Recap
In response to Brexit, on 1st January 2022, the UK brought in NIMAR (Northern Ireland MHRA Authorised Route) as a new supply route for ensuring prescription only medicines (POMs) are available to Northern Ireland. Supplying medicines via NIMAR is essential on public health grounds and having this additional option for supply route means POMs can be supplied to Northern Ireland, to meet clinical need. For information on NIMAR criteria and supply see our original and follow-up blogs.
Useful fact:
Pharmacy medicines and General Sales List medicines are not eligible for supply to NI via NIMAR.
How does the Windsor Framework affect NIMAR?
NIMAR will continue to function to help with the supply of medicines into Northern Ireland and this route is unaffected by the terms of the Windsor Framework agreement. However, as medicines released in UK-wide compliant packaging* are now becoming available on the UK market (from 1st January 2025), it is anticipated that NIMAR will no longer be needed to support the supply of medicines into Northern Ireland.
*”UK Only” must appear on outer packaging and no uploading of 2D barcode encoding an alphanumeric character sequence to the European repositories system.
Bear in mind that although Great Britain (GB) authorisations have been converted to UK-wide authorisations from 1 January 2025, medicines released into the GB market prior to 1 January 2025 in non-compliant Windsor Framework packaging, i.e. without ‘UK only’ on their outer packaging etc., and cannot be placed onto the market in Northern Ireland.
Top Tip
Ensure your company has put in place useful and timely communications to other areas of the business (i.e. outside of regulatory) for as and when your products come off NIMAR and what actions may need to be taken. This could be in terms of updating product materials such as Summary of Product Characteristics (SPCs), Patient Leaflet (PILs) and outer packaging.
How does NIMAR affect my advertising and promotion?
There are 2 scenarios here:
- Product licences which have been converted to a UK-wide authorisation from 1 January 2025:
In this case, NIMAR medicines released into the market, prior to 31 December 2024, as GB licensed and packaged stock, may now be advertised** (i.e. actively promoted) UK wide – yippee! - However, for medicines holding a GB licence (issued by the MHRA in exceptional circumstances) and on the NIMAR list:
These medicines can only be advertised** (i.e. actively promoted) in England, Scotland, and Wales.
**Legitimate interactions and communications necessary to maintain medicines supply are allowed. MAHs must take all reasonable precautions to ensure that advertisements do not appear in the territory where the medicine is not licensed.
What should I do in the case of supply problems?
A reminder that if you, as the licence-holder, are unable to supply medicines to Northern Ireland (e.g. due to unavailability of Northern Ireland/UK compliant packs), this should be reported to the Department of Health and Social Care (DHSC) via DHSC’s Discontinuations and Shortages (DaSH) portal.
For information on distinguishing between supply under NIMAR and Regulation 167 (specials route) please see our former blog on “NIMAR vs Specials”
If you would like to discuss how Fusion Pharma can support you with NIMAR, or indeed any Windsor Framework-related activity, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
