art_20__para_5__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

The Member State concerned shall assess the application and shall submit to the sponsor, through the EU portal, Part II of the assessment report, including its conclusion, and the decision as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused.

← 5. · All articles · art_20__para_5__text_2 →

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