6. — Regulation (EU) 2022/123 of the European Parliament and of the Council of 25…

6.

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

Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), the marketing authorisation holders referred to in paragraph 2 shall: provide any comments they have to the Agency; take into account any recommendations referred to in Article 8(3) and (4) and any guidelines referred to in Article 12, point (c); comply with any measures taken at Union or Member State level pursuant to Articles 11 and 12; inform the MSSG of any measures taken and report on the monitoring and results of those measures, including providing information on the resolution of the actual or potential shortage of medicinal products.

← art_10__para_5__text_1 · All articles · art_10__para_6__text_1 →

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