The UK’s decision to leave the EU will cause considerable upheaval for holders of marketing authorisations. As the recognised Brexit experts in the regulatory affairs sector we have some advice and a number of articles to help companies that are now seeking further information about moving a marketing authorisation as a result of Brexit
Since the result of the election was announced in June of 2016 we have been working closely with a large number of companies to ensure that they will be able to trade with no disruption to their business when the UK leaves the European Union. Moving a marketing authorisation for a company takes time and expert advice and we are able to help.
The recent EMA notice regarding the issue of marketing authorisations stated:
Preparing for the withdrawal is therefore not just a matter for European and national administrations, but also for private parties. 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.
Marketing authorisation holders 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, the Commission and the European Medicines Agency expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.
Here are some handpicked articles from our website that we hope will help you when considering moving a marketing authorisation.