Medicines Healthcare Products Regulatory Agency
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1. Overview
This guidance provides information on how to renew marketing authorisations (MA) for products granted through different routes in the UK following the agreement of the Windsor Framework arrangements for human medicines. It also includes guidance for 5-year renewal of full authorisation and the annual renewal of a conditional marketing authorisation (CMA).
The?Medicines and Healthcare products Regulatory Agency (MHRA)?acts as the regulator for products placed on the market in Northern Ireland (NI). 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.
New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework. From that date all medicines licensed in the UK will be authorised by the MHRA under the Human Medicines Regulations 2012.
Products that fall under the EUs centralised procedure that were previously automatically granted by the EU in NI (as a centrally authorised product (CAP)) will no longer be authorised in this manner. Instead, these products will be authorised UK-wide under national UK requirements by the MHRA.These products will be known as category 1 products under UK law. Products which do not fall under this category will be known as category 2.
2. Renewal of a marketing authorisation
An MA will be valid for 5 years from the date of authorisation and market authorisation holders (MAH) should continue to submit renewal applications 9 months before expiry, unless the application is being submitted via the International Recognition Procedure (IRP).For advice on this procedure please see below, together with further guidance on International Recognition Procedure.
Once an application has been submitted for renewal, the authorisation will remain in force until the MAH isinformed of the decision on the application.
The authorisation may be renewed for an unlimited period or, where there are pharmacovigilance grounds which require it, for a period of 5 years, after which one further renewal application may be made.
The requirements for the content renewal submissions to the MHRA for products authorised in the UK will remain aligned with current EU submission requirements, dependent on the route of authorisation, as detailed below.
2.1 Renewal of MAs for category 1 products
Renewal applications for category 1 products should be submitted to the MHRA but continue to include the elements currently set out in the EU guidance for renewals in the EU centralised procedure.
This also applies to renewal applications submitted via the IRP (see below).
2.2 Renewal of MAs for category 2 products
2.2.1 Applications submitted via the mutual recognition and decentralised procedure (MRDCP)
Renewal applications for category 2 products which are within the MRDCP with Northern Ireland as a concerned member state (CMS) should continue to be submitted in line with the requirements for renewals for products authorised through?MRP?or?DCP?procedures.
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:
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confirmation that no new data is 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)
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a declaration that full documentation is available for submission on request
No changes to the?MA?particulars can be made in the standard renewal procedure.
The default position to maintain a UK wide marketing authorisation aligned with the MR procedure and UK in respect of Northern Ireland (UK(NI)) as a CMS will be retained unless there are UK-specific requirements which are not aligned with the MR position. In this case MAHs will be required to withdraw NI from the procedure and the existing UK-wide MA will then be managed as a standalone national UK authorisation.
2.2.2 Applications for standalone UK-wide authorisations
Renewal applications for standalone national UK-wide authorisations for category 2 products should be submitted to the MHRA but including the elements required as part of renewal applications in the MRDCP.
The submission of a consolidated dossier is not expected and may be reduced to a cover letter from the MAH accompanied by an application form (without annexes).
The cover letter should include:
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confirmation that no new data is 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)
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a declaration that full documentation is available for submission on request
No changes to the?MA?particulars can be made in the standard renewal procedure. Any changes must be made via a variation procedure.
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.
3. Annual renewal of a conditional marketing authorisation
With the exception of applications submitted via IRP, MAHs should continue to submit renewal applications for conditional?MAs?6 months before they expire.
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.
Applications should include a cover letter accompanied by the same documents as currently required by the EU renewal annual re-assessment marketing authorisation.
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 the renewal of a conditional MA.