Licensing routes to obtain a marketing authorisation for a medicine in the UK, GB or NI post Brexit

Last updated: 14 June 2024

See list of updates at the end of the post.

Post Brexit, there are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) (GB) or Northern Ireland (NI) as shown in the table below.

The options available will be determined by:

  • the intended market(s) and
  • the application route/procedure type available.

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.

On mobile devices, the table below is best viewed by scrolling sideways.

Licensing routesAims of the
procedure
Product types/applications for which the route is suitableProcedure no of daysLeads to authorisation in one or more of UK, GB and NIExample of a product(s) authorised via the route
National routes
The Innovative Licensing and Access Pathway
(ILAP)
Aims to accelerate the time to market and facilitate patient access for innovative medicines.

It comprises of:
· an Innovation Passport designation,
· a Target Development Profile (TDP)
· access to a toolkit for applicants, to support all stages of the design, development and approvals process.
· New chemical entities
· biological medicines
· repurposed medicines
· new indications
UK or GB only.

NI unlikely scenario
Belzutifan awarded first Innovation passport by the MHRA.
The product Welireg® 40 mg film-coated tablets has been granted a Marketing Authorisation
National procedure This accelerated procedure is to authorise nationally, a medicine in the United Kingdom (UK), Great Britain (GB) or Northern Ireland (NI).

National applications in NI, must continue to comply with the requirements of European Directive 2001/83/EC, and Regulation (EC) 726/2004
Is available for high-quality applications for:
· new or existing active substances
· biosimilar products


150 day accelerated procedureUK / GB / NIVisublend 0.3 mg/nl + 5mg/ml Eye Drops Solution
A national marketing authorisation was granted for this product in the UK.
Rolling review Permits the submission of MA applications in module(s)
MAAs for:
· any New Active Substance (NAS) based on a ‘full dossier’, including biological products,
· biosimilar products
UK / GB / NI1. Lageverio 200mg hard capsules (molnupiravir).
Application was evaluated as part of the rolling review licensing route.
Conditional Marketing Authorisation (CMA) was issued in GB. Temporary Regulation 174 authorisation issued for NI to ensure supply across all of the UK.
If the EMA grants a CMA for Lagevrio it will apply in NI and the Regulation 174 authorisation would no longer be in place.

2. Nuvaxovid dispersion for injection
Application was evaluated as part of the rolling review licensing route.
A national MA was granted in GB.
Nuvaxovid is authorised in Northern Ireland under the Conditional Marketing Authorisation (CMA) granted by the EMA.
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.

UAP is available to MAs approved in NI via European procedures (centralised, MRP or DCP ) or via the NI National route.
67 day procedureGB only
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.
Only Prescription Only Medicines (POMs) with a valid GB Marketing Authorisation and on the NIMAR list can be supplied to NI via this route.

International recognition Procedure

This procedure is operational from 1 January 2024.

It replaces the the EC Decision Reliance Procedure (ECDRP).

The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be 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.
The scope of such authorisations depends on whether the product would fall within the scope of the EMA’s centrally authorised procedure.  If it does, then the IRP authorisation would be for GB only, until 1 January 2025.  From that date, the Windsor Framework will come into force and then the UK will licence all medicines, UK-wide.

If the product has been authorised nationally or through MRDC, then MHRA can issue a UK wide authorisation providing that Northern Ireland is not part of the MRDC procedure.
Reliance on EU decisions/authorisations to seek authorisation in the UK or GB
EC Decision Reliance Procedure
(ECDRP)


This procedure no longer available.

As confirmed by the MHRA, from 1 January 2024, the EC Decision Reliance Procedure (ECDRP) has been replaced by the new International Recognition procedure (IRP).
 
This means that the ECDRP is no longer available as a procedure.

MR/DC Reliance Procedure
(MRDCRP)

This procedure is no longer available.

As confirmed by the MHRA, from 1 January 2024, the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP.

This means that the MRDCRP is no longer available as a standalone procedure.

European routes (for NI only)
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 onlyPregabalin Teva Hartkapseln
Procedure No DE/H/5003/008
The PAR can be downloaded from the CMDh website here.
European Union Centralised procedure Marketing authorisations approved in the EU centralised procedure will automatically have effect in NI. This procedure results in a single European Licence valid in all 27 member states. All products that are eligible for authorisation via the centralised procedureNI onlyTruvelog Mix 30 100 units/mL suspension for injection in cartridge or pre-filled pen.
Commission implementing decision

Annexes


Centrally Authorised Products (CAP) bridging mechanism for Northern Ireland

MAs issued by the EC in relation to Centrally Authorised Products (CAPs) are not valid in Great Britain (GB) and a separate national application is needed for GB. There is therefore a possibility that in the case of parallel applications to the EMA and the MHRA, the MHRA may issue an MA for a medicinal product before an MA has been granted for the same medicinal product in the EU. Where this is the case, in order to ensure that patients in Northern Ireland have access to those medicinal products at the same time as patients in other parts of the UK, under a CAP bridging mechanism, companies will be able to supply a GB licenced product (PLGB) to Northern Ireland for a period of 6 months or until the EC authorises a CAP in Northern Ireland or the EC refuses an application for the product, whichever of these is sooner.
Further information is available in this post.

This bridging mechanism is only applicable until the Windsor Framework comes into effect on 1 January 2025.
All products that are eligible for authorisation via the centralised procedureGB only but with scope for product to be be supplied to NI for a period of 6 months or until the EC authorises a CAP in Northern Ireland.
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 or GB only although the likelihood of a GB authorisation is greater as most products authorised via this route would also quite likely be assessed by the EMA via the centralised procedure, so if an authorisation were to be granted, then Northern Ireland would be included.Vabysmo, the first treatment approved via the Access Consortium ‘New Active Substance Work Sharing Initiative’
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 or GB only although the likelihood of a GB authorisation is greater as most products authorised via this route would also quite likely be assessed by the EMA via the centralised procedure, so if an authorisation were to be granted, then Northern Ireland would be included.
New Access Consortium Promise Pilot Pathway
(Work-Sharing Pathway for Priority Procedures)

Note that this is only a pilot procedure.
Further information is available in this post.

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
GB onlyTagrisso 40mg and 80mg film-coated tablets (osimertinib) – Type II variation to add an indication


Lumykras 120 mg film-coated tablets

Tukysa 50mg and 150mg film-coated tablets (tucatinib)

Kimmtrak 200 micrograms/ mL concentrate for solution for infusion (Tebentafusp)

Source: MHRA website

Updates
DateUpdate
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.