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

23.

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 report shall contain, in an appendix, the RSI in effect at the start of the reporting period.

← 3. ANNUAL SAFETY REPORTING BY THE SPONSOR · All articles · anx_III__cpt_3__point_23__text_1 →

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