anx_I__cpt_6__point_35__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

For processes related to investigational medicinal products set out in Article 61(5), which are not subject to an authorisation in accordance with Article 61, documentation to demonstrate compliance with the requirements referred to in Article 61(6) shall be submitted.

← 35. · All articles · G. INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD) →

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