(c)

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 draft text of the labelling and package leaflet proposed by the applicant, presented in accordance with Directive 92/27/EEC, without prejudice to the provisions of Article 7 (2) of that Directive;

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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.