The European Medicines Agency (EMA) and the European Commission are currently providing guidance to help pharmaceutical companies responsible for medicines to be prepared for the UK withdrawal from the EUwhich will become a third country as of 30 March 2019. The objective is to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines for the benefit of patients.
The European Medicines Agency (EMA) consulted by the beginning of 2018 marketing authorisation holders of centrally authorised medicines that are located in UKor who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilanceor pharmacovigilance system master file in the UK, to achive the following objetives:
- to identify those companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health,
- to help the Agency and the European Commission plan resources in the areas where these submissions will be processed, and
- to stimulate those companies who have not yet taken any action to start planning for any regulatory steps required for their centrally authorised productsto remain on the EU market post-Brexit in order to minimise disruption to medicines supply and avoid shortages.
Findings and recommendations from this survey will be shared with the European Commission and presented to EMA’s Management Board. A high-level summary of the overall results of the survey will be published on the EMA website.
In addition, further surveys may be carried out by the EU national competent authorities in relation to nationally authorised products.