Medicines Healthcare Products Regulatory Agency
The MHRA acts as the regulator for products placed on the market in Northern Ireland. There are some different requirements for products placed on the market in the UK with respect to Great Britain (England, Scotland, Wales) and Northern Ireland.
Renewals for converted Centrally Authorised Products (CAPS)
CAPSconverted from EU to UKMAswill be treated as if they were granted on the date the corresponding EUMAwas granted. The renewal date will stay the same.
Please refer to Guidance on Converting Centrally Authorised Product (CAPS) to UKMAs.
YourMAsremain in force until a decision has been made on your renewal applications.
Renewals submitted forMAsgranted through mutual recognition (MR) or decentralised (DC) procedures
All holders of existing marketing authorisations (MAs), or applicants forMAswith applications submitted by 1 January 2021 and under review within a decentralised or mutual recognition procedure with UK as a CMS will have a choice on how to manage their marketing authorisations/applications.
Refer to the guidance on handling of decentralised and mutual recognition procedures.
The default position is to maintain a UK wide marketing authorisation and retain UK in respect of Northern Ireland (UK(NI) (UK in respect of Northern Ireland) as a CMS. In this case, the authorisation will continue to be a UK wideMAwith Northern Ireland as a CMS and Great Britain aligned with, but not part of, theDCP/MRP.
Where this applies any pending applications will be processed to conclusion after 1 January 2021 as MR/DC renewals using the relevant MR/DC procedures led by the RMS.
New applications for a renewal of theMAshould be submitted via theDCP/MRPand if approved would apply to the UK wide authorisation with Great Britain implementing the European decision unless theMHRAnotifies the MAH within 30 days of the RMS decision that the decision cannot be accepted in Great Britain.
In this case, a separateMAfor Great Britain would need to be issued. Other options include having separateMAsfor UK(NI) as CMS, and Great Britain. Renewal applications for Great BritainMAswill be processed via the purely national route.
If youve submitted renewals forMAsgranted through the DCP/MRPand do not get a decision before 1 January 2021, you will not need to resubmit them.
If a final decision has been made on your renewal but it hasnt been processed in the UK before 1 January 2021, theMHRAwill implement the agreed outcome.
Where a final decision has not been made, theMHRAwill ensure that the renewal process is concluded and processed by the appropriate route.
Renewals submitted from 1 January 2021
You should continue to submit your renewal applications 9 months before they expire.
The requirements for renewal submissions will remain the same for products authorised in the UK and should include the same documents currently required in the EU as detailed in the following guidance, dependent on the nature of the authorisation:
For purely national UK-wide authorisations, the requirements set out in the CMDh Best Practice Guide on processing renewals in theMRP/DCP should also be followed As the MAH has the obligation to keep the dossier up to date throughout the lifecycle of the medicinal product no submission of the consolidated dossier is expected. By default, the consolidated file may be reduced to a cover letter from the MAH accompanied by an application form (without annexes). The cover letter should include confirmation that no new data are available that changes, or would result in a re-evaluation of, the benefit/risk balance and that the product information is up to date with current scientific knowledge (or otherwise a commitment to update the product information by the appropriate variation within 3-months of the finalisation of the renewal), and a declaration that full documentation is available for submission on request. Within the standard renewal procedure, no changes to the MA particulars can be made.
Renewals for Great-Britain-only MAs which fall within the scope of the centralised procedure should follow the submission requirements set out in CAP renewals and annual reassessments.
Fees apply for the first 5-year renewal of aMAwhich was granted for a new active substance. Where this applies it should be clearly stated in the cover letter. Details on fees are included below.
Annual renewal of Conditional Marketing Authorisations
You should continue to submit your renewal applications for conditionalMAs6 months before they expire.
See guidance on convertingCAPSto UKMAs for advice on converted EUMAswhich were granted as conditionalMAs.
For Great BritainMAsyour application should be submitted to theMHRA, who will consider the application in accordance with new regulation 66B of the Human Medicines Regulations 2012. There is no application form for a renewal of a conditionalMAand the application form for a 5-year renewal of anMAis not applicable. Your application should include a cover letter accompanied by the same documents as currently required by the EU. The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.
There are no fees for conditional renewals.
Recognition route
Where an identical renewal application (for either aMAor a conditionalMA) has been submitted for the corresponding centralised product the renewal application can be submitted for the Great Britain-MA.
Where this route is used it must be clearly indicated in the cover-letter and evidence of acceptance provided (the CHMP opinion) together with a copy of the final assessment report and any updates e.g. track-change of any updated product information should be submitted.
For renewals relying on a EU decision, a copy of the Commission Decision must also be submitted . before the renewal can be concluded.
Where there have been changes to the Patient Information Leaflet (PIL) as part of the renewal, a full colour mock-up of the leaflet must be submitted where