Brexit: Consequences for Batch Release

The EU withdrawal of the United Kingdom, UK (Brexit), is through. However, 31 January is by no means the end of the story. On 01 February, a transitional phase until the end of December 2020 began and the UK will remain in the internal market and customs union for the time being. New negotiations between London and the EU are now starting, which - ideally - will lead to a trade agreement. But what will change by then for the Qualified Person (QP)?

Understanding of European QP Association of Batch Release Situation in Transition Period

In the European QP Association's (EQPA) understanding the current situation is as follows:

During the transition period UK is a third country, but formally all EU laws remain applicable to it. QP certification by UK QPs would be valid across the EU, but in practice this might now be limited to "Confirmation". The reason for that is because since 2016 official advice to the industry has been to prepare for UK becoming a Third Country and has required all EU Marketing Authorisations (MA) with a UK batch release site to be varied in favour of a batch release site in EU. Therefore, although there may be some MAs that have still not been varied, essentially all final batch certification and subsequent release decisions for the EU should now be occurring within EU. During the transition period, QPs in EU will be able to rely on "Confirmation" from UK QPs.

If full testing is carried out in UK at a site which is still listed in the MA, then testing on import into EU is not required even if dossiers have been varied to include a testing site in EU.

After 31 December 2020 any MAs that have still not been varied will become invalid. If there is no formal trade agreement, testing of imports from UK will be required in the EU and even "Confirmation" by UK QPs can not be recognised. On the other hand, if there is a formal trade agreement covering pharmaceuticals, then import testing might be waived and EU QPs will be able to accept confirmation from UK QPs to certify a batch.

Finally, although the Withdrawal Agreement provides for extension of the Transition Period, current UK law has ruled this out. By the way, the Northern Ireland Protocol is part of the Withdrawal Agreement and so will continue to be in force after 31 December 2020 - regardless of the status of negotiations on the future trade arrangement.