BRUSSELS, May 3 (APM) - Pharma companies operating in the UK need to start planning now for life post Brexit if they want to maintain the validity of their EU marketing authorisations, European authorities warned on Tuesday.
A formal notice from the European Medicines Agency and the European Commission reminds marketing authorisation holders of centrally authorised medicines "of certain legal repercussions, which need to be considered."
Principally, the notice points out that EU law requires that marketing authorisation holders are established in one of the EU member states or one of the three EEA countries, Norway, Iceland or Liechtenstein.
In addition, activities including pharmacovigilance and batch release must be carried in one of those countries.
That puts the ball right into the court of drug firms operating in the UK and wanting to continue operating in the EU.
From the time of the UK withdrawal from the EU - currently expected to be March 30, 2019 - "all Union primary and secondary law ceases to apply to the United Kingdom", which will then become what the EU terminology brands a 'third country'.
'Third countries' include everything from Russia to Burkina Faso - and companies functioning there have no rights to market their products in the EU.
"Preparing for the withdrawal is therefore not just a matter for European and national administrations, but also for private parties," continues the notice.
Marketing authorisation holders "may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union."
Companies "will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union."
In particular, companies should already start to "prepare and proactively screen authorisations they hold for the need for any changes."
Any transfers or variation requests on authorisations "will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework."
The Commission and the EMA say in the notice that they "stand ready to support marketing authorisation holders."
They are currently preparing additional background documentation and a series of Q&As.
A dedicated page of the EMA website already contains general information relating to the outcome of the UK referendum, and this page will be updated and expanded as from this month.
Products that have been authorised in decentralised or mutual recognition procedures will also need attention and further information will be provided through the websites of the relevant groupings of national medicines agencies.
pod\nh
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
