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2008/0257/COD
Procedure 2008/0257/COD
COM (2008) 664: Proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency {SEC(2008) 2670} {SEC(2008) 2671}
Adopted acts: 32010R1235
For a more detailed overview of the procedure, please visit the EU
Law Tracker.
-
Economic and Social Committee
-
European Committee of the Regions
-
The European Data Protection Supervisor
-
European Parliament
-
Council of the European Union
-
European Commission
- Legal basis:
Commission: 12006E095 ; 12006E251 ; TFUE/art 114, 168 par 4 c; 12008E294 ; 12008E168 ; 12008E114- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Proposal for a Regulation
- EuroVoc thesaurus:
- marketing; medicinal product; European Medicines Agency
- Directory code:
- 13.30.15.00 Industrial policy and internal market / Internal market: approximation of laws / Proprietary medicinal products
- Rapporteur:
- Sylvia GAUCI
- Documents:
- CESE/2009/1023
JO C/2009/306/22 - CELEX number of the main document:
- 52009AE1023
- Rapporteur:
- Susanna HABY
- Documents:
- CDR/2009/137
JO C/2010/79/50 - CELEX number of the main document:
- 52009AR0137
- Documents:
- JO C/2009/229/19
- CELEX number of the main document:
- 52009XX0923(04)
15/12/2010: Signature by the President of the EP and by the President of the Council
- Council agenda:
- ITEM "B" ON COUNCIL AGENDA
- Council session:
- 2947
- Subject:
- EMPLOYMENT, SOCIAL POLICY, HEALTH AND CONSUMER AFFAIRS
- Documents:
- PRES/2009/124
17/12/2008: Transmission to Council
- Type of file:
- Regulation
- Documents:
- CSPE/2010/46
PE-CONS/2010/46
JO L/2010/348/1
JO L/2012/201/138 - CELEX number of the main document:
- 32010R1235
17/12/2008: Transmission to Parliament
22/09/2010: EP position at first reading
- Documents:
- SEC/2008/2670
- CELEX number of the main document:
- 52008SC2670
- Decision:
- Approval with amendments
- Rapporteur:
- Linda MCAVAN
- Documents:
- A7/2010/153
JO C E/2012/50/70
TA/2010/331/P7 - CELEX number of the main document:
- 52010AP0331
- Documents:
- SEC/2008/2671
- CELEX number of the main document:
- 52008SC2671
- Council agenda:
- ITEM "A" ON COUNCIL AGENDA
- Council session:
- 3050
- Subject:
- AGRICULTURE/FISHERIES
- Documents:
- CSST/2010/16801
CSST/2010/17149/ADD 1
PRES/2010/320
- Council agenda:
- ITEM "B" ON COUNCIL AGENDA
- Council session:
- 2980
- Subject:
- EMPLOYMENT, SOCIAL POLICY, HEALTH AND CONSUMER AFFAIRS
- Documents:
- PRES/2009/348
- Decision:
- Agreement
- Leading person:
- Günter VERHEUGEN
- Leading service:
- Directorate-General for Enterprise and Industry
- Decision mode:
- Oral procedure
- Addressee for formal act:
- European Parliament ; Council of the European Union
- Addressee for mandatory consultation:
- European Economic and Social Committee
- Addressee for optional consultation:
- European Committee of the Regions
- Legal basis:
- 12006E095 ; 12006E251 ; TFUE/art 114, 168 par 4 c
- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Proposal for a Regulation
- Documents:
- COM/2008/664/FINAL
CS/2008/17501 - CELEX number of the main document:
- 52008PC0664
- Legal basis:
- 12008E294 ; 12008E168 ; 12008E114
- Documents:
- COM/2009/665/FINAL
- CELEX number of the main document:
- 52009DC0665