The Pharmacy Order 2010

Amendment of the Medicines Act 1968 E+W+S

1.—(1) The Medicines Act 1968(1) is amended as follows.

(2) In section 69(2) (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(3) (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(4) (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(5) (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(6) (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(7) (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(8) (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(9) (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(10) (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(11) (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(12) (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(13) (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(14) (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(15) (enforcement in England and Wales), in subsection (6)(c), for “sections 77 and 78” substitute “section 78”.

(18) In section 132(1)(16) (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

I1 Sch. 4 para. 1 in force at 10.2.2010 for specified purposes, see art. 1(3)

I2 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.

I3 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.

(1)

1968 c.67.

(2)

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.

(3)

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.

(4)

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).

(5)

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.

(6)

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.

(7)

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.

(8)

Section 75 was amended by S.I.1968/1699.

(9)

Section 76(4) was repealed by the Statute Law (Repeals) Act 1993 (c.50).

(10)

Section 77 was amended by the Health Act 2006 (c.28), sections 30(2), 80(2) and Schedule 8.

(11)

Section 78(5) was amended by the Statute Law (Repeals) Act 1993, Schedule 1, Part 12 and by S.I.2007/289.

(12)

Section 79 was amended by S.I.2006/2407.

(13)

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.

(14)

Section 81(1) was amended by S.I.2007/289.

(15)

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.

(16)

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).