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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 17 CELEX: 02004R0726-20220128 The applicant or the holder of a marketing authorisation shall be responsible for the accuracy of the documents and of the data submitted. |