3.
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
to give reasons for the use of the references to published data referred to in point 10 (a) and (b) of the second paragraph of Article 5, according to the conditions laid down by Council Directive 81/852/EEC. The experts' detailed reports shall form part of the documentation which the applicant shall lodge with the competent authorities. CHAPTER III Examination of applications for authorization - Authorization - Renewal of authorization
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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.