Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
Following implementation of the Northern Ireland Protocol, decisions taken by the European Commission (EC) on the approval of new Marketing Authorisations (MA) in the centralised procedure will continue to be applicable to Northern Ireland.
From 1 January 2021, UK acting for Northern Ireland will have limited access to systems and databases operated by the European Medicines Agency (EMA).
This means that the MHRA will no longer have access to the Common Repository of data supporting marketing authorisation applications. As a result of this there are some practical changes that applicants need to be aware of.
Marketing Authorisations granted before 31 December 2020
For existing MAs that were approved via the centralised procedure before 31 December 2020 but not converted into a PLGB licence (grandfathering process), Marketing Authorisation Holders (MAH) should submit a baseline sequence to the UK(NI) (the UK in respect of Northern Ireland) through MHRA Submissions.
This submission to the MHRA should be made in parallel with the next regulatory action submitted to EMA or by 1 January 2022. Subsequent lifecycle changes e.g. variation, Article 61(3) and renewal applications should also be submitted to the MHRA.
Further detailed guidance on how to submit the baseline will be issued in due course.
Marketing Authorisation Applications submitted or ongoing from 1 January 2021
The applicant should inform the MHRA of the procedural timetable issued by the EMA via the CentralisedMHRA@mhra.gov.uk at the earliest opportunity.
In parallel with the EMA submission, applicants should submit the complete dossier directly to the UK(NI) as one electronic Common Technical Document sequence through MHRA Submissions. Updated response sequences should also be submitted at relevant timepoints throughout the procedure.
In addition, all iterations of the CHMP assessment reports should be submitted directly to the UK(NI) as soon as possible following receipt from EMA at the various procedural timepoints.
If the Applicant intends to apply for an MA in Great Britain via the EC Decision Reliance Procedure they should inform the MHRA at the earliest opportunity by emailing ECDRP@mhra.gov.uk.