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Document 52022SC0191
Revision of the Union legislation on blood, tissues and cells
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
- Initiative summary:
- The EU legislation provides high safety and quality standards for blood, tissues and cells. The initiative aims to update the current EU rules for scientific and technological developments, including accommodating innovative therapies. It will also address the (re-)emergence of communicable diseases, including lessons learnt from the COVID-19 pandemic, as well as increasing commercialisation and globalisation of the sector, thereby contributing to a stronger health Union.
- EuroVoc thesaurus:
- health policy; safety standard; therapeutics; blood transfusion; quality standard; health control; substance of human origin; artificial reproduction; cytology; stem cell
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- Documents:
-
Ares(2020)6649649 (Inception impact assessment)Ares(2020)6649649 (Inception impact assessment)
Ares(2021)5131819 (Factual summary report of the public consultation)Ares(2021)5131819 (Factual summary report of the public consultation) - Leading service:
- Directorate-General for Health and Food Safety
- Planned adoption period:
- 01/10/2021 - 31/12/2021
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Consultation type:
- Public consultation
- Consultation duration (weeks):
- 12
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
-
COM/2022/338 final (Proposal for a regulation)
SWD/2022/190 final (Impact assessment)
SWD/2022/191 final (Summary of impact assessment)
SWD/2022/189 final (Staff working document) - Leading service:
- Directorate-General for Health and Food Safety
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8