Compassionate use permits
Importing medicines that are not marketed in Denmark after Brexit
The UK has decided to leave the EU including the single market and the customs union. Consequently, the trading conditions between the UK and Denmark will change.
The negotiations on the exact details of the agreement between the EU and the UK are still ongoing, and there are still uncertainties in a number of areas. However, it cannot be ruled out that the UK and the EU will not agree on a deal, or that the British parliament will not pass the exit deal.
If the UK leaves the EU without any collaboration or trade agreements with the EU, the UK will be considered as a third country (the hard Brexit scenario). Consequently, the EU principle on the free movement of goods within the EU's external borders will not apply between the UK and the EU countries, including Denmark.
If your company is responsible for importing into Denmark medicines that are not marketed in Denmark by way of compassionate use permits issued by the Danish Medicines Agency, a hard Brexit may have consequences for the import thereof. 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.
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.
Importers of medicines not marketed in Denmark who anticipate that a potential hard Brexit will lead to serious post-Brexit supply difficulties regarding specific medicines are strongly encouraged to notify the situation to the Danish Medicines Agency on firstname.lastname@example.org.