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Procedure file Procedure file

Procedure file : Etat actuel du dossier

The information here reflects the current status of the procedure
Identification
Reference COD/1997/0197  
Title Medicinal products for human use: implementation of good clinical practice in the conduct of clinical trials
Legal Basis EC 095  
Dossier of the committee ENVI/5/13000
Subject(s) 4.20.02.06 clinical practice and experiments
4.20.04 pharmaceutical products and industry
Stage reached Procedure ended
Stages
Stages Documents: references Dates
Source reference Equivalent references Votes and amendments Joint resolution of document of publication in Official Journal
Commission/Council: initial legislative document Summaries EC COM(1997)0369 C4-0446/1997         03/09/1997 C 306 08.10.1997, p. 0009
Economic and Social Committee: opinion, report Summaries ESC CES0099/1998           28/01/1998 C 095 30.03.1998, p. 0001
EP: draft report by the committee responsible   EP PE224.735           10/08/1998  
EP: decision of the committee responsible, 1st reading/single reading Summaries               29/10/1998  
EP: tabled legislative report, 1st reading or single reading   EP A4-0407/1998           29/10/1998 C 379 07.12.1998, p. 0005
EP: position, 1st reading or single reading Summaries EP T4-0648/1998           17/11/1998 C 379 07.12.1998, p. 0017-0034
Commission: modified legislative proposal Summaries EC COM(1999)0193 C4-0223/1999         26/04/1999 C 161 08.06.1999, p. 0005
Council: common position Summaries CSL 08878/1/2000 C5-0424/2000         20/07/2000 C 300 20.10.2000, p. 0032
Commission: communication on the common position Summaries EC SEC(2000)1293           26/07/2000  
EP: draft report by the committee responsible   EP PE293.678           21/11/2000  
EP: decision of the committee responsible, 2nd reading Summaries               21/11/2000  
EP: tabled legislative report, 2nd reading   EP A5-0349/2000           21/11/2000 C 232 17.08.2001, p. 0010
EP: position, 2nd reading Summaries EP T5-0548/2000           12/12/2000 C 232 17.08.2001, p. 0035-0052
Final legislative act Summaries EU 32001L0020           04/04/2001 L 121 01.05.2001, p. 0034
Agents
European Parliament
Committee
Rapporteur / Co-rapporteurs   Previous
Political group Appointed
Environment, Public Health, Consumer Policy (responsible)
Liese Peter
PPE-DE
11/09/2000
European Commission and Council of the Union
Council of the Union
  Previous Councils
  Agriculture meeting: 2332 of: 26/02/2001
Links to other sources
European Commission PreLex
 
04/04/2001 - Final legislative act
PURPOSE : to establish specific provisions regarding the conduct of clinical trials of medicinal products on human subjects, particularly in relation to the implementation of good clinical practice.
COMMUNITY MEASURE : Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
CONTENT : This directive obliges Member States to adopt detailed rules to protect from abuse individuals who are incapable of giving their informed consent. This includes minors, and incapacitated adults. Such persons should not participate in trials if the same results would be obtained from persons who are capable of giving consent. The directive sets out the preconditions under which trials may take place. The foreseeable risks and inconveniences must be weighed against the anticipated benefits for the individual trial subject and other patients. A trial may only be initiated by the Ethics Committees, the establishment and duties of which are set out in the directive. The trial subject or his legal representative must be given certain information about the trial, including the right of withdrawal. The directive establishes rules on the commencement and conduct of trials, suspension of the trials or infringements, the manufacture and import of investigational medicinal products, labelling, and verification of compliance with good clinical and manufacturing practice.
ENTRY INTO FORCE : 01/05/2001
DATE OF APPLICATION : Member States shall adopt and publish before 1 May 2003 the laws to comply with the Directive.
The provisions will apply at the latest with effect from 1 May 2004.
 
List of summaries
Summaries 04/04/2001 Final legislative act
Summaries 14/12/2000 Council's activities
Summaries 12/12/2000 EP: position, 2nd reading
Summaries 21/11/2000 EP: decision of the committee responsible, 2nd reading
Summaries 26/07/2000 Commission: communication on the common position
Summaries 20/07/2000 Council: common position
Summaries 25/05/2000 Council's activities
Summaries 26/04/1999 Commission: modified legislative proposal
Summaries 17/11/1998 EP: position, 1st reading or single reading
Summaries 29/10/1998 EP: decision of the committee responsible, 1st reading/single reading
Summaries 28/01/1998 Economic and Social Committee: opinion, report
Summaries 03/09/1997 Commission/Council: initial legislative document
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