15.

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

The protocol shall be identified by: the title of the clinical trial; the EU trial number; the sponsor's protocol code number specific for all versions of it (if relevant); the date and number of the version, to be updated when it is amended; a short title or name assigned to the protocol; and the name and address of the sponsor, as well as the name and function of the representative or representatives of the sponsor authorised to sign the protocol or any substantial modification to the protocol.

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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.