art_5__para_10__continuation__2
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products · European Union
However, (a) a copy of the published references relating to the toxicological and pharmacological tests and clinical trials and the data concerning the withdrawal period may be substituted for the relevant test results in the case of: (i) a veterinary medicinal product with an established use, which has been adequately tested on animals so that its effects, including side-effects, are already known and are included in the published references;
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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.