Late last month, the European Medicines Agency (EMA) released a survey to help assess pharmaceutical companies’ preparedness for Brexit. The purpose of this assessment is to identify and address any issues that could potentially disrupt medicines access, or negatively affect human and animal health, following the UKs departure from the European Union (EU).
The survey was sent to all companies in the UK which have marketing authorization of centrally authorized products. This includes companies located in the UK, as well as foreign companies which have an important part of their site operations in the country. The survey questions were designed to gather information on these companies’ plans for submitting transfers, notifications or variations of their marketing authorization following Brexit.
The results of this survey will be used to:
- Identify those companies requiring assistance to address medicines supply issues/concerns
- Help the EMA and European Commission ensure that adequate resources are directed to the areas where submissions of transfers, notifications or variations of marketing authorizations will be made
- Prompt pharmaceutical companies to begin preparing for the regulatory steps that must be followed to allow their centrally authorized products to remain on the EU market post-Brexit
The deadline for completion of the survey was 9 February, 2018. The findings will now be reviewed by the EMA and European Commission and presented to the EMA’s Management Board. The Management Board is the EMA’s governance body responsible for budgetary and planning matters, as well as monitoring the Agency’s performance. Following this, a high-level summary of the survey questions and results will be published on the EMA’s website.
The UK is set to leave the EU in March of 2019. Already there are serious concerns that Brexit will lead to a disruption in medicines access for UK and EU patients alike. To find out more, check out WEP Clinical’s earlier blog article.