rec_16

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

(16) The authorisation procedure should provide for the possibility to extend the timelines for the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier. Moreover, it should be ensured that, within the extension period, there is always sufficient time for assessing the additional information submitted.

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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.