Compassionate use permits

09 May 2019, Updated 04 March 2020
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Compassionate use permits issued for medicines from the EU/EEA will continue to apply to medicines from the UK until the end of 2020.

Compassionate use permits that have been issued 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 2020.

Withdrawal agreement agreed between the EU and the UK

The UK government and the 27 remaining EU member states have agreed on a withdrawal agreement that lays 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.

The agreement establishes a transition period, which will start on the withdrawal date 31 January 2020 and end on 31 December 2020 with the possibility of a one-year or two-year extension. During this period, the UK will no longer be a member of the EU and therefore not represented in the EU institutions, but all the rules of the European Union will continue to apply to British citizens and businesses.

The agreement also provides that any reference to member states in the Union law, as implemented and applied by member states, shall be understood as including the United Kingdom in the transition period. 

Compassionate use permits that have been issued with the condition of import from the “EU/EEA” or the “EU/EEA and Switzerland” will therefore also cover medicines from the UK until the expiry of the transition period.

The transition period will allow the EU and the UK to negotiate the future relationship between the EU and the UK, e.g. negotiations on a future trade agreement.

The transition period may be extended for up to 24 months if both the EU and the UK agree.

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.

Link to more information about company authorisations and Brexit.

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