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The European Medicines Agency (EMA) is surveying pharmaceutical companies on their preparedness for Brexit, in order to identify issues that could disrupt medicines supply and impact on human and animal health when the UK exits the European Union (EU).
The survey is targeted at marketing authorisation holders of centrally authorised human and veterinary medicines that are located in the UK, or who have an important part of their site operations in the country. It asks about their plans for submitting transfers, notifications or variations to their marketing authorisations after Brexit.
The EMA said information gathered in the survey will help identify companies with a need for concerted action to address medicines supply concerns, and help the EMA and the European Commission ensure they direct adequate resources to the areas where submissions will be made. Information from the survey will also be used to inform next steps in Brexit preparedness for the EMA, the European Commission and the European medicines regulatory network.
The EMA also hopes that the survey will prompt pharmaceutical companies to prepare for the regulatory steps required for their centrally authorised products to remain on the EU market after Brexit, in order to minimise disruption to medicines supply and avoid shortages.
The Brexit Health Alliance, which includes the NHS Confederation, NHS Providers, and the Academy of Medical Royal Colleges among its members, warned in January 2018 that the distribution of medicines could be disrupted if the UK and the EU reached ‘no deal’ over Brexit.
The deadline for return of completed questionnaires to the EMA is 9 February 2018.
