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As previously noted, the Brexit and EMA saga continues. In my last post, I covered the EMA perspective. Here I will discuss in depth the current lack of a Brexit agreement between the UK and the EU.

No Brexit Agreement between the UK and EU

Finally, on August 23 of this year, the UK issued three documents covering many fields of business if there is no agreement between the UK and EU before March 29, 2019 and no extension. The first is a guidance (that is, high level) and covers medicines and devices. The second is a detailed guide on technical information on human and veterinary medicines.  The third is a detailed guide on clinical trials in the UK.

The first one touches on PV and other related areas:  “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal.” Nothing on devices is noted in this post, so see the document for such information.

Key points on PV and other issues:

Comment: UK PV will be done by the MHRA and ICSRs, PSURs and all other issues will be adjudicated in the UK for the UK as far as we know now.  Whether an arrangement with the EMA (e.g. for PRAC) is done remains to be seen.  This will impose duplicate work on the companies and a significant increase in work for the MHRA.

Comment: This is tricky. Companies need a UK QPPV in the UK. If one is based in the UK already this sounds fine. If not, the UK company has until December 31, 2020 to establish one in the UK. Companies can have the EU-based QPPV continue to function for the UK till establishment of a QPPV in 2020. The trick here is that the UK-based QPPV will no longer be accepted by the EU and he/she must be in the EU. What will happen if the UK-based QPPV moves to the EU from the UK is unclear.

Bottom Line

We are slowly beginning to get information and a bit of clarity on what will happen after March 31, 2019, though there is a lot of kicking the can down the road. It seems that there may be an implementation period running from March 2019 to December 31, 2020 during which some of the EU requirements will continue to apply in the UK in regard to pharmaceuticals. On the other hand, the UK has issued information should there be no agreement with the EU (“no deal”).

The high level framework is being put in place for this period. The current EU law will be transposed into UK law so that it continues to apply during the implementation period. Some broad agreements have been discussed and agreed upon in regard to continuing PV, GMP, some inspections, etc. as is more or less.

But the devil is in the details and they have not yet been worked out, particularly for PV.  There will be an added burden on the companies and perhaps an even heavier one on the MHRA.

What is less clear is what happens if these laws are changed by the EU/EMA during this period. Will the changes also apply in the UK (if yes, automatically or not)?  We seem to know that a QPPV can still sit in the UK with the PV Master File. How this will play out if the rapporteur or “leading authority” is in the EU remains to be seen.

So we don’t yet know how PV will really be done after March, 2019.

More to follow.  Watch this space.

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