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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) article 12 CELEX: 02022R0123-20250101 Role of the Commission regarding the monitoring and mitigation of shortages of medicinal products
The Commission shall take into account the information from and recommendations of the MSSG referred to in Article 8(1) and (2) and in Article 8(3) and (4), respectively, and shall: (a) take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medicinal products included on the critical medicines lists; (b) facilitate the coordination between marketing authorisation holders and other relevant entities to address demand surges, where necessary; (c) consider the need for guidelines and recommendations to be addressed to Member States, marketing authorisation holders, and other entities, including relevant entities from the supply chain for medicinal products, where relevant; (d) inform the MSSG of any measures taken by the Commission and report on the results of those measures; (e) request the MSSG to provide recommendations or coordinate measures as provided for in Article 8(3), (4) and (5); |
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) article 12 CELEX: 02022R0123-20250101 (f) consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law; (g) liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medicinal products included on the critical medicines lists or their active substances, where those medicinal products or active substances are imported into the Union and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MSSG, where relevant. |