At the end of the transition period, MHRA will need to put in place arrangements for the continued authorisation of medicinal products. Transitional provisions in the Human Medicines (EU Exit) Regulations 2019 will ensure that all currently granted Centrally Authorised Products (CAPs) automatically become Great Britain MAs on exit day. The Medicines and Healthcare products Regulatory Agency (MHRA) will assign a Great Britain Product Licence (PLGB) number to CAPs based on the existing practice for national licences.
Advise the MHRA of any product/presentations that have been withdrawn or cancelled. If possible, provide them with a single point of contact for all your products.
If an MAH chooses to opt-out, after 21 January 2021 their product(s) will no longer be licensed in the Great Britain. For the purposes of operating the Sunset Clause, the period of three (3) years will be restarted from the date of conversion to a Great Britain MA. There is no fee associated with the conversion from a CAP to a Great Britain MA.
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK's stand-alone medicines and medical devices regulator.
The format of the UK MA valid only in Great Britain will be PLGB XXXXX/YYYY. There is no fee associated with the conversion from a CAP to a Great Britain MA.
An annual service fee will be due for converted EU MAs from 1 April 2021 unless the MAH opts out by the required date. The MAH must submit the following information to the MHRA for each converted EU MA.
All historical Regulatory activity from the grant date of the original CAP until the data is submitted. This will include, type of submission (such as initial new Marketing Authorisation Applications (MAA), Variation, Periodic Safety Update Report (PSUR), Renewal). If it is not, the MAH must tell us whether the product has been on the Great Britain market at any time after 1 January 2021.
The submission must reflect only what is relevant to the product intended for Great Britain so that this can be used as the start of the lifecycle for the nationally registered product(s), The eCTD sequence must pass technical validation (sections 4 and 5 below).
The MHRA will apply an abbreviated content validation and will not issue a validation report. The presence of an SmPC, PIL and packing information are mandatory. The MHRA has developed a new national portal to be ready by 1 January 2021 and expect that submissions will be made via this portal. Information on the use of this portal will be published in advance of 1 January 2021.
The date, on which the minimal or full initiating sequence is received, is referred to as "the data submission date". The MAH should construct a single, technically valid, eCTD sequence showing the current, approved information of the converted EU MA(s).
The submission must include a full eAF for each of the products in the application. The "Initial MAA" eAF should be used with the initiating sequence and only approved information should be included. The summary of historical Regulatory activity must begin with the original CAP MAA submission and continue up to the data submission date.
The MHRA strongly prefers MAHs submit the initiating sequence as a single event. If MAHs take this approach, a further complete initiating sequence must still be submitted within a period of one (1) year starting on 1 January 2021.
MHRA will not consider variations to converted EU MAs before at least a minimal initiating sequence and related documentation has been submitted. In exceptional circumstances, we may consider a variation before the data submission date if, in our view, the following circumstances apply.
MHRA has adopted a pragmatic approach to variations submitted to the EMA but not granted before 1 January 2021. For minor variations of Type IA and Type 1B, these may be implemented in relation to the converted EU MA at the same time as they are implemented in relation to the corresponding EU MA. For major variations of type II, if the variation had reached positive Committee for Medicinal products for Human Use (CHMP) opinion stage before 1 January 2021, the variation must be included within the initiating sequence submission.
The appropriate fee will apply for these variations and the variation will be reviewed by the MHRA. The variation will only be considered after the initiating sequence is processed.
This advice applies where the holder of a converted EU MA has notified the EMA of, or applied to the EMA for, a variation of the EU MA from 1 January 2021 but before the data submission date. Type IA Variations For minor variations of Type IA these may be implemented in relation to the converted EU MA at the same time as they are implemented in relation to the corresponding EU MA. Type IB and Type II Variations For minor variations of type IB, and major variations of type II, if the variation has not been rejected by the EMA before the data submission date, a copy of the variation application must be included.
The table at the bottom of this page provides a summary of the approach to variations that the MHRA will take in different scenarios which may arise. For the purpose of renewals, converted EU MAs are treated as if they were granted on the date on which the corresponding EU MA was granted. The converted EU MA will therefore have the same renewal date in the UK as in the EU.
This section applies where the holder of a converted EU MA has made an application to the EMA for a renewal of the EU MA before 1 January 2021. No final decision was made by the EMA before 1 January 2021. A copy of the renewal application must be included in the data submission package as a separate eCTD sequence.
Before 1 January 2021, the CHMP had not given a positive final opinion or had given a negative final opinion or had given a positive final opinion but the UK recorded a divergent opinion. The MA will remain in force until the MHRA notifies the MAH of its decision on the renewal application.
The MHRA will consider the application in accordance with new regulation 66B. No fee is due. The MA will remain in force until the MHRA notifies the MAH of its decision on the renewal application.
MHRA will not consider Article 61(3) notifications for converted EU MAs before at least a minimal initiating sequence. In exceptional circumstances, we may consider an Article 61(3) notification before the data submission date.
The holder of a converted EU MA must notify the MHRA if the EMA rejects the notification from 1 January 2021, but before the data submission date. For grandfathered CAP MAs with a non-UK MAH, there is a requirement to establish an MAH in the UK within 24 months of 1 January 2021.
MAHs using option 2 must ask for PL numbers to be issued for the UK MAH by requesting them from email@example.com. The initiating sequence must contain the current granted EU patient information. Mock-ups of the UK patient information should be included or text-only versions.