2. — Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…

2.

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 · European Union

By way of derogation from paragraph 1, the sponsors shall be jointly responsible for establishing: a sponsor responsible for compliance with the obligations of a sponsor in the authorisation procedures set out in Chapters II and III; 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; a sponsor responsible for implementing the measures taken in accordance with Article 77.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.