Procedure File: 2008/0257(COD)

European Parliament / Legislative Observatory

Procedure file

2008/0257(COD)

Medicinal products for human use: pharmacovigilance of products

Basic information
Key players
Key events
Technical information
Documentation gateway
Links to other sites
Final act

Basic information

2008/0257(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation

Medicinal products for human use: pharmacovigilance of products

Amending Regulation (EC) No 726/2004, Community procedures 2001/0252(COD)
Amending Regulation (EC) No 1394/2007 2005/0227(COD)
See also 2008/0260(COD)

Subject
4.20.04 Pharmaceutical products and industry
4.20.05 Health legislation and policy
4.60.08 Safety of products and services, product liability

Procedure completed

Please go to Documentation gateway for any follow-up documents.

Key players

European Parliament

Committee responsible	Rapporteur	Appointed
ENVI Environment, Public Health and Food Safety	MCAVAN Linda	10/09/2009

Former committee responsible	Former rapporteur	Appointed
ENVI Environment, Public Health and Food Safety

Committee for opinion	Rapporteur for opinion	Appointed
ITRE Industry, Research and Energy	RIVASI Michèle	16/09/2009
IMCO Internal Market and Consumer Protection	TURMES Claude	28/09/2009

Former committee for opinion	Former rapporteur for opinion	Appointed
IMCO Internal Market and Consumer Protection
ITRE Industry, Research and Energy

Council of the European Union

Council configuration

Meeting

Date

Agriculture and Fisheries

3050

29/11/2010

Former Council configuration
Employment, Social Policy, Health and Consumer Affairs	2980	30/11/2009

European Commission

Commission DG

Health and Consumers

Commissioner

DALLI John

Key events

10/12/2008	Legislative proposal published	COM(2008)0664	Summary
13/01/2009	Committee referral announced in Parliament, 1st reading/single reading
19/10/2009	Committee referral announced in Parliament, 1st reading/single reading
30/11/2009	Debate in Council		Summary
27/04/2010	Vote in committee, 1st reading/single reading		Summary
10/05/2010	Committee report tabled for plenary, 1st reading/single reading	A7-0153/2010
21/09/2010	Debate in Parliament
22/09/2010	Decision by Parliament, 1st reading/single reading	T7-0331/2010	Summary
22/09/2010	Results of vote in Parliament
29/11/2010	Act adopted by Council after Parliament's 1st reading
15/12/2010	Final act signed
15/12/2010	End of procedure in Parliament
31/12/2010	Final act published in Official Journal

Technical information

Procedure reference	2008/0257(COD)
Procedure type	COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype	Legislation
Legislative instrument	Regulation
	Amending Regulation (EC) No 726/2004, Community procedures 2001/0252(COD) Amending Regulation (EC) No 1394/2007 2005/0227(COD) See also 2008/0260(COD)
Legal basis	Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114-p1
Stage reached in procedure	Procedure completed
Committee dossier	ENVI/7/00162

Documentation gateway

European Parliament

Committee draft report	PE430.928	17/12/2009
Amendments tabled in committee	PE438.413	01/03/2010
Committee report tabled for plenary, 1st reading/single reading	A7-0153/2010	10/05/2010
Text adopted by Parliament, 1st reading/single reading	T7-0331/2010	22/09/2010	Summary

European Commission

Legislative proposal	COM(2008)0664	10/12/2008	Summary
Document attached to the procedure	SEC(2008)2670	10/12/2008
Document attached to the procedure	SEC(2008)2671	10/12/2008
Commission response to text adopted in plenary	SP(2010)7193	13/10/2010

Other institutions

Document attached to the procedure	JOC_2009/C/229/04 OJ C 229 23.09.2009, p. 0019	22/04/2009	Summary
Economic and Social Committee: opinion, report	CES1023/2009	10/06/2009

All

Legislative proposal	COM(2008)0664	10/12/2008	Summary
Document attached to the procedure	SEC(2008)2670	10/12/2008
Document attached to the procedure	SEC(2008)2671	10/12/2008
Document attached to the procedure	JOC_2009/C/229/04 OJ C 229 23.09.2009, p. 0019	22/04/2009	Summary
Economic and Social Committee: opinion, report	CES1023/2009	10/06/2009
Committee draft report	PE430.928	17/12/2009
Amendments tabled in committee	PE438.413	01/03/2010
Committee report tabled for plenary, 1st reading/single reading	A7-0153/2010	10/05/2010
Text adopted by Parliament, 1st reading/single reading	T7-0331/2010	22/09/2010	Summary
Commission response to text adopted in plenary	SP(2010)7193	13/10/2010

Links to other sites

National parliaments	IPEX
European Commission	PreLex

Final act

Regulation 2010/1235
OJ L 348 31.12.2010, p. 0001 Summary

Corrigendum to final act 32010R1235R(01)
OJ L 201 27.07.2012, p. 0138

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