Procedure 2023/0131/COD COM (2023) 193:
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation
and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending
Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No
141/2000 and Regulation (EC) No 1901/2006
Ongoing
Type: Ordinary legislative procedure (COD)
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Council of the European Union
Council of the European Union
Economic and Social Committee
Economic and Social Committee
The European Data Protection Supervisor
The European Data Protection Supervisor
European Parliament
European Parliament
European Commission
European Commission
Follow the steps of procedure 2023/0131/COD
First reading
European Parliament
European Parliament
EP position at first reading
10/04/2024
Council of the European Union
Council of the European Union
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
29/11/2023
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
23/11/2023
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
27/10/2023
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
10/11/2023
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
28/04/2023
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
22/06/2023
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
09/01/2024
Discussions within the Council or its preparatory bodies
Discussions within the Council or its preparatory bodies
08/12/2023
Opinions
The European Data Protection Supervisor
The European Data Protection Supervisor
European Data Protection Supervisor opinion
European Data Protection Supervisor opinion
19/06/2023
Economic and Social Committee
Economic and Social Committee
European Economic and Social Committee opinion
European Economic and Social Committee opinion
25/10/2023
Responsible body:
Section for the Single Market, Production and Consumption
Rapporteur:
Martin Josef SCHAFFENRATH
Procedure:
Ordinary legislative procedure (COD)
Plenary session:
582
Plenary date:
25/10/2023 -
26/10/2023
Documents:
EESC 2023-01968
CELEX number of the main document:
52023AE1968
Proposal
European Commission
European Commission
Adoption of legislative proposal by the Commission
Adoption of legislative proposal by the Commission
26/04/2023
Leading person:
Stella KYRIAKIDES
Leading service:
Directorate-General for Health and Food Safety
Decision mode:
Oral procedure
Addressee for formal act:
European Parliament ; Council of the European Union ; National parliaments
Addressee for information:
European Data Protection Supervisor
Addressee for mandatory consultation:
European Economic and Social Committee ; European Committee of the Regions
Legal basis:
12016E294 ; 12016E114 ; 12016E168 -P4 ;
Procedure:
Ordinary legislative procedure (COD)
Documents:
COM/2023/193/FINAL SWD/2023/194/FINAL
CELEX number of the main document:
52023PC0193 ; 52023SC0194