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.
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.
Other forms relevant for the application for an MIA:
- Template for the List of Contract Acceptors (Excel file, in Danish only)
- Form regarding missing subjects for a QP (Word file, in Danish only)
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.
Here you can find a list of companies authorised to manufacture and import medicines and intermediates in Denmark. The list is in Danish only:
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