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Repealed by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
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European Parliament
Committee responsible Rapporteur Appointed ENVIEnvironment, Climate and Food Safety
LIESE Peter (PPE-DE)
11/09/2000
-
Former committee responsible Former rapporteur Appointed ENVIEnvironment, Climate and Food Safety
AMADEO Amedeo (NI)
08/10/1997
-
Former committee for opinion Former rapporteur for opinion Appointed BUDGBudgets
The committee decided not to give an opinion. ENERResearch, Technological Development and Energy
SCAPAGNINI Umberto (UPE)
08/10/1997
-
-
Council of the European Union
Council configuration Meetings Date Competitiveness (Internal Market, Industry, Research and Space) 2265 25/05/2000 Agriculture and Fisheries 2332 26/02/2001 Budget 2285 20/07/2000 Health 2319 14/12/2000
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
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Document type Committee Reference Date Summary Committee report tabled for plenary, 1st reading/single reading A4-0407/1998 OJ C 379 07.12.1998, p. 0005 29/10/1998 Committee recommendation tabled for plenary, 2nd reading A5-0349/2000 OJ C 232 17.08.2001, p. 0010 21/11/2000 Text adopted by Parliament, 2nd reading T5-0548/2000 OJ C 232 17.08.2001, p. 0035-0052 12/12/2000 -
Document type Reference Date Summary Council position 08878/1/2000 OJ C 300 20.10.2000, p. 0032 20/07/2000 -
Document type Reference Date Summary Legislative proposal COM(1997)0369 OJ C 306 08.10.1997, p. 0009 03/09/1997 Modified legislative proposal COM(1999)0193 OJ C 161 08.06.1999, p. 0005 26/04/1999 Commission communication on Council's position SEC(2000)1293 26/07/2000 -
Institution/body Document type Reference Date Summary ESC Economic and Social Committee: opinion, report CES0099/1998 OJ C 095 30.03.1998, p. 0001 28/01/1998
Additional information
| Source | Document | Date |
|---|---|---|
| European Commission | EUR-Lex |