(iii)

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

a new veterinary medicinal product containing only known constituents that have already been used together in comparable proportions in adequately tested medicinal products with an established use; in the case of a new veterinary medicinal product containing known constituents not hitherto used together for therapeutic purposes, references to published data may be substituted for the tests on such constituents;

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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.