Brexit: The Implications on Existing Marketing Authorisations
In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations.
London, as host city to the European Medicines Agency (EMA), with a full-time staff of more than 600, is the largest EU body in Britain and has overseen pan-European drug approvals since 1995 from its headquarters tucked away among global banks in London’s Canary Wharf. The centralised procedure is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance, which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes.
‘Brexit’ is likely to see the EMA faced with relocating to another European Union Member State (EU MS). Sweden, Denmark, Italy and Germany have all expressed interest in hosting the EMA instead of London, since firms in these countries are keen to be located close to the region’s key regulator. The UK has acted as Rapporteur or Co-Rapporteur for significant number of centralised procedures over the years. What effect will the relocation of the EMA to another EU MS have on such medicinal products?
The UK’s National Competent Authority; Medicines and Healthcare Regulatory Products Agency (MHRA) has dominated the last two decades as the Reference Member State (RMS) of choice for large numbers of European marketing authorisation applications such as the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). It is anticipated that these MA’s faced with a ‘decoupling process’ whereby they will need to select an alternative RMS to act on their behalf.
We can support you with this ‘decoupling process’ and ensure the product lifecycle remains unaffected in all territories. We will be monitoring the various options available and keep you informed every step of the way.
Significantly, however, is the intrinsic link between the UK and Irish medicinal products supply chain. Many medicinal products in Ireland are registered under the Dual Pack import Registration (DPR) scheme and parallel product authorisation (PPA). Such products are typically imported from cheaper markets such as the UK and bear either a DPR number or PPA number on their packs. Additionally, some MA’s bear both a Product Authorisation (PA) number and also a Product Licence (PL) number whereby the package leaflet and the labelling has been assessed in parallel by both the MHRA & the HPRA and the use of a common pack for both markets has been agreed. Once Article 50 (the mechanics for withdrawal from the EU) is triggered, are we likely to see withdrawal of these products from the Irish market?
We will negotiate on your behalf with the Competent Authorities involved and ensure the best possible outcome at all times. If you would like to speak to us about your Brexit related regulatory issues, then call us today. We are the Brexit experts. Call us on 00553 52 61 76 706.
Download our first Brexit whitepaper right here:
How will clinical trials be impacted by the UK’s decision to leave the European Union?
The currently expected Brexit day of October 31st 2019 is approaching and with a no-deal or cliff edge Brexit a very real possibility, there are several key areas for medical device companies to consider in terms of impact to their business in the event of a no-deal Brexit scenario. We wish to highlight here two areas for consideration for the medical devices sector:
- Non-European medical device manufacturers that currently use a UK based Authorised Representative
- Medical device manufacturers who rely on the services of a UK based Notified Body for their certification