Brexit: EMA appoints new rapporteurs for centralized authorizations

In view of the upcoming Brexit, the European Medicines Agency (EMA) has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. The changes will come into effect upon the withdrawal of the United Kingdom from the European Union, i.e. presumably on 30 March, 2019 ("when the UK withdraws from the European Union and becomes a third country"). The appointment of new rapporteurs affects the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT). According to EMA, the holders of the authorizations concerned are to be informed of this by the end of April 2018.

The redistribution plan includes the post-authorization phase in the lifecycle of a medicinal product, i.e. after its authorization. For redistribution, the individual expertise of regulatory authorities within the European network as well as their capacities will be considered. If possible, medicinal products with the same active ingredient and/or several authorizations of the same marketing authorization holder (MAH) will be assigned to the same rapporteur. Additionally, the redistribution method considers the type of medicinal products.

Generic drugs, for example, will be assigned to the national authorities of "newer" member states, who haven't been involved much in EMA evaluations in the past but wish for more inclusion. For authorizations based on a full application and biosimilars, the past co-rapporteur will now become the new rapporteur, up to a limit of ten medicinal products per national authority. If the United Kingdom had been co-rapporteur in the CHMP for the authorization procedure, this function will be transferred to the peer reviewer (up to fifteen authorizations per national authority).

In PRAC (pharmacovigilance/drug safety): in case of generic authorizations, the UK rapporteurship will automatically be transferred to the rapporteur of the reference product. For all other medicinal products, the redistribution will take place based on possible bundling with other products containing the same active substance, PRAC expertise and the workload in connection with the work as a PRAC rapporteur. Each national authority will be assigned five medicinal products at most as a PRAC rapporteur. The procedure for redistributing the UK PRAC rapporteurships is also supposed to facilitate the review of Periodic Safety Update Report Single Assessments (PSUSAs).

Further information on EMA's procedure for appointing new rapporteurs for centralized authorizations can be found in the article "Redistribution of the UK´s portfolio of centrally authorized products".

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