Article 5

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

The Committee for Proprietary Medicinal Products established by Article 8 of Directive 75/319/EEC, in this Title referred to as 'the Committee', shall be responsible for formulating the opinion of the Agency on any question concerning the admissibility of the files submitted in accordance with the centralized procedure, the granting, variation, suspension or withdrawal of an authorization to place a medicinal product for human use on the market arising in accordance with the provisions of this Title and pharmacovigilance.

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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.