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GCP implementation in Denmark


To whom it may concern


The European Parliament and the Council of the European Union issued Directive 2001/20/EC of 4th 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 of medicinal products for human use (GCP directive).

The directive is based on the principles of ICH-GCP. With regard to the Danish committee system on health research ethics the main part of the directive has been implemented in Danish law through Act no. 1083 of 15th September 2017, the Act on Research Ethics Review of Health Research Projects. The directive has been incorporated into the legislation of the Danish committee system on health research since 1st January 2012.

The relevant parts of the GCP Directive concerning the committees is implemented in the above mentioned act. Any further questions about the implementation of the GCP Directive fall within the Ministry of Health.

 

The above statement can be printed
and used as documentation for
GCP implementation in Denmark
.



Region Syddanmark | Damhaven 12 | 7100 Vejle | Email: komite@regionsyddanmark.dk | Tlf: 76 63 10 00 | Fax: 76 63 20 00