Yesterday, the European Medicines Agency (EMA) announced its plan to consult all marketing authorisation holders of centrally authorised products that are located in the UK or who have an important part of their site operations in the UK on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the withdrawal of the UK from the European Union.
The aim of the survey is to stimulate companies to start planning for the regulatory consequences of Brexit on their centrally authorised products as well as to enable the EMA and the European Commission to plan their own resources to process submissions.
The survey represents one step further by the EMA in the preparation for Brexit, which adds to the already numerous guidance documents that have been issued at EU level. Furthermore, the EMA prompted companies that further surveys may be carried out by the EU national competent authorities in relation to nationally authorised products.
Companies will receive the survey directly from the EMA, and have until 9 February 2018 to complete the questionnaire.