Here you can find guidelines and application forms for authorisation to manufacture and import medicines and intermediates (manufacturer's and importer's authorisation, MIA). The Danish Health and Medicines Authority grants MIAs according to section 39 of the Danish Medicines Act.
Please see Company authorisations for general guidance on applications for company authorisations, including the requirements and deadlines to be observed.
In the box to the right, you can find a list of companies authorised to manufacture and import medicines and intermediates in Denmark. The list is in Danish only.
Guidelines
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Guidelines on activities subject to a section 39 authorisation (PDF file, opens in a new window)
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Guidelines on applications for authorisation to manufacture and import medicines and intermediates (PDF file, opens in a new window)
Forms
- Application form for authorisation to manufacture and import medicines and intermediates - human (Word file, opens in a new window)
- Application form for authorisation to manufacture and import medicines and intermediates - veterinary (Word file, opens in a new window)
- Template for the List of Contract Acceptors (Excel file, opens i a new window)
Inspection
Companies authorised to manufacture and import medicines are supervised regularly by the Danish Health and Medicines Authority. In the box to the right, you can find information about the frequency of such inspections. Inspections will be performed in pursuance of the GMP and/or GDP rules.
