The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union. This follows an earlier notice issued by the EMA and the European Commission ("EC") calling for marketing authorization holders to prepare in advance and proactively screen authorizations they hold and to apply to make any necessary changes in good time.
The guidance confirms that UK-based pharmaceutical companies will be required to transfer their marketing authorizations and orphan designations for their medicines to entities established in the EEA when Brexit takes effect. They also must ensure that the qualified person for pharmacovigilance activities as well as the pharmacovigilance system master file are located within the EEA. In addition, there is guidance regarding relocation of manufacturing sites, batch control, and batch release sites. A similar set of guidance has been issued by the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which is responsible for coordinating nationally authorized medicines between two or more EU Member States.
Marketing authorization holders should carefully review the guidance and consider how this affects their product portfolio. The administrative processes involved may require significant resources and are likely to be time-consuming, so it is recommended that companies start the planning process immediately. The EMA has set up a dedicated website with additional guidance for companies, which will be updated as further information becomes available.