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.