2. — Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community…

2.

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 Commission shall in consultation with the Agency forthwith examine the reasons advanced by the Member State concerned. It shall request the opinion of the Committee within a time limit which it shall determine having regard to the urgency of the matter. Whenever practicable, the person responsible for placing the medicinal product on the market shall be invited to provide oral or written explanations.

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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.