Article 35

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products · European Union

1. Authorization shall be valid for five years and shall be renewable for five-year periods, on application by the holder at least three months before the expiry date and after consideration by the Agency of a dossier containing up-to-date information on pharmacovigilance. 2. In exceptional circumstances and following consultations with the applicant, authorization may be granted subject to certain specific obligations, to be reviewed annually by the Agency. Such exceptional decisions may be adopted for objective and verifiable reasons. 3. Veterinary medicinal products which have been authorized by the Community in accordance with the provisions of this Regulation shall benefit from the 10-year period of protection referred to in point 10 of the second paragraph of Article 5 of Directive 81/851/EEC.

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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.