2022/0216(COD)
Standards of quality and safety for substances of human origin intended for human application
Basic information
2022/0216(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation
Subject
4.20.01 Medicine, diseases
4.20.02 Medical research
4.20.02.06 Clinical practice and experiments
4.20.04.02 Safety of blood and transfusion
4.20.05 Health legislation and policy
Status
Procedure completed
Key players
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European Parliament
Committee responsible Rapporteur Appointed COLIN-OESTERLÉ Nathalie (EPP)
20/10/2022
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European Commission
Commission DG Commissioner Health and Food Safety KYRIAKIDES Stella
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 14/07/2022 | Legislative proposal published | COM(2022)0338 | |
| 12/09/2022 | Committee referral announced in Parliament, 1st reading | ||
| 18/07/2023 | Vote in committee, 1st reading | ||
| 26/07/2023 | Committee report tabled for plenary, 1st reading | A9-0250/2023 | |
| 12/09/2023 | Decision by Parliament, 1st reading | T9-0299/2023 | |
| 12/09/2023 | Matter referred back to the committee responsible for interinstitutional negotiations | ||
| 14/02/2024 | Approval in committee of the text agreed at 1st reading interinstitutional negotiations | PE758.999 GEDA/A/(2024)000898 | |
| 24/04/2024 | Decision by Parliament, 1st reading | T9-0353/2024 | |
| 24/04/2024 | Results of vote in Parliament | ||
| 27/05/2024 | Act adopted by Council after Parliament's 1st reading | ||
| 13/06/2024 | Final act signed | ||
| 17/07/2024 | Final act published in Official Journal |
Technical information
| Procedure | Information |
|---|---|
| Procedure reference | 2022/0216(COD) |
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Nature of procedure | Legislation |
| Legislative instrument | Regulation |
| Legal basis | Treaty on the Functioning of the EU TFEU 168-p4 |
| Other legal basis | Rules of Procedure EP 165 |
| Mandatory consultation of other institutions | European Economic and Social Committee European Committee of the Regions |
| Stage reached in procedure | Procedure completed |
| Committee dossier |
ENVI/9/09602
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE738.661 18/01/2023 Amendments tabled in committee PE745.276 14/03/2023 Amendments tabled in committee PE745.277 14/03/2023 Amendments tabled in committee PE740.835 14/03/2023 Committee report tabled for plenary, 1st reading/single reading A9-0250/2023 26/07/2023 Text adopted by Parliament, partial vote at 1st reading/single reading T9-0299/2023 12/09/2023 Text agreed during interinstitutional negotiations PE758.999 30/01/2024 Text adopted by Parliament, 1st reading/single reading T9-0353/2024 24/04/2024 -
Document type Reference Date Summary Coreper letter confirming interinstitutional agreement GEDA/A/(2024)000898 30/01/2024 Draft final act 00008/2024/LEX 13/06/2024 -
Document type Reference Date Summary Document attached to the procedure SWD(2022)0191 14/07/2022 Document attached to the procedure SWD(2022)0189 14/07/2022 Legislative proposal COM(2022)0338 14/07/2022 Document attached to the procedure SWD(2022)0190 14/07/2022 Document attached to the procedure SEC(2022)0304 14/07/2022 Commission response to text adopted in plenary SP(2024)394 08/08/2024 -
Document type Parliament/Chamber Reference Date Summary Contribution ES_PARLIAMENT COM(2022)0338 10/10/2022 Contribution CZ_CHAMBER COM(2022)0338 14/10/2022 Contribution PT_PARLIAMENT COM(2022)0338 21/12/2022 -
Institution/body Document type Reference Date Summary EDPS Document attached to the procedure N9-0084/2022 OJ C 450 28.11.2022, p. 0007 07/09/2022 ESC Economic and Social Committee: opinion, report CES4815/2022 26/10/2022
Additional information
| Source | Document | Date |
|---|---|---|
| EP Research Service | Briefing | 12/02/2024 |
Transparency
Meetings with interest representatives published in line with the Rules of Procedure
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Name Role Committee Date Interest representatives GLÜCK Andreas Shadow rapporteur ENVI 31/01/2024 Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose GLÜCK Andreas Shadow rapporteur ENVI 30/01/2024 Pharma-Netzwerk Deutschland COLIN-OESTERLÉ Nathalie Rapporteur ENVI 05/12/2023 Epodin COLIN-OESTERLÉ Nathalie Rapporteur ENVI 16/11/2023 DKMS COLIN-OESTERLÉ Nathalie Rapporteur ENVI 10/11/2023 Blood and Beyond COLIN-OESTERLÉ Nathalie Rapporteur ENVI 04/09/2023 Alliance Promotion Microbiote GONZÁLEZ CASARES Nicolás Shadow rapporteur ENVI 29/08/2023 Transform GONZÁLEZ CASARES Nicolás Shadow rapporteur ENVI 12/07/2023 Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose GONZÁLEZ CASARES Nicolás Shadow rapporteur ENVI 06/07/2023 Grifols, S.A. GONZÁLEZ CASARES Nicolás Shadow rapporteur ENVI 05/07/2023 Blood and beyond
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Name Date Interest representatives DE MEO Salvatore 01/06/2023 Takeda Pharmaceuticals International AG SCHNEIDER Christine 21/03/2023 GIRP
PHAGRODE MEO Salvatore 07/03/2023 Takeda Pharmaceuticals International AG DE LANGE Esther 07/03/2023 Takeda Pharmaceuticals International AG WÖLKEN Tiemo 20/02/2023 Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose WÖLKEN Tiemo 09/02/2023 OSTWÄRTS CLUNE Deirdre 08/02/2023 Grifols, S.A. WÖLKEN Tiemo 08/02/2023 Grifols, S.A. SCHNEIDER Christine 08/02/2023 Grifols, S.A. WÖLKEN Tiemo 25/01/2023 Ständige Vertretung der Bundesrepublik Deutschland bei der EU
Final act
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Regulation 2024/1938
OJ OJ L 17.07.2024 -
Corrigendum to final act 32024R1938R(01)
OJ OJ L 26.07.2024