1983 No. 1729
The Medicines (Labelling) Amendment Regulations 1983
Made
Laid before Parliament
Coming into Operation
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:—
Title and commencement1
These regulations may be cited as the Medicines (Labelling) Amendment Regulations 1983 and shall come into operation on 21st December 1983.
Amendment of regulations2
The Medicines (Labelling) Regulations 19762 shall be amended as follows—
a
in regulation 3(1) (interpretation) after the definition of “proprietary designation”
there shall be inserted the following definition—
“proprietary medicinal product” and “ready-made veterinary drug” 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 “and in the case of a veterinary drug which is a proprietary medicinal product or a ready-made veterinary drug, the withdrawal period necessary before an animal which has been treated with the drug is slaughtered for the production of food and before products derived from such an animal are used as food.”
;
c
at the beginning of paragraphs 8 and 11 of Schedule 1 there shall be inserted the words “Except in the case of a veterinary drug which is a proprietary medicinal product or a ready-made veterinary drug,”
;
d
after paragraph 11 of Schedule 1 (as amended) there shall be inserted the following paragraph—
11
- A
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—
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.
Transitional provision3
These regulations shall not have effect in relation to a medicinal product in respect of which a product licence was granted prior to the coming into operation of these regulations, until 21st December 1985.
In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 26th October 1983.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 10th day of November 1983.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 10th day of November 1983.