Medicines (Labelling) Amendment Regulations 1983

JurisdictionUK Non-devolved
CitationSI 1983/1729
Year1983

1983 No. 1729

MEDICINES

The Medicines (Labelling) Amendment Regulations 1983

Made 21th November 1983

Laid before Parliament 30th November 1983

Coming into Operation 21th December 1983

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and in Wales, 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), 85(4) and 91(3) 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 in accordance with section 129(6) of the said Act, hereby make the following regulations:—

S-1 Title and commencement

Title and commencement

1. These regulations may be cited as the Medicines (Labelling) Amendment Regulations 1983 and shall come into operation on 21st December 1983.

S-2 Amendment of regulations

Amendment of regulations

2. The Medicines (Labelling) Regulations 19762shall be amended as follows—

(a) in regulation 3(1) (interpretation) after the definition of there shall be inserted the following definition—

““” and “” have the same meanings as in sections 7(7) and 8(4) of the Act3;”;

(b) at the end of paragraph 5 of Schedule 1 (standard particulars required in the labelling of containers and packages) there shall be inserted the words ;

(c) at the beginning of paragraphs 8 and 11 of Schedule 1 there shall be inserted the words ;

(d) after paragraph 11 of Schedule 1 (as amended) there shall be inserted the following paragraph—

S-11

“(A) 11 In the case of a veterinary drug which is a proprietary medicinal product or a ready-made veterinary drug—

(a) the name and address of the holder of the product licence which relates to the drug, and

(b) if different therefrom, the name and address of the person responsible for the composition of the drug.”;

and

(e) after paragraph 12 of Schedule 1 there shall be inserted the following paragraph—

S-13

“13 In the case of a veterinary drug which is a proprietary medicinal product or a ready-made veterinary drug, the species of animal for which the drug is intended and the method and the route of administration.”.

S-3...

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