The European Medicines Agency (EMA) and the European Commission have issued their first instalment of regulatory guidance to industry with the aim of helping pharmaceutical companies prepare for the UK’s withdrawal from the EU. The guidance relates to both human and veterinary medicines.
The questions and answers document concerns information on the location of companies, documents, persons and manufacturing sites, specifically:
- EU marketing authorisation (MA) holders
- Orphan designation holders
- Veterinary Minor Use Minor Species (MUMS) status
- Qualified persons for pharmacovigilance (QPPVs)
- Pharmacovigilance System Master Files (PSMF)
- Active pharmaceutical ingredient and finished product manufacturing sites
- Batch release sites
- SME eligibility.
Please click here to access the Q&A document.
Is the guidance helpful? Well, it describes accurately the legislation and the implications of the UK not being part of the EU or the European Economic Area (EEA), but it could be seen as prejudging the outcome of the forthcoming Brexit negotiations.
We know that the UK is leaving the EU and that it is unlikely to be part of the EEA, at least, under the current Conservative government; UK Prime Minister Theresa May has stated that there will not be free movement of EU citizens into the UK in the future. But if there were to be a shock result in the imminent UK General Election, or a reduced Conservative majority, is it possible that the UK could be part of the EEA? Or is it conceivable that the Brexit negotiations will deliver some compromises that would see this guidance change?
Let us hope that common sense prevails during negotiations between the EU and UK and that whilst fundamental legislation probably cannot be changed, some areas for cooperation and working sharing that rapidly deliver innovative healthcare products and safeguard and improve public health can be found.
At present companies need to plan for the worst, both for their EU and UK MAs. At this stage there is no mention of timescales or transition periods in the EMA/EC guidance, something which must surely be being considered and on which some guidance would be welcome as soon as possible.
If you would like an initial consultant on the regulatory and/or pharmacovigilance implications of Brexit on your medicinal products or medical devices, please contact us via our Contacts Page.