Procedure
Medicinal products for human use: pharmacovigilance of products
2008/0257(COD)·7th term·ENVI / IMCO / ITRE·COD - Ordinary legislative procedure (ex-codecision procedure)·CompletedProcedure completed
Subjects: Pharmaceutical products and industry · Health legislation and policy · Safety of products and services, product liability
Rapporteur (the Member appointed to lead Parliament's work on this text): MCAVAN Linda (S&D)
Summary
This dossier concerns pharmacovigilance of medicinal products for human use. Amendments address the Eudravigilance database as a single point of receipt, a medicines safety web-portal, creation of a Pharmacovigilance Risk Assessment Committee, post-authorisation safety studies, reporting of suspected adverse reactions by health professionals and patients, traceability of biological medicinal products, funding, and monitoring environmental effects of pharmaceutical residues.
Procedure timeline
- Committee amendments tabled5 Feb 2010 – 1 Mar 2010
- Procedure completed
118
Amendments
distinct, in window
32
Members
tabled at least one
3
Committee(s)
5 Feb 2010 – 1 Mar 2010
Dates
Official amendment documents
Connections
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Members who amended this procedure
32 Members · by amendment count1🇫🇷
Bernadette VERGNAUD
Socialists & Democrats · France
16(15 solo)
2🇫🇷Michèle RIVASI
Greens / EFA · France
14(14 solo)
3🇨🇿Jiří MAŠTÁLKA
The Left (GUE/NGL) · Czechia
9(9 solo)
4🇧🇬Antonyia PARVANOVA
ALDE · Bulgaria
9(3 solo)
5🇩🇪Anja WEISGERBER
European People's Party (EPP) · Germany
8(8 solo)
6🇪🇸Pilar AYUSO
European People's Party (EPP) · Spain
8(1 solo)
7🇫🇷Philippe JUVIN
European People's Party (EPP) · France
6(6 solo)
8🇪🇸Cristina GUTIÉRREZ-CORTINES
European People's Party (EPP) · Spain
6(6 solo)
9🇬🇧Ashley FOX
European Conservatives & Reformists · United Kingdom
6(6 solo)
10🇧🇪Anne DELVAUX
European People's Party (EPP) · Belgium
5(5 solo)
11🇷🇴Elena Oana ANTONESCU
European People's Party (EPP) · Romania
4(4 solo)
12🇩🇪Dagmar ROTH-BEHRENDT
Socialists & Democrats · Germany
4(4 solo)
13🇷🇴Marian-Jean MARINESCU
European People's Party (EPP) · Romania
3(3 solo)
14🇮🇹Patrizia TOIA
Socialists & Democrats · Italy
3(3 solo)
15🇸🇪Åsa WESTLUND
Socialists & Democrats · Sweden
2(2 solo)
16🇬🇷Michail TREMOPOULOS
Greens / EFA · Greece
2(2 solo)
17🇮🇹Oreste ROSSI
European People's Party (EPP) · Italy
2(2 solo)
18🇫🇷Françoise GROSSETÊTE
European People's Party (EPP) · France
2
19🇫🇷Corinne LEPAGE
ALDE · France
2(2 solo)
20🇧🇪Frédérique RIES
Renew Europe · Belgium
2(2 solo)
21🇩🇪Peter LIESE
European People's Party (EPP) · Germany
2(1 solo)
22🇩🇰Jens ROHDE
ALDE · Denmark
2(2 solo)
23🇬🇧Marina YANNAKOUDAKIS
European Conservatives & Reformists · United Kingdom
1(1 solo)
24🇩🇪Holger KRAHMER
ALDE · Germany
1(1 solo)
25🇮🇪Mairead McGUINNESS
European People's Party (EPP) · Ireland
1(1 solo)
The amendments, in full text
118 amendmentsEvery amendment as tabled — original text, proposed change and justification, with a link to the official PDF.
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