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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance article 62 CELEX: 02014R0536-20221205 Responsibilities of the qualified person
1. The qualified person shall ensure that each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 and shall certify that those requirements are fulfilled. 2. The certification referred to in paragraph 1 shall be made available by the sponsor at the request of the Member State concerned. |