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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 72 CELEX: 02014R0536-20221205 Co-sponsorship
1. Without prejudice to Article 74, where a clinical trial has more than one sponsor, all sponsors shall have the responsibilities of a sponsor set out in this Regulation, unless the sponsors decide otherwise in a written contract setting out their respective responsibilities. Where the contract does not specify to which sponsor a given responsibility is attributed, that responsibility shall lie with all sponsors. 2. By way of derogation from paragraph 1, the sponsors shall be jointly responsible for establishing: (a) a sponsor responsible for compliance with the obligations of a sponsor in the authorisation procedures set out in Chapters II and III; (b) a sponsor responsible for being a contact point for receiving all questions from subjects, investigators or any Member State concerned regarding the clinical trial and providing answers to them; (c) a sponsor responsible for implementing the measures taken in accordance with Article 77. |