To help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU), the European Medicines Agency (EMA) has published additional guidance.
To allow for the continued marketing of their medicine in the European Economic Area (EEA) after the UK withdraws from the EU, companies are advised to follow the guidance in the document which outlines the practical and simplified requirements to apply for changes to their marketing authorisation. The guidance has been written on the assumption that the UK will be a third country as of 30th March 2019, thus companies need to make sure the necessary changes are made by that date.
Before the UK leaves the EU, marketing authorisation holders, applicants and sponsors of centrally authorised medicines for human or veterinary use should be aware of how Brexit will impact their medicines and the changes they need to address.
For example, as many people know, Marketing Authorisation Holders (MAHs) established in the UK will need to be replaced with a MAH established in one of the remaining countries of the EEA. This calls for careful management of post-licensing activities to ensure progression of an application for a transfer of a marketing authorisation, whilst continuing to effect other necessary changes submissions such as variations and labelling changes. Whilst there is no information on a possible transitional period, we advise that companies should prepare for the worst whilst hoping for the best!
Further required changes relate to pharmacovigilance activities. It is already known that a company’s Qualified Person for Pharmacovigilance (QPPV) must reside and carry out their tasks in an EEA member state. The guidance states that the pharmacovigilance master file (PSMF) must also be located within the EEA. So, once Brexit occurs, the QPPC and PSMF must be located in the EEA.
This additional guidance complements the joint European Commission and EMA Q&A, providing greater procedural and practical guidance regarding submission of changes and related fees. For example, the guidance outlines submitting Type II variations separately for a new manufacturing site for the active substance and for the finished product and their respective consequential changes. The guidance contains further information on how to handle planned or ongoing regulatory procedures during the transfer of a marketing authorisation. The EMA guidance also contains greater detail about the application for transfer of a marketing authorisation from the current UK-based MAH to a different legal entity established in the EEA.
Further Brexit-related guidance from the EMA is being prepared and this advice will be published on the agency’s website in the near future. The EMA has advised companies to regularly check EMA’s webpage that is devoted to the consequences of Brexit. We will continue to do this and publish information on our website in addition to advising our clients.
To read the additional guidance from the EMA on preparing for Brexit, please click here.
If you have any questions regarding Brexit or would like to discuss how to manage the required activities in your company, please contact us by clicking here.