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Regulation (EU) No 536/2014 Article 72

Regulation (EU) No 536/2014 Article 72

Co-sponsorship

Article 72

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.

Read the full instrument → · Read this in context: CHAPTER XI — SPONSOR AND INVESTIGATOR →

Other provisions in CHAPTER XI — SPONSOR AND INVESTIGATOR

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 72 of Regulation (EU) No 536/2014 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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