Article 31

1. Where the opinion of the Committee is that: the application does not satisfy the criteria for authorization set out in this Regulation, or the summary of the product characteristics proposed by the applicant in accordance with Article 28 should be amended, or the labelling or package insert of the product is not in compliance with Directive 81/851/EEC, or the authorization should be granted subject to the conditions provided for in Article 35 (2), the Agency shall forthwith inform the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to appeal. In that case he shall forward the detailed grounds for his appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of the receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised, and the reasons for the conclusion reached on the appeal shall be annexed to the assessment report referred to in paragraph 2. 2. Within 30 days of its adoption, the Agency shall forward the final opinion of the Committee to the Commission, the Member States and the applicant together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. 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.

← 2. · All articles · 1. →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.