Blog: Brexit Pharma Update – The EMA Survey
The results of The European Medicines Agency Brexit preparedness survey, released in July 2018, show that the majority of Marketing Authorisation Holders (MAH’s) are taking steps to make the necessary changes to their marketing authorisations.Institutions, both public and private, are preparing for a ‘no deal’ Brexit and the possibility that the UK will ‘crash out’ of the EU on March 30th 2019. Regardless of the UK’s mode of departure they will become a ‘third country’ on that date and, as such, the EU rules relating to medicines for human and veterinary use will no longer apply. As a result of that (and as we have pointed out in previous articles) companies will need to make a number of changes as:
a) The MAH must be in the EU
b) The QPPV must be in the EU
c) The PSMF must be in the EU
d) Certain manufacturing sites must be in the EU in order for a company to market their medicine in the EU.
The EMA Survey Findings
The EMA database indicated that 400 Centrally Authorised Products (CAP’s) have their MAH’s registered in the United Kingdom. In a particularly high response rate for any survey, 373 respondents informed the agency that they intended to transfer/had already made arrangements to transfer their MAH to another country within the specified deadline. Somewhat surprisingly, 6% of CAP holders did not respond to the survey regarding their Brexit preparedness. CAP transfers have been moving at a brisk pace in recent months. Nevertheless, there are still a large number of CAP’s to be transferred ahead of the March 30th 2019 departure from the EU. The EMA expects approximately 150 of the 400 transfers to take place between the start of Q3 2018 and the end of Q1 2019.
The findings from the veterinary sector show that of the 18 CAP’s for veterinary products that the majority of them had not decided at the time of completing the survey when a submission to change CAP would be made.
QPPV’s in the UK
As referenced previously on this website, the QPPV for CAP’s will need to reside in the EU. The EMA survey has indicated that many companies are making progress on this issue and that 84% of QPPV’s in the UK (282) were making plans to ensure continuity of service.
The EMA in Amsterdam
The changes listed above, and others, would present a significant challenge to the EMA at any time. The need for the EMA to relocate to Amsterdam has compounded the pressures placed upon the agency. We have looked at their move to Amsterdam here.
We will delve further into the EMA survey in a further blog article on this website.
Acorn Regulatory has worked closely with a large number of companies to ensure that they are prepared for Brexit. We have successfully transferred CAP’s for companies, taken on the role of EU QPPV and many other tasks that will be impacted by the UK’s decision to leave the EU. If you would like to have a conversation with us about any Brexit related issues that your company might have then please call us on 00353 52 61 76 706 or complete the form below and we will get back to you.