Directive 2001/20 / EC on the application of good clinical practice
 Directive 2001/20 / EC |
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| Title: | Directive 2001/20 / EC of the European Parliament and of the Council of April 4, 2001 on the approximation of the laws, regulations and administrative provisions of the member states on the application of good clinical practice when conducting clinical trials on medicinal products for human use |
| Date of issue: | April 4, 2001 |
| Release date: | May 1, 2001 |
| Come into effect: | May 1, 2001 |
| Full text |
Consolidated version (not official) basic version |
| Regulation has expired. | |
| Please note the information on the current version of legal acts of the European Union ! | |
The Directive 2001/20 / EC on the approximation of 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 is one of the guidelines of the European Parliament and of the Council of 4 April 2001. She was in In force until May 27, 2016 and was repealed by "Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials with medicinal products for human use and repealing Directive 2001/20 / EC". It contains specific provisions for the conduct of clinical trials, including multi-center clinical trials that are carried out on people with medicinal products , particularly with regard to the application of good clinical practice (GCP) . Non-interventional studies are not covered by this guideline.
It is divided into the following 24 articles:
- scope
- Definitions
- Test taker protection
- Minors as exam candidates
- Adults who are unable to give their consent as exam participants
- Ethics Committee
- Only opinion
- Detailed instructions
- Start of a clinical trial
- Conducting a clinical trial
- Exchange of information
- Suspension of examination or violations
- Manufacture and import of preparations
- Labeling
- Verification of compliance with good clinical practice (GCP, Good Clinical Practice ) and good manufacturing practice (GMP, Good Manufactural Practice )
- Adverse Events (AE ) reports
- Reports of Serious Adverse Events (SAEs)
- Instructions for reports
- General provisions
- Adaptation to scientific and technical progress
- Committee
- Start of application
- Come into effect
- Addressees
Individual evidence
- ↑ EUR-Lex - 32014R0536 - EN - EUR-Lex. In: eur-lex.europa.eu. Retrieved July 20, 2020 .