Parallel import and parallel distribution
Parallel import and parallel distribution from the UK after expiry of the transition period ending on 31 December 2020
After the expiry of the transition period ending on 31 December 2020, the UK will be considered a third country in relation to the EU rules on medicines.
The withdrawal agreement between the EU and the UK regulates, among other things, goods already marketed before the expiry of the transition period. Any good that is marketed in the EU or the UK on or before 31 December 2020 can circulate freely in the EU and the UK until it reaches its end-user or until the good has expired.
The Danish Medicines Agency interprets this to mean that packages of medicine that were released to the European market or the British market on or before 31 December 2020 can still be parallel imported to Denmark after 31 December 2020 if the package is comprised by a valid parallel import licence. Parallel import of packages of medicine released to the European market or the British market on or before 31 December 2020 may continue until the package reaches the end-user or the medicine expires.
The parallel importer is required to submit definite evidence that a batch intended to be imported in parallel from the UK has been released on or before 31 December 2020. A control report, batch release certificate or corresponding document issued by the manufacturer or the original MAH is considered as definite evidence, but other forms of documentation in combination with a verified serial number will also be considered as definite evidence. The Danish Medicines Agency expects the parallel importer to produce a risk assessment on the basis of which it establishes a written procedure describing what documentation is considered definite evidence.
Please be aware that the Danish Medicines Agency may change its view in the matter as we know more about the Brexit outcome, and we recommend that you follow our updates on Brexit here on the website.
Please also note that after the expiry of the transition period, the Protocol on Ireland and Northern Ireland (the 'IE/NI Protocol') will apply. The IE/NI Protocol implies that certain EU rules will continue to apply in Northern Ireland and that Northern Ireland will be treated as an EU member state. You can find more information in the European Commission’s readiness notices to stakeholders.
This means, among other things, that parallel import from Northern Ireland can continue. Find out more in the EMA’s Q&A on the Northern Ireland protocol. However, we advise parallel importers to pay attention to any restrictions related to intellectual property rights, see more in the EC Notice to stakeholders on exhaustion of intellectual property rights.
For further information on parallel distribution, see the EMA’s Q&A.
Consider necessary adjustments and changes
We advise companies to consider very carefully and in good time which adjustments and changes they need to make for those of their medicinal products that are linked to the UK in order to deal with any needed changes before the UK transition period expires in 2020.
Companies which parallel import products should still be aware that changes are required once the UK will be generally considered a third country after the transition period.
If parallel importers as a result of a potential no deal scenario (Hard Brexit) expect serious supply difficulties for certain medicines after Brexit, we advise you to keep us informed on email.
Questions regarding Brexit and parallel import can be addressed to email
Questions about Brexit and parallel distribution should be sent to the EMA.
Links
The Commission's position paper on Goods Placed on the Market (PDF)
CMDh Brexit information including Q&A