In Europe, the centralised procedure allows a Marketing Authorisation Holder (MAH) to market a medicine across all EU Member States including Iceland, Liechtenstein and Norway on the basis of a single marketing authorisation application to the European Medicines Agency (EMA). Today, the great majority of new, innovative medicines pass through this procedure; ATMPs must be authorised in this way.
During the procedure, a rapporteur and a co-rappoteur from the National Competent Authority (NCA) (i.ethe MHRA for the United Kingdom) are appointed to coordinate the scientific assessment within the scope of the relevant committee.
Following the UK’s withdrawal from the European Union, the MHRA will no longer be able to engage in centralised procedure”.Consquently, the UK’s centrally authorised product (CAP) portfolio (over 370 procedures) will be transferred to new rapporteurs and co-rapporteurs from the EU27 Member States(MS) plus Iceland and Norway.
The redistribution of the UK CAP portfolio comprises UK rapporteurs and co-rapporteurs from Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Advanced Therapies (CAT).
According to the EMA, the methodology for the reallocation of medicines takes into account “both the diverse expertise in the European medicines regulatory network and the workload associated with each medicine”. This methodology is intended to allow Member States to participate in EMA activities according to their individual capacity and be easy to implement.
The new (co)-rapporteurships will be communicated to the relevant MAH before the end of April and are expected to take responsibility for the re-allocated products after 30 March 2019.
Sourced from Catapult