3.

In the event of an opinion in favour of granting the relevant authorization to market the veterinary medicinal product, the following documents shall be annexed to the opinion: the draft summary of the product characteristics, as referred to in Article 5a of Directive 81/851/EEC; where necessary this will reflect differences in the veterinary conditions pertaining in the Member States; in the case of a veterinary medicinal product intended for administration to food-producing animals, a statement of the maximum residue level which may be accepted by the Community in accordance with Regulation (EEC) No 2377/90; details of any conditions or restrictions which should be imposed on the supply or use of the veterinary medicinal product concerned, including the conditions under which the veterinary medicinal product may be made available to users, in accordance with the criteria laid down in Directive 81/851/EEC; the draft text of the labelling and package insert proposed by the applicant, presented in accordance with Directive 81/851/EEC; the assessment report.

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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.