Compassionate use permits

Updated 12 April 2021
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Compassionate use permits issued before 31 December 2020 for medicines from the EU/EEA will also apply to medicines from the UK until the end of 2022

Compassionate use permits that have been issued before 31 December 2020 with the condition of import from the “EU/EEA” or the “EU/EEA and Switzerland” will also cover medicines from the UK until the end of 2022 or until the expiry of the compassionate use permit, whichever comes first.

Transition period expires on 31 December 2020

The UK government and the 27 remaining EU member states agreed in the beginning of 2020 on a withdrawal agreement laying down the conditions and rules for how the UK is to leave the EU. You can find the withdrawal agreement on the website of the European commission.

To ensure the supply of medicines through compassionate use permits, it has been decided that compassionate use permits that have been issued before 31 December 2020 with the condition of import from the “EU/EEA” or the “EU/EEA and Switzerland” will also cover medicines from the UK until 31 December 2022 or until the expiry of the compassionate use permit, whichever comes first.

Import of medicines by a compassionate use permit after the transition period expiring on 31 December 2020

After the expiry of the transition period ending on 31 December 2020, the UK is no longer an EU member state and therefore has community status as a third country.

If your company is responsible for the import into Denmark of medicines that are not marketed in Denmark in connection with a compassionate use permit issued by the Danish Medicines Agency, a hard Brexit may have consequences for such import. If you are importing medicines from the UK, you may need to sort out certain matters in relation to Brexit for you to continue importing these specific products from the UK.

Wholesale distribution of medicines (receipt, storage, purchase/sale and delivery of medicines) within the EU is subject to an authorisation for wholesale distribution under section 39 of the Danish Medicines Act. At present, the import of medicines from the UK is therefore permitted under an authorisation for wholesale distribution. Enhanced requirements apply to the import of medicines from countries outside the EU as this type of import (defined as importation) is subject to a manufacturing and importation authorisation under section 39 of the Danish Medicines Act.

If you are importing medicines not marketed in Denmark from the UK under a wholesale distribution authorisation, such wholesale distribution authorisation will no longer be sufficient after a potential hard Brexit.

You can find further information about company authorisations on our website.
 
If the required manufacturing and importation authorisation has not been obtained before the UK leaves the EU, the conditions for importing medicines from the UK are in principle no longer met. This could have significant consequences for your company's continued activities related to importing medicines that are not marketed in Denmark from the UK and for the supply of medicines in Denmark after Brexit. We therefore advise you to consider what steps your company should take as a result of Brexit.
 
If you are an importer of medicines not marketed in Denmark and have questions about Brexit and compassionate use permits or anticipate post-Brexit supply difficulties regarding specific medicines, we encourage you to contact the Danish Medicines Agency on Send an email.

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