The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2000

Statutory Instruments

2000 No. 1070

MEDICINES

The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2000

Made

14th April 2000

Laid before Parliament

17th April 2000

Coming into force

10th May 2000

As respects England, Scotland and Wales, the Secretary of State concerned with health in England and the Minister of Agriculture, Fisheries and Food, 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 53(4) and 129(1) and (5) of the Medicines Act 1968(1) or, as the case may be, the powers conferred by those provisions and now vested in them(2), 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 and commencement

1.  These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment Regulations 2000 and shall come into force on 10th May 2000.

Amendment of regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980

2.  In regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(3) (pack size on retail sale or supply of certain medicinal products on a general sale list)—

(a) in paragraph (1), for “paragraphs (2) to (2F) and 3” there is substituted “paragraphs (2) to (2G) and 3”; and

(b) after paragraph (2F) there is inserted—

“(2G) Where a medicinal product for human use containing mepyramine maleate is sold by retail in the course of a business elsewhere than at a registered pharmacy or is so offered or exposed for sale by retail or so supplied in circumstances corresponding to retail sale, the product shall be presented for sale in a separate and individual container or package containing not more than 20 grams of the product.”.

Signed by authority of the Secretary of State for Health

Hunt

Parliamentary Under Secretary of State

Department of Health

11th April 2000

Hayman

Minister of State, Ministry of Agriculture, Fisheries and Food

12th April 2000

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

W. B. Smith

A Senior Officer of the

Department of Health, Social Services and Public Safety

on 14th April 2000

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

P. J. Small

A Senior Officer of the

Department of Agriculture and Rural Development

on 14th April 2000

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 by amending regulation 8 of those Regulations (pack size on retail sale or supply of certain medicinal products on a general sale list) to provide that medicinal products containing mepyramine maleate and which are on the general sale list may be sold or supplied from outlets other than registered pharmacies only in separate and individual containers or packages containing not more than 20 grams of the product.

An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament. Further copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

1968 c. 67; the expression “the Ministers” is defined in section 1(1) of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, and by articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142. The word “prescribed” in section 53(4) of that Act is defined in section 132(1) of that Act.

(2)

In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388, and articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Agriculture, Fisheries and Food, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Northern Ireland Departments, the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1).

(3)

S.I. 1980/1923; relevant amending instruments are S.I. 1982/28, 1990/1124, 1994/2411, 1995/3215, 1997/2045, 1999/644 and 1999/2510.