rec_20

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

(20) In practice, sponsors do not always have all the information needed for submitting a complete application for authorisation of a clinical trial in all of the Member States where a clinical trial is eventually going to be conducted. It should be possible for sponsors to submit an application solely on the basis of documents assessed jointly by those Member States where the clinical trial might be conducted.

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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.