NIMAR vs Specials

Following on from my other blogs on NIMAR (Northern Ireland MHRA Authorised Route) I have been asked about Specials.

What is the difference between NIMAR medicines and Specials?

We need to be careful to distinguish between supply under the NIMAR route and Regulation 167, which is the Specials Route:

  • Specials are unlicenced medicines which have been specifically manufactured or imported for treatment on an individual patient basis, where there is an unmet clinical need.  This route is still an option for eligible products.
  • NIMAR medicines are licenced by the Medicines and Healthcare Products Regulatory Agency (MHRA) for use in Great Britain (GB).  The MHRA also approves this route for their supply in Northern Ireland, where a suitable alternative is not available to meet clinical need.

Useful fact:  the medicines on the NIMAR list are therefore identical to medicines already used in Northern Ireland.

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.