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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) · European Union

The Agency shall forthwith inform the applicant if the opinion of the Committee for Medicinal Products for Human Use is that: the application does not satisfy the criteria for authorisation set out in this Regulation; the summary of the product characteristics proposed by the applicant needs to be amended; the labelling or package leaflet of the product is not in compliance with Title V of Directive 2001/83/EC; the authorisation needs to be granted subject to the conditions provided for in Article 14(7) and (8).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.