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.

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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.