By Saadia Basharat, PhD, Consultant
The question of what to do about selecting Marketing Authorization Holder (MAH) location for UK based companies, given Brexit, came up in a recent client meeting. Somebody shouted out “hire a European Regulatory Affairs person and they will know what to do”.
So, what are the recently formed recommendations by the European Commission (EC) and European Medicines Agency (EMA) to address this issue, and what should companies be considering?
The facts: according to the EMA, the MAH of centralised products has to be registered in an EU/EEA country – obviously when the UK leaves the EU, any MAHs registered in the UK will immediately no longer comply. With manufacturing and batch release in the UK, Brexit will mean the products are not compliant with EU law and so they will either need to have primary batch release performed somewhere in the EU, or will need to be re-released when imported to the EU. There is also the question of the Qualified Person Pharmacovigilance (QPPV) – they need to reside and perform their responsibilities in the EU.
What does the EC and EMA say?
- Any UK based sponsor of an orphan medicinal product designation will “need to transfer its designation to a holder established in the EEA, or change its place of establishment to an EEA member, and submit the corresponding documentation through a change of name and/or address of the orphan designation holder procedure, provided the legal entity remains the same."
- With regards to finished products, companies that currently manufacture this in the UK will have to accept that their products will be deemed imported medicinal products and would therefore only be accepted if a qualified person within the EEA is allocated and EU GMP inspection is carried out, etc. So, the MAH must specify an authorized importer established in the EEA and then submit the corresponding variation application.
- For batch release, the QP of the manufacturing and importation authorization holder has to certify that each batch of product aimed at the EEA market was indeed manufactured within EU GMP and the marketing authorization. For centrally authorized medicinal products, the MAH has to transfer its current UK-based site of batch release to an EEA location, and then submit the equivalent variation.
- Active substances manufactured in the UK will be considered imported substances. But these will be allowed into the EEA upon accompaniment of a letter from the UK’s competent authority confirming that the site conforms to GMP equivalent to that in the EEA. It’s even possible that written confirmation may not even be required if the UK is white-listed as an accredited country whose GMP framework is equivalent to that of the EU. This is a real possibility and seems like a sensible approach for both sides to agree on.
Clearly there is much change on the way, but none of this means companies need to shut up shop in the UK. The MAH can be an entity or a person so there must be careful consideration of which option to go for. While onerous in the first instance, carefully constructed export/import licences could help companies keep as much of their operations based in the UK as possible. And finally, the exit process and conditions negotiated have actually yet to complete, so who knows what the final package will really look like.
Sources:
· http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf
· http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_360_2017.pdf