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)·CompletedProcedure 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
Committee(s)
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)
2🇫🇷António Fernando CORREIA DE CAMPOS
Socialists & Democrats · France
91(55 solo)
3🇩🇰Margrete AUKEN
Greens / EFA · Denmark
76(38 solo)
4🇮🇹Roberta ANGELILLI
European People's Party (EPP) · Italy
53(53 solo)
5🇩🇰Anna ROSBACH
European Conservatives & Reformists · Denmark
51(22 solo)
6🇵🇹Alda SOUSA
The Left (GUE/NGL) · Portugal
42(19 solo)
7🇦🇹Richard SEEBER
European People's Party (EPP) · Austria
39(8 solo)
8🇩🇪Thomas ULMER
European People's Party (EPP) · Germany
38
9🇷🇴Elena Oana ANTONESCU
European People's Party (EPP) · Romania
37(8 solo)
10🇵🇹Edite ESTRELA
Socialists & Democrats · Portugal
33(1 solo)
11🇩🇪Peter LIESE
European People's Party (EPP) · Germany
32
12🇩🇰Christel SCHALDEMOSE
Socialists & Democrats · Denmark
29(29 solo)
13🇧🇪Anne DELVAUX
European People's Party (EPP) · Belgium
29
14🇸🇮Alojz PETERLE
European People's Party (EPP) · Slovenia
29
15🇸🇰Miroslav MIKOLÁŠIK
European People's Party (EPP) · Slovakia
29
16🇮🇹Paolo BARTOLOZZI
European People's Party (EPP) · Italy
29
17🇩🇪Horst SCHNELLHARDT
European People's Party (EPP) · Germany
29
18🇩🇪Dagmar ROTH-BEHRENDT
Socialists & Democrats · Germany
29(5 solo)
19🇫🇷Michèle RIVASI
Greens / EFA · France
28(11 solo)
20🇫🇷Bernadette VERGNAUD
Socialists & Democrats · France
28(28 solo)
21🇫🇷Françoise GROSSETÊTE
European People's Party (EPP) · France
25(6 solo)
22🇧🇬Antonyia PARVANOVA
ALDE · Bulgaria
25(16 solo)
23🇩🇪Jutta HAUG
Socialists & Democrats · Germany
24
24🇸🇮Zofija MAZEJ KUKOVIČ
European People's Party (EPP) · Slovenia
21(7 solo)
25🇬🇧Emma 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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