(ii)
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, in which the active ingredients are identical to those of a known medicinal product with an established use;
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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.