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.

Amendment of regulations

2. The Medicines (Labelling) Regulations 1976(2) 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 Act(3);";

(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-

(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 provision

3. 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.

EXPLANATORY NOTE

These Regulations further amend the Medicines (Labelling) Regulations 1976 which contained requirements relating to the labelling of containers and packages of medicinal products.

The Regulations amend the 1976 Regulations by prescribing additional standard particulars required in the labelling of containers and packages of veterinary drugs which are proprietary medicinal products or ready-made veterinary drugs (as defined in Regulation 2(a)) (Regulation 2(b), (d) and (e)).

The Regulations do not come into operation until 21st December 1985 in relation to a medicinal product in respect of which a product licence was granted prior to 21st December 1983 (Regulation 3).

The Regulations implement in part Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.