art_22__para_2__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

During the period referred to in paragraph 1, the Member State concerned may request, with justified reasons, additional information from the sponsor regarding this substantial modification as far as its territory is concerned.

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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.