As the end of the Brexit transition period draws closer, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided welcome clarification for the industry as to how it will deal with pending variations to converted EU marketing authorizations starting January 1, 2021.
A summary of the MHRA’s approach to variations to converted EU marketing authorizations, that are pending as at January 1 is included in the MHRA’s
guidance titled “Converting Centrally Authorized Products (CAPs) to UK Marketing Authorizations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes.”
Background
Starting January 1, 2021, all existing CAP MAs will be automatically converted into UK MAs effective in Great Britain (only); these UK MAs are referred to as “converted EU MAs.” Marketing authorization holders can opt out of this conversion process for all or some of their CAPs by notifying the MHRA in writing by the end of January 21, 2021.
The approach that the MHRA will adopt for pending variations to converted EU MAs depends on two main factors: (i) the type of variation and (ii) the stage that the application has reached as at January 1, 2021.
Variations of Type IA and Type IB
Minor variations to the converted EU MA of Type IA and Type IB may be implemented at the same time they are implemented in relation to the corresponding EU MA. The initiating sequences submission must include the variation as if it had already been accepted in Great Britain. The details of the variations must be listed in the summary of historical regulatory activity accompanying the initiating sequence. Within 30 days from the “data submission date” (date on which the minimal or full initiating sequence is received), the MHRA will notify the marketing authorization holder if the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification. No fee will apply for these variations. If the variation was rejected or refused by the European Medicines Agency (EMA) before the data submission date the marketing authorization holder must notify the MHRA, and the variation must be removed from the initiating sequence.
Variations of Type II
For major variations to the converted EU MA of Type II, the approach the MHRA will adopt depends on whether the variation had reached the positive Committee for Medicinal Products for Human Use (CHMP) opinion stage before January 1, 2021. If the variation had reached this stage, the MHRA will adopt the same approach that it will take in relation to minor variations of Type IA and Type IB set out above. If the variation had not reached CHMP opinion, the approach that the MHRA will adopt depends on whether the variation at January 1, 2021, was (i) in clock-stop following a request for further information or (ii) procedure clock-on, after first clock-off or (iii) before procedure first clock-stop. For a variation at all of these stages, a copy of the variation application must be included in the data submission package as a separate electronic Common Technical Document sequence, and the variation will be considered only after the initiating sequence is processed. For a Type II variation that was in clock-stop at January 1, 2021, following a request for further information, the MHRA will assess the replies when submitted. For a Type II variation that was before clock-stop at January 1, 2021, the MHRA will assess the variation. If the marketing authorization holder wishes the variation to be put on hold pending finalization by the EMA, this should be clearly indicated in the cover letter of each relevant variation, either at the time of initial submission or, where relevant, the time of submission of the responses to the MHRA. No fee will apply for major variations of Type II, with the exception of a Type II variation that had not reached CHMP opinion and was before clock-stop, for which the
appropriate fee will apply.
