anx_I__cpt_5__point_25__text_1 — Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16… · Lexiara

anx_I__cpt_5__point_25__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

An IB, which has been prepared in accordance with the state of scientific knowledge and international guidance, shall be submitted.

← 25. · All articles · 26. →

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