Standards of quality and safety for substances of human origin intended for human application
Standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
- Stage
- In force, reached 17 Jul 2024
- In force
- In force since 6 Aug 2024 · CELEX 32024R1938
- Procedure
- Ordinary legislative procedure
- Rapporteur
- Nathalie Colin-oesterlé (EPP)
- Lead DG
- DG SANTE
- Commissioner
- Stella Kyriakides
- Last activity
- 17 Jul 2024
Where it stands
Latest: Published in the Official Journal, 17 Jul 2024.
ShowHide the earlier record: 22 dates, 14 Dec 2020 to 30 Jan 2024
- 14 Dec 2020
- Inception impact assessment closed: Revision of the Union legislation on blood, tissues and cells , 82 responses · Commission
- 15 Apr 2021
- Public consultation closed: Revision of the Union legislation on blood, tissues and cells , 214 responses · Commission
- 14 Jul 2022
- Adoption of legislative proposal by the Commission
- 15 Jul 2022
- Discussions within the Council or its preparatory bodies
- 8 Sept 2022
- Feedback on adopted proposal closed: Revision of the Union legislation on blood, tissues and cells , 113 responses · Commission
- 12 Sept 2022
- Plenary sitting
- Referred to committee
- 19 Sept 2022
- Discussions within the Council or its preparatory bodies
- 6 Oct 2022
- Discussions within the Council or its preparatory bodies
- 11 Oct 2022
- Discussions within the Council or its preparatory bodies
- 19 Oct 2022
- Discussions within the Council or its preparatory bodies
- 16 Nov 2022
- Discussions within the Council or its preparatory bodies
- 1 Dec 2022
- Discussions within the Council or its preparatory bodies
- 8 Dec 2022
- Discussions within the Council or its preparatory bodies
- 18 Jan 2023
- Committee report tabled
- EP committee draft report
- 26 May 2023
- Discussions within the Council or its preparatory bodies
- 8 Jun 2023
- Discussions within the Council or its preparatory bodies
- 18 Jul 2023
- Committee report adopted
- 26 Jul 2023
- Tabled for plenary
- 12 Sept 2023
- EP decision on amendments to the legislative proposal
- Plenary vote
- Plenary amended the proposal
- Referred back to committee for interinstitutional negotiations
- 25 Oct 2023
- Adoption of negotiating mandate by Coreper
- 7 Nov 2023
- Discussions within the Council or its preparatory bodies
- 30 Jan 2024
- Discussions within the Council or its preparatory bodies
- Endorsement of the provisional agreement by Coreper
- 14 Feb 2024
- Committee approved the provisional agreement
- 24 Apr 2024
- EP position at first reading
- Plenary amended the proposal
- Plenary vote
- 30 Apr 2024
- Discussions within the Council or its preparatory bodies
- 15 May 2024
- Discussions within the Council or its preparatory bodies
- 21 May 2024
- Discussions within the Council or its preparatory bodies
- 27 May 2024
- Approval of the EP's first reading position by the Council (adoption of the legislative act)
- 13 Jun 2024
- Signed
- 17 Jul 2024
- Published in the Official Journal
Who is on it
The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.
| Role | Name | Group | Country | Committee |
|---|---|---|---|---|
| Rapporteur | Nathalie Colin-oesterlé | EPP | FR | ENVI |
| Shadow rapporteur | Andreas GLÜCK | Renew | DE | ENVI |
| Shadow rapporteur | Joanna Kopcińska | ECR | PL | ENVI |
| Shadow rapporteur | Kateřina Konečná | The Left | CZ | ENVI |
| Shadow rapporteur | Nicolás González Casares | S&D | ES | ENVI |
| Shadow rapporteur | Tilly Metz | Greens/EFA | LU | ENVI |
Amendments
Tabled between 6 Sept 2023 and 15 Apr 2024. The texts are in the amendment documents below.
By author
- Catherine Griset1
- Margarita de la Pisa Carrión · ECR1
- Mathilde Androuët1
- Pascal Canfin1
Amendments each member tabled or co-signed. The record names an author on 3 of the 4 amendments.
By article
- Recital 15 a (new)1
- Recital 18 a (new)1
- Recital 3 a (new)1
- –1
Delegated and implementing acts beneath it
By status: 1 published.
| Act | Kind | Status | Adoption |
|---|---|---|---|
| Commission Implementing Regulation (EU) 2025/1467 | Implementing · Regulation | Published |
Titles link to EUR-Lex where the act has been published.
Documents
Newest first. Each opens at its source.
- Report · A9-0250/2023Parliament
- Proposal · COM(2022)0338Parliament
- Text adopted · Corrigendum to final act 32024R1938R(01)Commission
- Agenda · GEDA/A/(2024)000898Parliament
- OJ C 450 28.11.2022, p. 0007Commission
- Text adopted · OJ L 17.07.2024Commission
- Text adopted · OJ L 26.07.2024Commission
- Report · PE738.661Parliament
- Amendments · PE740.835Parliament
- Amendments · PE745.276Parliament
- Amendments · PE745.277Parliament
- Agenda · PE758.999Parliament
- Text adopted · Regulation 2024/1938Commission
- Text adopted · SP(2024)394Parliament
- Text adopted · T9-0299/2023Parliament
- Text adopted · T9-0353/2024Parliament
Consultations on it
The Commission's Have Your Say consultations linked to this file. Where we publish the positions filed, the title opens them here.
| Consultation | Feedback deadline | Feedback received |
|---|---|---|
| 8 Sept 2022 | 409 |
Summary
GeneratedThis regulation updates EU-wide quality and safety standards for substances of human origin (SoHO) such as blood, tissues, and cells used in human applications. It affects healthcare providers, transplantation services, and biotech firms processing these materials. Signed in June 2024 and in force since July 2024, it repeals Directives 2002/98/EC and 2004/23/EC.
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A first draft
Sources: EP Legislative Observatory · EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.
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