1999 No. 2510

MEDICINES

The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No. 2) Regulations 1999

Made

Laid before Parliament

Coming into force

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of the powers conferred on them by sections 53(4) and 129(1) and (5) of the Medicines Act 19681 or, as the case may be, those 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 Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Regulations:

Citation and commencement1

These Regulations may be cited as the Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No. 2) Regulations 1999 and shall come into force on 30th September 1999.

Amendment of regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 19802

In regulation 8 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 19803 (pack size on retail sale or supply of certain medicinal products on a general sale list)—

a

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

b

after paragraph (2E) there is inserted—

2F

Where a medicinal product for human use containing ranitidine hydrochloride 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 12 tablets.

Signed by authority of the Secretary of State for Health

HuntParliamentary Under Secretary of State,Department of Health
David HansonParliamentary Under Secretary of State, The Welsh Office
John ReidSecretary of State, The Scotland Office
HaymanParliamentary Under Secretary of State, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

D. C. GowdyPermanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on

P. SmallPermanent Secretary

(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 ranitidine hydrochloride 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 12 tablets.

An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in 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.