The Danish Medicines Act regulates the authorisation and control of medicinal products and the companies manufacturing, storing or otherwise handling medicinal products.
It also lays down rules on the reporting of adverse reactions to medicinal products and advertising of medicinal products.The authorisation of clinical trials in humans is also regulated by the Act.
The Danish Medicines Act is a translation of the 'Lov om lægemidler (Lægemiddelloven)'. The English translation includes all amendments up until 1 February 2013.
Danish Medicines Act (pdf - 0.66 MB)
Includes all amendments up until 1 February 2013
The act is available in Danish at Retsinformation:
- Lov om lægemidler (Lægemiddelloven)(Retsinformation)
Please note that the Danish Lægemiddelloven at Retsinformation is not a consolidated text. Amendments to the act appear to the right under 'Senere ændringer til forskriften' at Retsinformation.