Procedure
Clinical trials on medicinal products for human use
2012/0192(COD)·7th term·ENVI / IMCO / ITRE / LIBE·COD - Ordinary legislative procedure (ex-codecision procedure)·Completed
Subjects: Medical research · Clinical practice and experiments · Pharmaceutical products and industry
Rapporteur (the Member appointed to lead Parliament's work on this text): WILLMOTT Dame Glenis (S&D)
Summary
Regulation on clinical trials on medicinal products for human use. The amendments rework the definition of a clinical trial and of low-risk, low-intervention and medium-risk trials, the conditions on whether investigational medicinal products are authorised for marketing, the assessment carried out by each Member State, the protection of subjects and informed consent, and the requirement for prior authorisation including review by an ethics committee.
Procedure timeline
- Committee amendments tabled1 Feb 2013 – 20 Mar 2013
- Procedure completed
841
Amendments
distinct, in window
59
Members
tabled at least one
4
Committees
1 Feb 2013 – 20 Mar 2013
Dates
Official amendment documents
Connections
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Members who amended this procedure
59 Members · by amendment count1
Philippe JUVIN
European People's Party (EPP) · 🇫🇷 France
226(196 solo)
2António Fernando CORREIA DE CAMPOS
Socialists & Democrats · 🇫🇷 France
91(55 solo)
3Margrete AUKEN
Greens / EFA · 🇩🇰 Denmark
76(38 solo)
4Roberta ANGELILLI
European People's Party (EPP) · 🇮🇹 Italy
53(53 solo)
5Anna ROSBACH
European Conservatives & Reformists · 🇩🇰 Denmark
51(22 solo)
6Alda SOUSA
The Left (GUE/NGL) · 🇵🇹 Portugal
42(19 solo)
7Richard SEEBER
European People's Party (EPP) · 🇦🇹 Austria
39(8 solo)
8Thomas ULMER
European People's Party (EPP) · 🇩🇪 Germany
38
9Elena Oana ANTONESCU
European People's Party (EPP) · 🇷🇴 Romania
37(8 solo)
10Edite ESTRELA
Socialists & Democrats · 🇵🇹 Portugal
33(1 solo)
11Peter LIESE
European People's Party (EPP) · 🇩🇪 Germany
32
12Christel SCHALDEMOSE
Socialists & Democrats · 🇩🇰 Denmark
29(29 solo)
13Anne DELVAUX
European People's Party (EPP) · 🇧🇪 Belgium
29
14Alojz PETERLE
European People's Party (EPP) · 🇸🇮 Slovenia
29
15Miroslav MIKOLÁŠIK
European People's Party (EPP) · 🇸🇰 Slovakia
29
16Paolo BARTOLOZZI
European People's Party (EPP) · 🇮🇹 Italy
29
17Horst SCHNELLHARDT
European People's Party (EPP) · 🇩🇪 Germany
29
18Dagmar ROTH-BEHRENDT
Socialists & Democrats · 🇩🇪 Germany
29(5 solo)
19Michèle RIVASI
Greens / EFA · 🇫🇷 France
28(11 solo)
20Bernadette VERGNAUD
Socialists & Democrats · 🇫🇷 France
28(28 solo)
21Françoise GROSSETÊTE
European People's Party (EPP) · 🇫🇷 France
25(6 solo)
22Antonyia PARVANOVA
ALDE · 🇧🇬 Bulgaria
25(16 solo)
23Jutta HAUG
Socialists & Democrats · 🇩🇪 Germany
24
24Zofija MAZEJ KUKOVIČ
European People's Party (EPP) · 🇸🇮 Slovenia
21(7 solo)
25Emma McCLARKIN
European Conservatives & Reformists · 🇬🇧 United Kingdom
21(21 solo)
The amendments, in full text
841 amendmentsEvery amendment as tabled — original text, proposed change and justification, with a link to the official PDF.
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