anx_II__cpt_1__point_1__text_1

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

Where a substantial modification concerns more than one clinical trial of the same sponsor and the same investigational medicinal product, the sponsor may make a single request for authorisation of the substantial modification. The cover letter shall contain a list of all clinical trials to which the application for substantial modification relates, with the EU trial numbers and respective modification code numbers of each of those clinical trials.

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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.