Update on The Redistribution of UK’s portfolio of centrally authorised products
In preparation for Brexit, the 27 EU Member States, together with the European Medicines Agency (EMA), have reached a major milestone in the EMA Transition Plan. The EMA has confirmed the reallocation of rapporteurs for the centrally authorised medicinal products that the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) currently have responsibility for. Rapporteurs and co-rapporteur are appointed by the EMA scientific committees to coordinate the evaluation of a medicine.
In this way, over 370 centrally authorised products have been transferred to new rapporteurs and co-rapporteurs from the 27 EU Member States, plus Iceland and Norway, following a methodology developed by EMA’s working groups on committees’ operational preparedness for human and veterinary medicines.
The new (co)-rapporteurships will be communicated to the relevant Marketing Authorisation Holders (MAHs) before the end of April, but they will only take full responsibility for the re-allocated products as of 30 March 2019, when the UK withdraws from the European Union and becomes a third country. Further information on the methodology can be found on the EMA website.
During the transition period, it has been agreed that the UK shall continue to function as the rapporteur/co-rapporteur, while the nominated agencies are tasked with shadowing until the transition is formalized. This announcement marks a significant step in the overall Transition Plan of UK’s responsibilities within the EMA.
Peter Embley, PGDPRA, MTOPRA
Peter brings over 19 years applied industrial and commercial biopharmaceutical experience to his role, including seventeen years in Regulatory Science; working within the Generic, R&D and CRO industries. Peter has a strong grounding in EU legislation and filing strategies and has developed both regional and global strategic perspectives coupled with commercial acumen and experience working with multicultural project teams.