Last updated: 16 April 2025
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This post is an attempt to present in a tabular format, information on the the currently available UK marketing authorisation routes for medicines. The information is by no means exhaustive and can be used as a starting point for further research.
From 1 March 2024, new process changes were introduced for applications for marketing authorisations for established medicines. The scope of established medicines includes:
- products that are not new active substances or
- line extensions to new active substances.
These process changes apply specifically to chemical products. Biosimilars are excluded.
From 1 January 2025 when the Windsor Framework came into effect, union authorisations issued by the European Commission are no longer valid for Northern Ireland. Instead, the MHRA will issue UK-wide authorisations for these centrally authorised products (CAPs).
Category 1 and Category 2 Products
From 1 January 2025, medicines that were previously within the scope of the EU centralised procedure are authorised as UK-wide MAs and no longer be limited in territorial scope as GB MAs. These products will be designated in line with definitions in UK law as ‘Category 1’. Category 1 includes the generic, hybrid or biosimilar products of Category 1 reference products. Medicines outside this scope (which can already be authorised as UK-wide MAs), are designated as ‘Category 2’.
Each application and existing authorised product is assigned by the MHRA to one or other category.
Categorisation criteria are provided in the Guidance UK-wide licensing for human medicines where they are summarised in Table 1 and explained in the subsequent paragraphs.
To be clear which applicable laws apply for UK authorisations, medicinal products will be assigned to Category 1 or Category 2. When submitting MA applications via the submission portal, you must assign the category when asked. The rules for assigning the category are published in the UK-wide licensing guidance. Additional guidance is provided within the submission portal.
On mobile devices, the table below is best viewed by scrolling sideways.
| Licensing routes | Aims of the procedure and/or conditions of eligibility | Product types/applications for which the route is suitable | Procedure no of days | Authorisation territory |
|---|---|---|---|---|
| National routes | ||||
| The New Innovative Licensing and Access Pathway (ILAP) The new ILAP was launched on 30 January 2025 and is operational from 31 March 2025. As of 31 March 2025, the ILAP registration portal and form are available . The ILAP webpage has been updated with a link to the ILAP registration Portal and Innovative Passport application form. Here is a link to a video demonstration of the ILAP registration portal. | The new UK-wide Innovative Licensing and Access Pathway (ILAP), will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible. You can read about the eligibility and selection criteria here. | Medicines in the scope of the ILAP include: · Novel products: no other product exists in clinical practice that uses the same mechanism of action such as a first in class molecule · New chemical or biological entities · Products which feature new or a novel modification of existing technologies · Approved medicines being developed in a clinically significant new indication Drug-device combinations in the scope of the ILAP include: · Novel drug-device combination products with a therapeutic aim, regulated under the Human Medicines Regulations 2012 | – | UK wide |
| National assessment procedure | On 3 April 2025, the MHRA published new Guidance on the MHRA’s national assessment procedure for marketing authorisation applications. This new guidance for applicants is effective for applications received after the publication date. The guidance applies to national MA applications for both innovative and established medicines, but the requirements, procedures and timetables differ. Timetables are measured in calendar days excluding regulatory clock-stops. Submission and assessment timetables for innovative medicines applications | The route applies to national MA applications for both innovative and established medicines. Innovative medicines applications are defined as applications for: · New active substances (NAS), defined as active substances that have not been authorised in a medicinal product in the UK before · All biological products (derived or manufactured from a living biological system) including advanced therapy medicinal products (ATMPs), vaccines and biosimilars · New combinations of existing active substances · Orphan medicinal products · Conditional MA or MA under exceptional circumstances · Line extensions of any of the above (for example, addition of strengths, pharmaceutical forms or routes of administration) Established medicines applications are defined as applications that do not meet the innovative medicines application criteria outlined above. | The innovative medicines timetable allows for a positive decision within 150 clock-on days if all issues are resolved following one round of questions. Where there are outstanding issues at Day 150, the MHRA will come to a final decision as soon as possible and within 210 clock-on days. For established medicines applications,, the MHRA will come to a final decision on established medicines applications within 210 days. If they have raised only minor issues, there is the opportunity for an earlier decision. | UK wide To be clear which applicable laws apply for UK authorisations, medicinal products will be assigned to Category 1 or Category 2. When submitting MA applications via the submission portal, you must assign the category when asked. The rules for assigning the category are published in the UK-wide licensing guidance. Additional guidance is provided within the submission portal. |
| Rolling review | Permits the submission of MA applications in module(s) Until the Windsor Framework was implemented on 1 January 2025 [1], Rolling Review applications could only be submitted for applications to Great Britain. From that date the MHRA will now license new active substances and biosimilars UK-wide and the rolling review process will be available for UK-wide applications. | MAAs for: · any New Active Substance (NAS) based on a ‘full dossier’, including biological products, · biosimilar products | – | UK wide |
| Conditional Marketing Authorisation (CMA) scheme | In cases where a medicinal product fulfils an unmet medical need, the MHRA may grant a CMA where comprehensive clinical data which are normally required, are not yet complete, but it is judged that such data will become available soon. A CMA can be converted into a standard (full) marketing authorisation (no longer subject to specific obligations) once the MAH fulfils the obligations imposed and the complete data confirm that the medicine’s benefits continue to outweigh its risks. | The scheme is aimed at products that fulfil an unmet medical need: 1. for the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases; or 2. for a product to be used in emergency situations, in response to public health threats. | UK wide In NI, until 1 January 2025, a CMA was only available through the EMA’s Centrally Authorised Procedure as laid down in Regulation (EC) No 726/2004. From 1 January 2025 when the Windsor Framework was implemented , the MHRA grants UK-wide CMAs for products in line with the conditions set out in Regulation 50I of the Human Medicines Regulations 2012 (as amended) These products are authorised as Windsor Framework Category 1 products. | |
| Scheme for marketing authorisation under exceptional circumstances | The MHRA’s scheme for applications under exceptional circumstances is available for medicines where a comprehensive data package cannot be provided, because the condition to be treated is rare or because collection of full information is not possible or is unethical. This authorisation route does not normally lead to a standard marketing authorisation. | UK wide For NI, Until 1 January 2025 applications for Marketing Authorisations under Exceptional Circumstances had to be be submitted to the EMA. From that date the MHRA can issue them as UK-wide MAs. | ||
| Unfettered access from Northern Ireland (UAP) | Applicants may seek recognition in GB of a marketing authorisation approved in NI under certain qualifying conditions. The conditions for eligibility of the UAP are that the MAH must be established in NI, and that the product to be placed on the market in GB must be a Qualifying Northern Ireland Good. | Products with a Marketing Authorisation (MA) approved in NI which are a Qualifying Northern Ireland Good. Following implementation of the Windsor Framework on 1 January 2025, UAP is only available for MAs approved in NI via the European mutual recognition or decentralised procedures. The national NI route will not be available. | 70 day procedure | UK wide New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework, and the MHRA will no longer issue GB-only MAs. If granted, an MA application made through UAP will result in a UK-wide MA and the NI MA will be revoked. This is because it is not possible to hold a UK MA and a NI MA simultaneously for the same product. |
| The Northern Ireland MHRA Authorised Route (NIMAR) | This supply route has been designed to ensure that people in Northern Ireland (NI) can continue to access prescription-only medicines (POMs) should clinical need be unable to be met through authorised products or any other existing regulatory routes. NIMAR provides a route for the lawful supply of POMs in compliance with UK and EU rules, where there is a risk that clinical need in NI for that product cannot be met. This includes supply of medicines that are unlicensed in NI, but which are licensed and approved in GB. Supplying medicines via NIMAR is essential on public health grounds and having this additional route for supply means POMs can be supplied to NI, to meet clinical need, in accordance with their GB marketing authorisation. | In order to supply a medicine from GB to NI via NIMAR, the following criteria must be met: 1) The product is classified as a Prescription Only Medicine (POM). Pharmacy medicines (P) and General Sales List (GSL) medicines are not eligible for supply to NI via NIMAR. 2) The medicine has a valid GB licence thereby meeting the MHRA’s stringent requirements for safety, quality and efficacy. Medicines which are unlicensed in GB will not be eligible. The medicine appears on the NIMAR list. This list sets out the medicines that can be supplied under the provisions of NIMAR, as decided by the Department for Health and Social Care (DHSC) in partnership with the MHRA and the Department of Health (DoH) Northern Ireland. | NI only Only Prescription Only Medicines (POMs) with a valid GB Marketing Authorisation and on the NIMAR list can be supplied to NI via this route. Market authorisation holders (MAHs) are reminded that NIMAR continues to function to support the supply of medicines into NI and is unaffected by the terms of the Windsor Framework agreement. From 1 January 2025 upon commencement of the measures set out in the Windsor Framework, the MHRA anticipate that NIMAR will no longer be required to support the supply of medicines to NI, though it will remain in place in law. | |
| International recognition Procedure This procedure has been operational since 1 January 2024. It replaces the the EC Decision Reliance Procedure (ECDRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has been incorporated under the umbrella of IRP. | The MHRA has created a new international recognition route for medicines licensing utilising pre-existing approvals from the following countries: · Australia · Canada · the European Union · Japan · Switzerland · Singapore · United States This new framework will support patients in the UK with expedited access to safe and effective medicines that have been approved by trusted regulatory partners. | chemical and biological new active substances and known active substances, generic applications, hybrid applications, biosimilar applications, new fixed combination product applications | There are two recognition timetables for initial MAAs: Recognition route A: 60-day timetable Recognition route B: 110-day timetable The timetables are calendar days and start once the IRP submission has been validated by MHRA. | UK wide |
| Decentralised or Mutual Recognition procedure (in which NI is a CMS) | ||||
| DC or MR procedure | Decentralised DC) or Mutual Recognition (MR) procedures in which NI is a Concerned Member state (CMS). The procedure leads to a national licence in NI. | All products that are eligible for licensing via the MR or DC procedures | NI only | |
| International routes-collaborative procedures | – | |||
| Access Consortium, New Active Substance and Biosimilar Work Sharing Initiatives | Use this route if you want to market a medicine in the following countries: · UK · Australia, · Canada, · Singapore · Switzerland | · New active substances · biosimilars | – | UK wide |
| Access Consortium, Generic Medicines Work Sharing Initiative | Use this route if you want to market a medicine in the following countries: · UK · Australia, · Canada, · Singapore · Switzerland | Generic medicines | – | UK wide |
| Access Consortium Promise Pilot Pathway (New Access Work-Sharing Pathway for Priority Procedures) | Applications for new active substances fulfilling the following criteria are eligible for the Promise Pilot Pathway: – diagnoses, treats or prevents a condition that is serious, life-threatening or severely debilitating and for which no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication Further information is available in this post. | |||
| Project Orbis | Project Orbis is a programme coordinated by the US FDA, involving the regulatory authorities of the following countries, to review and approve promising cancer treatments: · Australia (TGA) · Brazil (ANVISA) · Canada (Health Canada) · Israel Ministry of Health · Singapore (HSA) · Switzerland (Swissmedic) · United Kingdom (MHRA) Project Orbis provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe. | Oncology products Selection of products to be included in Project Orbis is coordinated by the FDA, and initial queries received by participating regulatory health authorities are referred to the FDA | – | UK wide |
Source: MHRA website