Council Directive 81/852/EEC 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.

Member States shall take all appropriate measures to ensure that the particulars and documents which shall accompany applications for authorization to place a veterinary medicinal product on the market, pursuant article 5 of Directive 81/851/EC, are submitted by the persons concerned in accordance with the Annex to this Directive. The Annex is divided in 3 parts: analytical (physico-chemical, biological or microbiological) tests of veterinary medicinal products (I), toxicological and pharmacological tests (II), clinical trials (III). (4 articles and 1 Annex).

1981-11-06