Guidance

The Northern Ireland MHRA Authorised Route (NIMAR)

Updated 29 September 2023

Why the Government has introduced 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.

The Northern Ireland MHRA Authorised Route (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 Great Britain (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.

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.

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. From 1 January 2025, once the measures set out in the Windsor Framework have commenced, we anticipate that NIMAR will no longer be required to support the supply of medicines to NI, though it will remain in place in law.

As such, if MAHs are unable to supply medicines to NI (e.g, due to a product shortage or discontinuation, including unavailability of a NI compliant pack) 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.

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

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 Prescription Only Medicine (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 thereby meeting 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 Department for Health and Social Care (DHSC) in partnership with the MHRA and the Department of Health (DoH) Northern Ireland.

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. MAHs should use existing processes to notify DHSC of their intention to discontinue a product in Northern Ireland or if there is an anticipated shortage of a product specific to the Northern Ireland market. DHSC and DoH will then assess unmet clinical need for the product, identify any suitable alternatives, and make a decision about its inclusion on the NIMAR list.

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

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 are licensed by the MHRA, as the UK’s medicines regulator, for use in Great Britain. The MHRA also approves this route for their supply in Northern Ireland, where a suitable alternative is not available to meet clinical need. The NIMAR medicines are therefore identical to medicines already used in NI.

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 marketing authorisation holders 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. New regulation 43ZA, sets out the obligations that are placed on holders of wholesale dealer’s licences in GB supplying NIMAR listed products to Northern Ireland.

Medicines which are NIMAR listed products can be supplied to NI on the same terms as medicines with a marketing authorisation valid in Northern Ireland (PL and PLNI). 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. Medicines with a marketing authorisation valid only in GB labelled as PLGB may not have a Unique Identifier to enable verification or decommissioning as required by EU Delegated Regulation 2016/161. 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.

Advertising and promotions

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. However, as NIMAR listed medicines hold a GB licence, they should 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. Marketing authorisation holders 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.

Prescribing medicines on the NIMAR list

Prescribers in Northern Ireland 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) of the PLGB. 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 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 NI patients have access to the same prescription only medicines and innovative products as patients in GB, ensuring that healthcare provision across the UK is equitable. All medicinal products supplied via this route will meet the MHRA’s stringent requirements for safety, quality and efficacy.

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 Northern Ireland (PL and PLNI). Medicines on the NIMAR list do not need to be serialised for FMD, there is no requirement to decommission these products as required by EU Delegated Regulation 2016/161.

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.

Contact

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

info@mhra.gov.uk

Telephone: 020 3080 6000.