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Directive 2001/20/EC

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Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

This Directive aims at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonize the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.

The Articles of the Directive:

  • Scope (Directive does not apply to non-interventional trials).
  • Definitions
  • Protection of clinical trial subjects
  • Clinical trials on minors
  • Clinical trials on incapacitated adults not able to give informed legal
  • Ethics Committee
  • Single opinion
  • Detailed guidance
  • Commencement of a clinical trial
  • Conduct of a clinical trial
  • Exchange of information
  • Suspension of the trial or infringements
  • Manufacture and import of investigational medicinal products
  • Labelling
  • Verification of compliance of investigational medicinal products with good clinical and manufacturing practice
  • Notification of adverse events
  • Notification of serious adverse reactions
  • Guidance concerning reports
  • General provisions
  • Adaptation to scientific and technical progress
  • Committee procedure
  • Application
  • Entry into force
  • Addressees

The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.

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