opinion of the Council to justify a prosecution came to the Council’s knowledge;

(b) in Scotland, at any time within the period of 6 months beginning with the date on which evidence sufficient in the opinion of the prosecutor to justify a prosecution came to the prosecutor’s knowledge;

but no proceedings may be begun after the expiry of the period of two years beginning with the date of the commission of the offence.

(8) For the purposes of paragraph (7), the date of the commission of the offence is the day after the day on which the period specified under paragraph (2)(c) of article 13 expires.

Commencement Information

I28 Art. 14 in force at 10.2.2010 for specified purposes, see art. 1(3)

I29 Art. 14 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Offences committed by partnerships E+W+S

15.—(1) Proceedings for an offence under article 14 alleged to have been committed by a partnership must be brought in the name of the partnership (and not in that of any of the partners).

(2) Rules of court relating to the service of documents are to have effect as if the partnership were a body corporate.

(3) In proceedings for an offence brought against a partnership, Schedule 3 to the Magistrates’ Courts Act 1980(32) (corporations) applies as it applies in relation to a body corporate.

(4) A fine imposed on a partnership on its conviction for an offence is to be paid out of the assets of the partnership.

Commencement Information

I30 Art. 15 in force at 10.2.2010 for specified purposes, see art. 1(3)

I31 Art. 15 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Appeals against improvement notices E+W+S

16.—(1) Any person on whom an improvement notice is served may appeal to a magistrates’ court or, in Scotland, to the sheriff.

(2) The procedure on appeal to a magistrates’ court under paragraph (1) is by way of complaint, and the Magistrates’ Courts Act 1980 applies to the proceedings.

(3) An appeal to the sheriff under paragraph (1) is by summary application.

(4) The period within which an appeal may be brought is 28 days beginning with the date on which the notice was served.

(5) The court may suspend an improvement notice pending the determination or abandonment of an appeal.

Commencement Information

I32 Art. 16 in force at 10.2.2010 for specified purposes, see art. 1(3)

I33 Art. 16 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Powers of a court on appeal E+W+S

17.  On an appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without modification.

Commencement Information

I34 Art. 17 in force at 10.2.2010 for specified purposes, see art. 1(3)

I35 Art. 17 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 4 E+W+S Registration

The Registrar E+W+S

18.—(1) The Council must appoint a fit and proper person to be Registrar.

(2) The Registrar is to have such functions as may be conferred by this Order or by rules under this Order or by any other enactment.

(3) The Council may delegate any of its functions to the Registrar, except any power to make rules.

(4) The Council may appoint a Deputy Registrar.

(5) The Registrar and any Deputy Registrar are to hold and vacate office in accordance with the terms of their appointment.

(6) The Registrar may authorise a Deputy Registrar or an employee of the Council to act for the Registrar in any matter.

Commencement Information

I36 Art. 18 in force at 10.2.2010 for specified purposes, see art. 1(3)

I37 Art. 18 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Establishment, maintenance of and access to the Register E+W+S

19.—(1) The Registrar must establish and maintain a register of pharmacists and pharmacy technicians and, for the purposes of section 74A of the Medicines Act 1968 (registration of premises: Great Britain) and section 74J of that Act (temporary registration with regard to emergencies involving loss of human life or human illness etc.)(33), premises.

(2) The Register is to be divided into five parts as follows—

(a) Part 1, relating to pharmacists other than visiting practitioners;

(b) Part 2, relating to pharmacy technicians other than visiting practitioners;

(c) Part 3, relating to premises;

(d) Part 4, relating to pharmacists who are visiting practitioners; and

(e) Part 5, relating to pharmacy technicians who are visiting practitioners.

(3) The Council may make such provision in rules in connection with the Register as it considers appropriate and may, in particular, make provision with regard to—

(a) the form and keeping of the Register and the making of entries in, and alterations and corrections to, the Register;

(b) the recording of the date of a registrant’s entry in the Register, or of that of a registered pharmacy, and of the period for which the entry is valid;

(c) the recording of home addresses of registrants;

(d) in any case where a retail pharmacy business carried on at a registered pharmacy is owned by a partnership or a body corporate, the recording of the address of the principal office of the partnership or the address of the registered or principal office of the body corporate;

(e) the recording of qualifications and specialisations of a registrant;

(f) the recording of any specialisations of a retail pharmacy business carried on at a registered pharmacy;

(g) the recording of continuing professional development matters;

(h) the recording of fitness to practise matters, including any warnings or advice given by, or undertakings agreed with, the Investigating Committee or the Fitness to Practise Committee;

(i) the recording of any improvement notices to which a person carrying on a retail pharmacy business at a registered pharmacy is subject;

(j) the recording of any conditions subject to which the entry of a registered pharmacy in the Register has effect; and

(k) the recording of the matters listed in sub-paragraphs (a) to (j), or of any other matters, in the Register in the Welsh language where appropriate.

(4) Rules under paragraph (3) may provide—

(a) for the marking of the Register so as to distinguish those registrants who are entered in Part 1 or 2 of the Register under article 34 from other registrants; and

(b) for the marking of the Register so as to distinguish those registered pharmacies which are entered in Part 3 of the Register under section 74J of the Medicines Act 1968 (temporary registration with regard to emergencies involving loss of human life or human illness etc.) from other registered pharmacies.

(5) The Registrar must, in such manner as the Registrar sees fit, compile lists comprising information in or derived from entries in the Register, but those lists must not include information in or derived from entries in respect of persons or premises whose entry in the Register is suspended.

(6) The Council must determine the information that the lists are to contain, which may include—

(a) a note specifying in which part of the Register a registrant is entered;

(b) the number of the entry of a registrant or of a registered pharmacy;

(c) the area (by reference to a city, town, district or country) in which a registrant lives or in which a registered pharmacy is located and contact details, but a registrant’s home address must not be published without that registrant’s consent;

(d) a note regarding any fitness to practise matters, including—

(i) any conditions to which a registrant’s entry in the Register is subject,

(ii) any warnings or advice given by, or undertakings agreed with, the Investigating Committee or the Fitness to Practise Committee regarding a registrant’s future conduct;

(e) a note in respect of any improvement notices to which a person carrying on a retail pharmacy business at a registered pharmacy is subject;

(f) a note in respect of any conditions subject to which the entry of a registered pharmacy in the Register has effect;

(g) a note in respect of a registrant’s specialisations which are the subject of any annotations;

(h) a note in respect of the specialisations of a retail pharmacy business carried on at a registered pharmacy which are the subject of any annotations;

(i) a note to distinguish those registrants who are entered in Part 1 or 2 of the Register under article 34 from other registrants;

(j) a note to distinguish annotations made in respect of registrants under article 35 from other annotations made in respect of registrants who are qualified to order drugs, medicines and appliances in a specified capacity;

(k) a note to distinguish those registered pharmacies entered in Part 3 of the Register under section 74J(34) of the Medicines Act 1968 (temporary registration with regard to emergencies involving loss of human life or human illness etc.) from other registered pharmacies; and

(l) a note to distinguish annotations made under section 74K of the Medicines Act 1968(35) (temporary annotations with regard to emergencies involving loss of human life or human illness etc.) from other annotations of entries made in respect of registered pharmacies which are designated as registered pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

(7) The Council must publish the lists compiled by the Registrar under paragraph (5) and may do so in such manner as it considers appropriate.

(8) If a registrant’s entry in any part of the Register is suspended, the registrant must be treated as not being entered in that part of the Register, even though that part of the Register still contains the registrant’s name, except—

(a) for the purposes of articles 28 to 31 and 43 and Part 6 (and rules under or that relate to those provisions); and

(b) for such other purposes of this Order as the Council may prescribe.

(9) Accordingly, a person whose entry in any part of the Register is suspended is not to be treated for the purposes of any enactment other than this Order as being entered in that part.

Commencement Information

I38 Art. 19 in force at 10.2.2010 for specified purposes, see art. 1(3)

I39 Art. 19 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Entitlement to entry in Part 1 or 2 of the Register: pharmacists and pharmacy technicians E+W+S

20.—(1) Subject to the provisions of, and rules under, this Order, a person (“P”) is entitled to be entered in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician if—

(a) the Registrar is satisfied that—

(i) P is appropriately qualified within the meaning given in article 21 or, as the case may be, article 22,

(ii) P’s fitness to practise is not impaired, and

(iii) where necessary, P meets such additional requirements (if any) relating to education, training or experience as the Registrar considers are appropriate to P’s case; and

(b) P has paid any fee prescribed under article 36(1)(a).

(2) Subject to the provisions of, and rules under, this Order, a person (“P”) is entitled to have P’s entry in Part 1 or, as the case may be, Part 2 of the Register renewed if—

(a) the Registrar is satisfied that—

(i) P’s fitness to practise is not impaired, and

(ii) P meets the standard of proficiency for the safe and effective practice of pharmacy set under article 43(1) together with such additional requirements (if any) relating to continuing professional development as the Registrar considers are appropriate to P’s case; and

(b) P has paid any fee prescribed under article 36(1)(a).

(3) A person is not entitled to be entered in Part 1 or 2 of the Register, or to have an entry in either of those parts renewed, if that person does not intend to practise as a pharmacist or, as the case may be, a pharmacy technician in Great Britain, the Channel Islands or the Isle of Man.

(4) The Registrar must treat a person who—

(a) is an exempt person who has qualified as a pharmacist in a relevant European State other than the United Kingdom;

(b) applies to be entered in Part 1 of the Register as a pharmacist; and

(c) is entered in the register of pharmaceutical chemists for Northern Ireland,

as meeting the requirements of paragraph (1)(a)(i).

Commencement Information

I40 Art. 20 in force at 10.2.2010 for specified purposes, see art. 1(3)

I41 Art. 20 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacists E+W+S

21.—(1) For the purposes of article 20(1)(a)(i), a person (“P”) is “appropriately qualified” as a pharmacist if—

(a) P has a qualification awarded in Great Britain which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register (and so is also a recognised pharmacy qualification within other relevant European States);

(b) P is an exempt person and has a qualification which the Privy Council has by order designated as being an approved qualification for the purpose of entry in Part 1 of the Register;

(c) P is an exempt person—

(i) whose case falls within regulation 3(9)(a) or (e) of the General Systems Regulations,

(ii) to whom regulations 20 to 26 of those Regulations apply by reason of the operation of regulation 3(4) of those Regulations, and

(iii) who is permitted to pursue the profession of pharmacist in Great Britain by virtue of Part 3 of those Regulations; or

(d) subject to paragraph (2), P has, elsewhere than in Great Britain, undergone training as a pharmacist, and—

(i) holds a qualification which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register, or

(ii) holds a qualification which—

(aa) in the case where P is an exempt person who does not have a qualification referred to in sub-paragraph (b) and to whom sub-paragraph (c) does not apply, taken together with P’s additional education, training or experience acquired elsewhere than in Great Britain (but at least in part within the European mutual recognition area) indicates that P has met the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register, or

(bb) whether or not P is an exempt person, taken together with the additional education, training or experience that the Registrar requires P to undertake pursuant to article 20(1)(a)(iii), indicates that P has met the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 1 of the Register.

(2) For the purposes of article 20(1)(a)(i), an exempt person who holds a qualification in pharmacy which—

(a) was granted otherwise than in a relevant European State; and

(b) has not previously been accepted by a relevant European State as qualifying that person to practise as a pharmacist in that State,

is “appropriately qualified” only if the qualification is evidence of training in pharmacy that meets, or under article 22(a) of the Directive (part-time training) is to be treated as meeting, the requirements of article 44 of the Directive (training as a pharmacist).

(3) An order under paragraph (1)(b) may provide that a qualification is only to be considered an approved qualification in such circumstances, or subject to such conditions, as are specified in the order.

(4) For the purposes of an application for entry in Part 1 of the Register, the Registrar must not require any exempt person to whom paragraph (1)(b), (c) or (d)(ii)(aa) applies to meet any requirements as to additional education, training or experience unless—

(a) the application is for restoration to the Register; and

(b) in so doing, the Registrar is acting in a manner that is consistent with the requirements of the EU Treaties and the Directive.

(5) In formulating its opinion under paragraph (1)(d)(ii) in relation to P, where P is an exempt person, the Council must—

(a) if P holds a qualification granted outside of the European mutual recognition area which has been accepted by another relevant European State as qualifying P to practise as a pharmacist in that State, take into account the acceptance of that qualification; and

(b) take into account all of P’s relevant qualifications, knowledge and experience, wherever acquired.

(6) For the purposes of article 20(1)(a)(iii), where P—

(a) is a person to whom paragraph (1)(a) or (d)(i) or (ii)(bb) applies; and

(b) is not an exempt person,

the Registrar may require P to meet requirements as to additional education which comprise or include reaching an adequate standard of proficiency in the knowledge and use of English.

Commencement Information

I42 Art. 21 in force at 10.2.2010 for specified purposes, see art. 1(3)

I43 Art. 21 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacy technicians E+W+S

22.—(1) For the purposes of article 20(1)(a)(i), a person (“T”) is “appropriately qualified” as a pharmacy technician if—

(a) T has a qualification awarded in Great Britain which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register;

(b) T is an exempt person and is permitted to pursue the profession of pharmacy technician in Great Britain by virtue of Part 3 of the General Systems Regulations; or

(c) T has, elsewhere than in Great Britain, undergone training as a pharmacy technician, and—

(i) holds a qualification which has been approved by the Council as attesting to a standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register, or

(ii) holds a qualification which—

(aa) in the case where T is an exempt person to whom sub-paragraph (b) does not apply, taken together with T’s additional education, training or experience acquired elsewhere than in Great Britain (but at least in part within the European mutual recognition area) indicates that T has met the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register,

(bb) whether or not T is an exempt person, taken together with the additional education, training or experience that the Registrar requires T to undertake pursuant to article 20(1)(a)(iii), indicates that T has met the standard of proficiency for the safe and effective practice of pharmacy that, in the Council’s opinion, it is necessary for a person to achieve in order to be entered in Part 2 of the Register.

(2) For the purposes of an application for entry in the Register as a pharmacy technician, the Registrar must not require any exempt person to whom paragraph (1)(b) or (c)(ii)(aa) applies to meet any requirements as to additional education, training or experience unless—

(a) the application is for restoration to Part 2 of the Register; and

(b) in so doing the Registrar is acting in a manner that is consistent with the requirements of the EU Treaties and the Directive.

(3) In formulating its opinion under paragraph (1)(c)(ii) in relation to T, where T is an exempt person, the Council must—

(a) if T holds a qualification granted outside the European mutual recognition area which has been accepted by another relevant European State as qualifying T to practise as a pharmacy technician in that State, take into account the acceptance of that qualification; and

(b) take into account all T’s relevant qualifications, knowledge and experience, wherever acquired.

(4) For the purposes of article 20(1)(a)(iii), where T—

(a) is a person to whom paragraph (1)(a) or (c)(i) or (ii)(bb) applies; and

(b) is not an exempt person,

the Registrar may require T to meet requirements as to additional education which comprise or include reaching an adequate standard of proficiency in the knowledge and use of English.

Commencement Information

I44 Art. 22 in force at 10.2.2010 for specified purposes, see art. 1(3)

I45 Art. 22 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Form, manner and content of applications for entry or for renewal of an entry in the Register: pharmacists and pharmacy technicians E+W+S

23.—(1) The Council may make such provision in rules as it considers appropriate in connection with applications for entry, or for the renewal of an entry, in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician and may, in particular, make provision with regard to—

(a) the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms and presenting certificates that are in such form as the Council may determine from time to time);

(b) the time prior to an entry ceasing to be valid by which an application for the renewal of the entry must have been received by the Registrar;

(c) the information to be provided by or in respect of the applicant, including—

(i) the name under which the applicant practises or intends to practise,

(ii) the applicant’s home address,

(iii) where the applicant is a national of the United Kingdom who is not an exempt person, proof of nationality;

(iv) where the applicant is an exempt person—

(aa) proof of nationality of a relevant European State, or

(bb) if the applicant is not a national of a relevant European State, proof of the [F1 EU] right by virtue of which the applicant is an exempt person, and

(v) the information to be provided for the purposes of determining whether the applicant’s fitness to practise is impaired; and

(d) consultation about the application with the Fitness to Practise Committee or the Investigating Committee.

(2) The Registrar may, in relation to an applicant—

(a) refuse to enter the applicant in the Register; or

(b) refuse to renew the entry of the applicant in the Register,

if the applicant fails to comply with, or if in respect of the applicant there is a failure to comply with, rules made under paragraph (1).

(3) If a registrant fails to comply with rules made under paragraph (1) in respect of an application for the renewal of an entry relating to the registrant in the Register, the failure may also be treated as misconduct for the purposes of article 51(1)(a) and the Registrar must consider, in accordance with article 52(1), whether or not to refer the matter to the Investigating Committee or (where rules under article 52(1) so provide) to the Fitness to Practise Committee.

(4) Paragraphs (5) to (8) apply to an exempt person (“E”)—

(a) to whom article 21(1)(b) or (c) or article 22(1)(b) applies; and

(b) who is making an application for entry in Part 1 or Part 2 of the Register.

(5) For the purpose of determining whether E’s fitness to practise is impaired, the Registrar must accept as sufficient evidence of E’s health a certificate which—

(a) confirms that there is no problem with E’s physical or mental health that would impair E’s fitness to practise as a pharmacist or, as the case may be, a pharmacy technician; and

(b) is required of a person who wishes to practise as a pharmacist or, as the case may be, a pharmacy technician in E’s attesting State.

(6) If no such certificate is required of such a person in E’s attesting State, the Registrar must, for the purpose of determining whether E’s fitness to practise is impaired, accept as sufficient evidence of E’s health a certificate which—

(a) confirms that there is no problem with E’s physical or mental health that would impair E’s fitness to practise as a pharmacist or, as the case may be, a pharmacy technician; and

(b) is issued by a competent authority in E’s attesting State.

(7) For the purpose of determining whether E’s fitness to practise is impaired, the Registrar must accept as sufficient evidence of E’s good character a certificate which—

(a) attests to E’s good character or good repute; and

(b) is issued by a competent authority in E’s attesting State.

(8) If no such certificate is issued by a competent authority in E’s attesting State, the Registrar must, for the purpose of determining whether E’s fitness to practise is impaired, accept as sufficient evidence of E’s good character a certificate (or certificates)—

(a) attesting to the authenticity of a declaration on oath made by E—

(i) before a competent judicial or administrative authority, notary, or qualified professional body in E’s attesting State, and

(ii) attesting to E’s good character; and

(b) issued by the authority, notary or body referred to in sub-paragraph (a)(i).

(9) In paragraphs (5) to (8) the “attesting State”, in relation to E, is—

(a) the relevant European State in which E’s qualification in pharmacy was obtained; and

(b) (if different), the relevant European State from which E comes to Great Britain.

(10) In paragraph (8)(a) “declaration on oath” includes a solemn declaration.

(11) The Registrar must not accept any certificate referred to in paragraph (5), (6), (7) or (8) if it is presented more than three months after the date on which it was issued.

Textual Amendments

F1 Words in Order substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 3-6

Commencement Information

I46 Art. 23 in force at 10.2.2010 for specified purposes, see art. 1(3)

I47 Art. 23 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Notification by the Registrar: entry and renewal E+W+S

24.—(1) Paragraphs (2) to (4) apply where a person (“A”) applies under article 23 for entry in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician.

(2) The Registrar must, within the period of one month beginning with the date of receipt of the application—

(a) acknowledge receipt of the application; and

(b) inform A of any missing document required for the purposes of the application.

(3) The Registrar must, within the specified period, notify A—

(a) of the result of the application; and

(b) if the Registrar refuses the application, of the reasons for the refusal, and of any right of appeal that A has to the Appeals Committee under article 40.

(4) Any failure by the Registrar to inform A of the result of the application as required by paragraph (3)(a) is to constitute a decision by the Registrar to refuse the application which is to be taken as having been made at the end of the specified period.

(5) In paragraphs (3) and (4) “the specified period” means—

(a) the period of three months beginning with the relevant date; or

(b) if A’s application is made on the grounds that A is appropriately qualified by virtue of article 21(1)(c) or 22(1)(b), the period of four months beginning with the relevant date.

(6) Paragraphs (7) to (9) apply where a person (“A”) applies under article 23 for the renewal of an entry in Part 1 of the Register as a pharmacist or in Part 2 of the Register as a pharmacy technician.

(7) The Registrar must, within the period of one month beginning with the date of receipt of the application—

(a) acknowledge receipt of the application; and

(b) inform A of any missing document required for the purposes of the application.

(8) The Registrar must, within the specified period, notify A—

(a) of the result of the application; and

(b) if the Registrar refuses the application, of the reasons for the refusal and of any right of appeal that A has to the Appeals Committee under article 40.

(9) Any failure by the Registrar to inform A of the result of the application as required by paragraph (8)(a) is to constitute a decision by the Registrar to refuse the application which is to be taken as having been made at the end of the specified period.

(10) In paragraphs (8) and (9) “the specified period” means the period of one month beginning with the relevant date.

(11) In this article, “the relevant date” means—

(a) the date on which the Registrar receives the application; or

(b) if any document required for the purposes of the application, or any fee which is payable in respect of that application by virtue of rules made under article 36(1)(a) (“the relevant fee”), is missing when the Registrar first receives the application, the date on which the Registrar first has all the documents required for those purposes together with the relevant fee.

Commencement Information

I48 Art. 24 in force at 10.2.2010 for specified purposes, see art. 1(3)

I49 Art. 24(1)-(5), (11) in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

I50 Art. 24(6)-(10) in force at 4.1.2011 in so far as not already in force by S.I. 2010/1621, art. 2(2)

Duration of entry E+W+S

25.—(1) The entry of a person entered in Part 1 or 2 of the Register pursuant to an application under article 23 is valid for the period of one year beginning with the date on which the entry was made.

(2) Each renewal of such an entry pursuant to a further application under that article extends the validity of the entry for the period of one year beginning with the relevant date.

(3) If the entry of a person in Part 1 or 2 of the Register ceases to be valid under this article then, except in such circumstances as may be prescribed, that person is to be treated for all purposes as no longer being entered in that part of the Register and accordingly the Registrar must remove the entry from the Register.

(4) Where the Registrar removes the entry of a person from the Register under paragraph (3), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it.

(5) In paragraph (2) the “relevant date”—

(a) on the first renewal of an entry, means the first anniversary of the date on which the entry was made;

(b) on a subsequent renewal of an entry, means the anniversary of the date on which the entry was made that occurs next after the making of the application for renewal.

Commencement Information

I51 Art. 25 in force at 10.2.2010 for specified purposes, see art. 1(3)

I52 Art. 25 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Notice of entry in the Register E+W+S

26.—(1) Subject to paragraph (3), the Registrar must, where requested to do so by a registrant (other than one entered in the Register under article 34), or where an application for entry in the Register as a pharmacist or a pharmacy technician, or for the renewal of such an entry, is granted, issue to the registrant free of charge written notice of that registrant’s entry in the Register.

(2) Notice of a registrant’s entry in the Register issued under this article must be in such form as the Council determines from time to time and must include—

(a) the number of the entry;

(b) the period in respect of which the entry is valid;

(c) the part of the Register in which the registrant is entered.

(3) The Registrar is not under a duty to issue further notice of a registrant’s entry in the Register to a person to whom such notice has already been issued (“R”), whether under this article, article 32 of the 2007 Order, or one of the Pharmacy Acts, unless R—

(a) satisfies the Registrar that the original notice, and any further notice already issued, has been lost or destroyed; or

(b) changes the name under which R practises,

and pays to the Council any fee in respect of the further notice prescribed under article 36(1)(f).

(4) The Council may make such provision in rules as it considers appropriate in connection with the return of notices of a registrant’s entry in the Register which—

(a) incorrectly state the part of the Register in which the registrant is entered; or

(b) incorrectly state the name under which the registrant practises.

Commencement Information

I53 Art. 26 in force at 10.2.2010 for specified purposes, see art. 1(3)

I54 Art. 26 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Specialisations: registrants and registered pharmacies E+W+S

27.—(1) The Council may make such provision in rules as it considers appropriate in connection with annotations to entries in the Register to denote specialisations, and may in particular make provision with regard to—

(a) the type of specialisations that are to be subject to annotations;

(b) the form and manner in which applications for entering, renewing or restoring annotations in respect of specialisations, or for the removal of such annotations, are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(c) the circumstances in which annotations in respect of specialisations are to be entered, renewed, restored or removed by the Registrar;

(d) the removal of annotations in respect of specialisations by the Registrar where a prescribed fee in respect of the renewal of the annotation has not been paid, after such warnings as may be prescribed;

(e) the standards of proficiency for the safe and effective practice of pharmacy that it is necessary for a registrant to achieve in order for an annotation in respect of a specialisation to be made to an entry in the Register of a registrant; and

(f) the standards provided for in rules made under article 7(1) that it is necessary to meet in connection with the carrying on of a retail pharmacy business at a registered pharmacy in order for an annotation in respect of a specialisation of the retail pharmacy business to be made to the entry in the Register of the registered pharmacy.

(2) Where the Registrar decides not to enter, renew or restore an annotation in respect of a specialisation of an entry in the Register of a registrant, or to remove such an annotation from the Register, the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(3) Where the Registrar decides not to enter, renew or restore an annotation in respect of a specialisation of an entry in the Register of a registered pharmacy, or to remove such an annotation from the Register, the Registrar must send to the person carrying on a retail pharmacy business at the registered pharmacy a statement in writing giving that person notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(4) The notice under paragraph (3) must be sent—

(a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the Register;

(b) where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

(c) where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

Commencement Information

I55 Art. 27 in force at 10.2.2010 for specified purposes, see art. 1(3)

I56 Art. 27 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Registrants’ duties with regard to their entries E+W+S

28.—(1) The Council may make such provision in rules as it considers appropriate in connection with the information to be provided by registrants with regard to their entries in Part 1 or 2 of the Register (provided the rules are consistent with paragraph (2)) and may, in particular, make provision with regard to the obligations of a registrant (“R”) to inform the Registrar—

(a) of the name under which R practises and of any changes to that name; and

(b) of R’s home address and of any changes to it.

(2) If the Registrar—

(a) sends by first class post to R a notice addressed to R at R’s last known home address enquiring whether R has—

(i) changed the name under which R practises,

(ii) ceased to practise as a pharmacist or, as the case may be, a pharmacy technician and intends to apply under article 31 for voluntary removal from the Register, or

(iii) changed home address,

and receives no reply within a period of one month beginning on the day of posting the notice; and

(b) upon the expiration of that period sends to R a second similar notice and receives no reply within one month beginning on the day of posting the notice,

the Registrar may remove R’s entry from Part 1 or, as the case may be, Part 2 of the Register.

(3) If a registrant entered in Part 1 or 2 of the Register fails to comply with rules made under paragraph (1), the Registrar may remove the entry of that registrant from that part of the Register.

(4) Where the Registrar removes the entry of a person from a part of the Register pursuant to paragraph (2) or (3), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Commencement Information

I57 Art. 28 in force at 10.2.2010 for specified purposes, see art. 1(3)

I58 Art. 28 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Corrections to the Register E+W+S

29.—(1) The Registrar must keep the Register correct and up to date, and, in so doing—

(a) must remove from the Register the entry of any registrant who has died; and

(b) from time to time, must make the necessary alterations—

(i) to any of the particulars in a registrant’s entry, and

(ii) to any of the particulars in the entry of a registered pharmacy.

(2) The Registrar General must, on registering the death of a person who the Registrar General believes to be a registrant, forthwith notify the Registrar of the death.

(3) If the Registrar determines—

(a) that a entry of a registrant in Part 1 or 2 of the Register (except in a case where the entry was made under article 34) or in Part 4 or 5 of the Register has been fraudulently procured or incorrectly made, or

(b) that the entry of a registered pharmacy in Part 3 of the Register has been fraudulently procured or incorrectly made,

the Registrar may remove the registrant or registered pharmacy from that part of the Register.

(4) The Council may make such provision in rules as it considers appropriate in connection with determinations by the Registrar under paragraph (3).

(5) Where the Registrar removes the entry of a person from a part of the Register pursuant to paragraph (3)(a), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(6) Where the Registrar removes the entry of a registered pharmacy from Part 3 of the Register pursuant to paragraph (3)(b), the Registrar must send to the person carrying on a retail pharmacy business at the registered pharmacy a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(7) The notice under paragraph (6) must be sent—

(a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the Register;

(b) where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

(c) where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

Commencement Information

I59 Art. 29 in force at 10.2.2010 for specified purposes, see art. 1(3)

I60 Art. 29 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Fitness to practise matters before entry or renewal of an entry E+W+S

30.—(1) The Registrar may remove the entry of a registrant from Part 1 or 2 of the Register if it is shown to the satisfaction of the Registrar that—

(a) the fitness to practise of the registrant was impaired as a result of prescribed circumstances or because of a problem with the registrant’s physical or mental health—

(i) at the time of the registrant’s entry in that part of the Register, or

(ii) at the time of an application to renew the registrant’s entry in that part of the Register; and

(b) the registrant had not informed the Registrar of those circumstances or that problem before the time mentioned in paragraph (a)(i) or (ii).

(2) For the purposes of paragraph (1), the Council may make such provision in rules as it considers appropriate in connection with the information to be provided to the Registrar by or in respect of a registrant for the purpose of determining whether the registrant’s fitness to practise was so impaired.

(3) If a registrant fails to comply, or if in respect of a registrant there is a failure to comply, with rules made under paragraph (2), the Registrar may remove the entry of that registrant from the part of the Register concerned.

(4) The Council may make such provision in rules as it considers appropriate in connection with the procedure to be followed by the Registrar before removing the entry of a registrant from Part 1 or 2 of the Register pursuant to paragraph (1) or (3).

(5) Where the Registrar removes the entry of a person from Part 1 or 2 of the Register pursuant to paragraph (1) or (3), the Registrar must send to that person at that person’s last known home address a statement in writing giving that person notice of the removal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Commencement Information

I61 Art. 30 in force at 10.2.2010 for specified purposes, see art. 1(3)

I62 Art. 30 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Voluntary removal from the Register E+W+S

31.—(1) The Council may make such provision in rules as it considers appropriate in connection with applications by registrants for voluntary removal of an entry from any part of the Register and may, in particular, make provision with regard to—

(a) the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b) the information to be provided by the applicant;

(c) fitness to practise matters;

(d) refusal of applications (in such circumstances as may be prescribed in the rules including where there are outstanding fitness to practise proceedings in respect of the applicant).

(2) Where the Registrar refuses an application for voluntary removal from any part of the Register, the Registrar must send to the applicant at the applicant’s last known home address a statement in writing giving the applicant notice of the refusal and of the reasons for it.

Commencement Information

I63 Art. 31 in force at 10.2.2010 for specified purposes, see art. 1(3)

I64 Art. 31 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Indemnity arrangements E+W+S

32.—(1) A registrant must have in force an adequate and appropriate indemnity arrangement that provides cover in relation to that registrant in respect of liabilities which may be incurred in practising as a pharmacist or, as the case may be, a pharmacy technician.

(2) For the purposes of this article, an “indemnity arrangement” may comprise—

(a) a policy of insurance;

(b) an arrangement made for the purposes of indemnifying a person; or

(c) a combination of the two.

(3) The Council may make rules about what is an adequate and appropriate indemnity arrangement for the purposes of this article.

(4) The Council may make such provision in rules as it considers appropriate in connection with the information to be provided to the Registrar—

(a) by or in respect of any person seeking to be entered in any part of the Register as a pharmacist or pharmacy technician (including on an application for restoration) for the purposes of determining whether, if that person is so entered, there will be in force an adequate and appropriate indemnity arrangement in relation to that person which commences, at the latest, on the date on which that person is entered in that part of the Register;

(b) by or in respect of a registrant for the purposes of determining whether, at any time, there is in force an adequate and appropriate indemnity arrangement in relation to that registrant.

(5) Rules under paragraph (4)(b) may require the information to be provided—

(a) at the request of the Registrar; or

(b) on such dates or at such intervals as the Registrar may determine, either generally or in relation to individual registrants or registrants of a particular description.

(6) The Council may also make rules requiring a registrant to inform the Registrar if there ceases to be in force an adequate and appropriate indemnity arrangement in relation to that registrant.

(7) Where there is a failure to comply with rules under paragraph (4) by or in respect of a person who is entered, or is seeking to be entered, in any part of the Register, the Registrar may refuse to enter the person in, or to restore the person’s entry to, that part of the Register.

(8) If a registrant is in breach of paragraph (1), or fails to comply with rules under paragraph (4)(b) or (6), or there is a failure to comply with rules under paragraph (4)(b) in respect of a registrant—

(a) the Registrar may remove that person’s entry from Part 1, 2, 4 or 5 of the Register (as the case may be); or

(b) the breach or failure may be treated as misconduct for the purposes of article 51(1)(a) and the Registrar must consider, in accordance with article 52(1), whether or not to refer the matter to the Investigating Committee or (where rules under article 52(1) so provide) to the Fitness to Practise Committee.

(9) Where the Registrar—

(a) refuses to enter a person in any part of the Register, or to restore a person’s entry to any part of the Register pursuant to paragraph (7); or

(b) removes a person’s entry from any part of the Register, pursuant to paragraph (8)(a),

the Registrar must send to the person at the person’s last known home address a statement in writing giving the person notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Commencement Information

I65 Art. 32 in force at 10.2.2010 for specified purposes, see art. 1(3)

I66 Art. 32 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Visiting pharmacists and pharmacy technicians from relevant European States E+W+S

33.  Schedule 2 has effect in respect of visiting pharmacists and visiting pharmacy technicians from relevant European States.

Commencement Information

I67 Art. 33 in force at 10.2.2010 for specified purposes, see art. 1(3)

I68 Art. 33 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Temporary entry with regard to emergencies involving loss of human life or human illness etc. E+W+S

34.—(1) If the Secretary of State advises the Registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this article, the Registrar may enter in Part 1 or 2 of the Register—

(a) a person as a pharmacist or a pharmacy technician if the Registrar considers that the person is a fit, proper and suitably experienced person to be so entered in the Register with regard to the emergency; or

(b) the persons comprising a specified group of persons as pharmacists or, as the case may be, pharmacy technicians if the Registrar considers that the group is comprised of persons who may reasonably be considered fit, proper and suitably experienced persons to be so entered in the Register with regard to the emergency.

(2) The Registrar may enter in Part 1 or Part 2 of the Register by virtue of paragraph (1)(b) all of the persons comprising a specified group of persons without first identifying each person in the group.

(3) The entry of a person in Part 1 or 2 of the Register under this article is subject to such conditions as the Registrar may specify, and the Registrar may at any time vary the conditions to which a person’s entry under this article is subject (including by adding to the conditions or removing any conditions).

(4) The entry of any person in Part 1 or 2 of the Register by virtue of paragraph (1)(b) as one of a specified group may be subject to the same conditions as the entries of other members of the group or it may be subject to different conditions.

(5) The entry of a person in Part 1 or 2 of the Register under this article ceases to have effect if revoked by the Registrar, which—

(a) the Registrar must do if the Secretary of State advises the Registrar that the circumstances that led the Secretary of State to advise the Registrar as mentioned in paragraph (1) no longer exist;

(b) the Registrar may do for any other reason at any time including where the Registrar has grounds for suspecting that the person’s fitness to practise may be impaired.

(6) The entry of a person in Part 1 or 2 of the Register by virtue of paragraph (1)(b) as one of a specified group may be revoked without revoking the entries of the other members of the group, or it may be revoked by virtue of a decision to revoke the entries of all the members of the group.

(7) Articles 20 to 25, 27 and 30, Part 5 and Part 6 (except articles 48 to 50) do not apply to persons entered in Part 1 or 2 of the Register under this article.

(8) If a person breaches any condition to which the person’s entry in Part 1 or 2 of the Register under this article is subject, anything done by that person in breach of the condition is to be treated as not being done by a registered pharmacist or, as the case may be, by a registered pharmacy technician.

(9) The Registrar may make available information to assist with the identification of persons entered in Part 1 or 2 of the Register under this article in such manner as the Registrar sees fit.

Commencement Information

I69 Art. 34 in force at 10.2.2010 for specified purposes, see art. 1(3)

I70 Art. 34 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Temporary annotations with regard to emergencies involving loss of human life or human illness etc. E+W+S

35.—(1) If the Secretary of State advises the Registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this article, the Registrar may annotate—

(a) the entry of a registrant in Part 1 or 2 of the Register to indicate that the registrant is qualified to order drugs, medicines and appliances in a specified capacity, notwithstanding that the registrant is not so qualified, if the Registrar considers that the registrant is a fit, proper and suitably experienced person to order drugs, medicines and appliances in that capacity with regard to the emergency; or

(b) the entries of a specified group of registrants in Part 1 or 2 of the Register to indicate that they are qualified to order drugs, medicines and appliances in a specified capacity, notwithstanding that they are not so qualified, if the Registrar considers that the group is comprised of registrants who are of a type who may reasonably be considered fit, proper and suitably experienced persons to order drugs, medicines and appliances in that capacity with regard to the emergency.

(2) The Registrar may make the annotation in such a way as to distinguish registrants whose entries are annotated by virtue of paragraph (1) from registrants in respect of whose entries the annotation is made otherwise than by virtue of paragraph (1).

(3) Annotations made by virtue of paragraph (1)—

(a) must be removed by the Registrar if the Secretary of State advises the Registrar that the circumstances that led the Secretary of State to advise the Registrar as mentioned in paragraph (1) no longer exist;

(b) may be removed by the Registrar at any time, including where the Registrar has grounds for suspecting that the person’s fitness to order drugs, medicines and appliances may be impaired.

(4) A registrant whose entry in Part 1 or 2 of the Register is annotated by virtue of paragraph (1)(b) as one of a specified group may have that annotation removed without the Registrar removing the equivalent annotations of the other members of the group or by virtue of a decision to remove the annotations made by virtue of paragraph (1)(b) of all the members of the group.

Commencement Information

I71 Art. 35 in force at 10.2.2010 for specified purposes, see art. 1(3)

I72 Art. 35 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Fees in connection with entry E+W+S

36.—(1) Subject to paragraph (3), the Council may make rules with respect to the charging of fees in connection with the entry in the Register of a person or of premises at which a retail pharmacy business is, or is to be, carried on, and in particular with respect to—

(a) applications for entry to, or for the renewal of an entry in, the Register of a person or premises under article 23 or, as the case may be, under section 74A of the Medicines Act 1968(36) (registration of premises: Great Britain);

(b) applications for the restoration of an entry to the Register pursuant to—

(i) article 37 (including provision for additional fees to be charged in connection with the application),

(ii) article 57,

(iii) under section 74C(1) of the Medicines Act 1968(37) (supplementary provision in respect of registration of premises: Great Britain), and

(iv) section 74I(1) of the Medicines Act 1968(38) (supplementary provision in respect of change of ownership of retail pharmacy business: Great Britain);

(c) amendments to the Register (including any amendments required to reflect the transfer of ownership of the retail pharmacy business carried on at a registered pharmacy or the voluntary removal of a registered pharmacy from the Register);

(d) applications for entering annotations in, or restoring annotations to, the Register;

(e) applications for the renewal of annotations in the Register; and

(f) issuing further notices of a registrant’s entry in the Register pursuant to article 26(3).

(2) The Council must publish any such rules in such manner as it sees fit.

(3) Rules under paragraph (1) must not provide for fees to be charged in respect of the entry or the renewal of an entry of a person in Part 4 or 5 of the Register.

(4) Rules under paragraph (1) may provide for a fee not to be charged, or to be waived in whole or in part, in prescribed cases or circumstances (which may include cases or circumstances defined by reference to the discretion of the Registrar).

(5) Rules under paragraph (1) may also, in relation to the entry of registered pharmacies in the Register, provide for—

(a) fees to be charged by reference to different periods; and

(b) fees to be charged by reference to the location of a registered pharmacy.

(6) Before making rules under paragraph (1), the Council must consult such persons as it considers appropriate including, where it considers appropriate, persons appearing to it to represent—

(a) registrants;

(b) professional bodies or organisations recognised by the Council as representing registrants;

(c) persons carrying on a retail pharmacy business at a registered pharmacy; or

(d) persons or bodies commissioning or funding the services provided by registrants or at registered pharmacies.

Commencement Information

I73 Art. 36 in force at 10.2.2010 for specified purposes, see art. 1(3)

I74 Art. 36 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Restoration to the Register of persons or premises removed from the Register E+W+S

37.—(1) Where the entry of a person in the Register has been removed from the Register—

(a) under article 25(3) pursuant to a decision by the Registrar under article 23(2)(b) to refuse to renew that entry;

(b) pursuant to article 28(2) or (3);

(c) pursuant to article 29(3);

(d) pursuant to article 30(1) or (3);

(e) pursuant to rules made under article 31;

(f) pursuant to article 32(8)(a); or

(g) by reason of a failure by that person to comply with the requirements or conditions of the framework adopted by the Council under article 43(4)(a) or by reason of a false declaration made by that person about compliance with those requirements or conditions,

the Registrar may, upon an application being made to the Registrar by that person, restore that person to the Register in such circumstances as may be prescribed.

(2) Where the entry of a registered pharmacy has been removed from the Register—

(a) under article 14(4)(a) because the person who was carrying on a retail pharmacy business at the registered pharmacy failed to comply with the provisions of an improvement notice; or

(b) under rules made under section 74G of the Medicines Act 1968(39) (voluntary removal from the register: Great Britain),

the Registrar may, upon an application being made to the Registrar by the person who, immediately prior to the removal, was carrying on the retail pharmacy business at the registered pharmacy, restore that pharmacy to the Register in such circumstances as may be prescribed.

(3) The Council may make such provision in rules as it considers appropriate in connection with applications for restoration pursuant to paragraphs (1) and (2) and may, in particular, make provision with regard to—

(a) the form and manner in which applications are to be made (including rules to the effect that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b) the information to be provided by the applicant; and

(c) in the case of applications for restoration made in respect of individuals—

(i) fitness to practise matters;

(ii) whether any, and if so what, additional education, training or experience is required before restoration, and the rules may make provision for these issues to be determined in individual cases by the Registrar,

(iii) whether, and if so what, continuing professional development is required after restoration, and the rules may make provision—

(aa) for these issues to be determined in individual cases by the Registrar, and

(bb) enabling the Registrar to determine that the application for restoration is to be granted subject to the applicant agreeing to comply with such undertakings with regard to continuing professional development as the Registrar considers appropriate; and

(d) refusal of applications (including where the applicant has not paid the fee prescribed under article 36(1)(b)).

(4) Where a person who has agreed to comply with an undertaking pursuant to rules made under paragraph (3)(c)(iii)(bb) breaches that undertaking, that breach may be treated as misconduct for the purposes of article 51(1)(a) and the Registrar must consider, in accordance with article 52(1), whether or not to refer the matter to the Investigating Committee or (where rules under article 52(1) so provide) the Fitness to Practise Committee.

(5) Where the Registrar refuses an application for restoration to Part 1, 2, 4 or 5 of the Register, the Registrar must send to the applicant at the applicant’s last known home address a statement in writing giving the applicant notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(6) Where the Registrar refuses an application for restoration to Part 3 of the Register, the Registrar must send to the person who, immediately prior to the removal of the entry of the registered pharmacy, was carrying on a retail pharmacy business at the registered pharmacy a statement in writing giving that person notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(7) The notice under paragraph (6) must be sent—

(a) where the person who was carrying on the business is an individual, to that individual at that individual’s home address in the Register;

(b) where the person who was carrying on the business is a partnership, to that partnership at its principal office; or

(c) where the person who was carrying on the business is a body corporate, to that body corporate at its registered or principal office.

Commencement Information

I75 Art. 37 in force at 10.2.2010 for specified purposes, see art. 1(3)

I76 Art. 37 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Offences relating to the Register E+W+S

38.—(1) A person who makes a false representation as to being—

(a) entered in the Register as a pharmacist;

(b) entered in the Register as a pharmacy technician; or

(c) entered in any part of the Register with a particular annotation,

commits an offence.

(2) A person who—

(a) uses the title “pharmacist” or “fferyllydd” (its equivalent in the Welsh language) without being entered as a pharmacist in Part 1 or 4 of the Register;

(b) uses the title “pharmacy technician” or “technegydd fferylliaeth” (its equivalent in the Welsh language) without being entered as a pharmacy technician in Part 2 or 5 of the Register; or

(c) uses a title in respect of a particular annotation, which is a prescribed specialist title, where that person does not have an entry in any part of the Register with that particular annotation,

commits an offence.

(3) For the purposes of paragraph (2)(c), “prescribed specialist title” means—

(a) in the case of a pharmacist, a title for a pharmacist which the Council prescribes by rules as being a title that is only to be used by a registrant with a particular annotation; and

(b) in the case of a pharmacy technician, a title for a pharmacy technician which the Council prescribes by rules as being a title that is only to be used by a registrant with a particular annotation.

(4) A person who practises—

(a) as a pharmacist while not being entered as such in Part 1 or 4 of the Register; or

(b) as a pharmacy technician while not being entered as such in Part 2 or 5 of the Register,

commits an offence.

(5) A person who exhibits any notice or certificate which—

(a) purports to be a notice of entry issued under article 26 in respect of a pharmacist but which is not a notice of entry issued under that article in respect of a pharmacist;

(b) purports to be a certificate of registration issued under one of the Pharmacy Acts in respect of a pharmaceutical chemist but which is not a certificate of registration issued under one of those Acts in respect of a pharmaceutical chemist; or

(c) purports to be a certificate of registration issued under the 2007 Order in respect of a pharmacist but which is not a certificate of registration issued under that Order in respect of a pharmacist,

commits an offence.

(6) A person who exhibits any notice or certificate which—

(a) purports to be a notice of entry issued under article 26 in respect of a pharmacy technician but which is not a notice of entry issued under that article in respect of a pharmacy technician;

(b) purports to be a certificate of registration issued under the 2007 Order in respect of a pharmacy technician but which is not a certificate of registration issued under that Order in respect of a pharmacy technician,

commits an offence.

(7) A person who, for fraudulent purposes—

(a) uses or lends to, or allows to be used by, another person—

(i) a notice of entry or certificate of registration in respect of a pharmacist or a pharmaceutical chemist (whether issued under article 26 or one of the Pharmacy Acts or the 2007 Order), or

(ii) a notice of entry or certificate of registration in respect of a pharmacy technician issued under article 26 or the 2007 Order; or

(b) makes or possesses any document closely resembling such a notice or certificate,

commits an offence.

(8) Any person who commits an offence under paragraph (1), (2) or (4) is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(9) Any person who commits an offence under paragraph (5), (6) or (7) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

(10) Proceedings for an offence under this article may be begun—

(a) in England and Wales, at any time within the period of 6 months beginning with the date on which evidence sufficient in the opinion of the Council to justify a prosecution came to the Council’s knowledge;

(b) in Scotland, at any time within the period of 6 months beginning with the date on which evidence sufficient in the opinion of the prosecutor to justify a prosecution came to the prosecutor’s knowledge,

but no proceedings may be begun after the expiry of the period of two years beginning with the date of the commission of the offence.

Commencement Information

I77 Art. 38 in force at 10.2.2010 for specified purposes, see art. 1(3)

I78 Art. 38 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Appealable decisions E+W+S

39.—(1) Subject to paragraph (2), the following decisions are appealable decisions for the purposes of article 40—

(a) a decision under Part 3 of the General Systems Regulations to require an exempt person to whom article 21(1)(c) or 22(1)(b) applies to complete an adaptation period, or pass an aptitude test, before deciding whether that person is “appropriately qualified” for the purposes of article 20(1)(a)(i);

(b) a decision by the Registrar to refuse to enter a person in Part 1 or 2 of the Register as a pharmacist or a pharmacy technician (excluding restoration cases);

(c) a decision by the Registrar to refuse to enter a person in Part 4 or 5 of the Register (excluding restoration cases);

(d) a decision by the Registrar under article 23(2)(b) to refuse to renew an entry of a registrant in Part 1 or 2 of the Register;

(e) a decision by the Registrar under paragraph 5 or 14 of Schedule 2 to refuse to renew the entry of a visiting practitioner in Part 4 or 5 of the Register;

(f) a decision by the Registrar to refuse to enter, renew or restore an annotation in any part of the Register in respect of a specialisation pursuant to rules under article 27(1);

(g) a decision by the Registrar to remove an annotation in respect of a specialisation from any part of the Register pursuant to rules under article 27(1);

(h) a decision by the Registrar to remove the entry of a registrant from Part 1 or 2 of the Register pursuant to article 28(2) or (3);

(i) a decision by the Registrar to remove the entry of a registrant from Part 1, 2, 4 or 5 of the Register or a registered pharmacy from Part 3 of the Register pursuant to article 29(3)(a) or (b);

(j) a decision by the Registrar to remove the entry of a registrant from Part 1 or 2 of the Register pursuant to article 30(1) or (3);

(k) a decision by the Registrar to remove an entry of a registrant from Part 1 or 2 of the Register under article 32(8)(a);

(l) a decision by the Registrar to refuse an application for restoration of a person’s entry in Part 1, 2, 4 or 5 of the Register but only if the decision is for a reason that does not relate to a person’s fitness to practise;

(m) a decision by the Registrar in accordance with rules made by the Council under article 43(7) to suspend the entry of a registrant in the Register or to remove such an entry from the Register on the ground that the registrant has failed to comply with the requirements or conditions of the framework adopted by the Council under article 43(4)(a) or has made a false declaration about compliance with those requirements or conditions;

(n) a decision by the Council under article 47(6)(a) or (b) to refuse to approve, or to withdraw approval from, any education, training, qualification, test or institution or other provider or to impose probationary or remedial measures on an institution or other provider;

(o) a decision by the Registrar to refuse to enter a person in Part 2 of the Register under paragraph 6(2) of Schedule 5 on the ground that the person does not have the requisite knowledge, skill and experience for practising as a pharmacy technician in Great Britain;

(p) a decision by the Registrar under section 74A of the Medicines Act 1968(40) (registration of premises: Great Britain) to refuse to enter premises in Part 3 of the Register or to refuse to renew the entry of premises in Part 3 of the Register;

(q) a decision by the Registrar under section 74H of the Medicines Act 1968(41) (change of ownership of retail pharmacy business: Great Britain) not to restore an entry of premises to Part 3 of the Register;

(r) a decision by the Registrar under paragraph (4) of article 14 to suspend or remove an entry of premises in Part 3 of the Register; and

(s) a decision which, by virtue of rules under this Order, may be appealed to the Appeals Committee.

(2) A decision is not an appealable decision if it was taken—

(a) because of a failure to pay any fee prescribed under article 36(1); or

(b) because the applicant is not appropriately qualified, in circumstances where the applicant contends that the applicant’s qualifications should be approved by the Council pursuant to article 21(1)(d)(i) or 22(1)(c)(i).

Commencement Information

I79 Art. 39 in force at 10.2.2010 for specified purposes, see art. 1(3)

I80 Art. 39 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Appeals to the Appeals Committee E+W+S

40.—(1) Except as provided for by paragraphs (2) and (3), a person in respect of whom an appealable decision has been made may appeal against it to the Appeals Committee by giving notice of appeal to the Registrar within 28 days beginning with the date on which the written statement of the reasons for the decision was sent.

(2) In the case of an appealable decision to which paragraph (4) or (9) of article 24 applies, the person in respect of whom that decision has been made may appeal against it to the Appeals Committee by giving notice of appeal to the Registrar within 28 days beginning with the date on which the application is, by virtue of that paragraph, taken to have been refused by the Registrar.

(3) In the case of an appealable decision to which paragraph (6)(a) or (b) of article 47 applies, the institution or other provider on which probational or remedial measures have been imposed or from or in relation to which approval has been withdrawn or refused may bring an appeal to the Appeals Committee by giving notice of appeal to the Council within 28 days beginning with the date on which the decision is made or within such longer period as the Council may, in the circumstances of any particular case, allow.

(4) Where, on an application by a person in respect of whom an appealable decision to which paragraph (1) relates has been made, the Registrar is satisfied that that person did not receive the written statement of the reasons for the decision within 14 days of the statement being sent, the Registrar may by authorisation in writing extend the time for giving notice of appeal under paragraph (1).

(5) Where an appealable decision to which paragraph (3) relates has been taken, the decision to impose probational or remedial measures on, or to refuse approval of or withdraw approval from, an institution or other provider does not take effect—

(a) until the period for bringing an appeal in respect of the decision has expired, but if the period for bringing an appeal has been extended under paragraph (4), that extended period is, for the purposes of this paragraph, to be treated as a period for bringing an appeal (notwithstanding that this may require reversal of the action taken); and

(b) where an appeal is brought within the period for bringing an appeal, until the date on which the appeal is finally disposed of, or is abandoned or fails by reason of its non-prosecution.

(6) Where an appealable decision has been taken to remove an entry or an annotation in respect of a person or a registered pharmacy from any part of the Register, or to refuse to renew such an entry or annotation in any part of the Register, the decision does not take effect—

(a) until the period for bringing an appeal in respect of the decision has expired, but if the period for bringing an appeal has been extended under paragraph (4), that extended period is, for the purposes of this paragraph, to be treated as the period for bringing an appeal (notwithstanding that this may require reversal of the action taken); and

(b) where an appeal is brought within the period for bringing an appeal, until the date on which the appeal is finally disposed of, or is abandoned or fails by reason of its non-prosecution.

(7) Having considered the appeal, the Appeals Committee may—

(a) dismiss the appeal;

(b) allow the appeal and quash the decision appealed against;

(c) substitute for the decision appealed against any other decision that the person taking the decision could have taken; or

(d) remit or refer the case to the Registrar for disposal of the matter in accordance with the Appeals Committee’s directions.

(8) The Appeals Committee must, as soon as reasonably practicable, send to the person bringing the appeal a statement in writing giving the person notice of the Committee’s decision and the reasons for it and of any right of appeal under article 41(1).

(9) Except as provided in paragraph (10), the statement referred to in paragraph (8) must be sent—

(a) where the appellant is an individual, to that individual at that individual’s home address in the Register;

(b) where the appellant is a partnership, to that partnership at its principal office; and

(c) where the appellant is a body corporate, to that body corporate at its registered or principal office.

(10) Where the appellant is an institution or other provider on which probational or remedial measures have been imposed or from or in relation to which approval has been withdrawn or refused, the statement referred to in paragraph (8) must be sent to that institution or other provider at the last known address of that institution or other provider.

(11) Subject to paragraph (12), the Appeals Committee must, as soon as reasonably practicable, publish, in such manner as it sees fit, its decision and the reasons for it.

(12) If the Appeals Committee has allowed the appeal, or has taken a decision or issued a direction that has the effect of allowing the appeal, it is not required to publish its decision and the reasons for it unless the person making the appeal so requests.

(13) For the purposes of paragraphs (5) and (6) an appeal is finally disposed of once all rights in relation to the appeal have been exhausted.

(14) In this article any reference to a person in respect of whom an appealable decision has been made is, in a case where the decision relates to a registered pharmacy, or to premises that have been or would have been a registered pharmacy, to be construed as a reference to the applicant for registration or, as the case may be, to the person who is or has been carrying on a retail pharmacy business at the premises.

Commencement Information

I81 Art. 40 in force at 10.2.2010 for specified purposes, see art. 1(3)

I82 Art. 40(1), (3)-(14) in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

I83 Art. 40(2) in force at 27.9.2010 for specified purposes by S.I. 2010/1621, art. 2(1), Sch.

I84 Art. 40(2) in force at 4.1.2011 in so far as not already in force by S.I. 2010/1621, art. 2(2)

Appeals from the Appeals Committee E+W+S

41.—(1) Except where the Appeals Committee has allowed an appeal, or has taken a decision or issued a direction that has the effect of allowing the appeal, a person in respect of whom a decision by the Appeals Committee has been taken may appeal against that decision to the relevant court.

(2) Notice of any appeal under this article must be filed at, or in Scotland lodged in, the relevant court and served on the Council, in accordance with rules of court, within 28 days beginning with the date on which the written notice of the reasons for the decision was sent, or within such longer period as the relevant court may, in accordance with the rules of court, allow.

(3) In this article, “the relevant court” means—

(a) in the case of an appeal relating to an individual domiciled in Scotland or to premises in Scotland, the sheriff in whose sheriffdom the individual is domiciled or the premises are located; and

(b) in any other case, the county court (the Central London County Court if the person making the appeal is not domiciled in Great Britain).

(4) Having considered an appeal under this article, the relevant court may—

(a) dismiss the appeal;

(b) allow the appeal and quash the decision appealed against;

(c) substitute for the decision appealed against any other decision that the Appeals Committee could have taken; or

(d) remit or refer the case to the Registrar for disposal of the matter in accordance with the relevant court’s directions,

and may make such order as to costs or, in Scotland, expenses as the relevant court thinks fit.

Commencement Information

I85 Art. 41 in force at 10.2.2010 for specified purposes, see art. 1(3)

I86 Art. 41 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 5 E+W+S Education, training and acquisition of experience and continuing professional development

Education, training and acquisition of experience E+W+S

42.—(1) In connection with its general function under article 4(3)(e), in so far as that function relates to the education, training and acquisition of experience of registrants and prospective registrants, the Council must—

(a) except in the case of persons who are appropriately qualified by virtue of article 21(1)(b) or (c) or article 22(1)(b), set the standards of proficiency for the safe and effective practice of pharmacy which it is necessary for a person to achieve in order to be entered in Part 1 or 2 of the Register as a pharmacist or, as the case may be, a pharmacy technician; and

(b) set—

(i) the standards of education, training and experience that providers of education and training must meet in order to enable a person undertaking such education or training, or acquiring such experience, to achieve the standards referred to in sub-paragraph (a) having regard, in particular, to the outcomes to be achieved, and

(ii) any requirements to be satisfied for admission to, and continued participation in, education and training for prospective pharmacists or prospective pharmacy technicians, which may include requirements as to fitness to practise unimpaired by health.

(2) The Council must publish the standards and requirements set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) The Council must—

(a) ensure that all providers in Great Britain concerned with the education and training of prospective pharmacists and prospective pharmacy technicians are notified of the standards and requirements set under paragraph (1)(b)(i) and (ii); and

(b) take appropriate steps to satisfy itself that those standards and requirements are met.

(4) The Council may—

(a) approve, or arrange with others to approve, courses of education or training which the Council is satisfied confer, or would confer, on persons completing them successfully the standards of proficiency referred to in paragraph (1)(a);

(b) approve, or arrange with others to approve, such other courses of education or training as the Council considers appropriate;

(c) approve, or arrange with others to approve, qualifications which are granted following success in an examination, or some other assessment, taken as part of an approved course;

(d) approve, or arrange with others to approve, such tests of competence, or tests of proficiency in the knowledge and use of English, as the Council may require; or

(e) approve, or arrange with others to approve—

(i) institutions,

(ii) other providers, including tutors,

of postgraduate education and training which leads to an approved qualification, if the Council considers that they are properly organised and equipped for conducting the whole or part of an approved course;

(f) approve, or arrange with others to approve, premises as being suitable for postgraduate education and training which leads to an approved qualification.

(5) In connection with paragraph (4), the Council may approve, or arrange with others to approve—

(a) a course of education or training run outside Great Britain which is intended to lead to an approved qualification;

(b) an institution or other provider of a course of education or training to which sub-paragraph (a) refers.

(6) The Council must publish a statement of—

(a) the criteria by reference to which the standards of education, training and experience referred to in paragraph (1)(b)(i) are set; and

(b) the criteria that will be taken into account in deciding whether to grant approval under paragraph (4),

as they exist from time to time.

(7) The Council must publish and maintain a list of the courses of education and training, qualifications and institutions or other providers (including tutors)—

(a) which are for the time being approved under this Order; or

(b) which have been approved under this Order but which are no longer so approved,

together with a record of the periods in respect of which approval was given.

(8) References in this Part to an approved course of education and training, an approved qualification, an approved test or an approved institution or other provider are references to such a course, qualification, test, institution or other provider approved under paragraph (4).

Commencement Information

I87 Art. 42 in force at 10.2.2010 for specified purposes, see art. 1(3)

I88 Art. 42 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Continuing professional development E+W+S

43.—(1) In connection with its general function under article 4(3)(e), in so far as that function relates to the continuing professional development of registrants, the Council must—

(a) set the standards of proficiency for the safe and effective practice of pharmacy which it is necessary for a registrant to maintain in order to have an entry in Part 1 or 2 of the Register renewed; and

(b) set the standards of continuing professional development which it is necessary for a registrant to maintain in order to continue to meet the standards of proficiency referred to in sub-paragraph (a).

(2) The Council must publish the standards set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) The Council must—

(a) consult such persons as it considers appropriate about the development of criteria by reference to which compliance with the standards set under paragraph (1)(b) is to be monitored; and

(b) publish those criteria as they exist from time to time in such manner as it considers appropriate.

(4) The Council must—

(a) adopt and maintain a framework relating to the requirements and conditions to be met by registrants in respect of their continuing professional development; and

(b) require registrants—

(i) to complete an annual declaration regarding their compliance with such requirements and conditions in respect of their continuing professional development as they are obliged to meet by that framework, and

(ii) to submit records about any continuing professional development undertaken by them to the Registrar for review.

(5) The framework adopted by the Council under paragraph (4)(a)—

(a) must include provision relating to—

(i) the amount and type of continuing professional development that a registrant is required to undertake,

(ii) the information to be provided by a registrant about the continuing professional development that the registrant has undertaken and the form and manner in which that information is to be provided,

(iii) the times at which information about the continuing professional development that a registrant has undertaken is to be provided (including any continuing professional development that relates to an annotation in respect of a particular specialisation that is to be recorded in the Register),

(iv) the keeping of records about the continuing professional development undertaken by registrants; and

(b) must require that any continuing professional development that is undertaken by a registrant in accordance with it is relevant to—

(i) the safe and effective practice of pharmacy, and

(ii) a learning need for the individual registrant that is relevant to the current scope of the practice of pharmacy including any specialisation of that individual registrant and the environment in which they practise;

(c) in so far as it relates to a person (“P”) who is a registrant only as a result of being entered in Part 4 or 5 of the Register—

(i) may not impose requirements on P if P is required to undertake, in P’s home State, continuing professional development in relation to the profession of pharmacist or, as the case may be, pharmacy technician; and

(ii) where they impose requirements on P—

(aa) must take account of the fact that P is fully qualified to pursue the profession in P’s home State, and

(bb) must specify that continuing professional development which P is required to undertake by the requirements may be undertaken outside Great Britain.

(6) The Council must publish the framework adopted by it under paragraph (4)(a), as it exists from time to time, in such manner as it considers appropriate.

(7) The Council must make such provision in rules as it considers appropriate with respect to registrants who fail to comply with any requirements of the framework adopted by the Council under paragraph (4)(a).

(8) Rules under paragraph (7) must—

(a) make provision about the circumstances in which the Registrar may remove the entry of a registrant from the Register, or impose such other remedial measures as may be prescribed in the rules, where the registrant—

(i) has failed to comply with the requirements or conditions of the framework adopted by the Council under paragraph (4)(a) relating to the continuing professional development of registrants; or

(ii) has made a false declaration about compliance with those requirements or conditions;

(b) where the framework adopted by the Council under paragraph (4)(a) makes provision in respect of a person (“P”) who is a registrant only as a result of being entered in Part 4 or 5 of the Register, secure that any sanction imposed in relation to P by reference to that provision is appropriate and proportionate in view of P’s continued lawful establishment in P’s home State as a pharmacist or, as the case may be, a pharmacy technician;

(c) make provision for the Registrar to send a statement in writing to the registrant concerned at the registrant’s last known home address giving that registrant notice of the removal and the reasons for it and of right of appeal to the Appeals Committee under article 40; and

(d) make provision for the suspension of a registrant’s entry in the Register pending the outcome of any appeal against a decision to remove the registrant from the Register.

(9) In this article “home State”, in relation to a registrant entered in Part 4 or 5 of the Register, means the relevant European State in which the registrant is lawfully established as a pharmacist or, as the case may be, a pharmacy technician.

Commencement Information

I89 Art. 43 in force at 10.2.2010 for specified purposes, see art. 1(3)

I90 Art. 43 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Specific obligations and powers of the Council in respect of education and training E+W+S

44.—(1) In the exercise of its function under article 4(3)(e), the Council must—

(a) determine—

(i) programmes or courses in respect of, or any combination of, education, training or experience required in order to obtain an annotation in respect of a specialisation,

(ii) the amount and type of education, training and experience required in order to obtain an annotation in respect of a specialisation,

(iii) the education, training and experience that is necessary to address fitness to practise matters;

(b) hold or cause to be held assessments in respect of—

(i) approved qualifications, or any education, training or experience leading to an approved qualification,

(ii) additional education, training or experience required for the purposes of article 20(1)(a)(iii), and

(iii) becoming and acting as tutors of, or in relation to, any education, training or experience leading to an approved qualification or any additional education, training or experience required for the purposes of article 20(1)(a)(iii),

and determine the arrangements under which those assessments are to be held (including arrangements for dealing with disciplinary matters with regard to candidates and prospective candidates);

(c) appoint or arrange for the appointment of persons (“examiners”) to carry out or oversee assessments of the type mentioned in paragraph (b), and pay them such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine; and

(d) establish, publish and maintain lists of premises that are to be used as training establishments.

(2) The duty imposed by paragraph (1)(c) does not prevent the Council from determining arrangements under which assessments of the type mentioned in paragraph (1)(b) are to be held which do not involve examiners.

Commencement Information

I91 Art. 44 in force at 10.2.2010 for specified purposes, see art. 1(3)

I92 Art. 44 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Visitors E+W+S

45.—(1) The Council may appoint persons (“visitors”) to visit any place at which, or any institution or other provider by which, or under whose direction—

(a) any relevant course of education or training is, or is proposed to be, given;

(b) any examination or other assessment is, or is proposed to be, held in connection with any such course; or

(c) any test of competence is, or is proposed to be, conducted in connection with any such course or for any other purposes connected with this Order.

(2) For the purposes of this article, “test of competence” includes such tests of proficiency in the knowledge and use of English as the Council may require.

(3) In this article, “relevant course of education or training” means—

(a) any course of education or training which forms, or is intended to form, part of an approved course of education or training; or

(b) any course which a registrant may be required to undergo for the purpose of applying for an annotation in respect of a specialisation to be made to an entry in a part of the Register in accordance with rules made by the Council under article 27.

(4) No visitor may exercise the functions of a visitor under this Order in relation to—

(a) any place at which that visitor regularly gives instruction in any subject; or

(b) any institution or other provider with which that visitor has, in the opinion of the Council, a significant connection.

(5) A person is not prevented from being a visitor merely because that person is a member of the Council or any of its committees; but no person may be a visitor if that person is employed by the Council.

(6) Visitors must be selected with due regard to the profession with which the education and training they are to report on is concerned and at least one of the visitors must be entered in a part of the Register which relates to that profession.

(7) Where a visitor visits any place or institution or other provider in the exercise of the functions of a visitor under this article, the visitor—

(a) must report to the Council—

(i) on the nature, content and quality of the instruction given, or to be given, and the facilities provided, or to be provided, at that place or by that institution or provider, and

(ii) on such other matters (if any) as the Council may require; and

(b) may, having regard to the contents of the report in so far as it relates to the matters referred to in sub-paragraph (a)(i), send a copy of the report to the inspectorate established under article 8(1).

(8) Requirements of the kind mentioned in paragraph (7)(a)(ii) may be imposed by the Council—

(a) generally in relation to all visits made to a specified kind of place or institution or other provider or in respect of a specified type of course; or

(b) specifically in relation to a particular visit.

(9) Where a visitor reports to the Council in accordance with paragraph (7)(a), the Council must on receipt of the report—

(a) send a copy of it to the institution or other provider concerned; and

(b) notify that institution or other provider of the period within which it may make observations on the report.

(10) The period specified by the Council in a notice given under paragraph (9)(b) must not be less than one month beginning with the date on which a copy of the report is sent to the institution or other provider concerned under paragraph (9)(a).

(11) The Council must not take any steps in the light of any report made under paragraph (7) before the end of the specified period mentioned in paragraph (10).

(12) The Council must publish such reports together with, at the request of the institution or other provider concerned, the response of that institution or provider to the report.

(13) The Council may make such provision in respect of visitors as it may reasonably determine—

(a) for the payment of allowances, including the payment of allowances to employers of visitors, for the purposes of enabling visitors to perform functions under this article; and

(b) for the reimbursement of such expenses as visitors may reasonably have incurred in the course of carrying out their functions under this article.

Commencement Information

I93 Art. 45 in force at 10.2.2010 for specified purposes, see art. 1(3)

I94 Art. 45 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Information to be given by institutions or other providers E+W+S

46.—(1) This article applies to any institution or other provider in Great Britain by which, or under whose direction, whether inside or outside Great Britain—

(a) any relevant course of education or training is, or is proposed to be, given; or

(b) any test of competence is, or is proposed to be, conducted in connection with any such course or for any other purpose connected with this Order.

(2) In paragraph (1), “test of competence” and “relevant course of education or training” have the same meaning as in article 45.

(3) Whenever required to do so by the Council, any institution or other provider to which this article applies must give to the Council such information and assistance as the Council may reasonably require in connection with the exercise of its functions under this Order.

(4) Where an institution or other provider refuses any reasonable request for information made by the Council under this article, the Council may, in accordance with article 47, refuse to approve or withdraw approval from, any course of education or training, qualification, test or institution or other provider to which the information relates.

Commencement Information

I95 Art. 46 in force at 10.2.2010 for specified purposes, see art. 1(3)

I96 Art. 46 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Refusal or withdrawal of approval of courses, qualifications and institutions E+W+S

47.—(1) Paragraph (2) applies to a case where, as a result of any visitor’s report or other information acquired by the Council, the Council is of the opinion that—

(a) the standards set under article 42(1)(b)(i) are not, or will not, be met by an institution or other provider; or

(b) an institution or other provider is not observing the requirements referred to in article 42(1)(b)(ii).

(2) In a case to which this paragraph applies, the Council may—

(a) impose such probationary or remedial arrangements (including action plans for providers of new courses) or such conditions as may be prescribed; or

(b) refuse to approve, or withdraw approval from, any course of education or training, qualification, test, or institution or other provider to which that opinion relates.

(3) If the Council is considering taking any action under paragraph (2)(a) or (b), the Council must act in accordance with paragraphs (4) to (6).

(4) The Council must—

(a) notify the institution or other provider concerned of its opinion, setting out its reasons; and

(b) inform the institution or other provider of the period within which it may make observations on the matters raised, which must not be less than one month beginning with the date on which the reasons are sent to the institution or other provider under sub-paragraph (a).

(5) The Council may take no further steps before the expiry of the period about which the institution or other provider has been informed under paragraph (4)(b).

(6) If, taking account of any visitor’s report or other information acquired by the Council together with any observations submitted by the institution or other provider under paragraph (4), the Council decides that it is appropriate to—

(a) impose probationary or remedial arrangements or conditions on the institution or other provider; or

(b) refuse or withdraw approval,

it must send to the institution or other provider concerned at the last known address of the institution or provider a statement in writing giving the institution or other provider notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(7) A decision under paragraph (6) has effect from the date of the decision or from such later date as may be specified in the decision.

(8) Where, under this article, approval of a course of education or training or an institution or other provider is withdrawn, the Council must use its best endeavours to secure that any person who, at that time, is undertaking that course or is studying at that institution or with that other provider is given the opportunity to attend an approved course conducted by an approved institution or other provider.

(9) Where, under this article, approval of a qualification, a course of education or training or an institution or other provider is withdrawn, that withdrawal does not affect the entitlement of any person to be entered in a part of the Register on the basis of the award of a qualification to that person before the date on which the decision withdrawing approval from that qualification, the course of education or training which led to the award of that qualification or, as the case may be, the institution or other provider that conducted the course that led to the award of that qualification, had effect.

Commencement Information

I97 Art. 47 in force at 10.2.2010 for specified purposes, see art. 1(3)

I98 Art. 47 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 6 E+W+S Fitness to practise

Standards of conduct and performance E+W+S

48.—(1) The Council must—

(a) set standards relating to the conduct, ethics and performance expected of registrants; and

(b) make provision in rules regarding the criteria to which the Fitness to Practise Committee is to have regard when deciding, in the case of any registrant, whether or not the requirements as to fitness to practise are met in relation to that registrant.

(2) The Council must publish the standards set under this article, as they exist from time to time, in such manner as it considers appropriate.

(3) Where any registrant is alleged to have failed to comply with standards set under this article, that failure—

(a) is not, of itself, to be taken to constitute misconduct on the registrant’s part; but

(b) is to be taken into account in any proceedings against the registrant under this Order.

Commencement Information

I99 Art. 48 in force at 10.2.2010 for specified purposes, see art. 1(3)

I100 Art. 48 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Disclosure of information: general E+W+S

49.—(1) For the purpose of assisting the Council (including its staff and its committees) in carrying out functions in respect of the fitness to practise of a registrant, or of assisting the Registrar in carrying out functions in respect of identifying any person entered in the Register by virtue of article 34(1)(b), a person authorised by the Council may require—

(a) a registrant (except the registrant in respect of whom the information or document is sought); or

(b) any other person,

who, in the opinion of the authorised person, is able to supply information or produce any document which appears to be relevant to the discharge of any such function, to supply the information or produce the document.

(2) Nothing in paragraph (1) requires or permits—

(a) any disclosure of information which is prohibited by or under any enactment, but where that prohibition arises because the information is in a form which allows for the identification of an individual, the person authorised by the Council may require that information to be put in a form which does not allow for the identification of that individual; or

(b) the supplying of information or production of a document which a person could not be compelled to produce in civil proceedings in the High Court or the Court of Session under article 58 .

(3) In determining, for the purposes of paragraph (2)(a), whether a disclosure of personal data is prohibited, it is to be assumed, for the purposes of section 35(1) of the Data Protection Act 1998(42) (disclosures required by law or made in connection with legal proceedings etc.), that the disclosure of personal data is required by paragraph (1).

(4) If a person fails to supply any information or to produce any document within 14 days of being required to do so under paragraph (1), or within such longer period as the Council in the circumstances of a particular case may allow, the Council may seek an order of the relevant court requiring the information to be supplied or the document to be produced.

(5) For the purposes of this article, the “relevant court” means—

(a) in a case where the person in respect of whom the information or document is sought is domiciled in Scotland, the sheriff in whose sheriffdom that person is domiciled; and

(b) in any other case, the county court (the Central London County Court if the person in respect of whom the information or document is sought is not domiciled in Great Britain).

Commencement Information

I101 Art. 49 in force at 10.2.2010 for specified purposes, see art. 1(3)

I102 Art. 49 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Disclosure of fitness to practise matters in the public interest E+W+S

50.—(1) The Council may, if it considers it to be in the public interest to do so, publish or disclose to any person—

(a) information which relates to a particular pharmacist’s or pharmacy technician’s fitness to practise, whether the matter to which the information relates arose before or after the entry in the Register of that pharmacist or pharmacy technician, or arose in Great Britain or elsewhere; or

(b) information of a particular description related to fitness to practise in relation to every pharmacist or pharmacy technician, or to every pharmacist or pharmacy technician of a particular description.

(2) For the purposes of paragraph (1)(b), the Council need not consider whether it is in the public interest to publish or disclose the information in question in relation to each individual pharmacist or pharmacy technician to whom it relates.

Commencement Information

I103 Art. 50 in force at 10.2.2010 for specified purposes, see art. 1(3)

I104 Art. 50 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Impairment of fitness to practise E+W+S

51.—(1) A person’s fitness to practise is to be regarded as “impaired” for the purposes of this Order only by reason of—

(a) misconduct;

(b) deficient professional performance (which includes competence);

(c) adverse physical or mental health which impairs their ability to practise safely and effectively or which otherwise impairs their ability to carry out the duties of a pharmacist or a pharmacy technician in a safe and effective manner;

(d) failure to comply with a reasonable requirement imposed by an individual assessor or an assessment team in connection with carrying out a professional performance assessment;

(e) a conviction in the British Islands for a criminal offence;

(f) a conviction elsewhere than in the British Islands for an offence which, if committed in England, Wales or Scotland, would constitute a criminal offence;

(g) an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995(43) discharging the person absolutely (admonition and absolute discharge);

(h) having accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995(44) (fixed penalty: conditional offer by procurator fiscal);

(i) having agreed to pay a penalty under section 115A of the Social Security Administration Act 1992(45) (penalty as alternative to prosecution);

(j) a police caution in the British Islands;

(k) having agreed to be bound over to keep the peace by a magistrates’ court in England or Wales;

(l) a determination made by a regulatory body in the United Kingdom responsible under any enactment for the regulation of a health or social care profession to the effect that the person’s fitness to practise as a member of a profession regulated by that body is impaired, or a determination by a regulatory body elsewhere to the same effect;

(m) the [F2 Disclosure and Barring Service] including the person in a barred list (within the meaning of the Safeguarding Vulnerable Groups Act 2006(46) or the Safeguarding Vulnerable Groups (Northern Ireland) Order 2007(47)); or

(n) the Scottish Ministers including the person in the children’s list or the adults’ list (within the meaning of the Protection of Vulnerable Groups (Scotland) Act 2007(48)).

(2) The demonstration towards a patient or customer, or a prospective patient or customer, by a pharmacist or pharmacy technician of attitudes or behaviour from which that person can reasonably expect to be protected may be treated as misconduct for the purposes of paragraph (1)(a).

(3) References in this article to a conviction include a conviction by court martial.

(4) A person’s fitness to practise may be regarded as impaired because of matters arising—

(a) outside Great Britain; and

(b) at any time.

(5) The Council may make such provision in rules as it considers appropriate in connection with the information to be provided to the Registrar by a registrant about fitness to practise matters that arise while the registrant is entered in any part of the Register.

(6) If a registrant fails to comply with rules under paragraph (5), the failure may be treated as misconduct for the purposes of paragraph (1)(a) and the Registrar must consider, in accordance with article 52(1), whether or not to refer the matter to the Investigating Committee or (where rules under article 52(1) so provide) the Fitness to Practise Committee.

Textual Amendments

F2 Words in art. 51(1)(m) substituted (1.12.2012) by The Protection of Freedoms Act 2012 (Disclosure and Barring Service Transfer of Functions) Order 2012 (S.I. 2012/3006), arts. 1(1), 13(1)(3)(z) (with Pt. 4)

Commencement Information

I105 Art. 51 in force at 10.2.2010 for specified purposes, see art. 1(3)

I106 Art. 51 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Initial action in respect of allegations E+W+S

52.—(1) Where—

(a) an allegation is made to the Council against a registrant that the registrant’s fitness to practise is impaired; or

(b) the Council has information that calls into question a registrant’s fitness to practise, even though no allegation to that effect has been made to the Council,

the Registrar must, except in such cases and subject to such considerations as the Council may prescribe, refer the matter (referred to in this article as “the allegation”) to the Investigating Committee.

(2) Rules under paragraph (1) may provide for—

(a) an allegation not to be referred where it is of a type that the Council has stated in threshold criteria, which it has published and which it may amend from time to time, should not be referred; and

(b) an allegation to be referred, in prescribed cases, directly by the Registrar to the Fitness to Practise Committee.

(3) Where the Registrar—

(a) refers an allegation directly to the Fitness to Practise Committee under rules made by virtue of paragraph (2)(b); and

(b) is of the opinion that the Fitness to Practise Committee should consider making an interim order under article 56,

the Registrar must notify the Committee accordingly.

(4) Where the Registrar refers an allegation to the Fitness to Practise Committee under rules made by virtue of paragraph (2)(b), the Registrar must inform the registrant who is the subject of the allegation and the person, if any, who made the allegation of that decision.

(5) Once a decision has been taken to refer the allegation to the Investigating Committee or (where rules so provide) the Fitness to Practise Committee, the Registrar must, as soon as is reasonably practicable—

(a) require from the registrant who is the subject of the allegation details of any person—

(i) by whom the registrant is employed or engaged to provide services in, or in relation to, any area of pharmacy, or

(ii) with whom the registrant has arrangements to provide such services;

(b) notify the Secretary of State, the Scottish Ministers and the Welsh Ministers of the investigation of the registrant’s fitness to practise;

(c) notify the Department of Health, Social Services and Public Safety in Northern Ireland of the investigation of the registrant’s fitness to practise where the registrant is also entered in the register of pharmaceutical chemists for Northern Ireland or the register of visiting pharmaceutical chemists made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976(49); and

(d) notify any person of whom the Registrar is aware—

(i) by whom the registrant is employed or engaged to provide services in, or in relation to, any area of pharmacy, or

(ii) with whom the registrant has arrangements to provide such services,

of the investigation of the registrant’s fitness to practise.

(6) Where a registrant fails to comply with a requirement imposed under paragraph (5)(a) within 14 days of the requirement being imposed, or within such longer period as the Registrar may in the circumstances of the particular case allow—

(a) the failure may be treated as misconduct for the purposes of article 51(1)(a) and the Registrar may refer the matter to the Committee that is considering the allegation in respect of the registrant; and

(b) the Registrar may seek an order of the relevant court requiring the requested details to be supplied.

(7) For the purposes of this article, the “relevant court” means—

(a) in a case where the registrant is domiciled in Scotland, the sheriff in whose sheriffdom that registrant is domiciled; and

(b) in any other case, the county court (the Central London County Court if the registrant is not domiciled in Great Britain).

Commencement Information

I107 Art. 52 in force at 10.2.2010 for specified purposes, see art. 1(3)

I108 Art. 52 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Consideration by the Investigating Committee E+W+S

53.—(1) Where an allegation or a matter (referred to in this article as “the allegation”) is referred to the Investigating Committee by—

(a) the Registrar under article 52(1) or (6)(a); or

(b) an individual assessor or an assessment team under rules made under article 55(3)(c),

the Committee must decide whether the allegation ought to be considered by the Fitness to Practise Committee.

(2) If the Investigating Committee decides that the allegation need not be considered by the Fitness to Practise Committee, then unless the person who is the subject of the allegation (referred to in this article as “the person concerned”) has requested a referral under paragraph (3)—

(a) the Investigating Committee may give—

(i) a warning to the person concerned in connection with any matter arising out of or related to the allegation and give a direction that details of the warning be recorded in the Register,

(ii) advice to the person concerned in connection with any matter arising out of, or related to, the allegation, and

(iii) advice to any other person or other body involved in its investigation of the allegation on any issue arising out of, or related to, the allegation; and

(b) the Registrar must inform the person concerned and the person who made the allegation, if any, of the Investigating Committee’s decision and any action it is taking under sub-paragraph (a).

(3) If the Investigating Committee determines that the allegation ought to be considered by the Fitness to Practise Committee or the person concerned has requested a referral under this paragraph—

(a) the Investigating Committee must refer the allegation to the Fitness to Practise Committee;

(b) where the Investigating Committee considers that the Fitness to Practise Committee should consider making an interim order under article 56, it must notify the Fitness to Practise Committee accordingly; and

(c) the Registrar must inform the person concerned and the person who made the allegation, if any, of the Investigating Committee’s decision to refer the allegation to the Fitness to Practise Committee.

(4) If, having considered the allegation, the Investigating Committee considers that the Council should consider exercising any of its powers to bring criminal proceedings under any enactment, it must notify the Registrar accordingly.

Commencement Information

I109 Art. 53 in force at 10.2.2010 for specified purposes, see art. 1(3)

I110 Art. 53 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Consideration by the Fitness to Practise Committee E+W+S

54.—(1) Where an allegation or matter (referred to in this article as “the allegation”) is referred to the Fitness to Practise Committee by the Registrar—

(a) under rules made by virtue of article 52(2)(b);

(b) under article 52(6)(a);

(c) by the Investigating Committee under article 53; or

(d) by an individual assessor or an assessment team under rules made under article 55(3)(c),

the Fitness to Practise Committee must determine whether or not the fitness to practise of the person in respect of whom the allegation is made (referred to in this article as “the person concerned”) is impaired.

(2) If the Fitness to Practise Committee determines that the fitness to practise of the person concerned is impaired, it may—

(a) give a warning to the person concerned in connection with any matter arising out of, or related to, the allegation and give a direction that details of the warning be recorded in the Register;

(b) give advice to any other person or other body involved in the investigation of the allegation on any issue arising out of, or related to, the allegation;

(c) give a direction that the entry in the Register of the person concerned be removed;

(d) give a direction that the entry in the Register of the person concerned be suspended, for such period not exceeding 12 months as may be specified in the direction; or

(e) give a direction that the entry in the Register of the person concerned be conditional upon that person complying, during such period not exceeding 3 years as may be specified in the direction, with such requirements specified in the direction as the Committee thinks fit to impose for the protection of the public or otherwise in the public interest or in the interests of the person concerned.

(3) Where the Fitness to Practise Committee has given a direction under this article, other than a direction that the entry in the Register of the person concerned be removed, it may, if it thinks fit, following a review—

(a) where the entry in the Register of the person concerned is suspended, give a direction that—

(i) the entry be removed from the Register,

(ii) the suspension of the entry be extended for such further period not exceeding 12 months as may be specified in the direction, starting from the time when the period of suspension would otherwise expire,

(iii) the entry be suspended indefinitely, if the suspension has already been in force throughout a period of at least two years,

(iv) in the case of an indefinite suspension, terminate the suspension, provided that the review takes place in the circumstances provided for in paragraph (4), or

(v) on expiry or termination of the period of suspension (including a period of suspension that was expressed to be indefinite), the entry be conditional upon that person complying, during such period not exceeding 3 years as may be specified in the direction, with such requirements specified in the direction as the Committee thinks fit to impose for the protection of the public or otherwise in the public interest or in the interests of the person concerned;

(b) where the entry in the Register of the person concerned is conditional upon that person complying with requirements specified in a direction given under this article, give a direction that—

(i) the period specified in the direction for complying with the requirements be extended for such further period not exceeding 3 years as may be specified in the direction, starting from the time when the earlier period would otherwise expire,

(ii) the requirements be added to, removed or otherwise varied in such manner as may be specified in the direction,

(iii) the entry instead be suspended (for example, where that person has failed, whether wholly or partly, to comply with the requirements), for such period not exceeding 12 months as may be specified in the direction, or

(iv) the entry be removed from the Register, if that person has failed, whether wholly or partly, to comply with the requirements.

(4) If the Fitness to Practise Committee gives a direction under paragraph (3)(a)(iii), the Committee must review the direction if—

(a) the person concerned asks it to do so; and

(b) at least two years have elapsed—

(i) since the direction took effect, or

(ii) if the direction has already been reviewed by the Committee, since the conclusion of the last review by the Committee.

(5) If the Fitness to Practise Committee determines that the fitness to practise of the person concerned is not impaired—

(a) the Committee may give—

(i) a warning to the person concerned in connection with any matter that the Committee considers necessary or desirable taking into account the Committee’s findings and give a direction that details of the warning be recorded in the Register,

(ii) advice to the person concerned in connection with any such matter, and

(iii) advice to any other person or other body involved in the investigation of the allegation on any issue arising out of, or related to, the allegation;

(b) the Registrar must inform the person concerned and the person who made the allegation, if any, of the Committee’s decision and any action it is taking under sub-paragraph (a); and

(c) the Committee must, if the person concerned so requests, publish in such manner as it sees fit a statement summarising its determination, or may publish such a statement if that person consents.

(6) If the person concerned is entered in more than one part of the Register, the Fitness to Practise Committee—

(a) must make separate determinations under this article in relation to each part of the Register; and

(b) may give a direction under paragraph (2) or (3) in relation to only one part of the Register or different directions in relation to different parts of the Register,

but may otherwise deal with the matter as a single case.

(7) If the Fitness to Practise Committee determines under this article that a person’s fitness to practise is impaired solely by reason of adverse physical or mental health, it may not give a direction under paragraph (2)(c), (3)(a)(i) or (3)(b)(iv) that the entry in the Register in respect of that person be removed.

(8) If the Fitness to Practise Committee gives a warning or a direction under this article, the Registrar must on its behalf send to the person concerned at the last known home address of that person a statement in writing giving the person notice of the reasons for the warning or the direction and of any right of appeal under article 58.

(9) If, having considered the allegation, the Fitness to Practise Committee considers that the Council should consider exercising any of its powers to bring criminal proceedings under any enactment, it must notify the Registrar accordingly.

Commencement Information

I111 Art. 54 in force at 10.2.2010 for specified purposes, see art. 1(3)

I112 Art. 54 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Professional performance assessments E+W+S

55.—(1) The Council may make rules about the circumstances in which the Registrar, the Investigating Committee and the Fitness to Practise Committee are authorised to give directions requiring an assessment of the standard of a registrant’s professional performance by an individual assessor or an assessment team.

(2) The circumstances that may be prescribed under paragraph (1) include circumstances arising during proceedings of either Committee.

(3) The Council may make such provision as it considers appropriate in rules in connection with the composition of assessment teams and the functions of and procedures to be followed by individual assessors and assessment teams and may, in particular, make provision with regard to—

(a) the Council entering into arrangements with other bodies for those bodies to provide individual assessors or assessment teams to carry out the assessments;

(b) allowing an assessment by an individual assessor or an assessment team to include an assessment of the standard of a registrant’s professional performance both at any time before the assessment and at the time of the assessment; and

(c) referring to the Investigating Committee or the Fitness to Practise Committee a case where an individual assessor or an assessment team considers that a registrant has failed to comply with a reasonable requirement that has been imposed on that registrant by the individual assessor or the assessment team.

(4) An individual assessor or an assessment team, in connection with carrying out an assessment of the standard of a registrant’s professional performance—

(a) may require the production of, and inspect and take copies of, any records (in whatever form they are held) arising out of or related to the registrant’s professional practice; and

(b) where such records are kept otherwise than in legible form, may require a copy of them to be given in legible form.

(5) Nothing in, or in rules under, this article requires or permits—

(a) any disclosure of information which is prohibited by or under any enactment, but where that prohibition arises because the information is in a form which allows for the identification of an individual, an individual assessor or an assessment team, when requiring the production of records under paragraph (4)(a), may require that the records be put in a form which does not allow for the identification of that individual; or

(b) the production of records which a person could not be compelled to produce in civil proceedings in the High Court or the Court of Session under article 58.

(6) In determining, for the purposes of paragraph (5)(a), whether a disclosure of personal data is prohibited, it is to be assumed, for the purposes of section 35(1) of the Data Protection Act 1998(50) (disclosures required by law or made in connection with legal proceedings etc.), that the disclosure of personal data is required by paragraph (4).

(7) If a person fails to produce any records within 14 days of being required to do so under paragraph (4), the Registrar, the Investigating Committee or the Fitness to Practise Committee on whose behalf the individual assessor or assessment team is carrying out the assessment in connection with which the records are being sought, may seek an order of the relevant court requiring the records to be produced.

(8) For the purposes of this article, the “relevant court” means—

(a) in a case where records are being sought in relation to a registrant who is domiciled in Scotland, the sheriff in whose sheriffdom that registrant is domiciled; and

(b) in any other case, the county court (the Central London County Court in the case of a registrant who is not domiciled in Great Britain).

Commencement Information

I113 Art. 55 in force at 10.2.2010 for specified purposes, see art. 1(3)

I114 Art. 55 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Interim orders E+W+S

56.—(1) Where the Fitness to Practise Committee is satisfied that it is necessary for the protection of members of the public or is otherwise in the public interest or is in the interests of the registrant for an entry in the Register relating to a registrant to be suspended or to be made subject to conditions, the Committee may make an order—

(a) that the entry in question be suspended for such period not exceeding 18 months as may be specified in the order (an “interim suspension order”); or

(b) that the entry in question be conditional upon the registrant complying, during such period not exceeding 18 months as may be specified in the order, with such requirements specified in the order as the Committee thinks fit to impose (an “order for interim conditional entry”).

(2) Subject to paragraph (7), where the Fitness to Practise Committee has made an order under paragraph (1), the Committee—

(a) must review it within the period of 6 months beginning with the date on which the order was made, and must after that, for so long as the order continues in force, further review it—

(i) before the end of the period of 6 months beginning with the date of the decision of the immediately preceding review, or

(ii) if, after the end of the period of 3 months beginning with the date of the decision of the immediately preceding review, the person concerned requests an earlier review, as soon as practicable after that request; and

(b) may review it where new evidence relevant to the order has become available after it was made.

(3) Where an interim suspension order or an order for interim conditional entry has been made in relation to any person under any provision of this article (including this paragraph) the Fitness to Practise Committee may—

(a) revoke the order;

(b) add to, remove or otherwise vary any condition imposed by the order; or

(c) if satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest—

(i) replace an order for interim conditional entry with an interim suspension order having effect for the remainder of the term of the previous order, or

(ii) replace an interim suspension order with an order for interim conditional entry having effect for the remainder of the term of the previous order.

(4) If an order is made, revoked or varied under any provision of this article, the Registrar must without delay send to the person in respect of whose entry in the Register it relates at the last known home address of that person a statement in writing giving the person notice of the order, the revocation or, as the case may be, the variation.

(5) The Council may apply to the relevant court for an order made by the Fitness to Practise Committee under paragraph (1) or (3) to be extended or, if it has been extended, further extended, and on such application the relevant court may extend, or further extend, for up to 12 months the period for which the order has effect.

(6) Any reference in this article to an interim suspension order, or to an order for interim conditional entry, includes a reference to such an order as extended under paragraph (5).

(7) For the purposes of paragraph (2), the first review after the relevant court’s extension of an order made by the Fitness to Practise Committee, or after a replacement order made by the Fitness to Practise Committee under paragraph (3)(c), must take place—

(a) if the order (or the order which has been replaced) has not been reviewed at all under paragraph (2), within the period of 6 months beginning with the date on which the relevant court ordered the extension or on which the replacement order under paragraph (3)(c) was made; and

(b) if the order (or the order which has been replaced) has been reviewed under paragraph (2), within the period of 3 months beginning with that date.

(8) A registrant who is aggrieved by the decision of the Fitness to Practise Committee to make or vary an order under this article may appeal against that decision to the relevant court, and the court may—

(a) in the case of an interim suspension order, terminate the suspension;

(b) in the case of an order for interim conditional entry, revoke the order or remove or vary any condition imposed by the order; and

(c) in either case, substitute for the period specified in the order (or in the order extending it) some other period which could have been specified in the order when it was made (or in the order extending it),

but unless the court otherwise directs, the order remains in force pending the outcome of the appeal.

(9) The decision of the relevant court on any application under paragraph (8) is final.

(10) If an order is made in relation to any person under this article and that order remains in effect immediately before the determination in respect of the allegation against that person under article 54(1), the Fitness to Practise Committee must revoke the order once it has been determined whether or not the person’s fitness to practise is impaired.

(11) In this article, “the relevant court” means—

(a) in a case relating to a registrant who is domiciled in Scotland, the Court of Session; and

(b) in any other case, the High Court.

Commencement Information

I115 Art. 56 in force at 10.2.2010 for specified purposes, see art. 1(3)

I116 Art. 56 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Restoration of names to the Register: fitness to practise E+W+S

57.—(1) Subject to paragraph (2)—

(a) a person whose entry has been removed from one or more parts of the Register, in accordance with a direction under article 54(2)(c) or (3)(a)(i) or (b)(iv) may apply to the Registrar under this article for restoration to any part of the Register from which that person’s entry has been removed; and

(b) the Registrar must refer that application to the Fitness to Practise Committee.

(2) An application may not be made under paragraph (1)—

(a) before the expiration of five years from the date of removal; or

(b) within 12 months of the date of an earlier application under paragraph (1) relating to the same entry.

(3) The Council may make such provision in rules in connection with applications for restoration by virtue of paragraph (1) as it considers appropriate and may, in particular, make provision with regard to—

(a) the form and manner in which applications for restoration are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b) the information to be provided by the applicant, including—

(i) the name under which the applicant intends to practise, and

(ii) the applicant’s home address;

(c) whether any, and if so what, additional education, training or continuing professional development is required before restoration (and the rules may make provision for these issues to be determined in individual cases by the Registrar);

(d) fitness to practise matters; and

(e) refusal of applications (including where the applicant has not paid the fee prescribed under article 36(1)(b)).

(4) An application under this article may not be granted unless the person applying for restoration provides such evidence of fitness to practise as the Fitness to Practise Committee directs.

(5) Where the Fitness to Practise Committee refuses an application for restoration, the Registrar must send to the applicant at the applicant’s last known home address a statement in writing giving the applicant notice of the decision and of the reasons for it.

(6) If the Fitness to Practise Committee grants the application, it may give a direction that the person’s entry in the part or parts of the Register to which it has been restored be conditional upon that person complying, during such period not exceeding 3 years as may be specified in the direction, with such requirements specified in the direction as the Committee thinks fit to impose for the protection of the public or otherwise in the public interest or in the interests of the person concerned.

(7) Where the Fitness to Practise Committee gives a direction under paragraph (6), that direction must, for the purposes of article 54(3), be treated as a direction under article 54.

(8) If the application under this article relates to more than one part of the Register, the Fitness to Practise Committee—

(a) must make separate determinations under this article in relation to each part of the Register; and

(b) may give a direction under paragraph (6) in relation to only one part of the Register or different directions in relation to different parts of the Register,

but may otherwise deal with the matter as a single case.

(9) If—

(a) the Fitness to Practise Committee refuses an application under this article (“the current application”);

(b) it had refused a previous application under this article made by the same person, whether relating to the same part of the Register as the current application or to another part or parts of the Register; and

(c) since the time when the previous application was refused, the person has not been entered in the part of the Register to which the current application and the previous application relate, or (if they relate to different parts) has not been entered in any of those parts of the Register,

the Fitness to Practise Committee may direct that the person may make no further application under this article in respect of the part or parts of the Register to which the current application and the previous application (or each of two or more previous applications falling within sub-paragraphs (b) and (c)) relate.

(10) If the Fitness to Practise Committee gives a direction under paragraph (6) or (9), the Registrar must on its behalf send to the applicant at the applicant’s last known home address a statement in writing giving the applicant notice of the decision and the reasons for it and, in the case of a direction under paragraph (9), of the right of appeal under article 58.

Commencement Information

I117 Art. 57 in force at 10.2.2010 for specified purposes, see art. 1(3)

I118 Art. 57 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Appeals against appealable fitness to practise decisions E+W+S

58.—(1) The following decisions are appealable fitness to practise decisions for the purposes of this Part—

(a) a decision of the Fitness to Practise Committee under article 54 to give a direction to remove the entry of a person from one or more parts of the Register;

(b) a decision of the Fitness to Practise Committee under article 54 to give a direction for suspension or for conditional entry (including a direction extending a period of earlier suspension or of conditional entry or making a period of suspension indefinite);

(c) a decision of the Fitness to Practise Committee under article 54 to give a direction to vary the conditions imposed by a direction for conditional entry; and

(d) a decision of the Fitness to Practise Committee to give a direction under article 57(9) that a person may make no further applications under that article in respect of one or more parts of the Register.

(2) A person in respect of whom an appealable fitness to practise decision has been made may appeal against that decision to the relevant court.

(3) Notice of any appeal under this article must be filed at, or in Scotland lodged in, the relevant court and served on the Council, in accordance with rules of court, within 28 days beginning with the date on which the written notice of the reasons for the decision was sent, or within such longer period as the relevant court may, in accordance with rules of court, allow.

(4) In this article, “the relevant court” means—

(a) in a case where the person making the appeal is domiciled in Scotland, the Court of Session; and

(b) in any other case, the High Court.

(5) Having considered the appeal, the relevant court may—

(a) dismiss the appeal;

(b) allow the appeal and quash the direction in respect of which the appeal is made;

(c) substitute for the direction in respect of which the appeal is made any other direction that the Fitness to Practise Committee could have given; or

(d) remit or refer the case to the Registrar or the Fitness to Practise Committee for disposal of the matter in accordance with the relevant court’s directions,

and may make such order as to costs or, in Scotland, expenses as the relevant court thinks fit.

Commencement Information

I119 Art. 58 in force at 10.2.2010 for specified purposes, see art. 1(3)

I120 Art. 58 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

The taking effect of directions in respect of appealable fitness to practise decisions E+W+S

59.—(1) Where an appealable fitness to practise decision is taken in respect of a direction, that direction does not take effect—

(a) until the period for bringing an appeal in respect of the direction has expired; or

(b) where an appeal is brought within the period for bringing an appeal, until the date on which the appeal is finally disposed of, is abandoned or fails by reason of its non-prosecution.

(2) Where, by virtue of paragraph (3) of article 58, the time for bringing an appeal in respect of the direction has been extended by the relevant court in accordance with rules of court—

(a) paragraph (1) applies to the direction as if the references to the period for bringing an appeal were references to that period as so extended; and

(b) if the relevant court allows an appeal to be brought after the expiration of the period for bringing an appeal specified in paragraph (3) of article 58, the direction is deemed not to have taken effect on the expiration of that period.

(3) Where, within the period for bringing an appeal (which includes that period as extended by virtue of article 58(3)), an appeal is brought against an appealable fitness to practise decision in respect of a direction (“the later direction”) that extends, varies or replaces an earlier direction, the earlier direction continues to have effect until the date on which the appeal is finally disposed of, is abandoned or fails by reason of its non-prosecution.

(4) Where, as a result of an extension of an earlier direction pursuant to paragraph (3), a later direction takes effect on a date after it was due to take effect, the period for which the later direction was originally expressed to have effect (howsoever expressed) is treated as commencing—

(a) on the date on which it was originally due to take effect; or

(b) if this would mean that the later direction would in practice expire before it commences, on the date on which the appeal is finally disposed of, is abandoned or fails by reason of its non-prosecution.

(5) For the purposes of paragraphs (3) and (4), an appeal is finally disposed of once all rights in relation to the appeal have been exhausted.

Commencement Information

I121 Art. 59 in force at 10.2.2010 for specified purposes, see art. 1(3)

I122 Art. 59 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Interim measures pending a direction taking effect E+W+S

60.—(1) Paragraph (2) applies where, under article 54, the Fitness to Practise Committee gives—

(a) a direction to remove a registrant’s entry from one or more parts of the Register; or

(b) a direction for suspension.

(2) If the Fitness to Practise Committee is satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest or in the interests of the registrant, it may order that the entry of the registrant who is the subject of the direction in the part or parts of the Register to which the direction relates be suspended forthwith, pending the coming into force of the direction.

(3) Paragraph (4) applies where the Fitness to Practise Committee gives a direction for conditional entry under article 54.

(4) If the Fitness to Practise Committee is satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest or in the interests of the registrant, it may order that the entry of the registrant who is the subject of the direction in the part or parts of the Register to which the direction relates, be conditional upon that registrant complying, pending the coming into force of the direction, with such requirements specified in the order as the Committee thinks fit to impose.

(5) If the direction referred to in paragraph (1) or (3) relates to the entry of the registrant in more than one part of the Register, the Fitness to Practise Committee may make an order under paragraph (2) or, as the case may be, (4) in relation to only one part of the Register and may impose different requirements under paragraph (4) in relation to the registrant’s entry in different parts of the Register.

(6) Where the Fitness to Practise Committee makes an order under paragraph (2) or (4), the Registrar must send to the registrant who is the subject of the order at that registrant’s last known home address a statement in writing giving that registrant notice of the contents of the order and of the right of appeal under paragraph (7).

(7) A registrant who is aggrieved by a decision of the Fitness to Practise Committee to make an order under this article may appeal against that decision to the relevant court, and the court may—

(a) dismiss the appeal;

(b) in the case of an order under paragraph (2), terminate the suspension; and

(c) in the case of an order under paragraph (4), revoke the order or remove or vary any condition imposed by the order,

and the decision of the relevant court on any application under this paragraph is final.

(8) In this article, “the relevant court” means—

(a) in a case where the person making the appeal is domiciled in Scotland, the Court of Session; and

(b) in any other case, the High Court.

Commencement Information

I123 Art. 60 in force at 10.2.2010 for specified purposes, see art. 1(3)

I124 Art. 60 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 7 E+W+S Proceedings

Rules in respect of proceedings E+W+S

61.—(1) Subject to the following provisions of this Part, the Council must make such provision as it considers appropriate in rules in connection with the procedure to be followed and rules of evidence to be observed by—

(a) the Investigating Committee;

(b) the Fitness to Practise Committee (whether exercising functions under this Order or the Medicines Act 1968(51)); and

(c) the Appeals Committee.

(2) The rules under paragraph (1) in respect of the Fitness to Practise Committee or the Appeals Committee must, and in respect of the Investigating Committee may, include provision—

(a) for securing that, where a hearing is to be held, notice of when and where the hearing is to be held is given, at such time and in such manner as may be specified in the rules, to any person to whom the proceedings relate;

(b) for securing that the person concerned (which for the purposes of this article, where appropriate, includes an individual who, or body corporate which, is subject to disqualification proceedings under Part 4 of the Medicines Act 1968) and the Council are, if they so require, entitled to be heard by the committee—

(i) at any hearing, or

(ii) in fitness to practise proceedings or on any other occasion when the committee is considering making an interim suspension order or an order for interim conditional entry;

(c) for allowing the person concerned and the Council to be represented at any hearing, or in fitness to practise proceedings or on any other occasion when the committee is considering making an interim suspension order or an order for interim conditional entry, by—

(i) a person with a general qualification (within the meaning of section 71 of the Courts and Legal Services Act 1990(52) (offences)),

(ii) an advocate in Scotland, or a solicitor with rights of audience to appear in the Court of Session or in the High Court of Justiciary by virtue of section 25A of the Solicitors (Scotland) Act 1980(53) (rights of audience in the Court of Session etc.), or

(iii) a person of such other description as may be specified in rules, if the rules so allow and the person concerned or the Council so elects;

(d) for proceedings before the committee to be held in public, except and to the extent that rules provide otherwise; and

(e) in respect of reviewing directions under article 54—

(i) which are due to expire,

(ii) in circumstances where the committee is considering varying the requirements specified in the direction, or

(iii) in the case of a direction for suspension or for conditional entry—

(aa) at the request of the Registrar or the person concerned, or

(bb) upon new evidence becoming available.

(3) The rules under paragraph (1) may include provision—

(a) in respect of preliminary consideration of a case before a committee (including considering representations from the person concerned and the Council during its preliminary consideration);

(b) following preliminary consideration of a case—

(i) in the case of an appeal before the Appeals Committee, allowing the Appeals Committee, in prescribed circumstances, to allow the appeal or take a decision which has the effect of allowing the appeal,

(ii) in fitness to practise proceedings, allowing the Fitness to Practise Committee, in prescribed circumstances, to make a finding that the fitness to practise of the person concerned is not impaired, and

(iii) in a disqualification case, allowing the Fitness to Practise Committee, in prescribed circumstances, to dismiss the case;

(c) in respect of consensual disposal of a fitness to practise case following preliminary consideration of it, including provision—

(i) enabling the Investigating Committee or the Fitness to Practise Committee, in prescribed circumstances, to agree with the person concerned that the person concerned will comply with such undertakings as the committee considers appropriate, and

(ii) with respect to the procedure to be followed when any such undertakings are breached (the rules may provide that the breach may be treated as misconduct for the purposes of article 51(1)(a) and for the matter to be dealt with as a misconduct allegation that is before the committee);

(d) in respect of consensual disposal of a disqualification case following preliminary consideration of it, including provision—

(i) enabling the Fitness to Practise Committee, in prescribed circumstances, to agree with the individual or body corporate that the individual or body corporate will comply with such undertakings as the Committee considers appropriate, and

(ii) with respect to the procedure to be followed where any such undertakings are breached;

(e) in respect of case management meetings (and the rules may provide that the preliminary consideration of a case is to take place at a case management meeting) and directions, including provision with respect to the procedure to be followed where case management directions are breached;

(f) in respect of cancelling, postponing or adjourning hearings and staying proceedings in appropriate circumstances;

(g) enabling the Appeals Committee to refer a case before it to the Investigating Committee or the Fitness to Practise Committee for advice;

(h) enabling the Fitness to Practise Committee to draw such inference as seems appropriate to it in the particular circumstances of the case if the person concerned fails—

(i) during fitness to practise proceedings, to submit to any examination or assessment required or directed to be carried out in accordance with the rules made under this article or article 55, or

(ii) to co-operate with the Committee;

(i) enabling the committee during the course of proceedings, to make such inquiries as it considers appropriate;

(j) enabling the Fitness to Practise Committee, following consideration of a disqualification case, instead of issuing a direction under section 80 of the Medicines Act 1968(54) (disqualification and removal from the Register)—

(i) to agree with the individual or body corporate that the individual or body corporate will comply with such undertakings as the Committee considers appropriate (and the rules may include provision with respect to the procedure to be followed where any such undertakings are breached), and

(ii) to dispose of the matter by giving advice or a warning; and

(k) for the award of, and in respect of the assessment of, costs or expenses, and may require the committee to have regard to a person’s ability to pay when considering the making of an award against the person under the rules.

(4) An award of costs may, by leave of the High Court, be enforced in the same manner as an order of the High Court to the same effect.

(5) An award of expenses may, by leave of the Court of Session, be enforced in the same manner as a decree of the Court of Session to the same effect.

(6) The rules under paragraph (1) may make provision—

(a) as to the form which is to be used for any document (and may provide that documents specified in the rules are to be in such form as the Council may determine from time to time); and

(b) for documents or certificates to be sent or received as an electronic communication.

Commencement Information

I125 Art. 61 in force at 10.2.2010 for specified purposes, see art. 1(3)

I126 Art. 61 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Procedure for the Fitness to Practise Committee and the Appeals Committee E+W+S

62.—(1) For the purposes of proceedings under this Order in England and Wales—

(a) the Fitness to Practise Committee or the Appeals Committee may administer oaths; and

(b) the Fitness to Practise Committee, the Appeals Committee or any party to proceedings before either of those committees may apply for the issue of a witness summons directing a person to attend the proceedings in order to give evidence or to produce a document.

(2) No person may be compelled under any such summons to give any evidence or to produce any document which that person could not be compelled to give or produce on the trial of an action.

(3) Section 36 of the Senior Courts Act 1981(55) (subpoena issued by High Court to run throughout the United Kingdom), which provides a special procedure for the issue of such a summons so as to be in force throughout the United Kingdom, applies in relation to any proceedings under this Order in England and Wales as it applies in relation to causes and matters in the High Court.

(4) For the purposes of any such proceedings in Scotland, the Fitness to Practise Committee or the Appeals Committee may administer oaths and the Court of Session has, on the application of any party to the proceedings, the like power as in any action in that court—

(a) to grant warrant for the citation of witnesses and havers to give evidence or to produce documents before the committee, and for the issue of letters of second diligence against any witness or havers failing to appear after due citation;

(b) to grant warrant for the recovery of documents; and

(c) to grant commissions to persons to take the evidence of witnesses or to examine havers and receive their exhibits and productions.

(5) Where—

(a) several sittings of the Fitness to Practise Committee or the Appeals Committee are required to enable the committee to dispose of the case; or

(b) on an appeal to the relevant court under article 58, the case is remitted to the Fitness to Practise Committee to dispose of the case in accordance with directions given by the court,

the validity of the proceedings on the case before the committee may not be called into question by reason only that members of the committee who were present at a former meeting were not present at a later meeting of the committee or that members present at a later meeting were not present at a former meeting of the committee.

Commencement Information

I127 Art. 62 in force at 10.2.2010 for specified purposes, see art. 1(3)

I128 Art. 62 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Legal advisers E+W+S

63.—(1) The Council may do either or both of the following—

(a) appoint suitably qualified and experienced barristers, solicitors or advocates to be legal advisers;

(b) make rules which provide for it to enter into arrangements with another person for that person to appoint on behalf of the Council suitably qualified and experienced barristers, solicitors or advocates to be legal advisers.

(2) Legal advisers appointed under this article may not be a member of the Council or of a statutory committee.

(3) Legal advisers appointed under this article may be appointed either generally or for any proceedings or particular class of proceedings and are to hold and vacate office in accordance with the terms of the instrument under which they are appointed.

(4) The Council may make rules as to the functions of legal advisers appointed under this article.

Commencement Information

I129 Art. 63 in force at 10.2.2010 for specified purposes, see art. 1(3)

I130 Art. 63 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Clinical and other specialist advisers E+W+S

64.—(1) The Council may do either or both of the following in connection with proceedings under this Order—

(a) appoint registered medical practitioners to be clinical advisers;

(b) make rules which provide for it to enter into arrangements with another person for that person to appoint on behalf of the Council registered medical practitioners to be clinical advisers.

(2) The Council may do either or both of the following in connection with proceedings under this Order—

(a) appoint persons to act as specialist advisers on issues on which, in the Council’s opinion, specialist knowledge is required;

(b) make rules which provide for it to enter into arrangements with another person for that person to appoint on behalf of the Council persons to be specialist advisers.

(3) Persons appointed to be—

(a) clinical advisers must have specialist expertise in a particular field or fields; and

(b) specialist advisers must have particular expertise in the speciality for which they are appointed.

(4) If clinical advisers are appointed under paragraph (1), their appointment is for the purpose of giving advice to—

(a) the Investigating Committee or the Fitness to Practise Committee on health related issues under consideration by the committee in the proceedings before it; and

(b) the Council or any of its other committees on health related issues.

(5) If specialist advisers are appointed under paragraph (2), their appointment is for the purpose of giving advice to—

(a) one or more of the statutory committees on issues falling within their speciality which are under consideration by the committee in the course of proceedings before it; and

(b) the Council or any of its other committees on issues falling within their speciality or related to it.

(6) Advisers appointed under this article may not be a member of the Council or of a statutory committee.

(7) Advisers appointed under this article—

(a) may be appointed generally; or

(b) may be appointed for the purpose of any proceedings or particular class of proceedings,

and are to hold and vacate office in accordance with the terms of the instrument under which they are appointed.

(8) The Council may make rules as to the functions of advisers appointed under this article.

Commencement Information

I131 Art. 64 in force at 10.2.2010 for specified purposes, see art. 1(3)

I132 Art. 64 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 8 E+W+S Miscellaneous

General fees E+W+S

65.—(1) Subject to paragraph (2), the Council may charge such fees as it may reasonably determine in connection with the exercise of its functions, or the functions of its statutory committees.

(2) No fee may be charged, pursuant to paragraph (1), in connection with the exercise of a function where provision is made elsewhere in this Order for the charging of a fee in connection with the exercise of that function.

Commencement Information

I133 Art. 65 in force at 10.2.2010 for specified purposes, see art. 1(3)

I134 Art. 65 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Rules E+W+S

66.—(1) Any power to make rules under this Order may be exercised—

(a) so as to make different provision—

(i) with respect to different cases or different classes of cases, or

(ii) in respect of the same case or class of case for different purposes;

(b) in relation to all cases to which the power extends or in relation to those cases subject to specified exceptions; or

(c) so as to make any supplementary, incidental, consequential, transitional, transitory or saving provision as the Council considers necessary or expedient.

(2) The Council must ensure that its rule making powers under this Order are exercised in such a way so as to ensure that its rules are and remain consistent with the requirements of the EU Treaties and the Directive.

(3) Before making rules under Parts 3 to 7 of this Order, the Council must consult such persons or organisations as it considers appropriate including—

(a) [F3 the National Health Service Commissioning Board] in England;

(b) Local Health Boards in Wales;

(c) Health Boards in Scotland;

(d) persons carrying on a retail pharmacy business at a registered pharmacy;

(e) professional bodies or organisations appearing to the Council to represent registrants;

(f) [F4 the Professional Standards Authority for Health and Social Care];

(g) such other regulatory bodies as the Council considers relevant; and

(h) other persons, bodies or organisations representing members of the public and patients.

(4) No rules made under this Order, except rules made solely under article 36 (or article 36 together with paragraph (1)), can come into force until approved by order of the Privy Council.

(5) The Privy Council may approve rules submitted to them for approval either in the form submitted to them or subject to such modifications as appear necessary to them.

Textual Amendments

F3 Words in art. 66(3)(a) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 144(2)

F4 Words in art. 66(3)(f) substituted (1.12.2012) by The Health and Social Care Act 2012 (Consequential Amendments – the Professional Standards Authority for Health and Social Care) Order 2012 (S.I. 2012/2672), arts. 1(2), 2(d)

Commencement Information

I135 Art. 66 in force at 10.2.2010 for specified purposes, see art. 1(3)

I136 Art. 66 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

The Directive: designation of competent authority etc. E+W+S

67.—(1) The Council is designated as the competent authority in Great Britain for the purposes of the Directive so far as it relates to the professions of pharmacist and pharmacy technician.

(2) Accordingly, the Council must in Great Britain carry out (in particular) the functions specified in Schedule 3.

(3) The Council is designated as the competent authority in Great Britain for the award of evidence of formal qualifications in pharmacy listed in relation to the United Kingdom in Annex V, point 5.6.2 of the Directive.

(4) Subject to paragraph (5), the Secretary of State may give directions to the Council in connection with its functions specified in Schedule 3, and it is the duty of the Council to comply with any such directions.

(5) Directions given under paragraph (4) may be as to matters of administration only.

(6) In Schedule 3—

“non-UK pharmacy qualification” means a qualification in pharmacy that is awarded to a person by a competent authority of a relevant European State other than the United Kingdom; and

“GB pharmacy qualification” means a qualification in pharmacy that is awarded to a person by a competent authority in Great Britain.

Commencement Information

I137 Art. 67 in force at 10.2.2010 for specified purposes, see art. 1(3)

I138 Art. 67 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendments, repeals and revocations E+W+S

68.  The amendments, repeals and revocations contained in Schedule 4 have effect.

Commencement Information

I139 Art. 68 in force at 10.2.2010 for specified purposes, see art. 1(3)

I140 Art. 68 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Transitional, transitory and saving provisions E+W+S

69.—(1) The transitional provisions contained in Schedule 5 have effect.

(2) The savings contained in Schedule 6 have effect.

(3) In connection with the commencement of any provision of this Order, the Privy Council may by order make such transitional, transitory or saving provisions as it considers appropriate.

(4) The power to make an order under paragraph (3) may be exercised—

(a) so as to make different provision—

(i) with respect to different cases or different classes of cases, or

(ii) in respect of the same case or class of case for different purposes;

(b) in relation to all cases to which the power extends or in relation to all those cases subject to specified exceptions; or

(c) so as to make any supplementary, incidental or consequential provisions which the Privy Council considers necessary or expedient.

Commencement Information

I141 Art. 69(1)-(4) in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

I142 Art. 69 in force at 10.2.2010 for specified purposes, see art. 1(3)

Privy Council procedures etc. E+W+S

70.—(1) Any power vested in the Privy Council to make an order under this Order may be exercised by any two or more members of the Privy Council.

(2) Any power of the Privy Council to make an order under this Order is exercisable by statutory instrument and, except for an order made solely in respect of approving rules under article 19, 27, 31 or 36 (or any of those articles together with article 66(1)), an order of the Privy Council under this Order is subject to annulment in pursuance of a resolution of either House of Parliament or of the Scottish Parliament.

(3) Paragraph (2) and article 66(4) do not preclude the inclusion of rules under article 19, 27, 31 or 36 in a set of rules which is to be approved by an order of the Privy Council that is subject to annulment in pursuance of a resolution of either House of Parliament or of the Scottish Parliament.

(4) For the purposes of section 1 of the Statutory Instruments Act 1946(56) (definition of “Statutory Instrument”), any power of the Privy Council to make an order under this Order is to be taken to be conferred by an Act of Parliament.

(5) Any act of the Privy Council under this Order is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

(6) Where an order or act of the Privy Council under this Order is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence, and in Scotland, sufficient evidence, of—

(a) the fact that the order was duly made, or the act duly done; and

(b) the order’s terms.

Commencement Information

I143 Art. 70 in force at 10.2.2010 for specified purposes, see art. 1(3)

I144 Art. 70 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Judith Simpson

Clerk of the Privy Council

Article 4(2) and (8)

SCHEDULE 1 E+W+S Constitution of the General Pharmaceutical Council

Membership: general E+W+S

1.—(1) The Council is to consist of—

(a) registrant members, that is members who are entered in the Register as a pharmacist or as a pharmacy technician; and

(b) lay members, that is members who—

(i) are not and never have been entered in the register of any regulatory body, and

(ii) do not hold qualifications which would entitle them to apply for registration under this Order.

(2) The members of the Council are to be appointed by the Privy Council.

(3) The Privy Council must ensure that, at any time, at least one of the members of the Council lives or works wholly or mainly in each of England, Scotland and Wales.

F5 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F5 Sch. 1 para. 1(4)(5) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 144(3)

Commencement Information

I145 Sch. 1 para. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I146 Sch. 1 para. 1 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Matters for the order of the Privy Council under article 4(2) E+W+S

2.—(1) An order under article 4(2) must include provision with regard to—

(a) the number of registrant members and lay members of the Council;

(b) the terms of office for which members of the Council are appointed and the order may provide that these are to be determined by the Privy Council, on appointment;

(c) the grounds on which persons are to be disqualified for appointment as registrant or lay members of the Council;

(d) the appointment (from among the members of the Council) of a chair of the Council and the chair’s term of office, and the order may provide that the term is to be determined by whoever makes the appointment as chair, on appointment;

(e) deputising arrangements in respect of the chair;

(f) the appointment of the first Chief Executive Officer of the Council;

(g) the quorum of the Council;

(h) the circumstances in which members cease to hold office or may be removed or suspended from office.

(2) An order under article 4(2) may include provision with regard to—

(a) the maximum period for which a member of the Council may hold office as a member during a specified period;

(b) the maximum period for which a member of the Council may serve as chair of the Council during a specified period;

(c) the education and training of members of the Council, and the order may provide for the Council to include the requirements with regard to education and training of its members in standing orders and for those standing orders to provide for—

(i) education and training to be the responsibility of another body, and

(ii) those requirements to be set and varied by that body from time to time;

(d) the attendance of members of the Council at meetings of the Council.

(3) An order under article 4(2) may make different provision for different cases or different classes of case and may contain such incidental, consequential, transitional, transitory, saving or supplementary provisions as appear to the Privy Council to be necessary or expedient.

Commencement Information

I147 Sch. 1 para. 2 in force at 10.2.2010 for specified purposes, see art. 1(3)

I148 Sch. 1 para. 2 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Powers of the Council E+W+S

3.—(1) Subject to the following provisions of this Schedule, the Council has power to do anything which is calculated to facilitate the discharge of its functions or which is incidental or conducive to the discharge of its functions.

(2) The Council has, in particular, power—

(a) to borrow;

(b) to institute criminal prosecutions under any enactment;

(c) to appoint such staff (including, subject to paragraph 2(1)(f), a Chief Executive Officer) as it may determine;

(d) to establish such sub-committees of any of its committees as it may determine;

(e) subject to any provision made by or under this Order, to regulate the procedure of any of its committees or their sub-committees;

(f) to abolish any of its committees, other than a statutory committee, or to abolish any sub-committee of any of its committees;

(g) to pay its members such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as may be determined by the Privy Council on appointment;

(h) to pay the members of its statutory committees (including co-opted members), the members of any of its other committees and the members of the sub-committees of any of its committees such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine;

(i) to pay its staff (including the Registrar and any Deputy Registrar) such remuneration, pensions, allowances, expenses or gratuities, or make such contributions or payments towards provision for such pensions, allowances or gratuities, as it may reasonably determine;

(j) to pay such remuneration, allowances or expenses as it may reasonably determine to advisers advising the Council or one of its committees on issues falling within the advisers’ speciality which are under consideration by the Council or committee, including legal advisers appointed under article 63 and clinical and other specialist advisers appointed under article 64.

(3) The powers of the Council may be exercised even though there is a vacancy among its members.

(4) No proceedings of the Council are to be invalidated by any defect in the appointment of a member.

(5) Subject to any provision made by or under this Order, the Council may regulate its own procedure.

Commencement Information

I149 Sch. 1 para. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I150 Sch. 1 para. 3 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Registration of members’ private interests E+W+S

4.—(1) The Council must establish and maintain a system for the declaration and registration of private interests of its members.

(2) The Council must publish in such manner as it sees fit entries recorded in its register of members’ private interests.

Commencement Information

I151 Sch. 1 para. 4 in force at 10.2.2010 for specified purposes, see art. 1(3)

I152 Sch. 1 para. 4 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

The statutory committees E+W+S

5.—(1) The Council must by rules, as regards each of the statutory committees, make provision with regard to—

(a) its size and composition (which may vary according to the functions the committee is performing), but the number of members of the committee who are registrants must not exceed the number of other members on the committee by more than one;

(b) the appointment, performance, suspension and removal from office of its members;

(c) the appointment, performance, suspension and removal from office of its chair (who is to be one of its members);

(d) the quorum at its meetings; and

(e) its procedures, including deputising arrangements with regard to its chair.

(2) The provisions with regard to size, composition and procedures of a statutory committee may, except in relation to the Investigating Committee, provide for the chair of the committee to have the power to determine a particular size and composition for the committee for a particular hearing or inquiry before the committee and, in particular, to determine—

(a) that only specified members of the full committee are entitled to sit at the hearing or inquiry and decide the matter to which the hearing or inquiry relates (but the chair or a deputy chair must be one of the specified members); and

(b) a different quorum for the hearing or inquiry and the related meetings of the committee than would otherwise be the case (which must not be less than three),

but where the chair does determine a particular size and composition of the committee for a particular hearing or inquiry, the chair must ensure that the number of registrants who are members of that formation of the committee does not exceed the number of other members by more than one.

(3) Rules under this paragraph may in addition include provision with regard to—

(a) the education and training of members of a statutory committee, and the rules may provide that members are to meet competencies that the Council may determine from time to time;

(b) the attendance of members of a statutory committee;

(c) requiring a statutory committee to—

(i) establish and maintain a system for the declaration and registration of private interests of its members, and

(ii) publish in such manner as it sees fit entries recorded in its register of members’ private interests; and

(d) the functions to be performed by a statutory committee and how it is to perform them.

(4) Rules under this paragraph must provide that—

(a) no person may be both a member of the Council and of the Appeals Committee or the Fitness to Practise Committee;

(b) no person may be both a member of the Investigating Committee and of the Fitness to Practise Committee;

(c) no person who is a member of the Fitness to Practise Committee that has made an interim order under article 56 in proceedings in any case may sit as a member of the Committee in subsequent proceedings in that case, unless the subsequent proceedings relate solely to measures under article 56; and

(d) the appointment, suspension and removal of members, chairs and deputy chairs of the statutory committees must be by the Council, except that the rules may provide for the Council to enter into arrangements with another person, body or committee (including a committee of the Council that is not one of the statutory committees) to carry out all or any of these functions on the Council’s behalf.

(5) Rules under this paragraph may provide for a statutory committee to—

(a) have more than one deputy chair;

(b) co-opt members onto the committee in such circumstances as may be specified in the rules; and

(c) discharge, in such circumstances and subject to such conditions as may be specified in the rules, functions of the Council.

(6) The powers of a statutory committee may be exercised even though there is a vacancy among its members.

(7) No proceedings of a statutory committee are to be invalidated by any defect in the appointment of a member.

Commencement Information

I153 Sch. 1 para. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I154 Sch. 1 para. 5 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

The Council’s duties in respect of publications E+W+S

6.—(1) The Council must from time to time publish or provide in such manner as it sees fit information about the regulation of pharmacists, pharmacy technicians and registered pharmacies.

(2) The Council may from time to time publish or provide in such manner as it sees fit guidance to registrants, employers and such other persons as it considers appropriate in respect of the standards for the education, training, supervision and performance of persons who are not registrants but who provide services in connection with those provided by registrants.

Commencement Information

I155 Sch. 1 para. 6 in force at 10.2.2010 for specified purposes, see art. 1(3)

I156 Sch. 1 para. 6 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Accounts E+W+S

7.—(1) The Council must—

(a) keep accounts, which must be in such form as the Privy Council may determine; and

(b) prepare annual accounts in respect of each financial year, which must be in such form and must be prepared by such date as the Privy Council determines.

(2) In sub-paragraph (1), “financial year” means—

(a) the period beginning with the day on which the Council is established and ending with the next 31 March following that day, and

(b) each successive period of 12 months ending with 31 March.

(3) The Council must ensure that a person eligible for appointment as a statutory auditor under Part 42 of the Companies Act 2006(57) (statutory auditors) audits the Council’s annual accounts.

(4) As soon as is reasonably practicable after those accounts have been audited, the Council must—

(a) cause them to be published together with any report made on them by the auditors appointed under sub-paragraph (3); and

(b) send a copy of those annual accounts and of any such report to the Privy Council,

and the Privy Council must lay before each House of Parliament and before the Scottish Parliament a copy of those annual accounts and of any report on the accounts made by the auditors appointed under sub-paragraph (3).

Commencement Information

I157 Sch. 1 para. 7 in force at 10.2.2010 for specified purposes, see art. 1(3)

I158 Sch. 1 para. 7 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Annual reports, statistical information and strategic plans E+W+S

8.—(1) The Council must publish, by such date in each calendar year as the Privy Council may determine—

(a) a report on the exercise of its functions which includes a description of the arrangements that the Council has put in place to ensure that it adheres to good practice in relation to equality and diversity (and for these purposes “equality” and “diversity” have the meanings given in section 8(2) of the Equality Act 2006(58) (equality and diversity));

(b) a statistical report which indicates the efficiency and effectiveness of, and which includes a description of, the arrangements which the Council has put in place to protect members of the public from registrants whose fitness to practise is impaired, together with the Council’s observations on the report; and

(c) a strategic plan for the Council in respect of such number of years as the Council determines.

(2) The Council must submit copies of the reports and the plan published under sub-paragraph (1) to the Privy Council and the Privy Council must lay copies of the reports and the plan before each House of Parliament and before the Scottish Parliament.

Commencement Information

I159 Sch. 1 para. 8 in force at 10.2.2010 for specified purposes, see art. 1(3)

I160 Sch. 1 para. 8 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(b)

Article 33

SCHEDULE 2 E+W+S Visiting Practitioners from relevant European States

PART 1 E+W+S Pharmacists

Application and interpretation E+W+S

1.—(1) This Part of this Schedule applies to an exempt person who is lawfully established as a pharmacist in a relevant European State other than the United Kingdom.

(2) In this Part—

(a) a “visiting practitioner” means an exempt person to whom this Part applies;

(b) the “home State”, in relation to a visiting practitioner, means the relevant European State in which the practitioner is lawfully established as a pharmacist;

(c) a reference to the provision of occasional pharmacy services is a reference to the provision of services as a pharmacist in Great Britain on a temporary and occasional basis; and

(d) “indemnity arrangement” has the same meaning as in article 32.

Commencement Information

I161 Sch. 2 para. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I162 Sch. 2 para. 1 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Registration in respect of provision of occasional pharmacy services E+W+S

2.—(1) A visiting practitioner is entitled to be entered in Part 4 of the Register if the practitioner is entitled under paragraph 3 or 6 to provide occasional pharmacy services; and the Registrar must give effect to that entitlement.

(2) A visiting practitioner who is entitled under sub-paragraph (1) to be entered in Part 4 of the Register, but who is not entered in that part of the Register, is to be treated as being so entered.

(3) The Registrar may refuse to enter a visiting practitioner in Part 4 of the Register if, in the Registrar’s opinion, that visiting practitioner is not entitled under paragraph 3 or 6 to provide occasional pharmacy services.

(4) If under sub-paragraph (3) the Registrar refuses to enter a visiting practitioner in Part 4 of the Register, the Registrar must send to the practitioner at the practitioner’s last known home address a statement in writing giving the practitioner notice of that decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(5) Sub-paragraph (6) applies where a person’s entitlement under sub-paragraph (1) to be entered in Part 4 of the Register ceases because, by reason of the operation of paragraph 7(1), (2) or (5), the person ceases to be entitled under this Part to provide occasional pharmacy services.

(6) If the person’s name is entered in Part 4 of the Register, the Registrar may remove that person’s name from that part of the Register.

(7) Sub-paragraphs (1), (2), (5) and (6) do not affect the application, in relation to persons entered in Part 4 of the Register on the basis of an entitlement under sub-paragraph (1), of any other provision of this Order under which a registered pharmacist’s name may be removed from that part of the Register or under which a registered pharmacist’s entry in that part of the Register may be suspended.

Commencement Information

I163 Sch. 2 para. 2 in force at 10.2.2010 for specified purposes, see art. 1(3)

I164 Sch. 2 para. 2 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Entitlement to provide occasional pharmacy services: first year E+W+S

3.  A visiting practitioner is entitled to provide occasional pharmacy services if—

(a) the practitioner has complied with the requirements of paragraph 4; and

(b) where the practitioner’s case falls within regulation 3(9)(a) or (e) of the General Systems Regulations, the provision by the practitioner of occasional pharmacy services is in accordance with regulations 14 to 16 of those Regulations (the practitioner having, in particular, successfully completed any adaptation period, or passed any aptitude test, that the practitioner may be required to undertake pursuant to Part 2 of those Regulations),

and paragraph 7 contains provision about the duration of entitlement under this paragraph.

Commencement Information

I165 Sch. 2 para. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I166 Sch. 2 para. 3 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

First provision of services: required documents E+W+S

4.—(1) A visiting practitioner who proposes to provide occasional pharmacy services for the first time must, before providing those services, send or produce to the Registrar the required documents.

(2) The required documents are—

(a) a written declaration that—

(i) states the practitioner’s wish to provide occasional pharmacy services, and

(ii) contains details of the indemnity arrangement, or the other means of personal or collective protection, that the practitioner has in place in respect of liabilities that may be incurred in practising as a pharmacist;

(b) if the practitioner is a national of a relevant European State, proof of nationality;

(c) if the practitioner is not a national of a relevant European State, proof of the [F1 EU] right by virtue of which the practitioner is an exempt person;

(d) evidence of qualifications in pharmacy (see also paragraph 5); and

(e) a certificate (or certificates) issued by a competent authority in the practitioner’s home State confirming—

(i) that the practitioner is lawfully established as a pharmacist in that State, and

(ii) that the practitioner is not prohibited (whether on a permanent or temporary basis) from practising as a pharmacist there.

(3) A declaration under sub-paragraph (2)(a) may be supplied by any means.

Textual Amendments

F1 Words in Order substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 3-6

Commencement Information

I167 Sch. 2 para. 4 in force at 10.2.2010 for specified purposes, see art. 1(3)

I168 Sch. 2 para. 4 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

First provision of services: supplementary E+W+S

5.—(1) Subject to sub-paragraph (3), the evidence referred to in paragraph 4(2)(d) is evidence of the European-recognised qualifications which entitle the visiting practitioner to provide, in the practitioner’s home State, the pharmacy services that the practitioner proposes to provide in Great Britain on a temporary and occasional basis.

(2) This sub-paragraph applies to a visiting practitioner whose case falls within regulation 3(9)(a) or (e) of the General Systems Regulations (with the result that the practitioner is not able to provide occasional pharmacy services unless their provision by the practitioner is in accordance with regulations 14 to 16 of those Regulations).

(3) If sub-paragraph (2) applies to a visiting practitioner, the evidence referred to in paragraph 4(2)(d) of the practitioner’s qualifications in pharmacy is evidence of the qualifications which entitle the practitioner to practise as a pharmacist in his home State.

(4) In this paragraph, “European-recognised qualifications” means qualifications which relevant European States are required by the Directive to recognise.

Commencement Information

I169 Sch. 2 para. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I170 Sch. 2 para. 5 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Entitlement to provide occasional pharmacy services after the first year: renewals E+W+S

6.—(1) Sub-paragraph (2) applies where the Registrar receives the required renewal documents from a visiting practitioner who is entitled under this Part to provide occasional pharmacy services before such time prior to the practitioner’s entitlement ceasing to be valid under article 7(1) or (2) as is prescribed by the Council for the receipt of those documents by the Registrar.

(2) The visiting practitioner is entitled to continue to provide occasional pharmacy services, and paragraph 7 contains provision about the duration of the entitlement continued under this sub-paragraph.

(3) Sub-paragraph (4) applies where the Registrar receives the required renewal documents from a visiting practitioner—

(a) who is not entitled under this Part to provide occasional pharmacy services;

(b) who has previously been entitled under this Part to provide occasional pharmacy services; and

(c) whose entry in Part 4 of the Register is not suspended.

(4) The visiting practitioner is once again entitled to provide occasional pharmacy services but, in a case where the practitioner’s name is not in Part 4 of the Register as a result of removal otherwise than under paragraph 2(6), only if the Registrar decides, after having regard (in particular) to the fact of that removal and the reasons for it, that the entitlement should be renewed, and paragraph 7 contains provision about the duration of entitlement under this sub-paragraph.

(5) In relation to a visiting practitioner “the required renewal documents” are—

(a) a renewal declaration; and

(b) each evidence of change document (if any).

(6) In this paragraph “renewal declaration”, in relation to a visiting practitioner, means a written declaration that—

(a) states the practitioner’s wish to provide occasional pharmacy services in a further year; and

(b) contains details of the indemnity arrangement, or the other means of personal or collective protection, that the practitioner has in place in respect of liabilities that may be incurred in practising as a pharmacist.

(7) Where a document—

(a) is, in relation to a visiting practitioner, one of the required documents for the purposes of paragraph 4;

(b) is not a declaration under paragraph 4(2)(a); and

(c) substantiates a matter as respects which there has been a material change since the practitioner last (whether under paragraph 4 or this paragraph) supplied the then-current version of the document to the Registrar,

the version of the document current when, under this paragraph, the practitioner supplies a renewal declaration to the Registrar is an “evidence of change document” for the purposes of sub-paragraph (5)(b).

(8) A renewal declaration supplied under this paragraph may be supplied by any means.

(9) If the Registrar refuses to renew the entry of a visiting practitioner in the Register, the Registrar must send to that practitioner at that practitioner’s last known home address a statement in writing giving that practitioner notice of the refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Commencement Information

I171 Sch. 2 para. 6 in force at 10.2.2010 for specified purposes, see art. 1(3)

I172 Sch. 2 para. 6 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Duration of entitlement to provide occasional pharmacy services E+W+S

7.—(1) Unless an entitlement under paragraph 3 or 6 is continued by paragraph 6(2), or further continued by paragraph 6(4), the entitlement ceases at the end of the year that begins with the end of the day on which the Registrar received the documents whose receipt gave rise to the entitlement.

(2) Where an entitlement under paragraph 3 or 6 is continued by paragraph 6(2), or further continued by paragraph 6(4), the entitlement is extended so as to cease at the end of the year that begins with the end of the relevant day.

(3) For the purposes of sub-paragraph (2)—

(a) if the day on which the Registrar receives the documents whose receipt gives rise to the continuation (or further continuation) is an anniversary of the start day, “the relevant day” means the day on which the Registrar receives those documents;

(b) otherwise, “the relevant day” means the anniversary of the start day that is the first such anniversary to occur after the Registrar receives the documents whose receipt gives rise to the continuation (or further continuation).

(4) In sub-paragraph (3) “the start day”, in relation to an entitlement under paragraph 3 or 6(4), means the day on which the Registrar receives the documents whose receipt gives rise to the entitlement.

(5) An entitlement under this Part to provide occasional pharmacy services ceases if—

(a) the visiting practitioner concerned becomes established as a pharmacist in the United Kingdom; or

(b) a disqualifying decision is made against the visiting practitioner concerned.

(6) In sub-paragraph (5), “disqualifying decision”, in relation to a visiting practitioner, means a decision made by a competent or judicial authority in the practitioner’s home State that has the effect that the practitioner—

(a) ceases in that State to be registered or otherwise officially recognised as a pharmacist; or

(b) is prohibited (whether on a permanent or temporary basis) from practising as a pharmacist in that State.

(7) If in the case of a visiting practitioner—

(a) the practitioner’s entry in Part 4 of the Register is suspended or the practitioner’s name is removed from that part of the Register; and

(b) immediately before the time when the suspension or, as the case may be, removal takes effect, the practitioner is entitled under this Part to provide occasional pharmacy services,

that entitlement ceases at that time.

Commencement Information

I173 Sch. 2 para. 7 in force at 10.2.2010 for specified purposes, see art. 1(3)

I174 Sch. 2 para. 7 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Conditions E+W+S

8.—(1) Sub-paragraph (2) applies if—

(a) the establishment of a visiting practitioner in the practitioner’s home State is subject to a condition relating to the practitioner’s practice as a pharmacist;

(b) the practitioner’s name is in Part 4 of the Register; and

(c) for any of the purposes of this Order it falls to be decided whether the practitioner’s fitness to practise is or may be impaired on the ground of misconduct.

(2) The matters that may be counted as misconduct include (in particular) any act or omission by the visiting practitioner during the course of the provision by the practitioner of occasional pharmacy services that is, or would be if the condition applied in relation to practice as a pharmacist outside the practitioner’s home State, a breach of the condition.

(3) In sub-paragraphs (1) and (2) “condition” includes limitation.

Commencement Information

I175 Sch. 2 para. 8 in force at 10.2.2010 for specified purposes, see art. 1(3)

I176 Sch. 2 para. 8 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 2 E+W+S Pharmacy technicians

Application and interpretation E+W+S

9.—(1) This Part of this Schedule applies to an exempt person who is lawfully established as a pharmacy technician in a relevant European State other than the United Kingdom.

(2) In this Part—

(a) a “visiting practitioner” means an exempt person to whom this Part applies;

(b) the “home State”, in relation to a visiting practitioner, means the relevant European State in which the practitioner is lawfully established as a pharmacy technician;

(c) a reference to the provision of occasional pharmacy services is a reference to the provision of services as a pharmacy technician in Great Britain on a temporary and occasional basis; and

(d) “indemnity arrangement” has the same meaning as in article 32.

Commencement Information

I177 Sch. 2 para. 9 in force at 10.2.2010 for specified purposes, see art. 1(3)

I178 Sch. 2 para. 9 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Registration in respect of the provision of occasional services E+W+S

10.—(1) A visiting practitioner is entitled to be entered in Part 5 of the Register if the practitioner is entitled under paragraph 11 or 14 to provide occasional pharmacy services: and the Registrar must give effect to that entitlement.

(2) A visiting practitioner who is entitled under sub-paragraph (1) to be entered in Part 5 of the Register as a pharmacy technician, but who is not entered in that part of the Register, is to be treated as being so entered.

(3) The Registrar may refuse to enter a visiting practitioner in Part 5 of the Register if, in the Registrar’s opinion, that visiting practitioner is not entitled under paragraph 11 or 14 to provide occasional pharmacy services.

(4) If under sub-paragraph (3) the Registrar refuses to enter a visiting practitioner in Part 5 of the Register, the Registrar must send to the practitioner at the practitioner’s last known home address a statement in writing giving the practitioner notice of that decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

(5) Sub-paragraph (6) applies where a person’s entitlement under sub-paragraph (1) to be entered in Part 5 of the Register ceases because, by reason of the operation of paragraph 15(1), (2) or (5), the person ceases to be entitled to provide occasional pharmacy services.

(6) If the person’s name is entered in Part 5 of the Register, the Registrar may remove that person’s name from that part of the Register.

(7) Sub-paragraphs (1), (2), (5) and (6) do not affect the application, in relation to persons entered in Part 5 of the Register on the basis of an entitlement under sub-paragraph (1), of any other provision of this Order under which a registered pharmacy technician’s name may be removed from that part of the Register or under which a registered pharmacy technician’s entry in that part of the Register may be suspended.

Commencement Information

I179 Sch. 2 para. 10 in force at 10.2.2010 for specified purposes, see art. 1(3)

I180 Sch. 2 para. 10 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Entitlement to provide occasional pharmacy services: first year E+W+S

11.  A visiting practitioner is entitled to provide occasional pharmacy services if—

(a) the practitioner has complied with the requirements of paragraph 12; and

(b) the practitioner has the benefit of regulation 8 of the General Systems Regulations (having complied with any requirements imposed under Part 2 of those Regulations in connection with the provision by a visiting practitioner of services as a pharmacy technician),

and paragraph 15 contains provision about the duration of entitlement under this paragraph.

Commencement Information

I181 Sch. 2 para. 11 in force at 10.2.2010 for specified purposes, see art. 1(3)

I182 Sch. 2 para. 11 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

First provision of services: required documents E+W+S

12.—(1) A visiting practitioner who proposes to provide occasional pharmacy services for the first time must, before providing those services, send or produce to the Registrar the required documents.

(2) The required documents are—

(a) a written declaration that—

(i) states the practitioner’s wish to provide occasional pharmacy services, and

(ii) contains details of the indemnity arrangement, or the other means of personal or collective protection, that the practitioner has in place in respect of liabilities that may be incurred in practising as a pharmacy technician;

(b) if the practitioner is a national of a relevant European State, proof of nationality;

(c) if the practitioner is not a national of a relevant European State, proof of the [F1 EU] right by virtue of which the practitioner is an exempt person;

(d) evidence of qualifications in pharmacy (see also paragraph 13); and

(e) a certificate (or certificates) issued by a competent authority in the practitioner’s home State confirming—

(i) that the practitioner is lawfully established as a pharmacy technician in that State, and

(ii) that the practitioner is not prohibited (whether on a permanent or temporary basis) from practising as a pharmacy technician there;

(f) if a certificate of the type referred to in paragraph (e) is not available, such other information or documents from such other individuals, authorities or organisations as the Council may prescribe.

(3) A declaration under sub-paragraph (2)(a) may be supplied by any means.

Textual Amendments

F1 Words in Order substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 3-6

Commencement Information

I183 Sch. 2 para. 12 in force at 10.2.2010 for specified purposes, see art. 1(3)

I184 Sch. 2 para. 12 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

First provision of services: supplementary E+W+S

13.—(1) The evidence referred to in paragraph 12(2)(d) is evidence of—

(a) the European-recognised qualifications which entitle the visiting practitioner to provide, in the practitioner’s home State, the pharmacy services that the practitioner proposes to provide in Great Britain on a temporary and occasional basis; or

(b) the qualifications which entitle the practitioner to practise as a pharmacy technician in the practitioner’s home State.

(2) In this paragraph, “European-recognised qualifications” means qualifications which relevant European States are required by the Directive to recognise.

Commencement Information

I185 Sch. 2 para. 13 in force at 10.2.2010 for specified purposes, see art. 1(3)

I186 Sch. 2 para. 13 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Entitlement to provide occasional pharmacy services after the first year: renewals E+W+S

14.—(1) Sub-paragraph (2) applies where the Registrar receives the required renewal documents from a visiting practitioner who is entitled under this Part to provide occasional pharmacy services before such time prior to the practitioner’s entitlement ceasing to be valid under article 15(1) or (2) as is prescribed by the Council for the receipt of those documents by the Registrar.

(2) The visiting practitioner is entitled to continue to provide occasional pharmacy services, but paragraph 15 contains provision about the duration of the entitlement continued under this sub-paragraph.

(3) Sub-paragraph (4) applies where the Registrar receives the required renewal documents from a visiting practitioner—

(a) who is not entitled under this Part to provide occasional pharmacy services;

(b) who has previously been entitled under this Part to provide occasional pharmacy services; and

(c) whose entry in Part 5 of the Register is not suspended.

(4) The visiting practitioner is once again entitled to provide occasional pharmacy services but, in a case where the practitioner’s name is not in Part 5 of the Register as a result of removal otherwise than under paragraph 10(6), only if the Registrar decides, after having regard (in particular) to the fact of that removal and the reasons for it, that the entitlement should be renewed, and paragraph 15 contains provision about the duration of entitlement under this sub-paragraph.

(5) In relation to a visiting practitioner, “the required renewal documents” are—

(a) a renewal declaration; and

(b) each evidence of change document (if any).

(6) In this paragraph, “renewal declaration”, in relation to a visiting practitioner, means a written declaration that—

(a) states the practitioner’s wish to provide occasional pharmacy services in a further year; and

(b) contains details of the indemnity arrangement, or the other means of personal or collective protection, that the practitioner has in place in respect of liabilities that may be incurred in practising as a pharmacy technician.

(7) Where a document—

(a) is, in relation to a visiting practitioner, one of the required documents for the purposes of paragraph 12;

(b) is not a declaration under paragraph 12(2)(a); and

(c) substantiates a matter as respects which there has been a material change since the practitioner last (whether under paragraph 12 or this paragraph) supplied the then-current version of the document to the Registrar,

the version of the document current when, under this paragraph, the practitioner supplies a renewal declaration to the Registrar is an “evidence of change document” for the purposes of sub-paragraph (5)(b).

(8) A renewal declaration supplied under this paragraph may be supplied by any means.

(9) If the Registrar refuses to renew the entry of a visiting practitioner in the Register, the Registrar must send to that practitioner at that practitioner’s last known home address a statement in writing giving that practitioner notice of the refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Commencement Information

I187 Sch. 2 para. 14 in force at 10.2.2010 for specified purposes, see art. 1(3)

I188 Sch. 2 para. 14 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Duration of entitlement to provide occasional pharmacy services E+W+S

15.—(1) Unless an entitlement under paragraph 11 or 14 is continued by paragraph 11(2), or further continued by paragraph 14(2), the entitlement ceases at the end of the year that begins with the end of the day on which the Registrar received the documents whose receipt gave rise to the entitlement.

(2) Where an entitlement under paragraph 11 is continued by paragraph 14(2), or further continued by paragraph 14(4), the entitlement is extended so as to cease at the end of the year that begins with the end of the relevant day.

(3) For the purposes of sub-paragraph (2)—

(a) if the day on which the Registrar receives the documents whose receipt gives rise to the continuation (or further continuation) is an anniversary of the start day, “the relevant day” means the day on which the Registrar receives those documents;

(b) otherwise, “the relevant day” means the anniversary of the start day that is the first such anniversary to occur after the Registrar receives the documents whose receipt gives rise to the continuation (or further continuation).

(4) In sub-paragraph (3), “the start day”, in relation to an entitlement under paragraph 11 or 14(4), means the day on which the Registrar receives the documents whose receipt gives rise to the entitlement.

(5) An entitlement under this Part ceases if—

(a) the visiting practitioner concerned becomes established as a pharmacy technician in the United Kingdom; or

(b) a disqualifying decision is made against the visiting practitioner concerned.

(6) In sub-paragraph (5), “disqualifying decision”, in relation to a visiting practitioner, means a decision made by a competent or judicial authority in the practitioner’s home State that has the effect that the practitioner—

(a) ceases in that State to be registered or otherwise officially recognised as a pharmacy technician; or

(b) is prohibited (whether on a permanent or temporary basis) from practising as a pharmacy technician in that State.

(7) If in the case of a visiting practitioner—

(a) the practitioner’s entry in Part 5 of the Register is suspended or the practitioner’s name is removed from that part of the Register; and

(b) immediately before the time when the suspension or, as the case may be, removal takes effect, the practitioner is entitled under this Part to provide occasional pharmacy services,

that entitlement ceases at that time.

Commencement Information

I189 Sch. 2 para. 15 in force at 10.2.2010 for specified purposes, see art. 1(3)

I190 Sch. 2 para. 15 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Conditions E+W+S

16.—(1) Sub-paragraph (2) applies if—

(a) the establishment of a visiting practitioner in the practitioner’s home State is subject to a condition relating to that practitioner’s practice as a pharmacy technician;

(b) the practitioner’s name is in Part 5 of the Register; and

(c) for any of the purposes of this Order it falls to be decided whether the practitioner’s fitness to practise is or may be impaired on the ground of misconduct.

(2) The matters that may be counted as misconduct include (in particular) any act or omission by the visiting practitioner during the course of the provision by the practitioner of occasional pharmacy services that is, or would be if the condition applied in relation to practice as a pharmacy technician outside the practitioner’s home State, a breach of the condition.

(3) In sub-paragraphs (1) and (2), “condition” includes limitation.

Commencement Information

I191 Sch. 2 para. 16 in force at 10.2.2010 for specified purposes, see art. 1(3)

I192 Sch. 2 para. 16 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Article 67

SCHEDULE 3 E+W+S The Directive: Designation of competent authority etc.

Commencement Information

I193 Sch. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I194 Sch. 3 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Provision of Directive	Function of Council
Article 7(2)(b)	Issuing certificates containing attestations in relation to persons established as pharmacists and pharmacy technicians in Great Britain.
Article 8(1)	Receiving information from, or providing information to, other competent authorities in relation to— (a) the legality of a person’s establishment as a pharmacist or pharmacy technician; (b) the good conduct of such a person; (c) the absence of any disciplinary or criminal sanctions of a professional nature against such a person.
Article 8(2)	Receiving information from, or providing information to, other competent authorities in connection with the investigation of complaints made against persons providing services as a pharmacist or pharmacy technician.
Article 23(1)	Issuing certificates of effective and lawful practice in Great Britain to pharmacists and pharmacy technicians.
Article 23(6)	Issuing certificates stating that GB pharmacy qualifications, which do not correspond to the titles set out in respect of the United Kingdom at point 5.6.2 of Annex V to the Directive, certify successful completion of training in pharmacy that is in accordance with article 44 of the Directive or that under article 22(a) of the Directive (part-time training) is to be treated as in accordance with article 44 of the Directive.
Article 50(1) and paragraph 1(b) of Annex VII	Providing information to other competent authorities concerning the training in Great Britain of a pharmacist or pharmacy technician to whom Chapter 1 of Part 3 of the General Systems Regulations applies.
Article 50(1) and paragraph 1(d) of Annex VII	Issuing, in respect of practice as a pharmacist or pharmacy technician, the certificates of current professional status referred to in sub-paragraph (d) of paragraph 1 of Annex VII to the Directive within the time limits set by that sub-paragraph.
Article 50(1) and paragraph 2 of Annex VII	Issuing certificates stating that evidence of GB pharmacy qualifications is that covered by the Directive.
Article 50(2)	In cases of justified doubts— (a) requiring confirmation of the authenticity of non-UK pharmacy qualifications; (b) requiring confirmation that holders of non-UK pharmacy qualifications satisfy the minimum training conditions set out in article 44 of the Directive or under article 22(a) of the Directive are to be treated as satisfying those conditions; (c) providing confirmation to competent authorities of other relevant European States of the authenticity of any person’s GB pharmacy qualifications; (d) providing confirmation that holders of GB pharmacy qualifications satisfy the minimum training conditions set out in article 44 of the Directive or under article 22(a) of the Directive are to be treated as satisfying those conditions.
Article 50(3)	In cases of justified doubts— (a) verifying information provided in connection with non-UK pharmacy qualifications awarded following training in a relevant European State other than the State in which the qualification was awarded; (b) providing information in connection with a person’s GB pharmacy qualifications awarded following training in another relevant European State.
Article 56(1)	Ensuring the confidentiality of information exchanged with other competent authorities.
Article 56(2)	Receiving information from, or providing information to, other competent authorities regarding disciplinary action, criminal sanctions or other serious circumstances likely to have consequences for the practice of the profession of pharmacist or pharmacy technician.
	Where such information is received by the Council— (a) examining the veracity of the circumstances; (b) deciding the nature and scope of any investigations that need to be carried out; (c) informing other competent authorities of the Council’s conclusions.

Article 68

SCHEDULE 4 E+W+S Amendments, repeals and revocations

PART 1 E+W+S Primary legislation

Amendment of the Medicines Act 1968 E+W+S

1.—(1) The Medicines Act 1968(59) is amended as follows.

(2) In section 69(60) (general provisions for Part 4)—

(a) in subsection (1ZA), for “registered in Part 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007 (visiting pharmacists from relevant European States)” substitute “registered in Part 4 of the register maintained under article 19 of the Pharmacy Order 2010 (visiting pharmacists from relevant European States)”;

(b) in subsection (3)—

(i) omit the definition of “the Council”,

(ii) insert, in the appropriate place, the following definition—

““the register” means—

(a)

in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; and

(b)

in relation to Northern Ireland, the register kept for the purposes of section 75;”,

(iii) for the definition of “the registrar”, substitute—

““the registrar” means—

(a)

in relation to Great Britain, the person appointed under article 18 of the Pharmacy Order 2010 as registrar for the purposes of that Order; and

(b)

in relation to Northern Ireland, the person appointed under Article 9(1) of the Pharmacy (Northern Ireland) Order 1976 as registrar for the purposes of that Order;”, and

(iv) for the definition of “the relevant disciplinary committee” substitute—

““the relevant disciplinary committee” means—

(a)

in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; and

(b)

in relation to Northern Ireland, the Statutory Committee appointed under Article 19 of the Pharmacy (Northern Ireland) Order 1976;”.

(3) In section 70(61) (business carried on by individual pharmacist or by partners)—

(a) in subsection (3), for paragraph (b) substitute—

“(b) the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and”;

(b) in subsection (4), for paragraph (b) substitute—

“(b) if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a person registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners), or”;

(c) for subsection (5) substitute—

“(5) In relation to premises in Great Britain that have been registered pharmacies for less than three years, the responsible pharmacist may not be a person who is a pharmacist by virtue of a qualification in pharmacy awarded in a relevant European State.

(6) Subsection (5) does not apply to premises entered in the register by virtue of section 74J.”.

(4) In section 71(62) (business carried on by body corporate)—

(a) in subsection (3), for paragraph (b) substitute—

“(b) the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and”;

(b) for subsection (5) substitute—

“(5) In relation to premises in Great Britain that have been registered pharmacies for less than three years, the responsible pharmacist may not be a person who is a pharmacist by virtue of a qualification in pharmacy awarded in a relevant European State.

(5A) Subsection (5) does not apply to premises entered in the register by virtue of section 74J.”;

(c) for subsection (7) substitute—

“(7) In subsection (6)(a) “pharmacist”—

(a) does not include a person registered in Part 4 of the register maintained under article 19 of the Pharmacy Order 2010 (visiting pharmacists from relevant European States) unless the retail pharmacy business under the management of the person is carried on (in whole or in part) at premises entered in the register by virtue of section 74J; and

(b) does not include a person registered in the register of visiting pharmaceutical chemists from relevant European States maintained under Article 9 of the Pharmacy (Northern Ireland) Order 1976.”; and

(d) after subsection (7), insert—

“(8) If a person who has managed a relevant retail pharmacy business as a superintendent ceases to do so (otherwise than by reason of death) the person must notify the registrar in writing of that fact within the period of 28 days beginning with the day on which the person ceases to manage the business.

(9) For the purposes of subsection (8), a “relevant retail pharmacy business” is a retail pharmacy business carried on (in whole or in part) at premises in Great Britain.”.

(5) In section 72(63) (representative of a pharmacist in case of death or disability) for paragraph (b) of subsection (2B) substitute—

“(b) the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and”.

(6) In subsection 72B(64) (section 72A: supplementary), for subsection (1) substitute—

“(1) The failure by a person to comply with any requirements of section 72A of this Act, or of regulations made under that section, may constitute misconduct for the purposes of section 80 of this Act, article 51(1)(a) of the Pharmacy Order 2010 and Article 20 of the Pharmacy (Northern Ireland) Order 1976 and the relevant disciplinary committee may deal with such a failure accordingly.”.

(7) In section 74(65) (meaning of “registered pharmacy”)—

(a) in subsection (1), omit “required to be kept under section 75 of this Act”;

(b) after subsection (1) insert—

“(1A) If the entry of a registered pharmacy in the register is suspended under paragraph (4)(b) of article 14 of the Pharmacy Order 2010 then, except for such purposes of that Order as the General Pharmaceutical Council may prescribe by rules, that registered pharmacy must be treated as not being entered in the register notwithstanding that the register still includes the address of that pharmacy.

(1B) Accordingly, premises whose entry in the register is suspended are not to be treated as a registered pharmacy for the purposes of this Act or any other enactment apart from that Order.”; and

(c) omit subsection (3).

(8) After section 74 insert—

“Registration of premises: Great Britain

74A.— (1) This section applies in relation to premises in Great Britain.

(2) If the registrar is satisfied that the conditions in section 74B are met in relation to premises that are not entered in the register, the registrar must enter the premises in Part 3 of the register unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

(3) Subject to subsection (5) and to section 74H, the entry of premises entered in Part 3 of the register under subsection (2) is valid for the period of one year beginning with the date on which the entry was made.

(4) If the registrar is satisfied that the conditions in section 74B are met in relation to premises entered in Part 3 of the register under subsection (2), the registrar must renew the entry of the premises unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

(5) Subject to subsection (7) and to section 74H, each renewal of the entry of premises entered in Part 3 of the register under subsection (2) extends the validity of the entry for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid.

(6) The registrar may, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, renew the entry of premises in Part 3 of the register for a period exceeding one year beginning with the day on which the entry would otherwise have ceased to be valid in which case the renewal of the entry of premises entered in that part of the register under subsection (2) extends the validity of the entry for that period.

(7) If the entry of premises entered in Part 3 of the register under this section ceases to be valid then, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, the premises are to be treated for all purposes as no longer being entered in Part 3 of the register and accordingly the registrar must remove the entry from that part of the register.

Conditions for registration: Great Britain

74B.— (1) The conditions referred to in section 74A are as follows.

(2) Condition A is that an application for the entry of the premises in Part 3 of the register or, as the case may be, for the renewal of the entry of the premises in Part 3 of the register is made—

(a) in such form and manner as is prescribed in rules made by the General Pharmaceutical Council; and

(b) if the application is an application for renewal, by such time prior to the entry ceasing to be valid as is so prescribed.

(3) Condition B is that the appropriate fee prescribed in rules made by the General Pharmaceutical Council under article 36(1) of the Pharmacy Order 2010 is paid.

(4) Condition C—

(a) if the application is an application for the entry of the premises in Part 3 of the register, is that either—

(i) the applicant is lawfully conducting a retail pharmacy business, or

(ii) if the premises are entered in Part 3 of the register, and the applicant begins to carry on a retail pharmacy business at the premises, the applicant will, from the time the applicant begins to do so, be a person lawfully conducting a retail pharmacy business; or

(b) if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is that the applicant is lawfully conducting a retail pharmacy business at the premises.

(5) Condition D—

(a) if the application is an application for the entry of the premises in Part 3 of the register, is that the standards that are provided for in rules made under article 7(1) of the Pharmacy Order 2010 are met, or are capable of being met, in connection with the carrying on of a retail pharmacy business at the premises; or

(b) if the application is an application for the renewal of the entry of the premises in Part 3 of the register, is—

(i) that the standards that are provided for in rules made under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at the premises, and

(ii) that the requirements of rules made under article 7(4) of that Order are met by the person carrying on a retail pharmacy business at the premises.

Supplementary provision in respect of registration of premises: Great Britain

74C.— (1) The registrar may restore to Part 3 of the register the entry of premises removed from that part of the register by virtue of section 74A(7) if an application is made to the registrar in accordance with this section.

(2) An entry restored under this section to Part 3 of the register—

(a) is still to be treated as having been entered in that part of the register under section 74A;

(b) is valid for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid by virtue of section 74A(7) or is valid for such longer period beginning with that day as the registrar may in any particular case allow; and

(c) may be subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of section 74A(7) or may be subject to such other conditions as the registrar may impose under section 74D(1).

(3) An application for restoration may be made to the registrar by the person who is the owner of the retail pharmacy business previously carried on at the premises and that person must be—

(a) a person who is lawfully conducting a retail pharmacy business; or

(b) a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at the premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

(4) The General Pharmaceutical Council may make rules in connection with applications under this section.

(5) Rules under subsection (4) may, in particular, include provision—

(a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

(b) about the information to be provided in respect of applications; and

(c) about the circumstances in which applications must or, as the case may be, may be refused (including where an application for renewal under this section was not received by the registrar by the time prescribed by the General Pharmaceutical Council in rules under section 74B(2)(b)).

(6) Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under this section, the registrar must give notice in writing of that restoration to the applicant.

(7) The notice under subsection (6) must specify—

(a) the period for which the entry restored to Part 3 of the register is valid;

(b) any conditions to which that entry is subject by virtue of subsection (2)(c).

(8) The notice under subsection (6) must be sent—

(a) where the retail pharmacy business was carried on by an individual, to that individual at that individual’s home address in the register;

(b) where the retail pharmacy business was carried on by a partnership, to that partnership at its principal office;

(c) where the retail pharmacy business was carried on by a body corporate, to that body corporate at its registered or principal office.

Conditional registration: Great Britain

74D.— (1) The registrar may make the entry of premises entered in Part 3 of the register under section 74A subject to such conditions as the registrar considers it necessary to impose for the purpose of securing the safe and effective practice of pharmacy at those premises.

(2) The power under subsection (1)—

(a) may be exercised on the making of the entry or subsequently (whether on a renewal of the entry or otherwise);

(b) includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

(3) Except as provided in subsection (4), the registrar may not under subsection (1)—

(a) impose a new condition in respect of premises already entered in Part 3 of the register; or

(b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on the retail pharmacy business at the premises and of the date from which that condition, variation or revocation is to have effect.

(4) The registrar may, with immediate effect—

(a) impose a new condition in respect of premises already entered in Part 3 of the register; or

(b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

if, in the registrar’s opinion, the giving of reasonable notice as required by subsection (3) would prejudice the health, safety or well-being of members of the public.

(5) The registrar must give notice in writing of any decision under subsection (4) to the person carrying on a retail pharmacy business at the premises.

(6) The notice under subsection (5) must be sent—

(a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

(b) where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

(c) where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

(7) Where premises are entered in the register because condition C in section 74B is met by virtue of subsection (4)(a)(ii) of that section, the registrar may, on making the entry of the premises in the register, also make that entry subject to a condition that the applicant for registration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is made.

Supplementary provision in respect of conditional registration: Great Britain

74E.— (1) Where the entry of premises entered in Part 3 of the register is subject to conditions imposed under section 74D(1), the person carrying on the business at the premises may apply to the registrar for any of the conditions imposed to be varied or revoked.

(2) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(3) Rules under subsection (2) may, in particular, include provision—

(a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

(b) about the information to be provided in respect of applications;

(c) about the circumstances in which applications may be refused by the registrar;

(d) about the giving of notice of the decision in respect of the application to the applicant by the registrar.

(4) The registrar may vary a condition imposed under section 74D(7) by extending the period within which the applicant for registration must become a person lawfully conducting a retail pharmacy business.

(5) Where premises are entered in the register subject to a condition imposed under subsection (7) of section 74D, the registrar may remove the entry if the applicant is not a person lawfully conducting a retail pharmacy business at the premises within the period determined by the registrar in accordance with that subsection or within such longer period as the registrar may, by virtue of subsection (4), allow.

(6) Where the registrar—

(a) varies a condition under subsection (5); or

(b) removes an entry of premises in Part 3 of the register under subsection (4),

the registrar must send to the person who applied for registration a statement in writing giving that person notice of the decision and the reasons for it.

(7) The notice under subsection (6) must be sent—

(a) where the person who applied for registration is an individual, to that individual at that individual’s home address in the register;

(b) where that person is a partnership, to that partnership at its principal office;

(c) where that person is a body corporate, to that body corporate at its registered or principal office.

Giving of notice by registrar: Great Britain

74F.— (1) Where, in pursuance of an application, the registrar enters premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the entry.

(2) The written confirmation under subsection (1) must include—

(a) the number of the entry;

(b) the date on which the entry was made;

(c) the period for which the entry is valid; and

(d) details of any conditions to which the entry is subject by virtue of section 74D.

(3) Where, in pursuance of an application, the registrar renews the entry of premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the renewal.

(4) The written confirmation under subsection (3) must include—

(a) the number of the entry;

(b) the date on which the renewal of the entry was made;

(c) the period for which the renewal of the entry is valid; and

(d) details of any conditions to which the renewal of the entry is subject by virtue of section 74D.

(5) Where the registrar refuses an application for the entry of premises in Part 3 of the register under section 74A, or for the renewal of an entry of premises in the register under that section, the registrar must give to the applicant written notice of that refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40 of the Pharmacy Order 2010.

(6) Where, under section 74J, the registrar enters premises or a group of premises in Part 3 of the register, the registrar must give written confirmation of the entry to the person who will be carrying on a retail pharmacy business at the premises, or at each set of premises in the group of premises.

(7) The written confirmation under subsection (6) must include—

(a) the number of the entry;

(b) the date on which the entry was made; and

(c) details of any conditions to which the entry is subject by virtue of section 74J(4).

Voluntary removal from the register: Great Britain

74G.— (1) An application may be made to the registrar by the person carrying on a retail pharmacy business at any premises entered in Part 3 of the register under section 74A or 74J for the premises to be removed from the register.

(2) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(3) Rules under subsection (2) may, in particular, include provision—

(a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b) about the information to be provided by the applicant;

(c) about the circumstances in which applications may be refused; and

(d) for written notice of the outcome of the application to be given to the applicant by the registrar.

Change of ownership of retail pharmacy business: Great Britain

74H.— (1) Subject to subsection (2), where a change occurs in the ownership of a retail pharmacy business carried on at premises entered in Part 3 of the register under section 74A, the entry of the premises in the register ceases to be valid at the end of the relevant period unless the registrar is notified in writing of the change prior to the end of the relevant period by the person who, as a result of the change, will be the person carrying on the business at the premises.

(2) Subsection (1) only applies if the relevant period is shorter than the period for which the entry would otherwise have remained valid under section 74A.

(3) Where, before the end of the relevant period, the registrar is notified of a change in the ownership of a retail pharmacy business carried on at premises entered in Part 3 of the register, the registrar must, on receipt of a fee of the amount prescribed in rules under article 36(1)(c) of the Pharmacy Order 2010, amend the entry relating to the premises in Part 3 of the Register to record the name and address of the person who, as a result of the change, will be the person carrying on the retail pharmacy business at the premises.

(4) For the purposes of subsections (1) to (3), the relevant period—

(a) if the change occurs on the death of the person carrying on the business or, in the case of a partnership, on the death of one of the partners, means the period of three months beginning with the date of death; and

(b) in any other case, means the period of 28 days beginning with the date on which the change occurred.

(5) If the entry of premises entered in Part 3 of the register under section 74A ceases to be valid under this section, the premises are to be treated for all purposes as no longer being entered in the register and accordingly the registrar must remove the entry from the register.

(6) The registrar must restore the entry of the premises to Part 3 of the register if—

(a) an application for restoration is made to the registrar in accordance with section 74I(1) and with rules made under section 74I(3);

(b) a fee of an amount prescribed in rules under article 36(1)(b) of the Pharmacy Order 2010 (fees in connection with entry) is paid; and

(c) the registrar is satisfied that the standards that are provided for in rules made under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at the premises.

(7) Subject to subsection (8), an entry restored to the register under subsection (6)—

(a) is still to be treated as having been entered in Part 3 of the register under section 74A;

(b) is subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of subsection (5);

(c) is valid for the same period as the period for which the entry would have been valid under section 74A had it not been removed from Part 3 of the register by virtue of subsection (5) of this section.

(8) Where an entry of premises in Part 3 of the register is restored by the registrar under subsection (6) and the applicant is a person falling within section 74I(2)(b), the registrar may—

(a) on restoring the entry of the premises to the register, make that entry subject to a condition that the applicant for restoration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is restored; and

(b) subsequently remove the entry of the premises from Part 3 of the register if the applicant is not a person lawfully conducting a retail pharmacy business within the period determined by the registrar in accordance with paragraph (a).

(9) Where under subsection (8)(b) the registrar removes an entry of premises from Part 3 of the register, the registrar must give to the person who was carrying on a retail pharmacy business at the premises immediately prior to the removal written notice of the removal and the reasons for it.

(10) The notice under subsection (9) must be sent—

(a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

(b) where the retail pharmacy business is carried on by a partnership, to the principal office of that partnership;

(c) where the retail pharmacy business is carried on by a body corporate, to the registered or principal office of that body corporate.

Supplementary provision in respect of change of ownership of retail pharmacy business: Great Britain

74I.— (1) An application may be made to the registrar for the entry of premises removed from Part 3 of the register by virtue of section 74H(5) to be restored to the register.

(2) An application under subsection (1) must be made by the person who, in consequence of the change of ownership, has become the owner of the business and that person must be—

(a) a person who is lawfully conducting a retail pharmacy business; or

(b) a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at those premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

(3) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

(4) Rules under subsection (3) may, in particular, include provision—

(a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

(b) about the information to be provided in respect of applications;

(c) about the circumstances in which an application for restoration under subsection (1) may be treated by the registrar as an application for the renewal of registration under section 74A(4) as well as an application for restoration.

(5) Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under subsection (1), the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the restoration.

(6) The notice given by the registrar under subsection (5) must specify—

(a) the period for which the entry restored to Part 3 of the register is valid;

(b) any conditions to which the entry of the premises restored to Part 3 of the register is subject.

(7) Where the registrar refuses an application under this section for the restoration to Part 3 of the register of an entry relating to any premises, the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the decision and the reasons for it.

(8) The notice under subsections (5) and (7) must be sent—

(a) where the applicant is an individual, to that individual at that individual’s home address in the register;

(b) where the applicant is a partnership, to the principal office of that partnership;

(c) where the applicant is a body corporate, to the registered or principal office of that body corporate.

Temporary registration with regard to emergencies involving loss of human life or human illness etc.

74J.— (1) This section applies in relation to premises in Great Britain.

(2) If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may under this section enter in Part 3 of the register—

(a) premises; or

(b) premises comprising a specified group of premises,

with regard to the emergency.

(3) The registrar may enter in Part 3 of the register by virtue of subsection (2)(b) all of the premises in a specified group of premises without first identifying each set of premises in the group.

(4) The registrar may make the entry of premises entered in Part 3 of the register under this section subject to such conditions as the registrar considers necessary to impose for the purpose of securing the safe and effective practice of pharmacy at those premises.

(5) The power in subsection (4)—

(a) may be exercised on the making of the entry or subsequently;

(b) includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

(6) The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group may be subject to the same conditions as the entry of the other premises in the group or it may be subject to different conditions.

(7) The conditions to which the entry of premises entered in Part 3 of the register under this section is subject may include conditions relating to their physical state, safety and security and the conditions in which medicinal products (including controlled drugs) are stored at those premises.

(8) The registrar may not under subsection (4)—

(a) impose a new condition in respect of the entry of premises already entered in Part 3 of the register; or

(b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on a retail pharmacy business at the premises and of the date from which that condition, variation or revocation is to have effect.

(9) The entry of premises entered in Part 3 of the register under this section may be removed by the registrar, which—

(a) the registrar must do if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (2) no longer exist;

(b) the registrar may do for any other reason at any time including where the registrar has grounds for suspecting that there is a failure to comply with any conditions to which the entry of the premises in Part 3 of the register is subject.

(10) The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group of premises may be removed without removing the entries of the other premises in the group, or it may be removed by virtue of a decision to remove the entries of all of the premises in the group.

(11) In this section, and in section 74K, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004 (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.

Temporary annotations with regard to emergencies involving loss of human life or human illness etc.

74K.— (1) If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may annotate—

(a) the entry of a registered pharmacy entered in Part 3 of the register under section 74J to designate that pharmacy as a pharmacy from which drugs, medicines and appliances may be ordered in a specified capacity; or

(b) the entries of a specified group of registered pharmacies entered in Part 3 of the register under section 74J to designate that group as a group of pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

(2) The registrar may make an annotation, by virtue of subsection (1), to the entry of a registered pharmacy entered in Part 3 of the register under section 74J in such a way as to distinguish that annotation from an annotation in respect of a registered pharmacy made otherwise than by virtue of subsection (1).

(3) Annotations made by virtue of subsection (1)—

(a) must be removed by the registrar if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (1) no longer exist;

(b) may be removed by the registrar for any other reason at any time.

(4) An annotation of the entry of a registered pharmacy made by virtue of subsection (1)(b) as one of a specified group may be removed without removing the annotations of the entries of the other registered pharmacies in the group, or it may be removed by virtue of a decision to remove the annotations of the entries of all the registered pharmacies in the group.

Evidence of registration: Great Britain

74L.   A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in Great Britain were, or were not, entered in Part 3 of the register (whether under section 74A or section 74J) is admissible in any proceedings as evidence (or in Scotland, as sufficient evidence) that those premises were, or were not, entered in the register on that date.”.

(9) In section 75(66) (registration of premises)—

(a) in the heading, after “premises” insert “: Northern Ireland”;

(b) before subsection (1), insert—

“(A1) This section applies in relation to premises in Northern Ireland.”;

(c) in subsection (1), omit “(in this Part of this Act referred to as “the register”)”;

(d) in subsection (8), omit—

(i) paragraphs (a) and (b),

(ii) “and” at the end of paragraph (b), and

(iii) “in relation to premises in Northern Ireland,” in paragraph (c).

(10) In section 76(67) (supplementary provisions as to the registration of premises)—

(a) in the heading, after “premises” insert “: Northern Ireland”;

(b) in subsection (1), after “entered in the register” insert “under section 75”;

(c) in subsection (2)—

(i) after “entered in the register” insert “under section 75”,

(ii) for “the Council” wherever those words occur, substitute “the appropriate Minister”,

(iii) in paragraph (b), for “direct” substitute “directs”,

(d) in subsection (7), insert “in Northern Ireland” after “specified premises”;

(e) omit subsection (8);

(f) for subsection (9), substitute—

“(9) In this section—

“the appropriate Minister” means the Minister of Health, Social Services and Public Safety for Northern Ireland;

“year” means a period of 12 months beginning with such date as the appropriate Minister may from time to time determine.”.

(11) In section 77(68) (annual return of premises to the registrar)—

(a) after “carries on a retail pharmacy business” insert “at premises in Northern Ireland”;

(b) in paragraph (a), before “premises” insert “such”.

(12) In section 78(69) (restrictions on use of titles, descriptions and emblems), for subsection (5) substitute—

“(5) A person who is not registered in the register of pharmaceutical chemists for Northern Ireland or in the register of visiting pharmaceutical chemists from a relevant European State made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 may not—

(a) take or use the title pharmaceutical chemist, pharmaceutist, pharmacist, member of the Pharmaceutical Society of Northern Ireland or Fellow of the Pharmaceutical Society of Northern Ireland; or

(b) take or use any of the titles mentioned in paragraph (a) in connection with a business carried on (whether by him or by some other person) at any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless those premises are a registered pharmacy or a hospital or health centre.

(5A) A person who is not registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010 may not take or use the title pharmacist or fferyllydd (its equivalent in the Welsh language) in connection with a business carried on (whether by him or by some other person) at any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless those premises are a registered pharmacy or a hospital or health centre.

(5B) Subsection (5) extends to Northern Ireland only; and subsection (5A) does not extend there.”.

(13) In section 79(70) (provision for modifying or extending restrictions under section 78), in subsection (3), for “the Council” substitute “the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland”.

(14) In section 80(71) (power for relevant disciplinary committee to disqualify and direct removal from register)—

(a) for subsection (1) substitute—

“(1) Where a body corporate carries on a retail pharmacy business and—

(a) that body is convicted of an offence under one of the relevant Acts;

(b) any member of the board or any officer of, or person employed by, that body is convicted of an offence, or has been guilty of misconduct, and the offence or misconduct is such as in the opinion of the relevant disciplinary committee renders him, or would if he were a pharmacist, render him unfit to be a pharmacist; or

(c) in respect of premises in Great Britain that are entered in the register as premises at which the body corporate carries on that business, there is a failure to meet the standards that are provided for in rules made under article 7(1) of the Pharmacy Order 2010 in connection with the carrying on of the business at those premises,

then, subject to the following provisions of this Part of this Act, the relevant disciplinary committee, after inquiring into the case, may direct that the body corporate is to be disqualified for the purposes of this Part of this Act.”; and

(b) in subsection (5), for the words from “the Pharmacy Act 1954” to “the Misuse of Drugs Act 1971” substitute “the Pharmacy Act 1954, this Act, the Misuse of Drugs Act 1971, the Pharmacy (Northern Ireland) Order 1976, the Pharmacists and Pharmacy Technicians Order 2007 and the Pharmacy Order 2010”.

(15) In section 81(72) (grounds for disqualification in certain cases)—

(a) for subsection (1) substitute—

“(1) Unless the conditions specified in subsection (1A) are satisfied, the relevant disciplinary committee may not do any of the following—

(a) give a direction under subsection (1) of section 80 of this Act—

(i) in a case falling within paragraph (b) of that subsection, or

(ii) in a case falling within paragraph (c) of that subsection, where the failure in question is by a member of the board or any officer of, or person employed by, the body in question; or

(b) give a direction under subsection (4) of that section.

(1A) The conditions are that—

(a) one or more of the facts specified in subsection (2) are proved to the satisfaction of the relevant disciplinary committee; and

(b) the committee are of the opinion, having regard to those facts, that the board of the body corporate or, as the case may be, the representative, is to be regarded as responsible for the offence, misconduct or failure in question.”;

(b) in subsection (2)—

(i) for “The facts referred to in subsection (1)(a) of this section are” substitute “The facts referred to in subsection (1A)(a) of this section are”,

(ii) in sub-paragraph (a), for “the offence or misconduct in question” substitute “the offence, misconduct or failure in question”,

(iii) for sub-paragraph (b) substitute—

“(b) that, in the case of a body corporate, a member of the board, or an officer of, or person employed by, the body corporate had, at some time within the twelve months immediately preceding the date on which the offence, misconduct or failure occurred, been guilty of a similar offence or failure or of similar misconduct and that the board had, or with the exercise of reasonable care would have had, knowledge of that previous offence, misconduct or failure;”, and

(iv) in sub-paragraph (d), for “offence or misconduct in question is a continuing offence or continuing misconduct” substitute “offence, misconduct or failure in question is a continuing offence or failure or is continuing misconduct”.

(16) After section 84 (offences under Part 4) insert the following section—

“Rules by the General Pharmaceutical Council

84A.— (1) The General Pharmaceutical Council may make such provision as it considers appropriate in rules for any purpose for which rules are authorised or required to be made by it under Part 4 of this Act.

(2) Article 66 of the Pharmacy Order 2010 (rules) applies to the making of rules by the General Pharmaceutical Council under Part 4 of this Act as it applies to the making of rules by the General Pharmaceutical Council under Part 3 of that Order (registered pharmacies: standards in retail pharmacies).”.

(17) In section 108(73) (enforcement in England and Wales), in subsection (6)(c), for “sections 77 and 78” substitute “section 78”.

(18) In section 132(1)(74) (general interpretation provisions)—

(a) in the definition of “Pharmaceutical Society”, for “the Pharmaceutical Society of Great Britain” substitute “the General Pharmaceutical Council”; and

(b) in the definition of “pharmacist”, for “a person registered in Part 1 or 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a person registered as a pharmacist in the register maintained under article 19 of the Pharmacy Order 2010”.

(19) In section 136 (short title, extent and commencement), for subsection (2) substitute—

“(2) Except as provided by section 78(5B), this Act extends to Northern Ireland.”.

Commencement Information

I195 Sch. 4 para. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I196 Sch. 4 para. 1(1)-(6), (7)(a), (9)-(19) in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

I197 Sch. 4 para. 1(7)(b)(8) in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Poisons Act 1972 E+W+S

2.—(1) The Poisons Act 1972(75) is amended as follows.

(2) In section 9 (inspection and enforcement)—

(a) omit subsections (1) to (3);

(b) in subsection (4)—

(i) for “the Society under this section” substitute “the General Pharmaceutical Council under article 8(1) of the Pharmacy Order 2010”,

(ii) for paragraph (a) substitute—

“(a) shall, for the purpose of securing compliance by pharmacists and persons carrying on a retail pharmacy business with the preceding provisions of this Act and with the Poisons Rules, have power at all reasonable times to enter any registered pharmacy, and”,

(iii) in paragraph (b)—

(aa) for “other persons” substitute “persons other than pharmacists and persons carrying on a retail pharmacy business”, and

(bb) omit “in either case”;

(c) in subsection (5), omit from “; and an inspector” to the end of that subsection;

(d) after subsection (5) insert—

“(5A) A local authority may, with the consent of the General Pharmaceutical Council, appoint an inspector appointed by the General Pharmaceutical Council under article 8(1) of the Pharmacy Order 2010 to be also an inspector for the purposes of subsection (5).”.

(3) In section 11(2) (interpretation), for the definition of “pharmacist” substitute—

““pharmacist” means a person registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners);”.

Commencement Information

I198 Sch. 4 para. 2 in force at 10.2.2010 for specified purposes, see art. 1(3)

I199 Sch. 4 para. 2 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Race Relations Act 1976 E+W+S

3.  In Part 2 of Schedule 1A to the Race Relations Act 1976(76) (bodies and other persons subject to general statutory duty), under the heading “Regulatory, audit and inspection”—

(a) at the appropriate place insert “The General Pharmaceutical Council.”; and

(b) omit “The Royal Pharmaceutical Society of Great Britain, in respect of its statutory functions and the regulation of the pharmacy profession.”.

Commencement Information

I200 Sch. 4 para. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I201 Sch. 4 para. 3 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Scotland) Act 1978 E+W+S

4.—(1) The National Health Service (Scotland) Act 1978(77) is amended as follows.

(2) In section 27(78) (arrangements for the provision of pharmaceutical services), in subsection (4)(ba), for “in the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland”, substitute “in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland”.

(3) In section 28(79) (persons authorised to provide pharmaceutical services), for subsection (2C) substitute—

“(2C) Where—

(a) arrangements have been made under this Part with a registered pharmacist; and

(b) the registration of that pharmacist is suspended by virtue of any direction or order under the Pharmacy Order 2010,

that pharmacist must not provide any services under those arrangements during the period of suspension.”.

(4) In section 108(80) (interpretation and construction), in subsection (1), for the definition of “registered pharmacist” substitute—

““registered pharmacist” means a person registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010;”.

Commencement Information

I202 Sch. 4 para. 4 in force at 10.2.2010 for specified purposes, see art. 1(3)

I203 Sch. 4 para. 4 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Value Added Tax Act 1994 E+W+S

5.—(1) The Value Added Tax Act 1994(81) is amended as follows.

(2) In Part 2 of Schedule 8 (zero rating – the Groups), in group 12, in item 1, for “the Register of Pharmacists maintained under the Pharmacists and Pharmacy Technicians Order 2007 or in the register of pharmaceutical chemists kept under” substitute “the register maintained under article 19 of the Pharmacy Order 2010 or in the register of pharmaceutical chemists kept under”.

(3) In Part 2 of Schedule 9 (exemptions – the Groups), in group 7, in item 3, for “the Register of Pharmacists maintained under the Pharmacists and Pharmacy Technicians Order 2007 or in the register of pharmaceutical chemists kept under” substitute “the register maintained under article 19 of the Pharmacy Order 2010 or in the register of pharmaceutical chemists kept under”.

Commencement Information

I204 Sch. 4 para. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I205 Sch. 4 para. 5 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Data Protection Act 1998 E+W+S

6.  In section 69(1)(d) of the Data Protection Act 1998(82) (meaning of “health professional”), for “a registered pharmacist or registered pharmacy technician within the meaning of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a registered pharmacist or a registered pharmacy technician within the meaning of article 3(1) of the Pharmacy Order 2010”.

Commencement Information

I206 Sch. 4 para. 6 in force at 10.2.2010 for specified purposes, see art. 1(3)

I207 Sch. 4 para. 6 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Health Act 1999 E+W+S

7.  In section 60(2) of the Health Act 1999(83) (regulation of health care and associated professions) for “the Pharmacists and Pharmacy Technicians Order 2007” in paragraph (aa)(84) substitute “the Pharmacy Order 2010”.

Commencement Information

I208 Sch. 4 para. 7 in force at 10.2.2010 for specified purposes, see art. 1(3)

I209 Sch. 4 para. 7 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Regulation of Investigatory Powers Act 2000 E+W+S

8.  In Part 2 of Schedule 1 to the Regulation of Investigatory Powers Act 2000(85) (relevant authorities for the purposes only of section 28), for paragraph 28 and the heading preceding it substitute—

“The General Pharmaceutical Council

28.   The General Pharmaceutical Council.”.

Commencement Information

I210 Sch. 4 para. 8 in force at 10.2.2010 for specified purposes, see art. 1(3)

I211 Sch. 4 para. 8 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Freedom of Information Act 2000 E+W+S

9.  In Part 6 of Schedule 1 to the Freedom of Information Act 2000(86) (public authorities for the purposes of that Act)—

(a) at the appropriate place insert “The General Pharmaceutical Council.”; and

(b) omit “The Royal Pharmaceutical Society of Great Britain, in respect of information held by it otherwise than as a tribunal.”.

Commencement Information

I212 Sch. 4 para. 9 in force at 10.2.2010 for specified purposes, see art. 1(3)

I213 Sch. 4 para. 9 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service Reform and Health Care Professions Act 2002 E+W+S

10.—(1) The National Health Service Reform and Health Care Professions Act 2002(87) is amended as follows.

(2) In section 25(88) ([F6 the Professional Standards Authority for Health and Social Care]), in subsection (3), for paragraph (f) substitute—

“(f) the General Pharmaceutical Council,”.

(3) In section 26(89) (powers and duties of the Council: general), omit subsection (5).

(4) In section 29(90) (references of disciplinary cases by Council to court), for paragraph (a) of subsection (1) substitute—

“(a) a direction of the Fitness to Practise Committee of the General Pharmaceutical Council under article 54 of the Pharmacy Order 2010 (consideration by the Fitness to Practise Committee) or under section 80 of the Medicines Act 1968 (power to disqualify and direct removal from register),”.

Textual Amendments

F6 Words in Sch. 4 para. 10(2) substituted (1.12.2012) by The Health and Social Care Act 2012 (Consequential Amendments – the Professional Standards Authority for Health and Social Care) Order 2012 (S.I. 2012/2672), arts. 1(2), 2(d)

Commencement Information

I214 Sch. 4 para. 10 in force at 10.2.2010 for specified purposes, see art. 1(3)

I215 Sch. 4 para. 10 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Income Tax (Earnings and Pensions) Act 2003 E+W+S

11.  In section 343 of the Income Tax (Earnings and Pensions) Act 2003(91) (deduction for professional membership fees), in the Table in subsection (2), in paragraph 1, for sub-paragraphs (l) and (m) substitute—

“(l) the register maintained under article 19 of the Pharmacy Order 2010 so far as relating to pharmacists or pharmacy technicians,”.

Commencement Information

I216 Sch. 4 para. 11 in force at 10.2.2010 for specified purposes, see art. 1(3)

I217 Sch. 4 para. 11 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Health Act 2006 E+W+S

12.  In the Health Act 2006(92)—

(a) in section 60 (Commission to exercise Privy Council’s appointment functions), omit subsection (2); and

(b) in Schedule 6 (the Appointments Commission: list of regulatory bodies), after “The General Osteopathic Council.” insert “The General Pharmaceutical Council.”.

Commencement Information

I218 Sch. 4 para. 12 in force at 10.2.2010 for specified purposes, see art. 1(3)

I219 Sch. 4 para. 12(a) in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

I220 Sch. 4 para. 12(b) in force at 12.3.2010 in so far as not already in force by S.I. 2010/299, art. 2

Amendment of the National Health Service Act 2006 E+W+S

13.—(1) The National Health Service Act 2006(93) is amended as follows.

(2) In section 129(94) (regulations as to pharmaceutical services) in subsection (6)(c), for “in the Register” to “Switzerland” substitute “as a pharmacist in the Register maintained under article 19 of the Pharmacy Order 2010 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland”.

(3) In section 132(95) (persons authorised to provide pharmaceutical services), for paragraph (b) of subsection (8) substitute—

“(b) his registration is suspended by virtue of any direction or order under the Pharmacy Order 2010,”.

(4) In section 275(96) (interpretation), in subsection (1), for the definition of “registered pharmacist” substitute—

““registered pharmacist” means a person registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010,”.

Commencement Information

I221 Sch. 4 para. 13 in force at 10.2.2010 for specified purposes, see art. 1(3)

I222 Sch. 4 para. 13 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Wales) Act 2006 E+W+S

14.—(1) The National Health Service (Wales) Act 2006(97) is amended as follows.

(2) In section 83(98) (regulations as to pharmaceutical services), in subsection (6)(c), for “in the Register” to “Switzerland” substitute “as a pharmacist in the Register maintained under article 19 of the Pharmacy Order 2010 by virtue of a qualification in pharmacy awarded in an EEA State other than the United Kingdom, or in Switzerland”.

(3) In section 86(99) (persons authorised to provide pharmaceutical services), for paragraph (b) of subsection (8) substitute—

“(b) his registration is suspended by virtue of any direction or order under the Pharmacy Order 2010,”.

(4) In section 206(100) (interpretation) in subsection (1), for the definition of “registered pharmacist” substitute—

““registered pharmacist” means a person registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010,”.

Commencement Information

I223 Sch. 4 para. 14 in force at 10.2.2010 for specified purposes, see art. 1(3)

I224 Sch. 4 para. 14 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Safeguarding Vulnerable Groups Act 2006 E+W+S

15.  In the table in section 41(7) of the Safeguarding Vulnerable Groups Act 2006(101) (registers: duty to refer)—

(a) for the second entry in column 1 under the heading “Relevant register” substitute—

“2.   The register maintained under article 19 of the Pharmacy Order 2010”; and

(b) for the second entry in column 2 under the heading “Keeper of the register” substitute—

“The registrar appointed under article 18 of that Order.”.

Commencement Information

I225 Sch. 4 para. 15 in force at 10.2.2010 for specified purposes, see art. 1(3)

I226 Sch. 4 para. 15 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Protection of Vulnerable Groups (Scotland) Act 2007 E+W+S

16.  In the Protection of Vulnerable Groups (Scotland) Act 2007(102)—

(a) in section 8(2) (reference by certain other persons), for “The registrar of pharmaceutical chemists” substitute “The registrar of pharmacists”;

(b) in section 19(3) (information held by public bodies etc.), for “The registrar of pharmaceutical chemists” substitute “The registrar of pharmacists”;

(c) in section 97(1) (general interpretation) for the definition of “registrar of pharmaceutical chemists” substitute—

““registrar of pharmacists” means the registrar appointed under article 18 of the Pharmacy Order 2010,”; and

(d) in Schedule 5 (index) in the left hand column, for “registrar of pharmaceutical chemists” substitute “registrar of pharmacists”.

Commencement Information

I227 Sch. 4 para. 16 in force at 10.2.2010 for specified purposes, see art. 1(3)

I228 Sch. 4 para. 16 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

PART 2 E+W+S Secondary legislation

Amendment of the Medicines (Pharmacies) (Applications for Registration and Fees) Regulations 1973 E+W+S

17.  The Medicines (Pharmacies) (Applications for Registration and Fees) Regulations 1973(103) are hereby revoked.

Commencement Information

I229 Sch. 4 para. 17 in force at 10.2.2010 for specified purposes, see art. 1(3)

I230 Sch. 4 para. 17 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 E+W+S

18.—(1) In Part 4 of Schedule 1 to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975(104) (excepted professions, offices, employments, work and occupations: interpretation)—

(a) for the definition of “registered pharmacist” substitute—

““registered pharmacist” means a person who is registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010;”; and

(b) for the definition of “registered pharmacy technician” substitute—

““registered pharmacy technician” means a person who is registered as a pharmacy technician in Part 2 or 5 of the register maintained under article 19 of the Pharmacy Order 2010;”; and

(2) in Part 4 (interpretation)(105), for the definition of “registered pharmacy technician” substitute—

““registered pharmacy technician” means a person who is entered in the register maintained under article 19 of the Pharmacy Order 2010;”.

Commencement Information

I231 Sch. 4 para. 18 in force at 10.2.2010 for specified purposes, see art. 1(3)

I232 Sch. 4 para. 18 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977 E+W+S

19.  In regulation 2(3) of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977(106) (prohibition of sale, supply and importation of Bal Jivan Chamcho), for sub-paragraph (e) substitute—

“(e) an inspector appointed by the General Pharmaceutical Council under article 8(1) of the Pharmacy Order 2010.”.

Commencement Information

I233 Sch. 4 para. 19 in force at 10.2.2010 for specified purposes, see art. 1(3)

I234 Sch. 4 para. 19 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 E+W+S

20.—(1) The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(107) are amended as follows.

(2) In regulation 1(2)(108) (citation, commencement and interpretation) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

(3) In regulation 2(3)(109) (enforcement) for “The Pharmaceutical Society shall continue to have power and be” substitute “The General Pharmaceutical Council has power and is”.

Commencement Information

I235 Sch. 4 para. 20 in force at 10.2.2010 for specified purposes, see art. 1(3)

I236 Sch. 4 para. 20 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines (Pharmacy and General Sale – Exemption) Order 1980 E+W+S

21.  In regulation 1(2) of the Medicines (Pharmacy and General Sale – Exemption) Order 1980(110) (citation, commencement and interpretation), in paragraph (b) of the definition of “relevant register” for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I237 Sch. 4 para. 21 in force at 10.2.2010 for specified purposes, see art. 1(3)

I238 Sch. 4 para. 21 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Employment Agencies Act 1973 (Exemption) (No 2) Regulations 1984 E+W+S

22.  In the Schedule to the Employment Agencies Act 1973 (Exemption) (No 2) Regulations 1984(111) (exempt organisations)—

(a) after “the Faculty of Actuaries in Scotland” insert “The General Pharmaceutical Council”; and

(b) omit “The Pharmaceutical Society of Great Britain”.

Commencement Information

I239 Sch. 4 para. 22 in force at 10.2.2010 for specified purposes, see art. 1(3)

I240 Sch. 4 para. 22 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 E+W+S

23.  Omit paragraph 9 of Schedule 1 and paragraph 1 of Schedule 2 to the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989(112).

Commencement Information

I241 Sch. 4 para. 23 in force at 10.2.2010 for specified purposes, see art. 1(3)

I242 Sch. 4 para. 23 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Pharmaceutical Services) Regulations 1992 E+W+S

24.  In regulation 2(1) of the National Health Service (Pharmaceutical Services) Regulations 1992(113) (interpretation)—

(a) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”, and

(b) for paragraph (a)(ii) of the definition of “supplementary prescriber” substitute—

“(ii) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010,”.

Commencement Information

I243 Sch. 4 para. 24 in force at 10.2.2010 for specified purposes, see art. 1(3)

I244 Sch. 4 para. 24 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Service Committees and Tribunal) Regulations 1992 E+W+S

F7 25.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F7 Sch. 4 para. 25 revoked (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), reg. 1, Sch. 8 para. 1(3)(l) (with Sch. 7 para. 14(2))

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 E+W+S

26.  In regulation 1(2) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(114) (citation, commencement and interpretation), in paragraph (b) of the definition of “relevant register” for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007”, substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I245 Sch. 4 para. 26 in force at 10.2.2010 for specified purposes, see art. 1(3)

I246 Sch. 4 para. 26 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Prescription Only Medicines (Human Use) Order 1997 E+W+S

27.  In article 1(2) of the Prescription Only Medicines (Human Use) Order 1997(115) (citation, commencement and interpretation), in paragraph (b) of the definition of “relevant register” for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I247 Sch. 4 para. 27 in force at 10.2.2010 for specified purposes, see art. 1(3)

I248 Sch. 4 para. 27 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Building Societies (Business Names) Regulations 1998 E+W+S

28.  In the Schedule to the Building Societies (Business Names) Regulations 1998(116) (specification of words, expressions and relevant bodies), in Column (2) of the entry for “apothecary”, for “Worshipful Society of Apothecaries of London or Pharmaceutical Society of Great Britain” substitute “Worshipful Society of Apothecaries of London or General Pharmaceutical Council”.

Commencement Information

I249 Sch. 4 para. 28 in force at 10.2.2010 for specified purposes, see art. 1(3)

I250 Sch. 4 para. 28 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Feeding Stuffs (Enforcement) Regulations 1999 E+W+S

29.  In regulation 2(1) of the Feeding Stuffs (Enforcement) Regulations 1999(117) (interpretation), in paragraph (a)(i) of the definition of “the competent authority”, for “the Royal Pharmaceutical Society of Great Britain” substitute “the General Pharmaceutical Council”.

Commencement Information

I251 Sch. 4 para. 29 in force at 10.2.2010 for specified purposes, see art. 1(3)

I252 Sch. 4 para. 29 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000 E+W+S

30.  In regulation 2(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2000(118) (interpretation)—

(a) in paragraph (a) of the definition of “pharmacist independent prescriber”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(b) for paragraph (a)(ii) of the definition of “supplementary prescriber” substitute—

“Part 1 of the register maintained under article 19 of the Pharmacy Order 2010;”.

Commencement Information

I253 Sch. 4 para. 30 in force at 10.2.2010 for specified purposes, see art. 1(3)

I254 Sch. 4 para. 30 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Representation of the People (England and Wales) Regulations 2001 E+W+S

31.  In regulation 53(2) of the Representation of the People (England and Wales) Regulations 2001(119) (additional requirements for applications for a proxy vote for a definite or indefinite period on grounds of blindness or any other disability), for sub-paragraph (e) substitute—

“(e) a registered pharmacist as defined by article 3(1) of the Pharmacy Order 2010;”.

Commencement Information

I255 Sch. 4 para. 31 in force at 10.2.2010 for specified purposes, see art. 1(3)

I256 Sch. 4 para. 31 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Representation of the People (Scotland) Regulations 2001 E+W+S

32.  In regulation 53(2) of the Representation of the People (Scotland) Regulations 2001(120) (additional requirements for applications for a proxy vote for a particular or indefinite period on grounds of blindness or any other disability), for sub-paragraph (e) substitute—

“(e) a registered pharmacist as defined by article 3(1) of the Pharmacy Order 2010;”.

Commencement Information

I257 Sch. 4 para. 32 in force at 10.2.2010 for specified purposes, see art. 1(3)

I258 Sch. 4 para. 32 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Family Health Services Appeal Authority (Procedure) Rules 2001 E+W+S

33.  In regulation 2(1) of the Family Health Services Appeal Authority (Procedure) Rules 2001(121) (interpretation), in the definition of “appropriate professional registration body”, for “the Royal Pharmaceutical Society of Great Britain” substitute “the General Pharmaceutical Council”.

Commencement Information

I259 Sch. 4 para. 33 in force at 10.2.2010 for specified purposes, see art. 1(3)

I260 Sch. 4 para. 33 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Misuse of Drugs Regulations 2001 E+W+S

34.—(1) The Misuse of Drugs Regulations 2001(122) are amended as follows.

(2) In regulation 8(2)(123) (production and supply of drugs in Schedules 2 and 5), in sub-paragraph (j), for “a person authorised by the Royal Pharmaceutical Society of Great Britain” substitute “a person authorised by the General Pharmaceutical Council”.

(3) In regulation 9(2)(124) (production and supply of drugs in Schedules 3 and 4), in sub-paragraph (h), for “a person authorised by the Royal Pharmaceutical Society of Great Britain” substitute “a person authorised by the General Pharmaceutical Council”.

Commencement Information

I261 Sch. 4 para. 34 in force at 10.2.2010 for specified purposes, see art. 1(3)

I262 Sch. 4 para. 34 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002 E+W+S

35.  In regulation 3(3) of the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002(125) (membership of the Committee), in sub-paragraph (e), for “pharmacist registered in Part 1 of one of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “pharmacist registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I263 Sch. 4 para. 35 in force at 10.2.2010 for specified purposes, see art. 1(3)

I264 Sch. 4 para. 35 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 E+W+S

36.  In regulation 14 of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002(126) (enforcement)—

(a) in paragraph (4), for “the Royal Pharmaceutical Society” substitute “the General Pharmaceutical Council”; and

(b) in paragraph (6), for “the Royal Pharmaceutical Society” substitute “the General Pharmaceutical Council”.

Commencement Information

I265 Sch. 4 para. 36 in force at 10.2.2010 for specified purposes, see art. 1(3)

I266 Sch. 4 para. 36 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003 E+W+S

F8 37.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F8 Sch. 4 para. 37 revoked (S.) (14.2.2013) by The Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2013 (S.S.I. 2013/50), art. 1(1), sch. 5

Amendment of the Medicines (Child Safety) Regulations 2003 E+W+S

38.  In regulation 1(2) of the Medicines (Child Safety) Regulations 2003(127), (citation, commencement and interpretation), in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I267 Sch. 4 para. 38 in force at 10.2.2010 for specified purposes, see art. 1(3)

I268 Sch. 4 para. 38 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Tribunal) (Scotland) Regulations 2004 E+W+S

39.  In regulation 2(1) of the National Health Service (Tribunal) (Scotland) Regulations 2004(128) (interpretation and forms)—

(a) for the definition of “pharmacist” substitute—

““pharmacist” means a registered pharmacist within the meaning of article 3(1) of the Pharmacy Order 2010;”; and

(b) for paragraph (d) of the definition of “relevant professional body” substitute—

“(d) in relation to a practitioner who is a pharmacist, the General Pharmaceutical Council;”.

Commencement Information

I269 Sch. 4 para. 39 in force at 10.2.2010 for specified purposes, see art. 1(3)

I270 Sch. 4 para. 39 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (General Medical Services Contracts) Regulations 2004 E+W+S

40.  In regulation 2(1) of the National Health Service (General Medical Services Contracts) Regulations 2004(129) (interpretation)—

(a) in paragraph (b) of the definition of “pharmacist independent prescriber”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”;

(b) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(c) for paragraph (b)(ii) of the definition of “supplementary prescriber” substitute—

“(ii) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010,”.

Commencement Information

I271 Sch. 4 para. 40 in force at 10.2.2010 for specified purposes, see art. 1(3)

I272 Sch. 4 para. 40 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004 E+W+S

41.  In regulation 2(1) of the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004(130) (interpretation)—

(a) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(b) for paragraph (b)(ii) of the definition of “supplementary prescriber” substitute—

“(ii) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010, or”.

Commencement Information

I273 Sch. 4 para. 41 in force at 10.2.2010 for specified purposes, see art. 1(3)

I274 Sch. 4 para. 41 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Personal Medical Services Agreements) Regulations 2004 E+W+S

42.  In regulation 2(1) of the National Health Service (Personal Medical Services Agreements) Regulations 2004(131) (interpretation)—

(a) in paragraph (b) of the definition of “pharmacist independent prescriber”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”;

(b) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(c) for paragraph (b)(ii) of the definition of “supplementary prescriber” substitute—

“(ii) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010,”.

Commencement Information

I275 Sch. 4 para. 42 in force at 10.2.2010 for specified purposes, see art. 1(3)

I276 Sch. 4 para. 42 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 E+W+S

43.  In regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004(132) (interpretation), for paragraph (a) of the definition of “pharmacist” substitute—

“(a) in relation to Great Britain, a person registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010, and”.

Commencement Information

I277 Sch. 4 para. 43 in force at 10.2.2010 for specified purposes, see art. 1(3)

I278 Sch. 4 para. 43 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004 E+W+S

44.  In regulation 2(1) of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004(133) (interpretation)—

(a) in paragraph (a) of the definition of “pharmacist independent prescriber”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”;

(b) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(c) for paragraph (b) of the definition of “supplementary prescriber”, substitute—

“(b) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010, or”.

Commencement Information

I279 Sch. 4 para. 44 in force at 10.2.2010 for specified purposes, see art. 1(3)

I280 Sch. 4 para. 44 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004 E+W+S

45.  In regulation 2(1) of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004(134) (interpretation)—

(a) in paragraph (a) of the definition of “pharmacist independent prescriber”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”;

(b) in paragraph (b) of the definition of “relevant register”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(c) for paragraph (b) of the definition of “supplementary prescriber”, substitute—

“(b) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010,”.

Commencement Information

I281 Sch. 4 para. 45 in force at 10.2.2010 for specified purposes, see art. 1(3)

I282 Sch. 4 para. 45 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Regulation of Care (Social Service Workers) (Scotland) Order 2005 E+W+S

46.  In article 3(1) of the Regulation of Care (Social Service Workers) (Scotland) Order 2005(135) (excluded persons), for sub-paragraph (l) substitute—

“(l) the General Pharmaceutical Council.”.

Commencement Information

I283 Sch. 4 para. 46 in force at 10.2.2010 for specified purposes, see art. 1(3)

I284 Sch. 4 para. 46 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Pharmaceutical Services) Regulations 2005 E+W+S

F9 47.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F9 Sch. 4 para. 47 revoked (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), reg. 1, Sch. 8 para. 9(2)(p)(i)

Amendment of the Medicines for Human Use (Prescribing) Order 2005 E+W+S

48.  In article 1(4) of the Medicines for Human Use (Prescribing) Order 2005(136) (citation, commencement, extent and interpretation), in paragraph (b) of the definition of “relevant register” for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I285 Sch. 4 para. 48 in force at 10.2.2010 for specified purposes, see art. 1(3)

I286 Sch. 4 para. 48 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Gender Recognition (Disclosure of Information) (England, Wales and Northern Ireland) (No. 2) Order 2005 E+W+S

49.  In article 5(3)(c) of the Gender Recognition (Disclosure of Information) (England, Wales and Northern Ireland) (No. 2) Order 2005(137) (disclosure for medical purposes), for “a pharmacist or pharmacy technician registered in Part 1 or 3 of one of the registers maintained under articles 10(1) and 21(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a pharmacist or a pharmacy technician registered in Part 1, 2, 4 or 5 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I287 Sch. 4 para. 49 in force at 10.2.2010 for specified purposes, see art. 1(3)

I288 Sch. 4 para. 49 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 E+W+S

50.  In Schedule 1 to the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005(138) (exemptions and exceptions from the provisions of regulation 4), in paragraph (b) of the definition of “relevant register” in paragraph 1, for “the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954” substitute “the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I289 Sch. 4 para. 50 in force at 10.2.2010 for specified purposes, see art. 1(3)

I290 Sch. 4 para. 50 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Gender Recognition (Disclosure of Information) (Scotland) Order 2005 E+W+S

51.  In article 5(2)(b)(iii) of the Gender Recognition (Disclosure of Information) (Scotland) Order 2005(139) (disclosure for medical purposes), for “a pharmacist or pharmacy technician registered in Part 1 or 3 of one of the registers maintained under article 10(1) and 21(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a pharmacist registered in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010 or a pharmacy technician registered in Part 2 or 5 of that register”.

Commencement Information

I291 Sch. 4 para. 51 in force at 10.2.2010 for specified purposes, see art. 1(3)

I292 Sch. 4 para. 51 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Discipline Committees) (Scotland) Regulations 2006 E+W+S

52.  In regulation 4(6) of the National Health Service (Discipline Committees) (Scotland) Regulations 2006(140) (provisions relating to the start of disciplinary proceedings), for sub-paragraph (iv) of the definition of “relevant professional body” substitute—

“(iv) in relation to a pharmacist, the General Pharmaceutical Council;”.

Commencement Information

I293 Sch. 4 para. 52 in force at 10.2.2010 for specified purposes, see art. 1(3)

I294 Sch. 4 para. 52 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 E+W+S

F10 53.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F10 Sch. 4 para. 53 revoked (E.W.) (1.4.2013) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (S.I. 2013/349), reg. 1, Sch. 10 para. 5(2)(e)

Amendment of the Controlled Drugs (Supervision of Management and Use) Regulations 2006 E+W+S

54.—(1) The Controlled Drugs (Supervision of Management and Use) Regulations 2006(141) are amended as follows.

(2) In regulation 2(1)(142) (interpretation), for the definition of “registered pharmacist” substitute—

““registered pharmacist” means a person registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010;”.

(3) In regulation 12(4) (powers to require declarations and self assessments) for “The Royal Pharmaceutical Society of Great Britain” substitute “The General Pharmaceutical Council”.

(4) In regulation 19(1)(b)(iii)(143) (periodic inspections), for “the Royal Pharmaceutical Society of Great Britain” substitute “the General Pharmaceutical Council”.

(5) In regulation 21(b) (inspections of private dwellings not requiring the presence of a constable), for “the Royal Pharmaceutical Society of Great Britain” substitute “the General Pharmaceutical Council”.

Commencement Information

I295 Sch. 4 para. 54 in force at 10.2.2010 for specified purposes, see art. 1(3)

I296 Sch. 4 para. 54 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007 E+W+S

55.  In regulation 2(1) of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007(144) (interpretation), for paragraph (b) of the definition of “relevant register” (“cofrestr berthnasol”) substitute—

“(b) in relation to a pharmacist, the register maintained under article 19 of the Pharmacy Order 2010 or the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976.”.

Commencement Information

I297 Sch. 4 para. 55 in force at 10.2.2010 for specified purposes, see art. 1(3)

I298 Sch. 4 para. 55 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Diwygio Rheoliadau’r Gwasanaeth Iechyd Gwladol (Presgripsiynau am Ddim a Ffioedd am Gyffuriau a Chyfarpar) (Cymru) 2007 E+W+S

56.  Yn rheoliad 2(1) o Reoliadau’r Gwasanaeth Iechyd Gwladol (Presgripsiynau am Ddim a Ffioedd am Gyffuriau a Chyfarpar) (Cymru) 2007(145) (dehongli), yn lle paragraff (b) yn y diffiniad o “cofrestr berthnasol” (“relevant register”) rhodder—

“(b) mewn perthynas â fferyllydd, y gofrestr a gedwir o dan erthygl 19 o Orchymyn Fferylliaeth 2010 neu’r gofrestr a gedwir o dan erthyglau 6 a 9 o Orchymyn Fferylliaeth (Gogledd Iwerddon) 1976.”.

Commencement Information

I299 Sch. 4 para. 56 in force at 10.2.2010 for specified purposes, see art. 1(3)

I300 Sch. 4 para. 56 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Assembly for Wales (Representation of the People) Order 2007 E+W+S

57.  In paragraph 4(2) of Schedule 1 to the National Assembly for Wales (Representation of the People) Order 2007(146) (additional requirements for applications on grounds of blindness or other disability), for paragraph (e) substitute—

“(e) a registered pharmacist as defined by article 3(1) of the Pharmacy Order 2010;”.

Commencement Information

I301 Sch. 4 para. 57 in force at 10.2.2010 for specified purposes, see art. 1(3)

I302 Sch. 4 para. 57 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Revocation of the Pharmacists and Pharmacy Technicians Order 2007 E+W+S

58.  The Pharmacists and Pharmacy Technicians Order 2007(147) is hereby revoked subject to the savings made in Schedule 5 to this Order.

Commencement Information

I303 Sch. 4 para. 58 in force at 10.2.2010 for specified purposes, see art. 1(3)

I304 Sch. 4 para. 58 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Licensing (Relevant Offences) (Scotland) Regulations 2007 E+W+S

59.  In paragraph 3 of Part 2 of the Schedule to the Licensing (Relevant Offences) (Scotland) Regulations 2007(148) (other statutory offences), for “An offence under the Pharmacy Act 1954” substitute “An offence under article 38 of the Pharmacy Order 2010”.

Commencement Information

I305 Sch. 4 para. 59 in force at 10.2.2010 for specified purposes, see art. 1(3)

I306 Sch. 4 para. 59 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Regulation of Investigatory Powers (Authorisations Extending to Scotland) Order 2007 E+W+S

60.  In Column 1 of the Schedule to the Regulation of Investigatory Powers (Authorisations Extending to Scotland) Order 2007(149), for “The Royal Pharmaceutical Society of Great Britain” substitute “The General Pharmaceutical Council”.

Commencement Information

I307 Sch. 4 para. 60 in force at 10.2.2010 for specified purposes, see art. 1(3)

I308 Sch. 4 para. 60 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Scottish Parliament (Elections etc.) Order 2007 E+W+S

61.  In paragraph 3(2) of Schedule 3 to the Scottish Parliament (Elections etc.) Order 2007(150) (additional requirements for applications on grounds of disability), for paragraph (e) substitute—

“(e) a registered pharmacist as defined by article 3(1) of the Pharmacy Order 2010;”.

Commencement Information

I309 Sch. 4 para. 61 in force at 10.2.2010 for specified purposes, see art. 1(3)

I310 Sch. 4 para. 61 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the European Communities (Recognition of Professional Qualifications) Regulations 2007 E+W+S

62.  In the European Communities (Recognition of Professional Qualifications) Regulations 2007(151) (sectoral professions)—

(a) in Part 1 of Schedule 1 (regulated professions), in the right hand column under the heading “Competent authority”, for “Royal Pharmaceutical Society of Great Britain” substitute “General Pharmaceutical Council”; and

(b) in Part 4 of Schedule 1 (regulated professions), in the right hand column under the heading “Competent authority”, for “Royal Pharmaceutical Society of Great Britain” substitute “General Pharmaceutical Council”.

Commencement Information

I311 Sch. 4 para. 62 in force at 10.2.2010 for specified purposes, see art. 1(3)

I312 Sch. 4 para. 62 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008 E+W+S

63.  In regulation 2(1) of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008(152) (interpretation)—

(a) in paragraph (a) of the definition of “pharmacist independent prescriber”, for “Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “Part 1 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(b) for paragraph (b) of the definition of “supplementary prescriber” substitute—

“(b) Part 1 of the register maintained under article 19 of the Pharmacy Order 2010;”.

Commencement Information

I313 Sch. 4 para. 63 in force at 10.2.2010 for specified purposes, see art. 1(3)

I314 Sch. 4 para. 63 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Controlled Drugs (Drug Precursors) (Intra-Community Trade) Regulations 2008 E+W+S

64.  In regulation 5(3) of the Controlled Drugs (Drug Precursors) (Intra-Community Trade) Regulations 2008(153), in sub-paragraph (a) for “a person registered in the register of pharmaceutical chemists established in pursuance of the Pharmacy Act 1852 and maintained in pursuance of regulation 10 of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a person registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I315 Sch. 4 para. 64 in force at 10.2.2010 for specified purposes, see art. 1(3)

I316 Sch. 4 para. 64 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Cosmetic Products (Safety) Regulations 2008 E+W+S

65.  In regulation 18(1) of the Cosmetic Products (Safety) Regulations 2008(154) (qualified persons), in sub-paragraph (a) for “article 11(1)(a)(i) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “article 20(1)(a)(i) of the Pharmacy Order 2010”.

Commencement Information

I317 Sch. 4 para. 65 in force at 10.2.2010 for specified purposes, see art. 1(3)

I318 Sch. 4 para. 65 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 E+W+S

66.  In regulation 5(1) of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008(155) (the pharmacy record), in sub-paragraph (b) for “the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “the register maintained under article 19 of the Pharmacy Order 2010”.

Commencement Information

I319 Sch. 4 para. 66 in force at 10.2.2010 for specified purposes, see art. 1(3)

I320 Sch. 4 para. 66 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Council for Healthcare Regulatory Excellence (Appointment, Procedure etc.) Regulations 2008 E+W+S

67.  In regulation 2(2) of the Council for Healthcare Regulatory Excellence (Appointment, Procedure etc.) Regulations 2008(156) (conditions of appointment for chair and non-executive members of the Council), for sub-paragraph (j)(viii) substitute—

“(viii) Pharmacy Order 2010, and”.

Commencement Information

I321 Sch. 4 para. 67 in force at 10.2.2010 for specified purposes, see art. 1(3)

I322 Sch. 4 para. 67 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 E+W+S

68.  In regulation 2 of the Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008(157) (interpretation)—

(a) for the definition of “registered pharmacist” (fferyllydd cofrestredig”) substitute—

““registered pharmacist” (“fferyllydd cofrestredig”) means a person registered as a pharmacist in Part 1 or 4 of the register maintained by the General Pharmaceutical Council under article 19 of the Pharmacy Order 2010;”; and

(b) for the definition of “registered pharmacy” (“fferyllfa gofrestredig”) substitute—

““registered pharmacy” (“fferyllfa gofrestredig”) means a retail pharmacy business in Wales that is for the time being entered in Part 3 of the register maintained by the General Pharmaceutical Council under article 19 of the Pharmacy Order 2010 (registration of premises);”.

Commencement Information

I323 Sch. 4 para. 68 in force at 10.2.2010 for specified purposes, see art. 1(3)

I324 Sch. 4 para. 68 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Diwygio Rheoliadau Cyffuriau a Reolir (Goruchwylio Rheolaeth a Defnydd) (Cymru) 2008 E+W+S

69.  Yn rheoliad 2 o Reoliadau Cyffuriau a Reolir (Goruchwylio Rheolaeth a Defnydd) (Cymru) 2008(158) (dehongli)—

(a) yn lle’r diffiniad o “fferyllydd cofrestredig” (“registered pharmacist”) rhodder—

“(a) ystyr “fferyllydd cofrestredig” (“registered pharmacist”) yw person sydd wedi’i gofrestru’n fferyllydd yn Rhan 1 neu 4 o’r gofrestr a gedwir gan y Cyngor Fferyllol Cyffredinol o dan erthygl 19 o Orchymyn Fferylliaeth 2010;”; a

(b) yn lle’r diffiniad o “fferyllfa gofrestredig” (“registered pharmacy”) rhodder—

“(c) ystyr “fferyllfa gofrestredig” (“registered pharmacy”) yw busnes manwerthu fferyllol yng Nghymru sydd am y tro wedi’i gofnodi yn Rhan 3 o’r gofrestr a gedwir gan y Cyngor Fferyllol Cyffredinol o dan erthygl 19 o Orchymyn Fferylliaeth 2010 (cofrestru mangreoedd);”.

Commencement Information

I325 Sch. 4 para. 69 in force at 10.2.2010 for specified purposes, see art. 1(3)

I326 Sch. 4 para. 69 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 E+W+S

70.  In regulation 2(1) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009(159) (interpretation and application)—

(a) in the definition of “pharmacist”, for “a person who is registered in Part 1 or 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007” substitute “a person who is registered as a pharmacist in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010”; and

(b) for paragraph (b) of the definition of “supplementary prescriber” substitute—

“(b) Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010;”.

Commencement Information

I327 Sch. 4 para. 70 in force at 10.2.2010 for specified purposes, see art. 1(3)

I328 Sch. 4 para. 70 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.

Amendment of the Veterinary Medicines Regulations 2009 E+W+S

F11 71.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Sch. 4 para. 71 revoked (1.10.2011) by The Veterinary Medicines Regulations 2011 (S.I. 2011/2159), regs. 1, 46(3)

Article 69(1)

SCHEDULE 5 E+W+S Transitional Provisions

Interpretation E+W+S

1.  In this Schedule—

“the 1968 Act” means the Medicines Act 1968(160);

“the 2007 registers” means—

(a)

Parts 1 and 3 of the register maintained under article 10 of the 2007 Order;

(b)

Parts 1 and 3 of the register maintained under article 21 of that Order; and

“the premises register” means the register of premises in Great Britain kept under section 75 of the 1968 Act as that section has effect immediately before the amendments made to that section by paragraph 1(8) of Schedule 4 come into force.

Commencement Information

I329 Sch. 5 para. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I330 Sch. 5 para. 1 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Members of committees E+W+S

2.—(1) Members of the committees referred to in article 7(1)(b) and (d) of the 2007 Order immediately before the appointed day are to be treated as having been appointed to the Fitness to Practise Committee in accordance with rules under paragraph 5 of Schedule 1.

(2) Members of the committee referred to in article 7(1)(e) of the 2007 Order immediately before the appointed day are to be treated as having been appointed to the Investigating Committee in accordance with rules under paragraph 5 of Schedule 1.

(3) Members of the committee referred to in article 7(1)(f) of the 2007 Order immediately before the appointed day are to be treated as having been appointed to the Appeals Committee in accordance with rules under paragraph 5 of Schedule 1.

(4) In this paragraph, “the appointed day” means the day appointed for the coming into force of article 4(6).

Commencement Information

I331 Sch. 5 para. 2 in force at 10.2.2010 for specified purposes, see art. 1(3)

I332 Sch. 5 para. 2 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Transfer of information to the Register E+W+S

3.—(1) The Society and the Council must enter into arrangements to facilitate the introduction of arrangements for the entry of pharmacists, pharmacy technicians and premises in the Register by the Council by virtue of this Order.

(2) The arrangements entered into under sub-paragraph (1) are to include arrangements to ensure that all the names of persons entered in the 2007 registers and all premises entered in the premises register which are to be entered in the Register with effect from the appointed day are so entered.

(3) If, immediately before the appointed, day a person’s name is included in the 2007 registers, the Registrar must enter that name in the part of the Register in which it is appropriate for that person’s name to be included, with effect from the appointed day.

(4) If, immediately before the appointed day, premises are included in the premises register, the Registrar must enter those premises in Part 3 of the Register with effect from the appointed day.

(5) Where the home address of a person entered in the 2007 registers appears in those registers and the entry for that person is transferred to the Register, the home address of that person must not be published in the Register without the consent of that person.

(6) Entries made in the Register pursuant to sub-paragraph (3) are, for the purposes of article 25, to be treated as having been made on 1 January 2010 pursuant to an application under article 23.

(7) Entries made in Part 3 of the Register pursuant to sub-paragraph (4) are, for the purposes of section 74A of the 1968 Act as inserted by paragraph 1(8) of Schedule 4, to be treated as having been made on 1 January 2010 pursuant to subsection (2) of that section.

(8) In this paragraph and in paragraphs 4 and 5, “the appointed day” means the day appointed by order for the coming into force of article 19.

Commencement Information

I333 Sch. 5 para. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I334 Sch. 5 para. 3 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

The register E+W+S

4.—(1) Where immediately before the appointed day there are outstanding applications for—

(a) entry in the 2007 registers or the premises register;

(b) retention in those registers;

(c) the recording of annotations in the 2007 registers; and

(d) any entry in the 2007 registers or in the premises register to be altered, removed or restored,

the Council must dispose of the applications in accordance with sub-paragraph (2).

(2) The applications must be disposed of in accordance with—

(a) in the case of the 2007 registers, the relevant provisions of the 2007 Order as if those provisions remained in force;

(b) in the case of the premises register, sections 75 and 76 of the 1968 Act as in force immediately before the amendments to that Act in Schedule 4 have effect; or

(c) in either case, in such other manner as the Council considers just.

(3) The Council may direct the Registrar to make such amendments (if any) of the Register as are necessary in consequence of the disposal of the applications referred to in sub-paragraph (1).

Commencement Information

I335 Sch. 5 para. 4 in force at 10.2.2010 for specified purposes, see art. 1(3)

I336 Sch. 5 para. 4 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Appealable registration decisions E+W+S

5.—(1) Proceedings in respect of an appealable registration decision within the meaning of article 42 of the 2007 Order which, immediately before the appointed day—

(a) are pending before the Registration Appeals Committee by virtue of article 43 of the 2007 Order; or

(b) have begun but in respect of which that committee has not communicated its decision to the person who is the subject of the proceedings,

must be referred to the Appeals Committee established under article 4(6)(c).

(2) Proceedings referred to in sub-paragraph (1) must be disposed of by that committee—

(a) in accordance with the relevant provisions of the 2007 Order as if those provisions remained in force; or

(b) in such other manner as it considers just.

Commencement Information

I337 Sch. 5 para. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I338 Sch. 5 para. 5 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

6.—(1) The revocation of article 44 of the 2007 Order (appeals from the Registration Appeals Committee) does not affect the application of that article—

(a) in relation to any appeal that is pending before the relevant court immediately before the appointed day; or

(b) in any case where, immediately before the appointed day, the period of 28 days within which an appeal could be brought in respect of a decision of the Registration Appeals Committee has not expired.

(2) Article 44 of the 2007 Order also applies in relation to any decision of the Appeals Committee established under article 4(6)(c) of this Order that is made by virtue of paragraph 5; and in its application by virtue of this sub-paragraph any reference in article 44 of the 2007 Order to the Registration Appeals Committee is to be read as a reference to the Appeals Committee.

(3) In this paragraph, “the appointed day” means the day appointed for the coming into force of Part 6.

Commencement Information

I337 Sch. 5 para. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I338 Sch. 5 para. 5 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

I339 Sch. 5 para. 6 in force at 10.2.2010 for specified purposes, see art. 1(3)

I340 Sch. 5 para. 6 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Transitional arrangements: pharmacy technicians E+W+S

7.—(1) This paragraph applies to a person (“P”) who, for the purpose of article 20(1)(a)(i), is not appropriately qualified within the meaning of article 22 but who, no later than 30 June 2011, applies to be entered in Part 2 of the Register.

(2) The Registrar may enter P’s name in Part 2 of the Register where P has—

(a) undergone education and training which, in the opinion of the Registrar, has provided P with a reasonable foundation for future employment as a pharmacy technician; and

(b) demonstrated to the satisfaction of the Registrar that P possesses the requisite knowledge, skill and experience for being entered in the Register as a pharmacy technician in Great Britain,

provided that, in so doing, the Registrar is acting in a manner which is consistent with the requirements of the Directive and the General Systems Regulations.

(3) The Council must establish and publish from time to time in such manner as it sees fit criteria to which the Registrar is to have regard for the purpose of determining—

(a) whether or not, for the purposes of sub-paragraph (2)(a), a particular course of education or training provides, or would provide, a person with a reasonable foundation for future employment as a pharmacy technician; and

(b) whether or not, for the purposes of sub-paragraph (2)(b), a person possesses the requisite knowledge, skill and experience for being entered in the Register as a pharmacy technician.

(4) Until such time as the criteria referred to in sub-paragraph (3) are published, the Registrar must have regard to the criteria established by the Society under paragraph 6(3) of Schedule 2 to the 2007 Order for the purpose of determining the matters referred to in sub-paragraph (3)(a) and (b).

(5) Where, under this paragraph, the Registrar refuses to enter P’s name in the Register, the Registrar must send to P at P’s last known home address a statement in writing giving P notice of the decision and the reasons for it and of the right of appeal to the Appeals Committee under article 40.

Commencement Information

I341 Sch. 5 para. 7 in force at 10.2.2010 for specified purposes, see art. 1(3)

I342 Sch. 5 para. 7 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Offences relating to the Register: pharmacy technicians E+W+S

8.—(1) A person may, before the relevant date, use the title “pharmacy technician” or “technegydd fferylliaeth” (its equivalent in the Welsh language), or practise as a pharmacy technician, without committing an offence under article 38(2)(b) or (4)(b).

(2) In this paragraph, “the relevant date” means 1 July 2011 except that in relation to a person who has applied to be registered as a pharmacy technician before that date and whose application has not been disposed of before that date, it means the date on which that application (including any appeal) is finally disposed of.

(3) For the purposes of sub-paragraph (2), an appeal is finally disposed of once all rights in relation to the appeal have been exhausted.

Commencement Information

I343 Sch. 5 para. 8 in force at 10.2.2010 for specified purposes, see art. 1(3)

I344 Sch. 5 para. 8 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Education and training E+W+S

9.—(1) Anything determined, approved or accredited by the Society under articles 14, 15, 25 and 26 of the 2007 Order immediately before the appointed day, except the approval or accreditation of providers of continuing professional development, is to be treated as having been set or approved by the Council under, as the case may be, article 42(1)(b)(ii), (4) or (5) as from the appointed day.

(2) An appeal as provided for in rules under article 16(3)(c)(iii) or (d) or (4) or 27(3)(c)(iii) or (d) or (4) of the 2007 Order which is pending or proceeding immediately before the day the 2007 Order is revoked must be dealt with as if those articles remained in force.

(3) In this paragraph, “the appointed day” means the day appointed for the coming into force of Part 5.

Commencement Information

I345 Sch. 5 para. 9 in force at 10.2.2010 for specified purposes, see art. 1(3)

I346 Sch. 5 para. 9 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Premises E+W+S

10.  Sections 74A(4) to (7), 74B(1) to (5), 74C to 74I and 74L of the 1968 Act, as inserted by paragraph 1(8) of Schedule 4, have effect in relation to premises which are entered in the Register pursuant to paragraph 3(4) as they have effect in relation to premises entered in the Register under section 74A of that Act as inserted by that provision of that Schedule.

Commencement Information

I347 Sch. 5 para. 10 in force at 10.2.2010 for specified purposes, see art. 1(3)

I348 Sch. 5 para. 10 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Fees E+W+S

11.—(1) Any fees which are payable by virtue of—

(a) rules under article 40 of the 2007 Order;

(b) article 63(1) of that Order; or

(c) regulations under section 75 or 76 of the 1968 Act,

but which are outstanding immediately before the appointed day remain payable and are to be paid to the Council.

(2) In sub-paragraph (1), “the appointed day” means the day appointed for the coming into force of article 4(1).

Commencement Information

I349 Sch. 5 para. 11 in force at 10.2.2010 for specified purposes, see art. 1(3)

I350 Sch. 5 para. 11 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Fitness to practise proceedings E+W+S

12.—(1) Proceedings in respect of an allegation relating to fitness to practice which, immediately before the appointed day—

(a) are pending before the Society or any of its committees; or

(b) have begun but in respect of which the Society or the committee dealing with the case has not communicated its decision to the person who is the subject of the proceedings,

must be referred to the Council.

(2) Proceedings referred to in sub-paragraph (1) must be disposed of by the Council—

(a) in accordance with the relevant provisions of the 2007 Order as if those provisions remained in force; or

(b) in such other manner as it considers just.

Commencement Information

I351 Sch. 5 para. 12 in force at 10.2.2010 for specified purposes, see art. 1(3)

I352 Sch. 5 para. 12 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

13.—(1) The revocation of Part 5 of and Part 4 of Schedule 2 to the 2007 Order does not affect the application of those provisions—

(a) in relation to any appeal that is pending before the relevant court immediately before the appointed day; or

(b) in any case where, immediately before the appointed day, the period of 28 days within which an appeal could be brought before the relevant court in respect of a decision of the Society or any of its committees has not expired.

(2) Part 5 of, and Part 4 of Schedule 2 to, the 2007 Order applies in relation to any decision of the Council that is made by virtue of paragraph 12; and in its application by virtue of this sub-paragraph any references—

(a) to the Society, are to be treated as references to the Council;

(b) to the Investigating Committee, are to be treated as references to the Investigating Committee established under article 4(6)(a);

(c) to the Disciplinary Committee or to the Health Committee, are to be treated as references to the Fitness to Practise Committee established under article 4(6)(b);

(d) to the Registrar, are to be treated as references to the Registrar for the purposes of this Order.

(3) In this paragraph “the appointed day” means the day appointed for the coming into force of Part 6.

Commencement Information

I351 Sch. 5 para. 12 in force at 10.2.2010 for specified purposes, see art. 1(3)

I352 Sch. 5 para. 12 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

I353 Sch. 5 para. 13 in force at 10.2.2010 for specified purposes, see art. 1(3)

I354 Sch. 5 para. 13 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Proceedings under section 80 of the 1968 Act E+W+S

14.—(1) Sub-paragraph (2) applies to matters referred to, but not dealt with by, the Disciplinary Committee established under article 7(1)(b) of the 2007 Order by virtue of section 80 of the 1968 Act immediately before the day appointed for the coming into force of paragraph 1(14) and (15) of Schedule 4.

(2) Those matters are to be dealt with by the Fitness to Practise Committee established under article 4(6)(b) as if the amendments to sections 80 and 81 of that Act made by paragraph 1(14) and (15) of Schedule 4 had not come into force.

Commencement Information

I355 Sch. 5 para. 14 in force at 10.2.2010 for specified purposes, see art. 1(3)

Supply of information E+W+S

15.  For the purpose of enabling the Council to discharge its functions under the preceding provisions of this Schedule, the Society must supply such information and documentation to the Council as is relevant to the discharge of those functions.

Commencement Information

I356 Sch. 5 para. 15 in force at 10.2.2010 for specified purposes, see art. 1(3)

I357 Sch. 5 para. 15 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Application of TUPE E+W+S

16.  The transfer of the functions of the Society to the Council by virtue of this Order is to be treated as a relevant transfer for the purposes of the Transfer of Undertakings (Protection of Employment) Regulations 2006(161), whether or not, apart from this paragraph, it would be considered such a transfer.

Commencement Information

I358 Sch. 5 para. 16 in force at 10.2.2010 for specified purposes, see art. 1(3)

I359 Sch. 5 para. 16 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Transfer of property, rights and liabilities E+W+S

17.  The Privy Council may by order provide for the transfer from the Society to the Council of any property, rights and liabilities.

Commencement Information

I360 Sch. 5 para. 17 in force at 10.2.2010 for specified purposes, see art. 1(3)

I361 Sch. 5 para. 17 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Grants and loans E+W+S

18.  The Privy Council may by order make provision authorising the Society to make grants or loans to any person in connection with the implementation or preparations for the implementation of this Order.

Commencement Information

I362 Sch. 5 para. 18 in force at 10.2.2010 for specified purposes, see art. 1(3)

I363 Sch. 5 para. 18 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Cancellation of elections to, and transitional measures relating to, the Council of the Society E+W+S

19.—(1) Elections which would have been held by virtue of regulations under article 8 of the Charter, are not to be held in respect of the vacancies that would have arisen in respect of the members of the Council of the Society who were due to vacate office at the end of 20 May 2010.

(2) The members of the Council of the Society referred to in sub-paragraph (1) are to remain in office until the end of —

(a) the day before the day on which the first order under article 4(2) comes into force; or

(b) 31 May 2011,

whichever first occurs.

(3) In sub-paragraph (1), “the Charter” means the Charter granted to the Society on 7 December 2004 as amended from time to time.

Commencement Information

I364 Sch. 5 para. 19 in force at 10.2.2010 for specified purposes, see art. 1(3)

Article 69(2)

SCHEDULE 6 E+W+S Savings

PART 1 E+W+S Primary legislation

Medicines Act 1968 E+W+S

1.—(1) Section 69(3) of the Medicines Act 1968(162) (general provision for Part 4 of the Act) is to continue to have effect with the insertion of the definition of “relevant European State” (originally made by paragraph 2(4)(b) of Schedule 1 to the 2007 Order).

(2) The following provisions of the Medicines Act 1968—

(a) section 72(3) (representative of a pharmacist in case of death or disability);

(b) the heading for section 80 (power for relevant disciplinary committee to disqualify and direct removal from the register);

(c) section 80(2), (3) and (4);

(d) section 82(1) and (5) (procedure relating to disqualification);

(e) section 83(1) and (2) (revocation of disqualification),

are to continue to have effect with the insertion of references to “relevant disciplinary committee”, “the relevant disciplinary committee” and “the committee” (originally made by paragraph 2(9), (12), (14) and (15) of Schedule 1 to the 2007 Order by way of substitution for references to “Statutory Committee”, “the Statutory Committee” and “the Committee”).

Commencement Information

I365 Sch. 6 para. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I366 Sch. 6 para. 1 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Income Tax (Earnings and Pensions) Act 2003 E+W+S

2.  Section 343(2) of the Income Tax (Earnings and Pensions) Act 2003(163) (deduction for professional membership fees) is to continue to have effect with the insertion, in paragraph (n) of the Table, of the entry relating to the register of pharmaceutical chemists kept under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976(164) (originally made by paragraph 9 of Schedule 1 to the 2007 Order).

Commencement Information

I367 Sch. 6 para. 2 in force at 10.2.2010 for specified purposes, see art. 1(3)

I368 Sch. 6 para. 2 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

PART 2 E+W+S Secondary legislation

Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 E+W+S

3.  Part 1 of Schedule 1 to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975(165) (excepted professions) is to continue to have effect with the insertion—

(a) in paragraph 8, of the entry relating to “Registered pharmacist”; and

(b) in paragraph 8A, of the entry relating to “Registered pharmacy technician”,

(originally made by paragraph 12(a) of Schedule 1 to the 2007 Order).

Commencement Information

I369 Sch. 6 para. 3 in force at 10.2.2010 for specified purposes, see art. 1(3)

I370 Sch. 6 para. 3 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

National Health Service (Pharmaceutical Services) Regulations 1992 E+W+S

4.  Regulation 4(5) of the National Health Service (Pharmaceutical Services) Regulations 1992(166) (pharmaceutical lists) is to continue to have effect with the insertion of the words “as a pharmacist in an EEA State other than the United Kingdom, or in Switzerland” (originally made by paragraph 16(b) of Schedule 1 to the 2007 Order).

Commencement Information

I371 Sch. 6 para. 4 in force at 10.2.2010 for specified purposes, see art. 1(3)

I372 Sch. 6 para. 4 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003 E+W+S

5.  Part 1 of Schedule 4 to the Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003(167) (excepted professions) is to continue to have effect with the insertion in paragraph 8 of the entry relating to “Registered pharmacist” (originally made by paragraph 31(1) of Schedule 1 to the 2007 Order).

Commencement Information

I373 Sch. 6 para. 5 in force at 10.2.2010 for specified purposes, see art. 1(3)

I374 Sch. 6 para. 5 in force at 11.2.2010 in so far as not already in force, see art. 1(2)(c)

National Health Service (Pharmaceutical Services) Regulations 2005 E+W+S

F12 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F12 Sch. 6 para. 6 revoked (1.9.2012) by The National Health Service (Pharmaceutical Services) Regulations 2012 (S.I. 2012/1909), reg. 1, Sch. 8 para. 9(2)(p)(ii)

EXPLANATORY NOTE

(This note is not part of the Order)

This Order makes provision for the establishment of the General Pharmaceutical Council (“the Council”) and sets out the arrangements for the regulation by the Council of the professions of pharmacist and pharmacy technician in Great Britain. It also amends and supplements various provisions in Part 4 of the Medicines Act 1968 (c.67), and in section 9 of the Poisons Act 1972 (c.66) in respect of the regulation and inspection of registered pharmacies in Great Britain. The regulation of the professions of pharmacist and pharmacy technician and the regulation and inspection of registered pharmacies was, prior to the commencement of this Order, undertaken by the Royal Pharmaceutical Society of Great Britain (“the Society”) in pursuance of arrangements set out in the Pharmacists and Pharmacy Technicians Order 2007 (“the 2007 Order”) (as amended), which is now revoked.

This Order implements in part Council Directive 2005/36/EC(168) (“the Directive”) on the recognition of professional qualifications. It replaces the necessary legislative framework for the implementation, in Great Britain, of the Directive which was previously set out in the 2007 Order.

Part 1 contains preliminary matters. These include commencement arrangements and the interpretation provisions (articles 1 and 3). This Order extends to Great Britain. Where other legislation is amended, the amendments have the same territorial extent as the provisions being amended (article 2).

Part 2 (articles 4 and 6) and Schedule 1 make provision for the establishment of the Council and of its statutory committees. The Council is to be constituted as provided for by an order of the Privy Council under article 4 and is required to make provision, in rules, in respect of the size, composition and procedures of each of its statutory committees. Part 2 also sets out the Council’s principal functions and general duties which are linked to the safe and effective practice of pharmacy. These include the Council’s main purpose which is to protect, promote and maintain the health, safety and well-being of the public when exercising functions that affect the public. It is also under a duty to prescribe requirements as to the evidence of health and good character that are to be met in order to satisfy the Council that a person is capable of the safe and effective practice of pharmacy (article 4). The Council is also under a duty to have proper regard to specified interests and in respect of co-operation with specified bodies (article 6).

Part 3 contains rule making powers for the purpose of implementing the Council’s function of establishing and promoting standards for the safe and effective practice of pharmacy at registered pharmacies. These standards are intended to supplement existing provision in Part 4 of the Medicines Act 1968 (Part 3 of the Medicines Act 1968 (section 66) also makes provision in respect of the standards to be met by registered pharmacies). Part 3 also makes provision for the inspection of registered pharmacies by inspectors appointed by the Council (under article 8) for the purpose of enforcing compliance by persons carrying on a retail pharmacy business at a registered pharmacy with such standards as are set in rules by the Council (under article 7). The inspectors are given various powers to enter, search and remove items from premises (articles 10 and 11) and any person who intentionally obstructs an inspector exercising these functions commits an offence (article 12). Provision is also made for the service of improvement notices on a person carrying on a retail pharmacy business at a registered pharmacy (article 13), in respect of a failure to comply with standards, for non compliance with the terms of an improvement notice to be an offence (article 14), and for a right of appeal to a magistrates’ court or, in Scotland, to the sheriff against an improvement notice (articles 16 and 17).

Part 4 contains provisions for the registration of pharmacists and pharmacy technicians in Great Britain. It also contains supplementary provision in respect of the registration of registered pharmacies in Great Britain to that which is contained in Part 4 of the Medicines Act 1968. Part 4 of this Order provides for the appointment of a Registrar (article 18) who is to establish and maintain a register of pharmacists, pharmacy technicians and premises at which the business of a retail pharmacy is lawfully conducted (“the Register”) and to perform the functions of Registrar conferred by this Order (article 19) and by any other enactment (pharmacists and pharmacy technicians who have been entered in the Register by the Registrar are defined in the Order as “registrants”). There are provisions in Part 4 relating to entitlement to entry in the Register, the procedure for dealing with applications for entry and for the renewal of an entry in the Register and for annotating the Register to denote specialisations. Provision is also made in Part 4 for the notification of decisions and the time limits within which certain applications need to be processed, for the form and keeping of the Register and for public access to certain information contained in lists derived from the Register. Prospective registrants must be appropriately qualified, fit to practise and, where appropriate, have met additional requirements as to education, training, experience and continuing professional development (article 20). There is also provision in Part 4 for the recognition of qualifications and of additional education, training and experience (articles 21 and 22). All registrants are also required to have in place adequate and appropriate professional indemnity arrangements (article 32). In addition to provision for the Registrar to enter in the Register visiting pharmacists and pharmacy technicians from relevant European States (article 33 and Schedule 2). Part 4 contains provision for the Registrar to temporarily enter in the Register a pharmacist or pharmacy technician, or a group of pharmacists or pharmacy technicians, when advised by the Secretary of State of the existence of emergency circumstances involving loss of life or human illness etc (article 34). Part 4 also contains offences relating to entries in the Register and the unlawful use of notices or certificates of registration and also restricts the use of the professional title “pharmacist” and “pharmacy technician” to registrants (article 38). There are provisions in respect of appealable decisions (articles 39 and 40) including provision for appealing from the Appeals Committee against such decisions to a court of law (article 41).

Part 5 makes provision in respect of the education, training and continuing professional development of registrants and prospective registrants. The Council is under a duty to publish and promote the standards of proficiency that it must set for the safe and effective practice of pharmacy which it is necessary for a person to achieve in order to be entered in the Register. The Council is also under a duty to establish and promote the standards of pre-registration education and training necessary to achieve those standards of proficiency. In this regard, the Council has a number of specific obligations relating to pre-registration education and training of prospective registrants. Part 5 includes other provision relating to the pre-registration education and training of prospective registrants including the approval of qualifications, courses and providers of education and training (including institutions and tutors). Similar provision is made in respect of the Council’s duty to establish and promote the standards of proficiency that it is necessary for registrants to maintain in order to be retained in the Register (article 42). The Council is under a duty to establish and promote the standards of continuing professional development necessary for a registrant to achieve and maintain those standards of proficiency, to adopt a framework setting out the requirements and conditions in respect of a registrant’s continuing professional development and to make rules in respect of persons who fail to comply with the requirements or conditions of the framework (article 43).

Part 6 makes provision relating to the fitness to practise of registrants. The Council is to establish the professional standards expected of registrants (article 48) and the Council has powers to obtain information from third parties about a particular registrant (article 49). The Council may also publish any information about the fitness to practise of registrants where it is in the public interest to do so (article 50). Provision is included in Part 6 about what it means for fitness to practise to be impaired (article 51) and a framework is set out within which allegations of impairment are to be considered. Usually, cases will firstly be considered by the Registrar who will then refer them to the Investigating Committee. The Investigating Committee has power to deal with the case by way of issuing warnings or giving advice. In addition, the Fitness to Practise Committee may suspend registrants or attach conditions to their entry in the Register and may also direct that the registrant be removed from the Register (article 54). Provision also exists in Part 6 for the review of earlier decisions to suspend a registrant or to impose conditions on a registrant’s entry in the Register. The Council may also establish a scheme of professional performance assessments to assist the Registrar, the Investigating Committee and the Fitness to Practise Committee (article 55). Provision is also made for interim orders suspending a registrant’s entry in the Register or attaching temporary conditions to an entry in the Register while an investigation is ongoing (article 56). If a registrant has been removed from the Register for fitness to practise reasons, there are arrangements for allowing that registrant to be restored to the Register in defined circumstances (article 57). Provision is also made for appeals to the courts against appealable fitness to practise decisions (article 58) and in respect of when fitness to practise decisions are to take effect – including provision for temporary measures pending the outcome of an appeal, if a decision is being appealed (articles 59 and 60).

Part 7 contains provisions relating to proceedings before the Investigating Committee, the Fitness to Practise Committee or the Appeals Committee. Essentially, these matters are to be provided for in rules. However, there are particular provisions relating to the use of legal, clinical and other specialist advisers. There are also provisions for dealing with witness summonses and orders for the production of documents which may be enforced through the courts (articles 61 to 64).

Part 8 makes miscellaneous provision which includes giving the Council a general power to charge fees which must not be used in relation to areas where there are specific charging arrangements under the Order (article 65). Provision is also made about the making of rules by the Council under this Order (article 66), the designation of the Council as the competent authority in Great Britain for the purposes of certain provisions of the Directive (article 67), for the amendments, repeals, revocations and transitional provisions and savings that are set out in Schedules 4, 5 and 6 (articles 68 and 69) and for the Privy Council procedures which are to apply in respect of the making of rules under this Order (article 70).

Consequential amendments, revocations and repeals (including the revocation of the 2007 Order) are made in respect of other legislation (Schedule 4) which are mostly minor in nature and are required to reflect the establishment of the Council and the creation of the Register. However, significant amendments have been made to sections 71 to 80 of Part 4 of the Medicines Act 1968 in order to reflect the new criteria and procedures for registration which are to apply in respect of premises at which a retail pharmacy business is conducted. In addition, twelve new sections have been inserted into the Part 4 of that Act (new sections 74A to L) which provide for the registration of premises in Great Britain and make supplemental provision in respect of that registration. These new provisions also enable the voluntary removal of registered pharmacies from the Register, the temporary registration of pharmacies in emergency circumstances and for temporary annotations to the Register to be made in respect of registered pharmacies entered in the Register under the new emergency registration provision. Significant amendments have also been made to section 9 of the Poisons Act 1972 the effect of which are to remove the function of inspecting registered pharmacies, previously undertaken by the Society, from that legislation and to confer that function on the Council.

Schedule 5 makes provision relating to the transition from the Society to the Council. In particular, it ensures that there is continuity of membership of the committees (paragraph 2), that outstanding applications for registration in the registers held by the Society are dealt with by the Council, that entries in the old registers are transferred over to the new Register established and maintained by the Council under this Order (paragraphs 3 and 4). Provision is also made for appeals in respect of appealable registration decisions that are pending before the Society immediately before the establishment of the Council to be dealt with by the Council (paragraph 5) and for appeals in respect of appealable registration decisions in relation to which the time limit for bringing an appeal has not expired before the establishment of the Council to be dealt with by the Council (paragraph 6). In addition, it allows pharmacy technicians, in certain cases, to be registered up to July 2011 even if they are not appropriately qualified (paragraph 7) and to be exempt from committing certain offences (paragraph 8). It preserves the validity of education, training and experience being undertaken at the point of change (paragraph 9). It provides for certain provisions of the Medicines Act 1968 as amended by Schedule 4 to this Order to have effect in relation to premises entered in the Register pursuant to paragraph 3(4) of Schedule 5 (paragraph 10). It allows outstanding fees to be collected by the Council (paragraph 11), for the Council to deal with outstanding fitness to practise proceedings or proceedings in respect of premises in accordance with the rules previously applying or in such other manner as it thinks fit (paragraphs 12 to 14, and requires the Society to supply necessary information to the Council (paragraph 15). It treats the transfer from the Society to the Council as a relevant transfer for the purpose of the Transfer of Undertakings (Protection of Employment) Regulations 2006 (S.I.2006/246) (paragraph 16) and allows for an order to be made in respect of the transfer of property, rights and liabilities from the Society to the Council (paragraph 17) and any necessary grants or loans necessary as a result of the transfer (paragraph 18). Finally, further transitional measures are made in respect of the cancellation of elections to the Council of the Society and the appointment of members of the Council of the Society as members of the Council (paragraph 19).

Schedule 6 makes savings to preserve the effect of amendments that were made to certain provisions of primary and secondary legislation by the 2007 Order which is now revoked.

(1)

1999 c.8. Section 60 was amended by section 26(9) of the National Health Service Reform and Health Care Professions Act 2002 (c.17) (“the 2002 Act”), by paragraph 1 of Schedule 8, paragraph 10 of Schedule 10 and Part 2 of Schedule 15 to the Health and Social Care Act 2008 (c.14) (“the 2008 Act”) and by S.I.2002/253 and 254. Subsection (4) of section 62 of the Act was substituted by subsections (4) and (4A) as inserted by paragraph 11 of Schedule 10 to the 2008 Act. Schedule 3 has been amended as follows: by section 26(10) of the 2002 Act; by paragraph 67 of Schedule 11, and Part 4 of Schedule 14, to the Health and Social Care (Community Health and Standards) Act 2003 (c.43); by Schedule 9 to the Health Act 2006 (c.28); by paragraphs 3 to 10 of Schedule 8, paragraph 12 of Schedule 10 and Part 2 of Schedule 15, to the 2008 Act; and by S.I.2002/254.

(2)

1972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c.51) and amended by S.I.2007/1388.

(3)

OJ No. L255, 30.09.2005, p22, as amended by Council Directive 2006/100/EEC of 20 November 2006, OJ No. L363 of 20.12.2006, p141.

(4)

S.I.2007/289; amended by S.I.2007/3101.

(5)

1971 c.38.

(6)

OJ No. L255, 30.09.2005, p22, as amended by Council Directive 2006/100/EEC of 20 November 2006, OJ No. L363 of 20.12.2006, p141.

(7)

2000 c.7.

(8)

See Schedule 1 to the Interpretation Act 1978 (c.30) for the definition of “EEA State” which was inserted by section 26(1) of the Legislative and regulatory Reform Act 2006 (c.51).

(9)

S.I.2007/2781 as amended by S.I.2009/1182.

(10)

S.I.2002/618. There are no relevant amendments.

(11)

1968 c.67. Section 130 was amended by section 12(2) of, and paragraph 3 of Schedule 1 to, the Animal Health and Welfare Act 1984 (c.40) and by S.I.1994/3119, 2005/50 and 2006/2407.

(12)

See the Medicines (Products other than Veterinary Drugs) (General Sale List) Order 1984 (S.I.1984/769).

(13)

1852 c.56; repealed by the Pharmacy Act 1954 (c.61).

(14)

1868 c.121; repealed by the Pharmacy Act 1954.

(15)

1908 c.55; repealed by the Pharmacy Act 1954.

(16)

1933 c.25; repealed by the Statute Law Revision Act 1950 (c.6), by Schedule 4 to the Pharmacy Act 1954, by Schedule 6 to the Medicines Act 1968 (c.67) and by Schedule 2 to the Poisons Act 1972 (c.66).

(17)

1954 c.61; repealed by S.I.2007/289.

(18)

1972 c.66. The rules currently in force are S.I.1982/218. These Rules have been amended by S.I.1985/1077, 1968/10, 1986/1704, 1989/112 and 1992/2293.

(19)

1953 c.37. Section 1 was amended by section 68 of the Statistics and Registration Service Act 2007 (c.18).

(20)

1965 c.49. Section 1(1) was amended by the Scotland Act 1998 (c.46), section 125.

(21)

1968 c.67. There are no relevant amendments.

(22)

1968 c.67. The definition of retail sale was amended by paragraph 138(2) of Schedule 4 to the National Health Service Reorganisation Act 1973 (c.32), by paragraph 30 of Schedule 16 to the National Health Service (Scotland) Act 1978 (c.29) and by paragraphs 43 and 44 of Schedule 1 to the National Health Service (Consequential Provisions) Act 2006 (c.43).

(23)

Section 71 is substituted by section 28 of the Health Act 2006 (as amended by S.I.2007/3101) from 1 October 2007 (see S.I.2008/2714 (C.119)).

(24)

2004 c.36.

(25)

2002 c.17. Section 25(3) was amended by paragraph 17 of Schedule 10 to the Health and Social Care Act 2008 (c.14).

(26)

1968 c.67. Section 10 was amended by paragraph 5 of Schedule 3 to the Regulation of Care (Scotland) Act 2001 (asp 8) and by S.I.1971/1445, 1993/384, 1994/2987 and 2006/2407.

(27)

1968 c.67.

(28)

1972 c.66.

(29)

Sections 74A and 74D are inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(30)

1978 c.30.

(31)

1971 c.80.

(32)

1980 c.43.

(33)

Sections 74A and 74J are inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(34)

Section 74J is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(35)

Section 74K is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(36)

Section 74A is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(37)

Section 74C is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(38)

Section 74I is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(39)

1968 c.67. Section 74G is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(40)

Section 74A is inserted into the Act by paragraph 1(8) of Schedule 1 to this Order.

(41)

Section 74H is inserted into the Act by paragraph 1(8) of Schedule 4 to this Order.

(42)

1998 c.29.

(43)

1995 c.46.

(44)

Section 302 was amended by section 406(1) of and Schedule 17, paragraph 133(1) and (2) to, the Communications Act 2003 (c.21), by paragraph 16 of Schedule 7 to the Wireless Telegraphy Act 2006 (c.36) and by section 50(1) of the Criminal Proceedings etc. (Reform) (Scotland) Act 2007 (asp 6).

(45)

1992 c.5. Section 115A was inserted by section 60 of the Social Security Administration (Fraud) Act 1997 (c.47) and amended by section 14 of the Social Security Fraud Act 2001 (c.11).

(46)

2006 c.47.

(47)

S.I.2007/1351 (N.I.11).

(48)

2007 asp14.

(49)

S.I.1976/1213 (N.I. 22).

(50)

1998 c.29.

(51)

1968 c.67.

(52)

1990 c.41.

(53)

1980 c.46. Section 25A was inserted by section 24 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (c.40) and amended by paragraph 31 of Schedule 4 to the Criminal Procedure and Consequential Provisions (Scotland) Act 1995 (c.40), by S.S.I.1999/1042 and by S.S.I.2001/121.

(54)

1968 c.67.

(55)

1981 c.54 as amended by section 59(5) of and Schedule 11 to the Constitutional Reform Act 2005 (c.4). Section 36 has been amended by the Courts and Legal Services Act 1990 (c.41), Schedule 17, paragraph 13.

(56)

1946 c.36. Section 1(1A) was inserted by paragraph 2 of Schedule 12 to the Government of Wales Act 1998 (c.38) and substituted by paragraph 2 of Schedule 10 to the Government of Wales Act 2006 (c.32).

(57)

2006 c.46.

(58)

2006 c.3.

(59)

1968 c.67.

(60)

Subsection (1ZA) was inserted by S.I.2007/3101, regulation 98(a) and amended by regulation 13 of the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 (S.R.2008/192). Subsection (3) was amended by the Statute Law Repeals Act 1993 (c.50), Schedule 1, Part 12, by S.I.1976/1213 and by S.I.2007/289.

(61)

Section 70 is substituted by section 27 of the Health Act 2006 (c.28) (as amended by S.I.2007/3101 as from 1 October 2009 (see S.I.2008/2714 (C.114))). Section 70(3) and (5) was amended by S.I.2007/289.

(62)

Section 71 is substituted by section 28 of the Health Act 2006 (as amended by S.I. 2007/3101 as from 1 October 2009 (see S.I.2008/2714 (C.114))). Section 71(3) and (5) was amended by S.I.2007/289. Section 71(7) was amended by the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 (S.R.2008/192).

(63)

Section 72(2), (2A) and (2B) was inserted by section 29 of the Health Act 2006 (as amended by S.I.2007/3101 as from 1 October 2009 (see S.I.2008/2714 (C.114)). Section 72(2B) was amended by S.I.2007/289.

(64)

Section 72B was substituted by section 30 of the Health Act 2006 as from 1 October 2009 (see S.I.2008/2714 (C.114)). Section 72B was amended by S.I.2007/289.

(65)

Section 74(1), (2), (4) and (6) were amended, and section 74(2) and (4) repealed, by the Statute Law (Repeals) Act 1993 (c.50) and S.I.2006/2407.

(66)

Section 75 was amended by S.I.1968/1699.

(67)

Section 76(4) was repealed by the Statute Law (Repeals) Act 1993 (c.50).

(68)

Section 77 was amended by the Health Act 2006 (c.28), sections 30(2), 80(2) and Schedule 8.

(69)

Section 78(5) was amended by the Statute Law (Repeals) Act 1993, Schedule 1, Part 12 and by S.I.2007/289.

(70)

Section 79 was amended by S.I.2006/2407.

(71)

Section 80(1) was amended by S.I.2007/289. Section 80(5) was amended by the Misuse of Drugs Act 1971 (c.38), section 12(7), and by S.I.1976/1213.

(72)

Section 81(1) was amended by S.I.2007/289.

(73)

Section 108(6) was amended by the Animal Health and Welfare Act 1984 (c.40), Schedule 1, paragraph 3(4) and by S.I.2006/2407.

(74)

The definition of “pharmacist” in section 132(1) was amended by S.I.1976/1213 and S.I.2007/289 and 3101 and by the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 (S.R.2008/192).

(75)

1972 c.66. Section 9(1) to (4), and the definition of pharmacist in section 11(2), were amended by S.I.2007/289.

(76)

1976 c.74. Schedule 1A was inserted by S.I.2001/3457.

(77)

1978 c.29.

(78)

Section 27(4) was amended by S.I.1987/2022.

(79)

Section 28(2C) was inserted by S.I.2007/289.

(80)

There are no relevant amendments to section 108(1).

(81)

1994 c.23; item 1 in group 12 in Part 2 of Schedule 8 was amended by S.I.1997/2744, 2006/1914 and 2007/289. Item 3 in group 7 in Part 2 of Schedule 9 was amended by S.I.2007/206 and 289.

(82)

1998 c.29. Section 69(1) was amended by S.I.2002/253 and 254, 2003/1590, 2005/848 and 2007/289.

(83)

1999 c.8. Subsection (2) was amended by the Health and Social Care Act 2008 (c.14), sections 111, 166 and Schedule 8 and by S.I.2002/253 and 254.

(84)

Paragraph (aa) of subsection (2) was inserted into section 60 by section 111 of, and Schedule 8 to, the Health and Social Care Act 2008.

(85)

2000 c.23.

(86)

2000 c.36. The words to be omitted by virtue of paragraph 9(b) of this Schedule were inserted by S.I.2005/3593.

(87)

2002 c.17

(88)

The name of the Council was changed by section 113 of the Health and Social Care Act 2008 (c.14). The section heading to section 25 was substituted by paragraph 16 of Schedule 10 to that Act and other amendments to section 25 were made by paragraph 17 of that Schedule.

(89)

Section 26(5) was amended by S.I.2007/289.

(90)

Section 29(1) was amended by the Health and Social Care Act 2008, section 118(2) and by S.I.2002/3135, 2004/1771, 2005/848 and 2011 and 2007/289.

(91)

2003 c.1. The list of fees in paragraph 1 of the Table in section 343(2) was amended by the Health and Social Care Act 2008 (c.14), Schedule 15 and by S.I. 2005/2011, 2007/289 and 2008/836.

(92)

2006 c.28.

(93)

2006 c.41.

(94)

Section 129(6)(c) was amended by S.I.2007/289.

(95)

Section 132(8)(b) was substituted by S.I.2007/289.

(96)

The definition of “registered pharmacist” was substituted by S.I.2007/289.

(97)

2006 c.42.

(98)

Section 83(6)(c) was amended by S.I.2007/289.

(99)

Section 86(8)(b) was substituted by S.I.2007/289.

(100)

The definition of “registered pharmacist” in section 206(1) was substituted by S.I.2007/289.

(101)

2006 c.47.

(102)

2007 asp. 14.

(103)

S.I.1973/1822; amended by S.I.2007/3282, regulation 1.

(104)

S.I.1975/1023. The definitions of “registered pharmacist” and “registered pharmacy technician” were inserted by S.I.2007/289.

(105)

The definition of “registered pharmacy technician” was inserted by S.I.2009/1182.

(106)

S.I.1977/670. Regulation 2(3) was amended by S.I.1990/2487.

(107)

S.I.1980/1923.

(108)

The definition of “relevant register” was inserted by S.I.2003/698 and amended by S.I.2004/1771, 2005/764 and 1520, 2006/914 and 2007/289.

(109)

Regulation 2(3) was amended by S.I.2005/2745.

(110)

S.I.1980/1924. The definition of “relevant register” was inserted by S.I.2004/1 and amended by S.I.2004/1771, 2005/766 and 1507, 2006/915 and 2007/289.

(111)

S.I.1984/978.

(112)

S.I.1989/684. Paragraph 1 of Schedule 2 was amended by S.I.2005/2754.

(113)

S.I.1992/662. These Regulations have been revoked in relation to England and now apply only to Wales (see S.I.2005/641). The definition of “relevant register” was inserted by S.I.2007/205 and amended by S.I.2007/289. The definition of “supplementary prescriber” was inserted by S.I.2003/2624, substituted by S.I.2007/205 and amended by S.I.2007/289.

(114)

S.I.1994/3144. The definition of “relevant register” was inserted by S.I.2005/768 and amended by S.I.2005/1520, 2006/914 and 2007/289.

(115)

S.I.1997/1830. The definition of “relevant register” was inserted by S.I.2003/696 and amended by S.I.2004/1711, 2005/765 and 1507, 2006/915 and 2007/289.

(116)

S.I.1998/3186.

(117)

S.I.1999/2325. These Regulations were revoked in relation to England by S.I.2005/280 and in relation to Wales by S.I.2005/3368. They were revoked in relation to Scotland by S.I.2005/608, except for certain purposes.

(118)

S.I.2000/620. The definition of “pharmacist independent prescriber” was inserted by S.I. 2006/913 and amended by S.I.2007/289. The definition of “supplementary prescriber” was inserted by S.I.2003/699, substituted by S.I.2005/578 and 2006/913, and amended by S.I.2007/289.

(119)

S.I.2001/341. Regulation 53(2) was substituted by S.I.2006/2910. Sub-paragraph (e) was substituted by S.I.2009/1182.

(120)

S.I.2001/497. Regulation 53(2) was substituted by S.I.2007/925. Sub-paragraph (e) was substituted by S.I.2009/1182.

(121)

S.I.2001/3750.

(122)

S.I.2001/3998.

(123)

Regulation 8(2) was amended by S.I.2005/271 and 2007/2154.

(124)

Regulation 9(2) was amended by S.I.2005/271.

(125)

S.S.I.2002/190. Regulation 3(3)(e) was amended by S.I.2007/289.

(126)

S.I.2002/1689.

(127)

S.I.2003/2317. The definition of “relevant register” was amended by S.I.2004/1771, 2005/1520, 2006/914 and 2007/289.

(128)

S.S.I.2004/38.

(129)

S.I.2004/291. The definition of “pharmacist independent prescriber” was inserted by S.I.2006/1501 and amended by S.I.2007/289; the definition of “relevant register” was amended by S.I.2007/289; and the definition of “supplementary prescriber” was amended by S.I.2005/893 and 3315, 2006/1501 and 2007/289.

(130)

S.I.2004/478. The definition of “relevant register” was amended by S.I.2007/205 and 289 and the definition of “supplementary prescriber” was amended by S.I.2006/358 and 2007/289.

(131)

S.I.2004/627. The definition of “pharmacist independent prescriber” was inserted by S.I.2006/1501 and amended by S.I.2007/289; the definition of “relevant register” was amended by S.I.2007/289; and the definition of “supplementary prescriber” was amended by S.I.2005/893 and 3315, 2006/1501 and 2007/289.

(132)

S.I.2004/1031. The definition of “Pharmacist” in regulation 2(1) was amended by S.I.2007/289 and 3101 and by the European Qualifications (Pharmacy) Regulations (Northern Ireland) 2008 (S.R.2008/192).

(133)

S.S.I.2004/115. The definition of “pharmacist independent prescriber” was inserted by S.S.I.2007/501; the definition of “relevant register” was amended by S.I.2007/289; and the definition of “supplementary prescriber” was amended by S.S.I.2006/247 and by S.I.2007/289.

(134)

S.S.I.2004/116. The definition of “pharmacist independent prescriber” was inserted by S.S.I.2007/502; the definition of “relevant register” was amended by S.I.2007/289 and the definition of “supplementary prescriber” was amended by S.S.I.2006/248 and by S.I.2007/289.

(135)

S.I.2005/318.

(136)

S.I.2005/765.The definition of “relevant register” was amended by S.I.2005/1507 and 2007/289.

(137)

S.I.2005/916. Article 5(3)(c) was amended by S.I.2007/289 and 3101.

(138)

S.I.2005/2750. The definition of “relevant register” was amended by S.I.2006/914.

(139)

S.S.I.2005/125. Article 5(2)(b)(iii) was amended by S.I.2007/289 and 3101 and by S.I.2009/1182.

(140)

S.S.I.2006/330.

(141)

S.I.2006/3148.

(142)

The definition of “registered pharmacist” was substituted by S.I.2007/3101.

(143)

Regulation 19(b)(i) is amended by the Health and Social Care Act (Commencement No. 9, Consequential Amendments and Transitory, Transitional and Savings Provisions) Order 2009 (S.I.2009/462).

(144)

S.I.2007/121 (W.11).

(145)

O.S.2007/121 (Cy.11).

(146)

S.I.2007/236. Paragraph (e) was substituted by S.I.2009/1182.

(147)

S.I.2007/289.

(148)

S.S.I.2007/513.

(149)

S.I.2007/934.

(150)

S.I.2007/937. Paragraph (e) was substituted by S.I.2009/1182.

(151)

S.I.2007/2781; as amended by S.I.2009/1182.

(152)

S.S.I.2008/27.

(153)

S.I.2008/295.

(154)

S.I.2008/1284.

(155)

S.I.2008/2789.

(156)

S.I.2008/2927.

(157)

S.I.2008/3239 (W.286).

(158)

O.S.2008/3239 (Cy.286).

(159)

S.S.I.2009/183.

(160)

1968 c.67.

(161)

S.I.2006/246.

(162)

1968 c.67. Other amendments to section 69(3) made by S.I.2007/289 are substituted by Schedule 4 to this Order. S.I.2007/289 is revoked by that Schedule.

(163)

2003 c.1. Other entries inserted in the Table by S.I.2007/289 are substituted by Schedule 4 to this Order.

(164)

S.I.1976/1213 (N.I. 22).

(165)

S.I.1975/1023. The definition of “registered pharmacist” and “registered pharmacy technician” that were inserted by paragraph 12(b) of the 2007 Order are substituted by Schedule 4 to this Order.

(166)

S.I.1992/662. These Regulations have been revoked in relation to England and now apply only in relation to Wales (see S.I.2005/641). Regulation 4(5) was also amended by S.I.2002/2469.

(167)

S.S.I. 2003/231. The definition of “registered pharmacist” inserted by S.I.2007/289 is substituted by Schedule 4 to this Order.

(168)

OJ No. L 255, 30.09.2005, p.22, as amended by Council Directive 2006/100/EC of 20 November 2006, OJ No. L 363 of 20.12.2006, p.141.