Renewing Marketing Authorisations for medicines
How to renew marketing authorisations for products granted through different routes and at different times.
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)
CAPS converted from EU to UK MAs will be treated as if they were granted on the date the corresponding EU MA was granted. The renewal date will stay the same.
Please refer to Guidance on Converting Centrally Authorised Product (CAPS) to UK MAs.
Your MAs remain in force until a decision has been made on your renewal applications.
Renewals submitted for MAs granted through mutual recognition (MR) or decentralised (DC) procedures
All holders of existing marketing authorisations (MAs), or applicants for MAs with 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 wide MA with Northern Ireland as a CMS and Great Britain aligned with, but not part of, the DCP/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 the MA should be submitted via the DCP/MRP and if approved would apply to the UK wide authorisation with Great Britain implementing the European decision unless the MHRA notifies the MAH within 30 days of the RMS decision that the decision cannot be accepted in Great Britain.
In this case, a separate MA for Great Britain would need to be issued. Other options include having separate MAs for UK(NI) as CMS, and Great Britain. Renewal applications for Great Britain MAs will be processed via the purely national route.
If you’ve submitted renewals for MAs granted through the DCP/MRP and 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 hasn’t been processed in the UK before 1 January 2021, the MHRA will implement the agreed outcome.
Where a final decision has not been made, the MHRA will 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:
- CAP renewals and annual reassessments
- Renewals for products authorised through MRP or DCP procedures
For purely national UK-wide authorisations, the requirements set out in the CMDh Best Practice Guide on processing renewals in the MRP/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 a MA which 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 conditional MAs 6 months before they expire.
See guidance on converting CAPS to UK MAs for advice on converted EU MAs which were granted as conditional MAs.
For Great Britain MAs your application should be submitted to the MHRA, 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 conditional MA and the application form for a 5-year renewal of an MA is 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 a MA or a conditional MA) 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 the product is marketed.
Where the application is for a first 5-year renewal of a MA which was granted for a new active substance, a reduced fee of £747 applies for the recognition route.
Renewals for MAs granted via unfettered access
Where you have a Great Britain-only MA granted via the Unfettered Access route, an application to renew the MA should be submitted in line with the above guidance. Where the MA has remained in line with the EU or Northern Ireland MA we will accept the same renewal application as submitted to the EU and a reduced fee will be applied.
Changes to fees
The new fees will be:
- £9,682 for the first renewal of a product containing a new active ingredient at the time of authorisation
- £747 for related applications made at the same time as the first renewal
- A reduced fee (£747) will apply where the MA was granted via automatic recognition, unfettered access and applications submitted according to the recognition route.
There will be no fees for:
- Renewal applications for MAs which were not granted as new active substance
- subsequent MA renewal applications
- renewing conditional MAs
Contact
For further information, please email our Customer Services Centre at [email protected]. Alternatively, contact your Trade Association by emailing:
- Association of the British Pharmaceutical Industry (ABPI): [email protected]
- British Generic Manufacturers Association (BGMA): [email protected]
- BioIndustry Association (BIA): [email protected]
- Clinical & Contract Research Association (CCRA): [email protected]
- Ethical Medicines Industry Group (EMIG): [email protected]
- Health Food Manufacturers’ Association (HFMA): [email protected]
- The National Pharmacy Association (NPA): [email protected]
Proprietary Association of Great Britain (PAGB): [email protected]
Updates to this page
Published 31 December 2020Last updated 28 July 2023 + show all updates
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Updated guidance on renewal applications to reflect changes to the submission requirements for products within the MR/DCP.
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‘The renewals guidance has been updated to provide advice for applicants on the use of the reliance/recognition procedure for both renewals of marketing authorisations and annual renewals of conditional marketing authorisations.’
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First published.