In January 2018, the European Medicines Agency (EMA) ran a survey (summarised here) to learn about the companies’ plans ahead of Brexit. In its clarification letter from 28 August, addressed to a number of stakeholders, including EUCOPE, the EMA noted that a total of 108 centrally authorised products (CAPs) still only have the UK-based manufacturing sites without any other alternatives. All these medicines are “considered to be at risk of supply disruption or shortages in the EU, if changes [to the quality control, batch release and/or import manufacturing sites, marketing authorisation holders (MAHs)] are not submitted and implemented by the MAHs in due time”.
As a reminder to pharma companies, the above-mentioned and other changes have to be in place before the deadline of 30 March 2019 approaches. To find out more about the steps your business should be taking to ensure continuous supply of medicines between the UK and the EU, and for useful Brexit presentation templates, please visit our Brexit section.