UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on "The Northern Ireland MHRA Authorised Route (NIMAR)" in the UK.

The Northern Ireland MHRA Authorised Route (NIMAR) is a critical pathway established for the lawful supply of Prescription-Only Medicines (POMs) in Northern Ireland, aligned with both UK and EU regulations. NIMAR is designed to bridge regulatory gaps ensuring essential medicines can be supplied to Northern Ireland even when those medicines are not licensed there but are approved in Great Britain (GB). This route ensures that medicines meet robust standards of safety, quality, and efficacy as set by the MHRA.

NIMAR and the Windsor Framework

The Windsor Framework is an agreement that addresses how EU and UK regulations apply to Northern Ireland post-Brexit, focusing on maintaining seamless trade and supply chains while respecting the unique position of NI.

Despite the introduction of this framework, NIMAR remains a necessary route for ensuring medicine supply continuity in NI. From January 2025, licenses are transitioning to UK-wide, but non-compliant products still cannot enter the NI market unless via NIMAR under exceptional circumstances.

Medicines Eligible for Supply via NIMAR

Only Prescription-Only Medicines (POMs) with a valid GB or UK-wide license can be supplied to NI via NIMAR. The medicines included on the NIMAR list are decided based on NI patient needs and clinical demand, with no application process required for inclusion. The list is regularly reviewed to represent available medicines accurately.

Distinguishing NIMAR from Regulation 167 (Specials Route)

While NIMAR deals with licensed medicines, Regulation 167 covers unlicensed "specials" for specific patient needs. NIMAR-listed medicines have valid licenses for their supply in NI, contrasting with the specials route.

Distribution of NIMAR Medicines to NI

NIMAR-listed products can be distributed directly from MAHs or via wholesalers in either GB or NI. Products must be on the NIMAR list to be eligible for this route, and remaining stock can be distributed even if a product is removed from the list. Generic or brand variants can be supplied unless a specific brand is stipulated for clinical reasons.

Advertising and Promotion

Products on the NIMAR list can be promoted UK-wide if their licenses convert to UK-wide from 2025. Medicines with specific GB-only licenses, however, can only be advertised in England, Scotland, and Wales, adhering to Part 14 of the Human Medicines Regulations 2012.

Prescribing Medicines on the NIMAR List

Prescribers in NI can continue regular prescribing practices for NIMAR-listed medicines. These products are vetted by the MHRA and meet stringent MHRA standards, separate from those authorized under Regulation 167.

Dispensing Medicines on the NIMAR List

Patients and health professionals do not need to take additional steps to access or supply NIMAR-listed medicines, which are dispensed just like those with a valid NI marketing authorization.

NIMAR plays a vital role in ensuring the continuous and reliable supply of essential medicines to Northern Ireland, bridging regulatory differences post-Brexit. This route is crucial for maintaining public health and meeting diverse clinical needs.

For more information, please refer to the official NIMAR Publication on GOV.UK.