Citation, commencement and interpretation

1. —(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 1980( 3 ).

Amendment of regulation 1 of the principal Regulations

2. 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—

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—

“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”—

  (a)

  in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 ( 7 ) , and

  (b)

  in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001 ( 8 ) ;

• “independent hospital”—

  (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

  (b)

  in relation to Scotland, means—

  (i)

  an independent hospital, or

  (ii)

  a private psychiatric hospital,

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

• “independent medical agency”—

  (a)

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

  (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 1997 ( 9 ) ; ” ;

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

“ “prison service” means—

“professional register” means the register maintained by the Nursing and Midwifery Council ( 14 ) pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001 ( 15 ) ; ” ;

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

“ “relevant register” means—

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

“ “supplementary prescriber” means—

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 Regulations

3. 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 Regulations

4. 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 Regulations

5. 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—

  (a)

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

  (b)

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

(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—

  (a)

  a police force in England, Wales or Scotland,

  (b)

  the Police Service of Northern Ireland,

  (c)

  a prison service, or

  (d)

  Her Majesty’s Forces. ” .

Amendment of Schedule 2 to the principal Regulations

6. 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”.