The Health Service Medicines (Information on the Prices of Specified Generic Medicines) Regulations 2001

Interpretation

2.—(1) In these Regulations—

“group of companies” means a holding company and its subsidiary or, where it has more than one subsidiary, each of them and in this definition “subsidiary” has the same meaning as in section 736(1) of the Companies Act 1985(1);

“the list of specified generic medicines” means the list of medicines which was published on 20th November 2001 on the internet at http://www.doh.gov.uk/generics/medicines.htm by the Department of Health(2);

“marketing authorisation” means a marketing authorisation for a medicinal product for human use granted—

(a)

by the competent authorities of the United Kingdom in accordance with Council Directive 65/65/EEC of 26th January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(3); or

(b)

by the European Agency for the Evaluation of Medicinal Products in accordance with Council Regulation (EEC) No. 2309/93 of 22nd July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(4);

“presentation” means a particular form of a medicine which may be distinguished from other forms of that medicine by reference to pack size;

“specified generic health service medicine” means a health service medicine which—

(a)

is included in the list of specific generic medicines notwithstanding the addition of a manufacturer’s or supplier’s name or trade mark; but

(b)

is not identifiable by and traded under a specified name given to it by any person who is the manufacturer, supplier or holder of a marketing authorisation relating to it;

“supply” means supply by way of sale to a person lawfully conducting a retail pharmacy business or to a registered medical practitioner, in order to enable that person or practitioner (as the case may be) to provide pharmaceutical services within the meaning of—

(a)

section 41 of the National Health Service Act 1977(5) in England or Wales;

(b)

section 27 of the National Health Service (Scotland) Act 1978(6) in Scotland;

(c)

article 63 of the Health and Personal Social Services (Northern Ireland) Order 1972(7) in Northern Ireland.

(2) A health service medicine is supplied on the date on which a contract for its sale for health service use is concluded.

(3) Any reference in these Regulations to a numbered regulation is a reference to a regulation which bears that number in these Regulations and any reference to a numbered paragraph in a regulation is a reference to the paragraph in that regulation which bears that number.

(1)

1985 c. 6, section 736 was substituted by the Companies Act 1989 (c. 40), section 144(1).

(2)

Copies printed from the internet may be obtained from Room 130, Richmond House, 79 Whitehall, London SW1A 2NS.

(3)

OJ No. L 22, 9.2.1965, p. 369 amended by Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC, 89/342/EEC, 89/343/EEC, 92/27/EEC, 92/73/EEC and 93/39/EEC.

(4)

OJ No. L 215, 24.8.1993, p. 1.

(5)

1977 c. 49: section 41 was amended by the Health Services Act 1980 (c. 53), sections 1 and 20(1) and Schedule 1, paragraph 53 and Schedule 7; S.I. 1985/39; the National Health Service and Community Care Act 1990 (c. 19), Schedule 9, paragraph 18(1) and Schedule 10; the Medicinal Products: Presciption by Nurses etc. Act 1992 (c. 28), section 2; the Health Authorities Act 1995 (c. 17), Schedule 1, paragraph 29: and the National Health Service (Primary Care) Act 1997 (c. 46), section 41(10) and Schedule 2, paragraph 13. As regards Wales, the functions of the Secretary of State under section 41 were transferred to the National Assembly for Wales under S.I. 1999/672 as amended by the Health Act 1999 (c. 8), section 66.

(6)

1978 c. 29; section 27 was amended by the Health Services Act 1980 (c. 53), section 20(2); the National Health Service (Amendment) Act 1986 (c. 66), section 3(3); S.I. 1987/2202; the National Health Service and Community Care Act 1990 (c. 19), Schedule 9, paragraph 19(7); the Medicinal Products: Prescription by Nurses etc Act 1992 (c. 28), section 3 and the National Health Service (Primary Care) Act 1997 (c. 46), Schedule 2, paragraph 44; and is to be read as one with the Health and Medicines Act 1988 (c. 49). The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998 (c. 46).

(7)

1972 N.I. 11; amended by S.I. 1997/1177 (N.I. 7).