Guidance on Handling Of Applications for Centrally Authorised Products (CAPs) Pending on 1 January 2021

This guidance sets out how the MHRA, acting for Great Britain, will handle centralised applications that are still pending on 1 January 2021. The handling will be determined by the Regulatory route chosen by the company. Applicants will need to submit an application and supporting dossier to the MHRA accompanied by all iterations of the CHMP assessment report.

This will be done in line with the CHMP opinion, unless the UK recorded a divergent decision. In other cases, MHRA will need to undertake a review.

The applicant makes an application relying on the CHMP positive opinion and the marketing authorisation approval decision issued by the European Commission.  Applications should be submitted following a receipt of the CHMP opinion and will be determined following confirmation of notification of the EC decision. In these cases, if the applicant intends to pursue the application in Great Britain the application will need to be submitted for independent assessment according to assessment routes.

Source: MHRA guideline on Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021