# 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: Co-sponsorship

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/72 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-72
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

