On 31 May 2017, the European Medicines Agency (EMA) and the European Commission (EC) published the first in a series of Q&As to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union. This guidance follows the EC/EMA Notice to marketing authorisation (MA) holders to begin preparations for Brexit that was published on 2 May 2017, and relates to both human and veterinary medicines within the framework of the centralised procedure.
Jointly drafted by the EC and the EMA, this first Q&A focuses on issues related to establishment requirements within the Union (EEA) for pharmaceutical companies. It specifically provides guidance on:
- The location of MA and orphan designation (OD) holders: MA holders for centrally authorised medicinal products and OD holders for designated orphan medicinal products established in the UK will need to transfer their MA or OD to a holder established in the EEA. OD holders may also change their place of establishment to an EEA Member State and submit the relevant documentation through a change of name and/or address of the OD holder procedure, provided that the legal entity remains the same.
- The location of the Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF): QPPVs residing in the UK will need to change their place of residence and carry out their tasks in the EEA or a new QPPV residing and carrying out his/her tasks in the EEA will need to be appointed. The same reasoning applies to the PSMF: the MA holder will need to change the location of the PSMF to an EEA Member State. For medicinal products for human use (as opposed to veterinary medicines), changes relating to both the QPPV and PSMF do not necessitate a variation but may be updated through the Article 57 database.
- Manufacturing, batch control and batch release: for medicinal products manufactured in the UK, MA holders will need to specify an authorised importer established in the EEA, and change the location of their current UK-based batch control and batch release sites to a location established in the EEA. For these changes, the corresponding variations must be submitted. Finally, the qualified person of the manufacturing and importation authorisation holder is responsible to certify that each batch of medicinal product intended to be placed on the EEA market was manufactured in accordance with EU good manufacturing practice requirements and the MA.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) prepared a similar guidance with respect to national authorised medicinal products for human use.
Further guidance documents are expected to be released as part of the Q&As series, and we will report on these in due course.