NIMAR – A Closer Look

by | Dec 12, 2022 | Brexit, News, Regulatory Affairs, Regulatory Intelligence | 0 comments

NIMAR vs Specials
NIMAR – A Closer Look

Following on from my original blog titled ‘An Introduction to NIMAR‘, today we shall have a look in more detail, particularly focussing on

  • Distribution of NIMAR medicines to Northern Ireland
  • Advertising and promotion of medicines on the NIMAR list
How are these products supplied to Northern Ireland via NIMAR?
  1. GB-based marketing authorisation holders (MAHs) and wholesale dealers may distribute directly, or
  2. Northern Ireland-based wholesaler dealers may supply them

Useful fact:  A holder of a wholesale dealer’s or manufacturers licence can lawfully supply NIMAR listed medicines to the following in Northern Ireland:

  • pharmacies
  • hospitals
  • wholesalers
What regulations should I follow?

Regulation 43ZA, explains the requirements for wholesale dealers in GB supplying NIMAR listed products to Northern Ireland.

Wholesalers should refer to the NIMAR list to to check if a product can be supplied to Northern Ireland using this route.  If it is on the list, then it can be supplied.

What happens if a product is removed from the NIMAR list?

If this happens then remaining stock already in the Northern Ireland market can be distributed but, once a product is removed from the NIMAR list it is not possible supply new stock from GB to Northern Ireland, under NIMAR.

Can I advertise NIMAR products?

MAHs are required to take all reasonable precautions to ensure that advertisements do not appear in the territory where the medicine is not licenced.

Useful tip:  NIMAR products should only be advertised (i.e. actively promoted) in England, Scotland, and Wales.

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.