art_16__para_3__text_1

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance) · European Union

The ETF shall establish procedures and guidance for requesting and submitting of the set of information and data required, including information on the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted.

← 3. · All articles · 4. →

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