An introduction to the Northern Ireland MHRA Authorised Route (NIMAR)
What is the background to NIMAR?
Following Brexit the UK Government brought in a new supply route, NIMAR, to ensure that prescription only medicines (POMs) are available to Northern Ireland (NI).
What are the criteria for going down the NIMAR route?
- There must be a clinical need which cannot be met through authorised products or any alternative regulatory routes
- The product must be classified as a POM
- The medicine must have a valid Great Britain (GB) licence
- The medicine must appear on the NIMAR list
Useful fact: Pharmacy medicines and General Sales List medicines are not eligible for supply to NI via NIMAR.
How does NIMAR work?
Products provided via NIMAR will be supplied in accordance with their GB marketing authorisations. Whilst there is no application process for a medicine to be placed on the NIMAR list you, as the Marketing Authorisation Holder, should still notify the Department of Health and Social Care (DHSC) of any expected shortage of a product or of your intention to discontinue a product in Northern Ireland. This way the DHSC and the Department of Health (DoH) can then asses unmet clinical need for the product, look at any alternatives and decide on whether to include the product on the NIMAR list.
Useful fact: The list is frequently reviewed and updated to accurately include the medicines available for supply via NIMAR into the Northern Ireland market.
Look out for my other Brexit or NIMAR-related blogs.
If you would like to discuss how Fusion Pharma can support you with any Brexit-related queries, 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.