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The Medicines (Medicines Act 1968 Amendment) Regulations 1983

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EXPLANATORY NOTE

These Regulations amend the Medicines Act 1968 (“the Act”) thereby implementing in part Council Directive 81/851/EEC, on the approximation of the laws of the Member States relating to veterinary medicinal products.

The Regulations—

(1) amend sections 7 and 8 of the Act so as to require persons responsible for placing on the market in the United Kingdom veterinary drugs which are proprietary medicinal products or ready-made veterinary drugs to hold licences and also to require distributors of such drugs imported from outside the European Communities to hold licences (Regulations 2 and 3); and

(2) amend section 18 of the Act so as to provide that documents forwarded to the licensing authority under Article 17 of Council Directive 81/851/EEC shall be treated as an application for the grant of a product licence under the Act (Regulation 4).

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