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

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

Within six days from the submission of the application dossier, the Member State concerned shall notify the sponsor through the EU portal of the following: whether the substantial modification concerns an aspect covered by Part II of the assessment report; and whether the application dossier is complete in accordance with Annex II.

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