2003 No. 698

MEDICINES

The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2003

Made

Laid before Parliament

Coming into force

As respects England, Scotland and Wales, the Secretary of State, and, as respects Northern Ireland, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, in exercise of the powers conferred on them by sections 61, 66(1) and 129(1) and (5) of the Medicines Act 19681 or, as the case may be, the powers conferred by those provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations, pursuant to section 129(6) of that Act, and after taking into account the advice of the Committee on Safety of Medicines and the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Regulations:

Citation, commencement and interpretation1

1

These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2003 and shall come into force on 4th April 2003.

2

In these Regulations, “the principal Regulations” means the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 19803.

Amendment of regulation 1 of the principal Regulations2

In regulation 1 of the principal Regulations (citation, commencement and interpretation), in paragraph (1), in sub-paragraph (a)—

a

after the definition of “controlled drug”, insert the following definition—

  • “district nurse/health visitor prescriber” means—

    1. a

      a person who—

      1. i

        is registered in Part 1 or 12 of the professional register, and

      2. ii

        has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 19834; or

    2. b

      a person who is registered in Part 11 of the professional register as a health visitor,

    against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;

b

after the definition of “excepted person”5, insert the following definitions—

  • “Extended Formulary” means the Nurse Prescribers' Extended Formulary Appendix in the current edition of the British National Formulary;

  • “extended formulary nurse prescriber” means a person—

    1. a

      who is a first level nurse, and

    2. b

      against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;

  • “first level nurse” means a person registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register;

c

after the definition of “Health Authority”6, insert the following definition—

  • “health care” means services for or in connection with the prevention, diagnosis or treatment of disease;

d

in the definition of “health prescription”, for “or dentist” substitute “, a dentist, a supplementary prescriber, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;

e

after the definition of “health prescription”, insert the following definitions—

  • “independent clinic”—

    1. a

      in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 20007, and

    2. b

      in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 20018;

  • “independent hospital”—

    1. a

      in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and

    2. b

      in relation to Scotland, means—

      1. i

        an independent hospital, or

      2. ii

        a private psychiatric hospital,

      as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001;

  • “independent medical agency”—

    1. a

      in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and

    2. b

      in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;

f

in the definition of “prescription only medicine”, for “Prescription Only Order” substitute “Prescription Only Medicines Order”;

g

for the definition of “the Prescription Only Order”, substitute the following definition—

  • “the Prescription Only Medicines Order” means the Prescription Only Medicines (Human Use) Order 19979;

h

after the definition of “Primary Care Trust”10, insert the following definitions—

  • “prison service” means—

    1. a

      in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 195211),

    2. b

      in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 198912), and

    3. c

      in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 195313);

  • “professional register” means the register maintained by the Nursing and Midwifery Council14 pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 200115;

i

after the definition of “registered ophthalmic optician”, insert the following definition—

  • “relevant register” means—

    1. a

      in relation to a first level nurse, the professional register, and

    2. b

      in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 195416 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 197617;

j

after the definition of “Special Health Authority”18, insert the following definition—

  • “supplementary prescriber” means—

    1. a

      a first level nurse, or

    2. b

      a pharmacist,

    against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber;

Amendment of regulation 5 of the principal Regulations3

Regulation 5 of the principal Regulations (restrictions on persons to be supplied with certain medicinal products), in paragraph (2)—

a

in sub-paragraph (a), for “column 1 of Schedule 4 to the Prescription Only Order” substitute “column 1 of Schedule 5 to the Prescription Only Medicines Order”;

b

in sub-paragraph (b), for “Article 8 of the Prescription Only Order” substitute “Article 10 of the Prescription Only Medicines Order”; and

c

sub-paragraph (d) is omitted.

Amendment of regulation 6 of the principal Regulations4

In regulation 6 of the principal Regulations (pharmacy records)19—

a

in paragraph (1), in sub-paragraph (b), for “Article 6(1) of the Prescription Only Order” substitute “Article 8(1) of the Prescription Only Medicines Order”; and

b

in paragraph (3), in sub-paragraph (d), for “column 3 of Schedule 4 to the Prescription Only Order” substitute “column 3 of Schedule 5 to the Prescription Only Medicines Order”.

Amendment of Schedule 1 to the principal Regulations5

In Schedule 1 to the principal Regulations (classes of persons for the purposes of regulation 5)—

a

for the entry “Authorities or persons carrying on the business of a hospital or health centre” substitute the following entry—

  • Authorities or persons carrying on the business of—

    1. a

      an independent hospital, independent clinic or independent medical agency, or

    2. b

      a hospital or health centre which is not an independent hospital or independent clinic.

b

at the end add the following entry—

  • A person other than an excepted person who carries on a business consisting (wholly or partly) of the supply or administration of medicinal products for the purpose of assisting the provision of health care by or on behalf of, or under arrangements made by—

    1. a

      a police force in England, Wales or Scotland,

    2. b

      the Police Service of Northern Ireland,

    3. c

      a prison service, or

    4. d

      Her Majesty’s Forces.

Amendment of Schedule 2 to the principal Regulations6

In Schedule 2 to the principal Regulations (particulars in pharmacy records)20—

a

in paragraph 1—

i

for “a practitioner or under Article 6(1) of the Prescription Only Order” substitute “a practitioner, a supplementary prescriber, a district nurse/health visitor prescriber or an extended formulary nurse prescriber, or under Article 8(1) of the Prescription Only Medicines Order”,

ii

in sub-paragraph (c), after “the practitioner” insert “, supplementary prescriber, district nurse/health visitor prescriber or extended formulary nurse prescriber”, and

iii

in sub-paragraph (f), for “Article 6(1) of the Prescription Only Order” substitute “Article 8(1) of the Prescription Only Medicines Order”;

b

in paragraph 3, for “Article 6(3) of the Prescription Only Order” substitute “Article 8(3) of the Prescription Only Medicines Order”; and

c

in paragraph 4, for “Article 6 of the Prescription Only Order” substitute “Article 8 of the Prescription Only Medicines Order”.

Signed by authority of the Secretary of State for Health

HuntParliamentary Under Secretary of State,Department of Health

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

D.C. GowdyPermanent Secretary,Department of Health, Social Services and Public Safety

Sealed with the Official Seal of the Department of Agriculture and Rural Development

P.J. SmallPermanent Secretary,Department of Agriculture and Rural Development

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 (“the principal Regulations”) which impose restrictions on the sale and supply of medicinal products.

Regulation 6 of, and Schedule 2 to, the principal Regulations imposes a requirement on persons conducting a retail pharmacy business to record the sale or supply of a prescription only medicine except in specified circumstances such as the sale or supply having been made pursuant to a prescription issued under or by virtue of legislation relating to the National Health Service. Regulations 2(a), (b), (d) and (h) to (j), 4 and 6 of these Regulations amends these provisions so as to include references to prescriptions written by supplementary prescribers, district nurse/health visitor prescribers and extended formulary nurse prescribers.

Schedule 1 to the principal Regulations specifies persons who may, subject to exemptions specified in the principal Regulations, be supplied with certain medicinal products. Regulation 5 of these Regulations adds—

a

authorities or persons carrying on the business of independent hospitals, clinics and medical agencies, and

b

persons who carry on a business consisting (wholly or partly) of the supply or administration of medicinal products for the purpose of assisting the provision of health care by the police, the prison services or the armed forces,

to the list of bodies specified in Schedule 1.

Regulations 2, 3, 4 and 6 make minor and consequential amendments to the principal Regulations. In particular, these include the removal of references to the Medicines (Prescription Only) Order 198021 and the substitution of references to the Prescription Only Medicines (Human Use) Order 199722.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.