2001/0252(COD)
Authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Basic information
2001/0252(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation
Amended by
2004/0217(COD)
Amended by
2005/0227(COD)
Amended by
2007/0064(COD)
Amended by
2008/0257(COD)
Amended by
2012/0023(COD)
Amended by
2014/0256(COD)
Amended by
2017/0328(COD)
Subject
3.10.08 Animal health requirements, veterinary legislation and pharmacy
4.20.04 Pharmaceutical products and industry
8.40.08 Agencies and bodies of the EU
Status
Procedure completed
Key players
-
European Parliament
Committee responsible Rapporteur Appointed ENVIEnvironment, Public Health and Food Safety
MÜLLER Rosemarie (PSE)
13/09/2001
-
Former committee responsible Former rapporteur Appointed ENVIEnvironment, Public Health and Food Safety
MÜLLER Rosemarie (PSE)
13/09/2001
-
Former committee for opinion Former rapporteur for opinion Appointed BUDGBudgets
KUCKELKORN Wilfried (PSE)
22/01/2002
CONTBudgetary Control
MULDER Jan (ELDR)
21/02/2002
JURILegal Affairs
The committee decided not to give an opinion. ITREIndustry, Research and Energy
SCAPAGNINI Umberto (PPE-DE)
23/01/2002
AGRIAgriculture and Rural Development
STURDY Robert (PPE-DE)
08/01/2002
-
-
Council of the European Union
Council configuration Meetings Date Employment, Social Policy, Health and Consumer Affairs 2512 02/06/2003 Employment, Social Policy, Health and Consumer Affairs 2470 02/12/2002 Competitiveness (Internal Market, Industry, Research and Space) 2570 11/03/2004 Agriculture and Fisheries 2528 29/09/2003 Health 2440 26/06/2002 -
European Commission
Commission DG Commissioner Internal Market, Industry, Entrepreneurship and SMEs
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 26/11/2001 | Legislative proposal published | COM(2001)0404 | |
| 13/12/2001 | Committee referral announced in Parliament, 1st reading | ||
| 26/06/2002 | Debate in Council | ||
| 02/10/2002 | Vote in committee, 1st reading | ||
| 02/10/2002 | Committee report tabled for plenary, 1st reading | A5-0330/2002 | |
| 22/10/2002 | Debate in Parliament | ||
| 23/10/2002 | Decision by Parliament, 1st reading | T5-0504/2002 | |
| 02/12/2002 | Debate in Council | ||
| 10/12/2002 | Modified legislative proposal published | COM(2002)0735 | |
| 29/09/2003 | Council position published | 10949/2/2003 | |
| 09/10/2003 | Committee referral announced in Parliament, 2nd reading | ||
| 27/11/2003 | Vote in committee, 2nd reading | ||
| 27/11/2003 | Committee recommendation tabled for plenary, 2nd reading | A5-0425/2003 | |
| 16/12/2003 | Debate in Parliament | ||
| 17/12/2003 | Decision by Parliament, 1st reading | T5-0576/2003 | |
| 11/03/2004 | Act approved by Council, 2nd reading | ||
| 31/03/2004 | Final act signed | ||
| 31/03/2004 | End of procedure in Parliament | ||
| 30/04/2004 | Final act published in Official Journal |
Technical information
| Procedure | Information |
|---|---|
| Procedure reference | 2001/0252(COD) |
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Nature of procedure | Legislation |
| Legislative instrument | Regulation |
|
Amended by
2004/0217(COD)
Amended by 2005/0227(COD) Amended by 2007/0064(COD) Amended by 2008/0257(COD) Amended by 2012/0023(COD) Amended by 2014/0256(COD) Amended by 2017/0328(COD) |
|
| Legal basis | EC Treaty (after Amsterdam) EC 152 EC Treaty (after Amsterdam) EC 095 |
| Stage reached in procedure | Procedure completed |
| Committee dossier |
ENVI/5/16943
|
Documentation gateway
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Document type Committee Reference Date Summary Committee report tabled for plenary, 1st reading/single reading A5-0330/2002 02/10/2002 Text adopted by Parliament, 1st reading/single reading T5-0504/2002 OJ C 300 11.12.2003, p. 0166-0308 E 23/10/2002 Committee recommendation tabled for plenary, 2nd reading A5-0425/2003 27/11/2003 Text adopted by Parliament, 2nd reading T5-0576/2003 OJ C 091 15.04.2004, p. 0133-0253 E 17/12/2003 -
Document type Reference Date Summary Council statement on its position 12155/1/2003 24/09/2003 Council position 10949/2/2003 OJ C 297 09.12.2003, p. 0001-0040 E 29/09/2003 -
Document type Reference Date Summary Legislative proposal COM(2001)0404 26/11/2001 Modified legislative proposal COM(2002)0735 10/12/2002 Commission communication on Council's position SEC(2003)1082 07/10/2003 Commission opinion on Parliament's position at 2nd reading COM(2004)0124 17/02/2004 Follow-up document C(2012)5562 08/08/2012 Follow-up document C(2012)9279 14/12/2012 Follow-up document COM(2015)0138 30/03/2015 Follow-up document SWD(2016)0284 08/08/2016 Follow-up document COM(2016)0498 08/08/2016 Follow-up document COM(2019)0591 15/11/2019 Follow-up document COM(2021)0497 31/08/2021 -
Institution/body Document type Reference Date Summary ESC Economic and Social Committee: opinion, report CES1007/2002 18/09/2002 EU Implementing legislative act 32005R2049 OJ L 329 16.12.2005, p. 0004-0007 15/12/2005 EU Implementing legislative act 32006R0507 OJ L 092 30.03.2006, p. 0006-0009 29/03/2006
Additional information
| Source | Document | Date |
|---|---|---|
| European Commission | EUR-Lex |
Delegated acts
| Reference | Subject |
|---|---|
| 2014/2562(DEA) | Examination of delegated act |