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Document 52012SC0201
Procedure 2012/0192/COD
COM (2012) 369: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Completed (Adopted act: 32014R0536)
Type: Ordinary legislative procedure (COD)
- Legal basis:
Commission: TFUE/art 114, 164 par 4 pt c- Type of file:
- Regulation
Proposal for a Regulation - EuroVoc thesaurus:
- medical research; harmonisation of standards; experiment on humans
- Directory code:
- 13.10.30.20 Industrial policy and internal market / Industrial policy: general, programmes, statistics and research / Research and technological development / Research sectors
-
European Commission
-
Economic and Social Committee
-
The European Data Protection Supervisor
-
European Parliament
-
Council of the European Union
/
Publication in the Official Journal
- Date of publication
- 27/05/2014
- CELEX number of the main document:
- 32014R0536
Signature
First reading
02/04/2014
- Decision:
- Approval with amendments
- Rapporteur:
- Glenis WILLMOTT
- Documents:
- A7/2013/208
JO C/2017/408/370
TA/2014/273/P7 - CELEX number of the main document:
- 52014AP0273
10/11/2015
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- ST 12987 2015 INIT
14/04/2014
- Type of file:
- Regulation
- Documents:
- CS-PRES/2014/8762
CSST/2014/8569
09/07/2014
- Decision:
- Agreement
Opinions
12/12/2012
- Decision mode:
- Procedure without debate
- Rapporteur:
- Ingrid KÖSSLER
- Documents:
- CESE/2012/2059
JO C/2013/44/99 - CELEX number of the main document:
- 52012AE2059
Proposal
18/09/2012
- Documents:
- COM/2012/369/FINAL/2
- CELEX number of the main document:
- 52012PC0369R(01)
Transmission to Council
17/07/2012
Transmission to Parliament
17/07/2012
17/07/2012
- Documents:
- SWD/2012/201/FINAL
CSST/2012/12751/ADD 1 - CELEX number of the main document:
- 52012SC0201
17/07/2012
- Documents:
- SWD/2012/200/FINAL
CSST/2012/12751/ADD 2
CSST/2012/12751/ADD 3 - CELEX number of the main document:
- 52012SC0200
17/07/2012
- Leading person:
- John DALLI
- Leading service:
- Directorate-General for Health and Consumers
- Decision mode:
- Written procedure
- Addressee:
- European Data Protection Supervisor
- Addressee for formal act:
- European Parliament ; Council of the European Union
- Addressee for mandatory consultation:
- European Economic and Social Committee ; European Committee of the Regions
- Legal basis:
- TFUE/art 114, 164 par 4 pt c
- Procedure:
- Ordinary legislative procedure (COD)
- Type of file:
- Proposal for a Regulation
- Documents:
- COM/2012/369/FINAL
CSST/2012/12751
IP/2012/795 - CELEX number of the main document:
- 52012PC0369