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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Medicines (Labelling) Amendment Regulations 1985 No. 1558 URL: http://www.bailii.org/uk/legis/num_reg/1985/uksi_19851558_en.html |
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Statutory Instruments
MEDICINES
Made
9th October 1985
Laid before Parliament
10th October 1985
Coming into Operation
31st 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 them(1) 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:-
1.
2.-(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.".
3. 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. Whitney
Parliamentary Under-Secretary of State
Department of Health and Social Security
2nd October 1985
Nicholas Edwards
Secretary of State for Wales
3rd October 1985
George Younger
Secretary of State for Scotland
7th October 1985
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on the 9th October 1985.
L.S.
Michael Jopling
Minister 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.
L.S.
Maurice N. Hayes
Permanent Secretary
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 7th day of October 1985.
L.S.
W.H. Jack
Permanent Secretary
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.
In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388), in the case of the Secretary of State concerned with agriculture in Wales by virtue of Article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272) and in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36), and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c. 28).
to which there are no amendments relevant to these regulations.
