Article 13

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 consultation with the applicant, an authorization may be granted subject to certain specific obligations, to be reviewed annually by the Agency. Such exceptional decisions may be adopted only for objective and verifiable reasons and must be based on one of the causes mentioned in Part 4 G of the Annex to Directive 75/318/EEC. 3. Some products may be authorized only for use in hospitals or for prescription by some specialists. 4. 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 8 of the second paragraph of Article 4 of Directive 65/65/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.