The Medicines (Labelling) Amendment Regulations 1985

Made9th October 1985

Laid before Parliament10th October 1985

Coming into Operation31st October 1985

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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 powers conferred by sections 85(1), 91(3) and 129(5) of the Medicines Act 1968 and now vested in them1 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 consulting and taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following regulations:—

Citation, interpretation and commencement1

These regulations, which may be cited as the Medicines (Labelling) Amendment Regulations 1985, amend the Medicines (Labelling) Regulations 19762 (hereinafter referred to as “the principal regulations”) and shall come into operation on 31st October 1985.

Amendment of Schedule 1 to the principal regulations2

1

At the beginning of paragraph 7 of Schedule 1 to the principal regulations (standard particulars required in the labelling of containers and packages), there shall be inserted the following words—

Subject to the provisions of paragraph 7A below,

2

Immediately after paragraph 7 of Schedule 1 to the principal regulations there shall be added the following paragraph—

7A
Where a medicinal product is for use by being administered to one or more human beings, the expiry date in plain language.

Temporary and transitional provision3

These regulations shall not have effect until 1st January 1990 in relation to a medicinal product in respect of which an application for a product licence under Part II of the Medicines Act 1968 has been granted by the licensing authority provided that such application was received by that authority prior to the coming into operation of these regulations.

Signed by authority of the Secretary of State for Social Services.

R.W. WhitneyParliamentary Under-Secretary of StateDepartment of Health and Social Security2nd October 1985

Nicholas EdwardsSecretary of State for Wales3rd October 1985

George YoungerSecretary of State for Scotland7th October 1985

In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on the 9th October 1985.

Michael JoplingMinister of Agriculture, Fisheries and Food

Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 7th day of October 1985.

Maurice N. HayesPermanent Secretary

Sealed with the official seal of the Department of Agriculture for Northern Ireland this 7th day of October 1985.

W.H. JackPermanent Secretary

EXPLANATORY NOTE

These regulations make further amendment to the Medicines (Labelling) Regulations 1976 (referred to as the principal regulations) and implement a Community obligation under Council Directive 83/570/EEC Regulation 2 amends Schedule 1 to the principal regulations so as to provide that containers and packages of medicinal products for human use shall be labelled with the expiry date of those products in plain language. Regulation 3 provides a temporary exemption in relation to medicinal products in respect of which an application for a product licence under Part II of the Medicines Act 1968 has been granted by the licensing authority provided that such application was received by that authority prior to the coming into operation of these regulations so that those products need not comply with these regulations until 1st January 1990.