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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) article 2 CELEX: 02004R0726-20220128 The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.
As a consequence, in this Regulation, the terms, ‘medicinal product’ and ‘medicinal product for human use’ mean a medicinal product as defined in point (2) of Article 1 of Directive 2001/83/EC.
In addition, the following definitions shall apply for the purposes of this Regulation: (1) ‘veterinary medicinal product’ means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and of the Council () ; (2) ‘antimicrobial’ means an antimicrobial as defined in point (12) of Article 4 of Regulation (EU) 2019/6.
The holder of a marketing authorisation for medicinal products covered by this Regulation must be established in the Union ◄ . The holder shall be responsible for the placing on the market of those medicinal products, whether he does it himself or via one or more persons designated to that effect. |