Document reference

2012/0025(COD)  
Pharmacovigilance: transparency and efficiency of the system. Directive  
Basic information  

2012/0025(COD)

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

Amending Directive 2001/83/EC 1999/0134(COD)
See also 2012/0023(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

Status

Procedure completed

 

Please go to Documentation gateway for any follow-up documents.: Please go to Documentation gateway for any follow-up documents. 
Key players  
Key events  
10/02/2012
Legislative proposal published
COM(2012)0052 Eur-Lex link
16/02/2012
Committee referral announced in Parliament, 1st reading
08/05/2012
Vote in committee, 1st reading
12/07/2012
Committee report tabled for plenary, 1st reading
A7-0165/2012
10/09/2012
Debate in Parliament
11/09/2012
Results of vote in Parliament
11/09/2012
Decision by Parliament, 1st reading
T7-0313/2012
04/10/2012
Act adopted by Council after Parliament's 1st reading
25/10/2012
Final act signed
25/10/2012
End of procedure in Parliament
27/10/2012
Final act published in Official Journal
Technical information  
Procedure reference
2012/0025(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Directive

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

See also 2012/0023(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114-p1
Other legal basis
Rules of Procedure EP 159
Mandatory consultation of other institutions
European Economic and Social Committee European Committee of the Regions
Stage reached in procedure
Procedure completed
Committee dossier
ENVI/7/08830
Documentation gateway  
Final act