NLClinicalTrialsIMP object

Applicable national regulations

National Act on Medicinal Products
Transposition of (CT) Directive 2001/20/EC
Transposition of (GCP) Directive 2005/28/EC

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

Lov om lægemidler (Lægemiddelloven) / Danish Medicines Act (en): unofficial translation including all amendments up until 1 February 2013
This act is the transposition of the Directive 2001/20/EC.

Lov om et videnskabsetisk komitésystem og behandling af biomedicinske forskningsprojekter / Act on Research Ethics Review of Health Research Projects: unofficial translation, hereinafter referred to as the Committee Act (en)This act contains provisions that implement parts of Directive 2001/20/EC as well as parts of directive 2005/28/EC.

Applicable to ATMP/ GMO trials


Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

Informed Consent & Trial Subjects:
Ministerial Order No 806 of 12 July 2004 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects