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

OJ L 121, 1.5.2001, p. 34–44 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 13 Volume 26 P. 299 - 309
Special edition in Estonian: Chapter 13 Volume 26 P. 299 - 309
Special edition in Hungarian Chapter 13 Volume 26 P. 299 - 309
Special edition in Lithuanian: Chapter 13 Volume 26 P. 299 - 309
Special edition in Latvian: Chapter 13 Volume 26 P. 299 - 309
Special edition in Maltese: Chapter 13 Volume 26 P. 299 - 309
Special edition in Polish: Chapter 13 Volume 26 P. 299 - 309
Special edition in Slovak: Chapter 13 Volume 26 P. 299 - 309
Special edition in Slovene: Chapter 13 Volume 26 P. 299 - 309
Special edition in Bulgarian: Chapter 13 Volume 31 P. 32 - 42
Special edition in Romanian: Chapter 13 Volume 31 P. 32 - 42

Directory code
13.30.15.00 Industrial policy and internal market ; Internal market: approximation of laws ; Proprietary medicinal products
15.30.00.00 Environment, consumers and health protection ; Health protection

EUROVOC descriptor
experiment on humans ; medicament ; approximation of laws ; code of conduct

Amended by
Corrected by 32001L0020R(01)
Amended by 32006R1901 Addition Article 11.4 from 26/01/2007
Amended by 32009R0596 Replacement Article 1.3 from 07/08/2009
Amended by 32009R0596 Replacement Article 13.1 from 07/08/2009
Amended by 32009R0596 Replacement Article 20 from 07/08/2009
Amended by 32009R0596 Replacement Article 21 from 07/08/2009
Subsequent related instruments
Amendment proposed by 52008PC0071
Amendment proposed by 52012PC0369 Repeal

Monitoring the decision-making process
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European Parliament - Legislative observatory