Procedure File: 2008/0045(COD)

European Parliament / Legislative Observatory

Procedure file

2008/0045(COD)

Medicinal products for human and veterinary use: marketing authorisations

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

Basic information

2008/0045(COD)

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

Medicinal products for human and veterinary use: marketing authorisations

Amending Directive 2001/83/EC 1999/0134(COD)
Amending Directive 2001/82/EC 1999/0180(COD)

Subject
3.10.08 Animal health requirements, veterinary legislation and pharmacy
4.20.04 Pharmaceutical products and industry
4.20.05 Health legislation and policy

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	PPE-DE GROSSETÊTE Françoise	14/04/2008

Committee for opinion	Rapporteur for opinion	Appointed
AGRI Agriculture and Rural Development	PPE-DE STAVREVA Petya	31/03/2008
IMCO Internal Market and Consumer Protection	The committee decided not to give an opinion.
JURI Legal Affairs	The committee decided not to give an opinion.
ITRE Industry, Research and Energy	The committee decided not to give an opinion.

Council of the European Union

Council configuration

Meeting

Date

Competitiveness (Internal Market, Industry, Research and Space)

2945

28/05/2009

Former Council configuration
Employment, Social Policy, Health and Consumer Affairs	2876	09/06/2008

European Commission

Commission DG

Enterprise and Industry

Commissioner

VERHEUGEN Günter

Key events

04/03/2008	Legislative proposal published	COM(2008)0123	Summary
13/03/2008	Committee referral announced in Parliament, 1st reading/single reading
09/06/2008	Debate in Council
09/09/2008	Vote in committee, 1st reading/single reading		Summary
15/09/2008	Committee report tabled for plenary, 1st reading/single reading	A6-0346/2008
22/10/2008	Debate in Parliament
22/10/2008	Decision by Parliament, 1st reading/single reading	T6-0510/2008	Summary
22/10/2008	Results of vote in Parliament
28/05/2009	Act adopted by Council after Parliament's 1st reading
18/06/2009	Final act signed
18/06/2009	End of procedure in Parliament
30/06/2009	Final act published in Official Journal

Technical information

Procedure reference	2008/0045(COD)
Procedure type	COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype	Legislation
Legislative instrument	Directive
	Amending Directive 2001/83/EC 1999/0134(COD) Amending Directive 2001/82/EC 1999/0180(COD)
Legal basis	EC Treaty (after Amsterdam) EC 095
Stage reached in procedure	Procedure completed
Committee dossier	ENVI/6/60575

Documentation gateway

European Parliament

Committee draft report	PE409.420	26/06/2008
Amendments tabled in committee	PE409.694	18/07/2008
Committee report tabled for plenary, 1st reading/single reading	A6-0346/2008	15/09/2008
Text adopted by Parliament, 1st reading/single reading	T6-0510/2008	22/10/2008	Summary

European Commission

Legislative proposal	COM(2008)0123	04/03/2008	Summary
Document attached to the procedure	SEC(2008)0273	04/03/2008
Document attached to the procedure	SEC(2008)0274	04/03/2008
Commission response to text adopted in plenary	SP(2008)6664	12/11/2008

Other institutions

Economic and Social Committee: opinion, report

CES1194/2008

09/07/2008

All

Legislative proposal	COM(2008)0123	04/03/2008	Summary
Document attached to the procedure	SEC(2008)0273	04/03/2008
Document attached to the procedure	SEC(2008)0274	04/03/2008
Committee draft report	PE409.420	26/06/2008
Economic and Social Committee: opinion, report	CES1194/2008	09/07/2008
Amendments tabled in committee	PE409.694	18/07/2008
Committee report tabled for plenary, 1st reading/single reading	A6-0346/2008	15/09/2008
Text adopted by Parliament, 1st reading/single reading	T6-0510/2008	22/10/2008	Summary
Commission response to text adopted in plenary	SP(2008)6664	12/11/2008

Links to other sites

National parliaments	IPEX
European Commission	PreLex

Final act

Directive 2009/53
OJ L 168 30.06.2009, p. 0033 Summary

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