Applications for authorisation to manufacture and import medicines and intermediates

Here you can find guidelines and application forms for authorisation to manufacture and import medicines and intermediates (Manufacturing and Importation Authorisation, MIA). The Danish Medicines Agency grants MIAs according to section 39 of the Danish Medicines Act.

Guidelines

Guidelines on activities subject to a section 39 authorisation

Guidelines on applications for authorisation to manufacture and import medicines and intermediates

Requirements and expections for the qualified person in a pharmaceutical company
 
Please see Company authorisations for general guidance on applications for company authorisations, including the requirements and deadlines to be observed.

Forms

Application form for authorisation to manufacture and import medicines and intermediates (Word file)

• Template for the List of Contract Acceptors (Excel file, in Danish only)
• Form regarding missing subjects for a QP (Word file, in Danish only)

Inspection

Companies authorised to manufacture and import medicines are supervised regularly by the Danish Medicines Agency. Inspections will be performed in pursuance of the GMP and/or GDP rules.

List

Here you can find a list of companies authorised to manufacture and import medicines and intermediates in Denmark. The list is in Danish only:

Companies authorised to manufacture and import medicines and intermediates in Denmark (Excel file)

Submission of Manufacturing and Importation Authorisations (MIA) to EudraGMDP

We submit Danish MIAs to the EMA’s EudraGMDP database as they are issued. This means that Danish MIAs are publicly available at EudraGMP and authorisations can be verified in the database.

You can read more about EudraGMDP on the EMA’s website under EudraGMDP database