Directive 2001/20 - 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

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1.

Current status

This directive has been published on May  1, 2001, entered into force on the same day and should have been implemented in national regulation on May  1, 2003 at the latest.

2.

Key information

official title

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
 
Legal instrument Directive
Number legal act Directive 2001/20
Original proposal COM(1999)193 EN
CELEX number i 32001L0020

3.

Key dates

Document 04-04-2001
Publication in Official Journal 01-05-2001; Special edition in Romanian: Chapter 13 Volume 031,Special edition in Czech: Chapter 13 Volume 026,Special edition in Slovak: Chapter 13 Volume 026,Special edition in Latvian: Chapter 13 Volume 026,Special edition in Lithuanian: Chapter 13 Volume 026,Special edition in Slovenian: Chapter 13 Volume 026,Special edition in Estonian: Chapter 13 Volume 026,OJ L 121, 1.5.2001,Special edition in Polish: Chapter 13 Volume 026,Special edition in Croatian: Chapter 13 Volume 061,Special edition in Bulgarian: Chapter 13 Volume 031,Special edition in Hungarian: Chapter 13 Volume 026,Special edition in Maltese: Chapter 13 Volume 026
Effect 01-05-2001; Entry into force Date pub. See Art 23
Deadline 01-05-2003; See Art 22.1
End of validity 31-12-9999; Repealed by 32014R0536
Transposition 01-05-2003; At the latest

4.

Legislative text

Avis juridique important

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5.

32001L0020

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

Official Journal L 121 , 01/05/2001 P. 0034 - 0044

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the Economic and Social Committee(2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

  • (1) 
    Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(4) requires that applications for authorisation to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products(5) lays down uniform rules on the compilation of dossiers including their presentation.
  • (2) 
    The accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the 1996 version of the Helsinki Declaration. The clinical trial subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities, and rules on the protection of personal data.
  • (3) 
    Persons who are incapable of giving legal consent to clinical trials should be given special protection. It is incumbent on the Member States to lay down rules to this effect. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. Normally these persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient, thereby outweighing the risks. However, there is a need for clinical trials involving children to improve the treatment available to them. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age- and development- related research important for their benefit. Medicinal products, including vaccines, for children need to be tested scientifically before widespread use. This can only be achieved by ensuring that medicinal products which are likely to be of significant clinical value for children are fully studied. The clinical trials required for this purpose should be carried out under conditions affording the best possible protection for the subjects. Criteria for the protection of children in clinical trials therefore need to be laid down.
  • (4) 
    In the case of other persons incapable of giving their consent, such as persons with dementia, psychiatric patients, etc., inclusion in clinical trials in such cases should be on an even more restrictive basis....

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This text has been adopted from EUR-Lex.

6.

Original proposal

 

7.

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