The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Amendment Regulations 1997

Explanatory Note

(This note is not part of the Regulations)

These Regulations consolidate, with amendments, regulations 2 to 5 of the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994, which implemented in part Council Directive 81/851/EEC (OJ No. L317, 6.11.81. p. 1) on the approximation of the laws of the Member States relating to veterinary medicinal products as amended by Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p. 15) and in part Council Directive 92/74/EEC (OJ No. L297, 13.10.92, p.12) widening the scope of Directive 81/851/EEC and laying down additional provisions on homeopathic veterinary medicinal products.

The principal amendments are made to implement—

(a) the judgment of the European Court of Justice in case C—297/94 Dominique Bruyere and Others v. Belgium to provide that the prohibition on administration of unauthorised veterinary medicinal products includes a prohibition on importation of such products for the purpose of administration (amended regulation 2(1)) and

(b) Title I, Part 4, Chapter II.1, 2nd paragraph of the Annex to Council Directive 81/852/EEC (OJ No. L317, 6.11.81, p. 16) on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products, as amended by Commission Directive 92/18/EEC (OJ No. L97, 10.4.92, p. 1), to allow a product authorised in accordance with Council Directive 81/851/EEC elsewhere than in the United Kingdom to be administered as part of an animal test when it is to be used as a comparison with a product the subject of the test (amended regulation 4(1)(a)).

Consequential amendments are made to the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994, the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 and the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997 (regulation 4).