Guidance

The Northern Ireland MHRA Authorised Route (NIMAR)

Updated 9 May 2025

1. Overview

The Northern Ireland MHRA Authorised Route (NIMAR) provides a route for the lawful supply of Prescription-Only Medicines (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 Great Britain (GB)^{[footnote 1]}. 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.

This route is tightly governed in accordance with the Human Medicines Regulations 2012, with all medicines supplied via NIMAR already complying with the strong regulatory safeguards required for a product to enter the GB market. All medicines supplied this way into NI will meet the Medicine and Healthcare Products Regulatory Agency’s (MHRA) robust standards for safety, quality and efficacy which are in place for the rest of the UK.

2. NIMAR and the Windsor Framework

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.

Although GB authorisations have been converted to UK-wide authorisations from 1 January 2025, medicines released by a qualified person (QP) onto the GB market prior to this date in non-compliant Windsor Framework packaging, i.e. without ‘UK only’ on their outer packaging, cannot be placed onto the NI market.

It is anticipated that NIMAR will not be required to support the supply of medicines to NI as medicines released by QPs in UK-wide compliant packaging become available on the UK market from 1 January 2025.

The MHRA will retain the right to issue GB authorisations ​​after 1 January 2025, although this will not be available through application. GB authorisations will be issued only in exceptional circumstances to safeguard the interests of patients’ health in the UK. If such a step is required, as NIMAR will remain in law, it could be utilised in these exceptional circumstances to meet clinical needs of patients in NI.

If MAHs are unable to supply medicines to the NI market (e.g. due to unavailability of NI/UK compliant packs), this should be reported to the Department of Health and Social Care (DHSC) via DHSC’s Discontinuations and Shortages (DaSH) portal and other usual reporting routes. 

Arrangements for licences associated with the implementation of the Windsor Framework are set out in our guidance UK-wide licensing for human medicines.  

3. Medicines eligible for supply via NIMAR

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 POM. Pharmacy medicines and General Sales List medicines are not eligible for supply to NI via NIMAR.

2. The medicine has a valid GB licence, issued by MHRA in exceptional circumstances, or a UK-wide licence which meets the MHRA’s stringent requirements for safety, quality and efficacy. Medicines which are unlicensed in GB will not be eligible. 

3. 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 DHSC in partnership with the MHRA and the Department of Health (DoH) Northern Ireland.

3.1 List eligibility

Inclusion on the NIMAR list is determined by assessing NI patient need and system-wide impact. A decision is taken on whether there may be a clinical unmet need for the medicine in NI. This process is managed by DHSC in partnership with DoH.

There is no application process for a medicine to be placed on the NIMAR list.

The list will be regularly reviewed and updated to accurately represent the medicines available for supply to the NI market via NIMAR.

4. Distinguishing between supply under NIMAR and Regulation 167 (specials route)

Specials are unlicensed medicines which have been specifically manufactured or imported for treatment on an individual patient basis, where there is an unmet clinical need. This route remains unchanged, and this supply route remains an option for eligible products.

Medicines on the NIMAR list have a valid GB or UK-wide licence authorised by the MHRA, as the UK’s medicines regulator route for their supply in Northern Ireland, where a suitable alternative is not available to meet clinical need.

5. Distribution of NIMAR medicines to NI

There are two methods by which NIMAR listed products may be supplied to end users in Northern Ireland:

1. Directly from MAHs and wholesale dealers based in Great Britain
2. Via wholesale dealers based in Northern Ireland

A holder of a wholesale dealer’s or manufacturers licence can lawfully supply NIMAR listed products to pharmacies, hospitals, and wholesalers in NI. Regulation 43ZA, sets out the obligations that are placed on holders of wholesale dealer’s licences in GB supplying NIMAR listed products to NI.

Medicines which are NIMAR listed products can be supplied to NI on the same terms as medicines with a marketing authorisation valid in NI (UK-wide and NI only licences). There will be no changes to licensing requirements for wholesale dealers supplying NIMAR products.

Wholesalers should refer to the NIMAR list to determine if a product can be supplied to NI using the NIMAR route. If it is on the list, then it can be supplied. If a product is removed from the NIMAR list, remaining stock that is already in the NI market can be distributed. However, once a product is removed from the NIMAR list it is not possible to supply new stock from GB to NI, under NIMAR. Reasonable notice will be provided prior to the removal of a product from the NIMAR list.

Where a brand is not stipulated for a product published on the NIMAR list, it means that any equivalent generic or brand of that molecule of that specific strength can be supplied to NI in any pack size. Wholesalers should not supply any strength other than the one specified. Products must be a POM presentation as only POM products are eligible for supply via NIMAR.

For some products on the list, brand names have also been included alongside the generic molecule for clinical reasons. For these products, only the brand specified should be supplied to NI via NIMAR.

GB wholesalers sending products to NI should ensure that medicines that are not authorised for NI are on the NIMAR list. There is currently no reporting requirement for medicines supplied to NI under NIMAR. This remains under review and should the requirement change, new guidance will be provided.

Marketing authorisation holders should manage the supply of NIMAR products in a similar manner to medicines with a valid marketing authorisation for NI in accordance with the specific rules that apply to NIMAR.

6. Advertising and promotion

Following implementation of the Windsor Framework, any products on the NIMAR list, where medicines were released onto the market prior to 31 December 2024 as GB licensed and packaged stock, may now be advertised (i.e. actively promoted) UK wide if the product licence has been converted to a UK-wide authorisation from 1 January 2025.

However, if a medicine holds a GB licence (issued by the MHRA in exceptional circumstances) and is on the NIMAR list, the medicine can only be advertised (i.e. actively promoted) in England, Scotland, and Wales. This does not preclude legitimate interactions and communications necessary to maintain medicines supply. MAHs must take all reasonable precautions to ensure that advertisements do not appear in the territory where the medicine is not licensed and must, in all other regards comply with Part 14 of the Human Medicines Regulations 2012.

7. Prescribing medicines on the NIMAR list

Prescribers in NI do not need to do anything different to prescribe or access medicines through this route. As such, medicines on the NIMAR list can continue to be prescribed to patients as normal. When prescribing products on the NIMAR list, prescribers should refer to the Summary of Product Characteristics (SPCs or SmPCs). All products on the NIMAR list will be authorised by the MHRA in GB and remain equally as safe and effective for patients in NI. They will all be products which DHSC and DoH NI consider are required to meet clinical need in NI. They are approved by the MHRA for supply on this basis and are a separate category from medicines authorised through Regulation 167 of the Human Medicines Regulations.

NIMAR is designed to ensure that the clinical needs of patients in NI are met. All medicinal products supplied via this route will meet the MHRA’s stringent requirements for safety, quality and efficacy.

8. Dispensing medicines on the NIMAR list

There is no requirement for end users to identify NIMAR products and they can be supplied to patients on the same terms as medicines with a marketing authorisation valid in NI (UK-wide or NI-only licence). Patients in NI do not need to do anything different to access medicines through this route. Registered health professionals who supply medicines to a pre-defined group of patients under Patient Group Directions (PGDs) do not need to do anything differently.

9. Contact

For further information, please email our Customer Services Centre at:

info@mhra.gov.uk

Telephone: 020 3080 6000.

1. Under the arrangements introduced by the Windsor Framework, Great Britain-only marketing authorisations will no longer be routinely issued but remain possible in law. ↩