The European Medicines Agency (EMA) has revised the number of centrally authorised medicines (CAP) with Brexit-related supply concerns from 108 to 39 (25 human medicines and 14 veterinary medicines).
A survey undertaken in July 2018 showed that of the 694 CAPs with an important step of their regulatory process in the UK, 58% were on track to safeguard their marketing authorisations once the UK leaves the EU.
The official date for the UK’s withdrawal from the EU is set for 29 March 2019, and companies must ensure that in order to continue marketing a medicine within the EU, the marketing authorisation holder, the qualified person for pharmacovigilance (QPPV), the pharmacovigilance system master file (PSMF) and certain manufacturing sites are based in the European Economic Area (EEA) before then.
Companies are reminded to regularly check the EMA’s webpage that highlights the consequences of the UK’s departure from the EU, as well as the Brexit-related guidance question and answers. They are also reminded that they have a legal obligation to inform the EMA if they anticipate any product supply issues.