EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Need more search options? Use the
Advanced search
You are here
Document 52022SC0191
Revision of the Union legislation on blood, tissues and cells
WERKDOCUMENT VAN DE DIENSTEN VAN DE COMMISSIE SAMENVATTING VAN HET EFFECTBEOORDELINGSVERSLAG bij Voorstel voor een verordening van het Europees Parlement en de Raad betreffende kwaliteits- en veiligheidsnormen voor stoffen van menselijke oorsprong die bestemd zijn voor toepassing op de mens en tot intrekking van Richtlijn 2002/98/EG en Richtlijn 2004/23/EG
- 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:
- gezondheidsbeleid; cytologie; stof van menselijke oorsprong; stamcel; bloedtransfusie; veiligheidsnorm; kunstmatige voortplanting; geneeswijze; gezondheidsinspectie; kwaliteitsnorm
-
- Documents:
-
Ares(2020)6649649 (Inception impact assessment)
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)
Impact assessment
SWD/2022/191 final (Summary of impact assessment)
Staff working document - Leading service:
- Directorate-General for Health and Food Safety
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8