The UK has recently published guidance which clarifies their position on batch testing and QP certification of medicinal product in the event of a ‘no deal’ Brexit scenario.
Negotiations are ongoing between the EU and UK to reach a positive deal. However, the UK will have to be prepared for all outcomes, including a ‘no deal’ Brexit. The UK has been working to ensure they will be ready from day 1 in all scenarios.
With March 2019 slowly but surely approaching, the preparations for a ‘no deal’ need to be accelerated to ensure plans are in place in the event that they would have to be relied upon.
The Prime Minister has outlined the UK’s desire to ensure that products only need to undergo one series of approvals in one country as it’s considered essential in allowing new medicinal products to reach patients quickly. Therefore, in the event that there’s no deal and the UK is no longer part of the EMA the following arrangements will come into force after 29 March 2019 in relation to batch testing and QP Certification:
· The UK will accept testing of batches performed in the EU/EEA and third countries with which the EU has an MRA.
· The UK will continue to accept testing of IMP batches manufactured in the EU/EEA and there won’t be any change to current arrangements for testing of IMP batches manufactured in third countries.
· For medicinal product manufactured in the UK, a UK-based QP will be required to perform batch certification.
· For medicinal product manufactured in a third country and directly imported into the UK, a UK-based QP will be required to perform batch certification.
· For medicinal product manufactured in a third country but imported into the UK from an EU/EEA country, QP batch certification performed by a QP in that EU/EEA country will continue to be recognised with no requirement for any further UK certification.
· For medicinal product manufactured in the EU/EEA which has the relevant QP certification, the UK will continue to recognise this with no requirement for any further UK certification.
· The approaches to QP certification of licensed medicines outlined above will also apply to IMPs.
From an EU perspective, the EMA has addressed queries regarding UK batch release sites in their Brexit Q&As for centrally authorised medicinal products. They confirm that the batch release site has to be located in the EU/EEA. Therefore, for centrally authorised medicinal products the MAH will need to transfer its current UK based site of batch release to a location established in the EU/EEA and submit the corresponding variation.
If you would like to discuss your specific requirements relating to Brexit readiness or are interested in changing your batch release site to MIAS Pharma in Ireland, get in touch with us at +353 (1) 846 3605 or firstname.lastname@example.org.