Article 9

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 6 should be amended, or the labelling or package leaflet of the product is not in compliance with Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets (11), or the authorization should be granted subject to the conditions provided for in Article 13 (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 conclusions 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 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 place the medicinal product concerned on the market, the following documents shall be annexed to the opinion: a draft summary of the product characteristics, as referred to in Article 4a of Directive 65/65/EEC; details of any conditions or restrictions which should be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, having regard to the criteria laid down in Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use (12), without prejudice to the provisions in Article 3 (4) of that Directive; the draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Directive 92/27/EEC, without prejudice to the provisions of Article 7 (2) of that Directive; 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.