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Document 32009L0053
Procedure 2008/0045/COD
COM (2008) 123: Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products {SEC(2008)273} {SEC(2008)274}
Adopted acts: 32009L0053
-
European Parliament
-
Council of the European Union
-
Economic and Social Committee
-
European Commission
- Legal basis:
Commission: 12006E095 ; 12006E251;- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Directive
Proposal for a Directive - EuroVoc thesaurus:
- pharmaceutical legislation; marketing standard; medicinal product
- Directory code:
- 13.30.15.00 Industrial policy and internal market / Internal market: approximation of laws / Proprietary medicinal products
- Type of file:
- Directive
- Documents:
- PE-CONS/2008/3713
- Decision:
- Approval with amendments
- Rapporteur:
- Françoise GROSSETÊTE
- Documents:
- A6/2008/346
JO C E/2010/15/140
TA/2008/510/P6 - CELEX number of the main document:
- 52008AP0510
- Decision mode:
- Majority
- Rapporteur:
- Carmelo CEDRONE
- Documents:
- CESE/2008/1194
JO C/2009/27/39 - CELEX number of the main document:
- 52008AE1194
07/03/2008: Transmission to Parliament
07/03/2008: Transmission to Council
- Leading person:
- Günter VERHEUGEN
- Leading service:
- Directorate-General for Enterprise and Industry
- Decision mode:
- Written 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
- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Proposal for a Directive
- Documents:
- COM/2008/123/FINAL
CS/2008/7529
BULLETIN/2008/3/1.13.5
JO C/2008/202/9 - CELEX number of the main document:
- 52008PC0123
- Documents:
- SEC/2008/273
CS/2008/7529/ADD 1 - CELEX number of the main document:
- 52008SC0273
- CELEX number of the main document:
- 32009L0053
- Documents:
- SEC/2008/274
CS/2008/7529/ADD 2 - CELEX number of the main document:
- 52008SC0274
18/06/2009: Signature by the President of the EP and by the President of the Council
22/10/2008: EP position at first reading
- Council agenda:
- ITEM "A" ON COUNCIL AGENDA
- Council session:
- 2945
- Subject:
- COMPETITIVENESS
- Type of file:
- Directive
- Documents:
- CS/2009/10242
CS/2009/10396/ADD 1
PRES/2009/155
- Decision:
- Agreement