New practice for MIAs

01 October 2015

As of 1 October 2015, the Danish Health and Medicines Authority will change the practice for issuing Manufacturing and Importation Authorisations (MIAs) to pharmaceutical companies. This means that all manufacturing activities will be listed on the authorisation.

An MIA is issued to a pharmaceutical company that manufactures medicinal products or imports medicinal products from non-EU countries, that is countries outside the EU/EEA. At 1 October 2015, we are changing the practice for authorisations to manufacture and import medicines and intermediates (MIAs) which will make it easier to decode MIAs. In future, we will list all manufacturing activities separately on the authorisation. This means that if a company manufactures bulk tablets, engages in primary and secondary packaging, performs quality control testing and batch releases the tablets, all these activities will appear from the authorisation.

Authorisations issued before 1 October 2015 do not list all activities

Previously, the activities which companies were authorised to carry out included full and partial authorisation to manufacture and release medicines, unless otherwise stated in the authorisation.

In February 2015, we updated the MIA format so that all activities can be listed separately. After a transition period, we will now begin to list all activities separately when we issue MIAs.

Read more about the updated MIA format

The change will appear from the authorisation at the next update

All authorisations issued before 1 October 2015 are still valid. The change will appear from the authorisation the next time it is updated due to changes to the information in the authorisation. Note that it is important to fill in the entire application form for all sites on the authorisation when you submit an application for the first time after 1 October 2015. This applies regardless of what the application is about.

More information in the guidelines

Read more about how to fill in the application form in the updated guidelines

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