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Document C(2024)8850
Health technology assessment – Joint scientific consultations on medicinal products for human use
UITVOERINGSVERORDENING (EU) …/... VAN DE COMMISSIE tot vaststelling van uitvoeringsbepalingen voor Verordening (EU) 2021/2282 wat betreft de procedures voor gezamenlijk wetenschappelijk overleg over geneesmiddelen voor menselijk gebruik op het niveau van de Unie
- Legal basis:
- 32021R2282 - A20P1PTC) ; 32021R2282 - A20P1PTB) ; 32021R2282 - A20P1PTA)
- Initiative summary:
- EU rules on health technology assessment (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. This initiative concerns joint scientific consultations on medicines. It set outs implementing rules detailing how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product.
- EuroVoc thesaurus:
- gezondheidsbeleid; volksgezondheid; wetenschappelijke samenwerking; inspectie van geneesmiddelen; uitwisseling van informatie; gezondheidsverzorging; EU-lidstaat; geneesmiddel; vernieuwing; gezondheidstechnologie; klinische proef
-
- 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)6931211 (Draft implementing regulation)Ares(2024)6931211 (Draft implementing regulation)
- Legal basis:
- 32021R2282 - A20P1PTC) ; 32021R2282 - A20P1PTB) ; 32021R2282 - A20P1PTA)
- 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/2024/8850 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32024R3169 (Implementing regulation)