Authorisation of companies

Companies that handle medicinal products must obtain a so-called section 39 authorisation from the Danish Medicines Agency (pursuant to section 39 of the Danish Medicines Act).

Application forms for section 39 authorisations can be downloaded and printed from "Guidelines and forms" or alternatively ordered from the Danish Medicines Agency.

A section 39 authorisation may cover:

• Manufacture and import of medicinal products, including investigational medicinal products,
• Wholesale distribution of medicinal products.

Manufacture and import authorisations for medicinal products, including investigational medicinal products, are transferred to EudraGMP. You can read more about EudraGMP in the factbox to the right.

Companies that perform toxicological and pharmacological testing (non-clinical trials) must be authorised by the Danish Medicines Agency according to section 85(1) of the Danish Medicines Act.

Before the granting of a section 39 authorisation, the company will be inspected by the Danish Medicines Agency. A medicines inspector will contact the company concerned to make arrangements for the inspection.

Companies holding a section 39 authorisation or a section 85 authorisation are inspected by the Danish Medicines Agency on a regular basis.

In the factbox to the right, you can find information about the frequency of such inspections. Inspections are performed in pursuance of the GMP, GDP or GLP rules in force.

In the factbox to the right, you can furthermore download a list in Danish of companies that hold a manufacturing authorisation granted under section 39 and a list of companies that hold a wholesale distribution authorisation granted under section 39.

Companies authorised pursuant to section 8 of Act no. 656 of 28 July 1995 are – until the renewal of such authorisation – authorised under section 39 of Act no. 1180 of 12 December 2005.

Danish Medicines Agency, last updated on 19 November 2009