The Pharmacy Order 2010

PART 1Preliminary

1Citation and commencement

3Interpretation

PART 2The Council and its Committees

4The Council and its Committees

5Standards and requirements: consultation and review

6The Council’s general duties

PART 3Registered Pharmacies: Standards in retail pharmacies

7Standards: general

8The Inspectorate

9Inspection and enforcement

10Power of entry

11Powers of an inspector

12Obstruction: offences

13Improvement notices

14Non-compliance with improvement notices

15Offences committed by partnerships

16Appeals against improvement notices

17Powers of a court on appeal

PART 4Registration

18The Registrar

19Establishment, maintenance of and access to the Register

20Entitlement to entry in Part 1 or 2 of the Register: pharmacists and pharmacy technicians

20AArticle 20: further provision relating to specified state professionals

21Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacists

21AEuropean qualifications: pharmacists

22Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacy technicians

23Form, manner and content of applications for entry or for renewal of an entry in the Register: pharmacists and pharmacy technicians

23ASupplementary provisions as to necessary knowledge of English

24Notification by the Registrar: entry and renewal

25Duration of entry

26Notice of entry in the Register

27Specialisations: registrants and registered pharmacies

28Registrants’ duties with regard to their entries

29Corrections to the Register

30Fitness to practise matters before entry or renewal of an entry

31Voluntary removal from the Register

32Indemnity arrangements

33Visiting pharmacists and pharmacy technicians from relevant European States

33AEuropean professional card

34Temporary entry with regard to emergencies involving loss of human life or human illness etc.

35Temporary annotations with regard to emergencies involving loss of human life or human illness etc.

36Fees in connection with entry

36AAdditional requirements for specified state professionals

37Restoration to the Register of persons or premises removed from the Register

38Offences relating to the Register

39Appealable decisions

40Appeals to the Appeals Committee

41Appeals from the Appeals Committee

PART 5Education, training and acquisition of experience and continuing professional development

42Education, training and acquisition of experience

42AProfessional traineeships carried out in other relevant European States, etc.

43Continuing professional development

44Specific obligations and powers of the Council in respect of education and training

46Information to be given by institutions or other providers

47Refusal or withdrawal of approval of courses, qualifications and institutions

PART 6Fitness to practise

48Standards of conduct and performance

48AInformation for specified state professionals

49Disclosure of information: general

50Disclosure of fitness to practise matters in the public interest

51Impairment of fitness to practise

52Initial action in respect of allegations

53Consideration by the Investigating Committee

54Consideration by the Fitness to Practise Committee

55Professional performance assessments

55AKnowledge of English assessments

56Interim orders

57Restoration of names to the Register: fitness to practise

58Appeals against appealable fitness to practise decisions

59The taking effect of directions in respect of appealable fitness to practise decisions

60Interim measures pending a direction taking effect

PART 7Proceedings

61Rules in respect of proceedings

62Procedure for the Fitness to Practise Committee and the Appeals Committee

63Legal advisers

64Clinical and other specialist advisers

PART 8Miscellaneous

67The Directive: designation of competent authority etc.

68Amendments, repeals and revocations

69Transitional, transitory and saving provisions

70Privy Council procedures etc.

SCHEDULE 1Constitution of the General Pharmaceutical Council

1Membership: general

2Matters for the order of the Privy Council under article 4(2)

3Powers of the Council

4Registration of members’ private interests

5The statutory committees

6The Council’s duties in respect of publications

8Annual reports, statistical information and strategic plans

SCHEDULE 2Visiting Practitioners from relevant European States

PART 1Pharmacists

1Application and interpretation

2Registration in respect of provision of occasional pharmacy services

3Entitlement to provide occasional pharmacy services: first year

4First provision of services: required documents

4AFirst provision of services: visiting practitioners from Northern Ireland

5First provision of services: supplementary

6Entitlement to provide occasional pharmacy services after the first year: renewals

7Duration of entitlement to provide occasional pharmacy services

PART 2Pharmacy technicians

9Application and interpretation

10Registration in respect of the provision of occasional services

11Entitlement to provide occasional pharmacy services: first year

12First provision of services: required documents

13First provision of services: supplementary

14Entitlement to provide occasional pharmacy services after the first year: renewals

15Duration of entitlement to provide occasional pharmacy services

SCHEDULE 2ADirective 2005/36/EC: European professional card

2Interpretation

PART 2General functions of the Council in relation to European professional cards

3Council not to request resubmission of valid documents

4Power to revoke a European professional card

5Rectification of the European professional card or the IMI file

6Duty to give reasons and to notify of right of appeal

7Updating the IMI file: disciplinary action or criminal sanctions

8Access to data

9Processing data

PART 3European professional cards for establishment in the United Kingdom or another relevant European State

10European professional cards for establishment in a host State other than the United Kingdom

11Issue of European professional card for establishment in Great Britain

PART 4European professional cards for the provision of occasional pharmacy services in a relevant European State other than the United Kingdom

12Issue of European professional card for the provision of occasional pharmacy services in a host State other than the United Kingdom

13Variation of a European professional card for the provision of occasional pharmacy services in a host State other than the United Kingdom

PART 5European professional card: requirements and entitlements as to registration

14Requirement to register: establishment cases

15Entitlement to registration: provision of occasional pharmacy services

PART 6Conditions in relation to fitness to practise

16Conditions in relation to fitness to practise: providers of occasional pharmacy services

SCHEDULE 3The Directive: Designation of competent authority etc.

SCHEDULE 4Amendments, repeals and revocations

PART 1Primary legislation

1Amendment of the Medicines Act 1968

2Amendment of the Poisons Act 1972

3Amendment of the Race Relations Act 1976

4Amendment of the National Health Service (Scotland) Act 1978

5Amendment of the Value Added Tax Act 1994

6Amendment of the Data Protection Act 1998

7Amendment of the Health Act 1999

8Amendment of the Regulation of Investigatory Powers Act 2000

9Amendment of the Freedom of Information Act 2000

10Amendment of the National Health Service Reform and Health Care Professions Act 2002

11Amendment of the Income Tax (Earnings and Pensions) Act 2003

12Amendment of the Health Act 2006

13Amendment of the National Health Service Act 2006

14Amendment of the National Health Service (Wales) Act 2006

15Amendment of the Safeguarding Vulnerable Groups Act 2006

16Amendment of the Protection of Vulnerable Groups (Scotland) Act 2007

PART 2Secondary legislation

17Amendment of the Medicines (Pharmacies) (Applications for Registration and Fees) Regulations 1973

18Amendment of the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975

19Amendment of the Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977

20Amendment of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980

21Amendment of the Medicines (Pharmacy and General Sale – Exemption) Order 1980

22Amendment of the Employment Agencies Act 1973 (Exemption) (No 2) Regulations 1984

23Amendment of the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989

24Amendment of the National Health Service (Pharmaceutical Services) Regulations 1992

25Amendment of the National Health Service (Service Committees and Tribunal) Regulations 1992

26Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

27Amendment of the Prescription Only Medicines (Human Use) Order 1997

28Amendment of the Building Societies (Business Names) Regulations 1998

29Amendment of the Feeding Stuffs (Enforcement) Regulations 1999

30Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000

31Amendment of the Representation of the People (England and Wales) Regulations 2001

32Amendment of the Representation of the People (Scotland) Regulations 2001

33Amendment of the Family Health Services Appeal Authority (Procedure) Rules 2001

34Amendment of the Misuse of Drugs Regulations 2001

35Amendment of the Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002

36Amendment of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002

37Amendment of the Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003

38Amendment of the Medicines (Child Safety) Regulations 2003

39Amendment of the National Health Service (Tribunal) (Scotland) Regulations 2004

40Amendment of the National Health Service (General Medical Services Contracts) Regulations 2004

41Amendment of the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004

42Amendment of the National Health Service (Personal Medical Services Agreements) Regulations 2004

43Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

44Amendment of the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004

45Amendment of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004

46Amendment of the Regulation of Care (Social Service Workers) (Scotland) Order 2005

47Amendment of the National Health Service (Pharmaceutical Services) Regulations 2005

48Amendment of the Medicines for Human Use (Prescribing) Order 2005

49Amendment of the Gender Recognition (Disclosure of Information) (England, Wales and Northern Ireland) (No. 2) Order 2005

50Amendment of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

51Amendment of the Gender Recognition (Disclosure of Information) (Scotland) Order 2005

52Amendment of the National Health Service (Discipline Committees) (Scotland) Regulations 2006

53Amendment of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006

54Amendment of the Controlled Drugs (Supervision of Management and Use) Regulations 2006

55Amendment of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007

56Diwygio Rheoliadau’r Gwasanaeth Iechyd Gwladol (Presgripsiynau am Ddim a Ffioedd am Gyffuriau a Chyfarpar) (Cymru) 2007

57Amendment of the National Assembly for Wales (Representation of the People) Order 2007

58Revocation of the Pharmacists and Pharmacy Technicians Order 2007

59Amendment of the Licensing (Relevant Offences) (Scotland) Regulations 2007

60Amendment of the Regulation of Investigatory Powers (Authorisations Extending to Scotland) Order 2007

61Amendment of the Scottish Parliament (Elections etc.) Order 2007

62Amendment of the European Communities (Recognition of Professional Qualifications) Regulations 2007

63Amendment of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008

64Amendment of the Controlled Drugs (Drug Precursors) (Intra-Community Trade) Regulations 2008

65Amendment of the Cosmetic Products (Safety) Regulations 2008

66Amendment of the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

67Amendment of the Council for Healthcare Regulatory Excellence (Appointment, Procedure etc.) Regulations 2008

68Amendment of the Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008

69Diwygio Rheoliadau Cyffuriau a Reolir (Goruchwylio Rheolaeth a Defnydd) (Cymru) 2008

70Amendment of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

71Amendment of the Veterinary Medicines Regulations 2009

SCHEDULE 5Transitional Provisions

1Interpretation

2Members of committees

3Transfer of information to the Register

5Appealable registration decisions

6(1) The revocation of article 44 of the 2007 Order...

7Transitional arrangements: pharmacy technicians

8Offences relating to the Register: pharmacy technicians

9Education and training

12Fitness to practise proceedings

13(1) The revocation of Part 5 of and Part 4...

14Proceedings under section 80 of the 1968 Act

15Supply of information

16Application of TUPE

17Transfer of property, rights and liabilities

18Grants and loans

19Cancellation of elections to, and transitional measures relating to, the Council of the Society

SCHEDULE 6Savings

PART 1Primary legislation

1Medicines Act 1968

2Income Tax (Earnings and Pensions) Act 2003

PART 2Secondary legislation

3Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975

4National Health Service (Pharmaceutical Services) Regulations 1992

5Rehabilitation of Offenders Act 1974 (Exclusions and Exceptions) (Scotland) Order 2003

6National Health Service (Pharmaceutical Services) Regulations 2005

2010 No. 231

Health Care And Associated Professions

The Pharmacy Order 2010

Made10th 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 19991 as read with paragraph 1A of Schedule 2 to the European Communities Act 19722.

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 qualifications3 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: