Directive 2001/20/EC of the European Parliament and of the Council of 4 April 200... (32001L0020)
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Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 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
- DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 4 April 2001
- 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
- Article 1
- Scope
- Article 2
- Definitions
- Article 3
- Protection of clinical trial subjects
- Article 4
- Clinical trials on minors
- Article 5
- Clinical trials on incapacitated adults not able to give informed legal consent
- Article 6
- Ethics Committee
- Article 7
- Single opinion
- Article 8
- Detailed guidance
- Article 9
- Commencement of a clinical trial
- Article 10
- Conduct of a clinical trial
- Article 11
- Exchange of information
- Article 12
- Suspension of the trial or infringements
- Article 13
- Manufacture and import of investigational medicinal products
- Article 14
- Labelling
- Article 15
- Verification of compliance of investigational medicinal products with good clinical and manufacturing practice
- Article 16
- Notification of adverse events
- Article 17
- Notification of serious adverse reactions
- Article 18
- Guidance concerning reports
- Article 19
- General provisions
- Article 20
- Adaptation to scientific and technical progress
- Article 21
- Committee procedure
- Article 22
- Application
- Article 23
- Entry into force
- Article 24
- Addressees
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