anx_I__cpt_12__point_63__text_1 — Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16… · Lexiara

anx_I__cpt_12__point_63__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

In the cases set out in paragraph 62, the information given to the subject and to his or her legally designated representative shall be submitted.

← 63. · All articles · M. SUITABILITY OF THE INVESTIGATOR (INFORMATION PER MEMBER STATE CONCERNED) →

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