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.
Please see Company authorisations for general guidance on applications for company authorisations, including the requirements and deadlines to be observed.
Guidelines
Guidelines on activities subject to a section 39 authorisation
Guidelines on applications for authorisation to manufacture and import medicines and intermediates
Guidelines on requirements and expectations for the qualified person in a pharmaceutical company
Receipt control by wholesale distributors (GDP) - DKMA practice
Forms
Note, that the first time you send an application after 1 October 2015, you have to submit a fully completed application form for all sites, regardless of what the application is about.
Read more about this change of practice
Template for the List of Contract Acceptors (Excel file, opens in a new window)
Inspection
Companies authorised to manufacture and import medicines are supervised regularly by the Danish Medicines Agency. 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.
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:
Submission of Manufacturing and Importation Authorisations (MIA) to EudraGMDP
We regularly 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