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Document 32001L0020
Procedure 1997/0197/COD
COM (1997) 369: Proposal for a European Parliament and Council Directive on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use
Adopted acts: 32001L0020
-
European Commission
-
European Parliament
-
Council of the European Union
- Legal basis:
Commission: 11997E251 ; 11997E095; 11992E189B ; 11992E100A- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Directive
Proposal for a Directive - EuroVoc thesaurus:
- pharmaceutical product; approximation of laws; therapeutics
- Directory code:
- 15.30.00.00 Environment, consumers and health protection / Health protection
- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Directive
- Documents:
- PE-CONS/2001/3605
BULLETIN/2001/4/1.3.17
JO L/2001/121/34 - CELEX number of the main document:
- 32001L0020
- Decision mode:
- Qualified majority
- Council agenda:
- ITEM "A" ON COUNCIL AGENDA
- Council session:
- 2332
- Subject:
- AGRICULTURE
- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Directive
- Documents:
- PRES/2001/66
BULLETIN/2001/1/-2/1.3.57
- Council agenda:
- ITEM "B" ON COUNCIL AGENDA
- Council session:
- 2319
- Subject:
- HEALTH
- Documents:
- CS/2000/14641
PRES/2000/478
BULLETIN/2000/12/1.3.26
- Decision:
- Agreement
- Decision:
- Approval with amendments
- Rapporteur:
- Peter LIESE
- Documents:
- A5/2000/349
BULLETIN/2000/12/1.3.26
JO C/2001/232/52
06/12/2000: Empowerment
- Rapporteur:
- Peter LIESE
- Author of report:
- Committee on the Environment, Public Health and Food Safety
- Documents:
- A5/2000/349
PE/293678
07/09/2000: Receipt by EP of Council common position
26/07/2000: Transmission to Council of declaration on common position
26/07/2000: Transmission to EP of declaration on common position
- Documents:
- SEC/2000/1293/FINAL
- CELEX number of the main document:
- 52000SC1293
- Decision mode:
- Qualified majority
- Council agenda:
- ITEM "A" ON COUNCIL AGENDA
- Council session:
- 2285
- Subject:
- BUDGET
- Documents:
- CS/2000/8878
PRES/2000/267
BULLETIN/2000/7/-8/1.3.15
JO C/2000/300/32 - CELEX number of the main document:
- 52000AG0044
- Council agenda:
- ITEM "B" ON COUNCIL AGENDA
- Council session:
- 2265
- Subject:
- INTERNAL MARKET
- Documents:
- CS/2000/8991
PRES/2000/180
BULLETIN/2000/5/1.3.32
- Legal basis:
- 11997E251 ; 11997E095
- Documents:
- SEC/1999/581/FINAL
27/04/1999: Transmission of the amended proposal to the Council
27/04/1999: Transmission to EP of amended proposal
- Leading service:
- Directorate-General for Enterprise and Industry
- Associated service:
- DG XV – Internal Market and Financial Services ; DG XXIII – Enterprise Policy, Distributive Trades, Tourism and Cooperatives ; Directorate-General for Budget ; Directorate-General for Employment, Social Affairs and Inclusion ; Directorate-General for Environment ; Directorate-General for Health and Consumers ; Directorate-General for Research and Innovation ; Secretariat-General
- Decision mode:
- Written procedure
- Addressee for formal act:
- European Parliament ; Council of the European Union
- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Proposal for a Directive
- Remarks:
- Follow-up to Economic and Social Committee opinion
EUR-OP
Follow-up to EP opinion - Documents:
- COM/1999/193/FINAL
BULLETIN/1999/4/1.3.23
JO C/1999/161/5 - CELEX number of the main document:
- 51999PC0193
- Decision:
- Partial agreement
- Remarks:
- Undertaking respected
- Decision:
- Approval with amendments
- Rapporteur:
- Amedeo AMADEO
- Remarks:
- Conciliation possible for EP
- Documents:
- A4/1998/407
JO C/1998/379/34
BULLETIN/1998/11/1.2.29 - CELEX number of the main document:
- 51998AP0407
- Rapporteur:
- Amedeo AMADEO
- Author of report:
- Committee on the Environment, Public Health and Food Safety
- Documents:
- PE/224735
- Draftsman:
- Umberto SCAPAGNINI
- Author of opinion:
- Committee on Industry, Research and Energy
- Documents:
- BULLETIN/1998/1/-2/1.3.38
JO C/1998/95/1 - CELEX number of the main document:
- 51998AC0099
04/09/1997: Transmission to Council
04/09/1997: Transmission to Parliament
- Leading service:
- DG III – Industry
- Associated service:
- DG XXIII – Enterprise Policy, Distributive Trades, Tourism and Cooperatives ; Directorate-General for Budget ; Directorate-General for Employment, Social Affairs and Inclusion ; Directorate-General for Environment ; Directorate-General for Health and Consumers ; Directorate-General for Research and Innovation
- Decision mode:
- Written procedure
- Addressee for formal act:
- European Parliament ; Council of the European Union
- Addressee for mandatory consultation:
- European Economic and Social Committee
- Legal basis:
- 11992E189B ; 11992E100A
- Procedure:
- Co-decision procedure (COD)
- Type of file:
- Proposal for a Directive
- Remarks:
- EUR-OP
- Documents:
- COM/1997/369/FINAL
C4/1997/446
BULLETIN/1997/9/1.2.15
JO C/1997/306/9 - CELEX number of the main document:
- 51997PC0369