The United Kingdom traditionally plays the role of the most important innovator and manufacturer of medicinal products. It is as of yet still unclear what shape Brexit will take. Under the current circumstances – in which there exists not as much as an understanding on a transitional period – the entire pharmaceutical industry must be prepared for the worst before 31 October 2019 comes around. What does this mean?
Most important consequences for the pharma sector
In the event of a hard Brexit, all marketing authorizations for medicinal products granted to UK entities will expire as of the day on which the UK leaves the EU. Mindful of this fact, British MAHs have begun on a massive scale to transfer their marketing authorizations to legal entities residing in the European Economic Area (EEA), following the procedure anticipated in Regulation No. 2141/96. The European Medicines Agency has already announced, in its Practical Guidance for procedures related to Brexit, that such transfers may now take up to 90 business days. In addition, the transfers must be accomplished prior to the UK leaving the EU. If the transfer is not complete in time, the authorizations will expire; the affected companies would then have to reapply for new authorizations, which is a much more arduous and involved procedure.
The British side is taking a noticeably more accommodating approach: according to an opinion of the competent British authority, i.e., the Medicines & Healthcare Products Regulatory Agency (MHRA), Great Britain will automatically recognize, post-Brexit, all centrally granted marketing authorizations as being equal to a marketing authorization for the given pharmaceutical in the United Kingdom. The marketing authorization holders merely have to submit to the MHRA the complete documentation based upon which the original EU authorization was granted. In terms of localization of the holders of authorizations recognized by the British, it suffices to name a contact person within four weeks from the Brexit date; only as of the end of 2020 will UK authorities insist that the marketing authorization holder itself be localized.
Substantial impact on QPs and QPPVs
Brexit also has substantial impact on QPs and QPPVs. Not a few among the MAH who previously drew upon UK residents as qualified persons or as qualified persons responsible for pharmacovigilance will now have to arrange for a transfer or find someone resident in the EEA.
In these paragraphs, we have merely scratched the surface when it comes to the issues that would have to be resolved in the event of a hard Brexit. The MHRA has professed unequivocal interest in close cooperation with the EU and a maximum of harmonization even after Brexit. Let’s hope that the necessary consensus for such close cooperation can be found.
Medicines & Healthcare products Regulatory Agency: Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
Medicines & Healthcare products Regulatory Agency: Regulating medical devices in the event of a no deal scenario
House of Commons: The impact of Brexit on the pharmaceutical sector European Medicines Agency: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within centralised procedure