Marketing authorisation routes for medicines licensing in the UK

Last updated: 16 April 2025

To see updates, click on the ‘+’ sign below.

DateUpdate
16 Apr 2025For the UAP route,
i) updated the second paragraph in the table column Product types/applications for which the route is suitable
ii) Updated the Procedure No of days column
8 Apr 20251) Information on the National assessment procedure updated following the recent publication of new guidance on the MHRA website.
2) The entire post has been updated to reflect current information.
3) Title of the post updated
31 Mar 2025First column of information on the New ILAP updated to reflect that as of 31 March 2025, the new ILAP route is operational and the registration portal and Innovative Passport application form are now available. Links are provided as appropriate.
30 Jan 2025Table updated to include information on the new ILAP pathway.
20 Nov 2024In column 1 of the tale, for ILAP, as per the MHRA website, information added that as of 20 November 2024 17:00 (GMT), applications under the current ILAP scheme are no longer accepted.
6 Nov 2024Column 1 in the table updated for ILAP to stathe that the ILAP will be relaunched in Q1 2025. Link provided to further information.
19 Oct 2024Updated table with:
i) Information on the scheme for conditional marketing authorisation and
ii) Information on scheme for marketing authorisations under exceptional circumstances.
iii) For the rolling review route, added information in the first column concerning the Windsor Framework.
iv) For the PRoject Orbis route, added added information in the first column concerning the Windsor Framework.
14 June 20241) Post updated to include link to new process changes introduced from 1 March 2024 for applications for marketing authorisations for established medicines.

2) Table updated to make it even more clearer that the ECDRP and the MRCDRP are no longer available as procedures since 1 January 2024.
13 Jan 2023For the International Regulatory Procedure, the columns Procedure no of days and Leads to authorisation in one or more of UK, GB and NI have now been populated.
2 Jan 2024Table updated to:
i) confirm that the IRP is available from 1 Jan 2024 and has now replaces the ECDRP. Confirmation link from the MHRA website added.
ii) confirm that from 1 Jan 2024, the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP.
iii) add information on the New Access Consortium Promise Pilot Pathway.
21 Dec 2023In the section on the ECDRP procedure, information added confirming that from 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP)
1 Sept 2023Added information on the International Recognition Procedure (IRP) which will be available from 1 January 2024.
11 Jun 2023Information added on Centrally Authorised Products (CAP) bridging mechanism for Northern Ireland.
25 Jan 2023EC Decision Reliance Procedure column entitled Aims of the procedure updated with the addition of paragraphs 2,3 and 4 in line with the MHRA update of 24 Jan 2023.
3 Oct 2022Table updated to clarify information on the Access consortium route as regards the grant of authorisations in GB or the UK.
30 Sept 2022The ECDRP route was meant to be available until 31 December 2022. It has now been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure that the GB citizens continue to have timely access to medicines while MHRA develop proposals for a new international reliance framework.
20 Sept 2022Information added on the NIMAR route. Be aware that this route has been operational since 1 Jan 2022.

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 routesAims of the
procedure and/or conditions of eligibility
Product types/applications for which the route is suitableProcedure no of daysAuthorisation
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 procedureOn 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 reviewPermits 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) schemeIn 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 circumstancesThe 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 procedureUK 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 applicationsThere 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 proceduresNI 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 medicinesUK 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 OrbisProject 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