1997/0197(COD)

Medicinal products for human use: implementation of good clinical practice in the conduct of clinical trials

Basic information

1997/0197(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Repealed by 2012/0192(COD)
Amended by 2004/0217(COD)
Amended by 2021/0431(COD)

Subject

4.20.02.06 Clinical practice and experiments
4.20.04 Pharmaceutical products and industry

Status

Procedure completed

Key players

Key events

Date Event Reference Summary
03/09/1997 Legislative proposal published COM(1997)0369
19/09/1997 Committee referral announced in Parliament, 1st reading
29/10/1998 Vote in committee, 1st reading
29/10/1998 Committee report tabled for plenary, 1st reading A4-0407/1998
16/11/1998 Debate in Parliament
17/11/1998 Decision by Parliament, 1st reading T4-0648/1998
26/04/1999 Modified legislative proposal published COM(1999)0193
20/07/2000 Council position published 08878/1/2000
07/09/2000 Committee referral announced in Parliament, 2nd reading
21/11/2000 Vote in committee, 2nd reading
21/11/2000 Committee recommendation tabled for plenary, 2nd reading A5-0349/2000
11/12/2000 Debate in Parliament
12/12/2000 Decision by Parliament, 1st reading T5-0548/2000
26/02/2001 Act approved by Council, 2nd reading
04/04/2001 Final act signed
04/04/2001 End of procedure in Parliament
01/05/2001 Final act published in Official Journal

Technical information

Procedure reference 1997/0197(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Regulation
Repealed by 2012/0192(COD)
Amended by 2004/0217(COD)
Amended by 2021/0431(COD)
Legal basis EC Treaty (after Amsterdam) EC 095
Stage reached in procedure Procedure completed
Committee dossier ENVI/5/13000

Documentation gateway

Additional information

Source Document Date
European Commission EUR-Lex