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Document 32024R2699
Health technology assessment – Cooperation with the European Medicines Agency
Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices
- Legal basis:
- 32021R2282 - A15P1PTB) ; 32021R2282 - A15P1PTA) ; 32021R2282 - A20P1PTD) ; 32021R2282 - A20P1PTC)
- Initiative summary:
- EU rules on health technology assessment (set out in Regulation 2021/2282) support cooperation by EU countries to clinically assess new health technologies. The aim is to contribute to a good use of health system resources, while respecting national competences. The initiative concerns cooperation with the European Medicines Agency (EMA). It sets out implementing rules on information exchanges for EU-level assessments of new health technologies, while preserving the remits of Health Technology Assessment Coordination Group and EMA.
- EuroVoc thesaurus:
- health policy; medicinal product; European Commission; European Medicines Agency; clinical trial; interinstitutional cooperation (EU); medical device; medical diagnosis; exchange of information
-
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- C118400
- Planned adoption period:
- 01/04/2024 - 30/06/2024
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2024)4600553 (Draft implementing regulation)Ares(2024)4600553 (Draft implementing regulation)
- Legal basis:
- 32021R2282 - A15P1PTB) ; 32021R2282 - A15P1PTA) ; 32021R2282 - A20P1PTD) ; 32021R2282 - A20P1PTC)
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- C118400
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2024/7201 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32024R2699 (Implementing regulation)