The Danish Act on Clinical Trials of Medicinal Products

The Danish Act on Clinical Trials of Medicinal Products regulates the Danish Medicines Agency’s and the medicinal research ethics committees’ assessment of and control with clinical trials of medicinal products in humans and animals. The Act is in accordance with the rules laid down in the EU regulation on clinical trials on medicinal products.

The Act describes the provisions on consent, the new medicinal research ethics committees and the collaboration and division of tasks between the new committees and the Danish Medicines Agency.

The Danish Act on Clinical Trials of Medicinal Products (an extract in English)

The act is available in Danish at Retsinformation:
Lov om kliniske forsøg med lægemidler