Why the Government has introduced NIMAR?
The Northern Ireland MHRA Authorised Route (NIMAR) is a supply route designed to ensure that people in Northern Ireland (NI) can continue to access prescription-only medicines (POMs) if they are unable to source them through other routes.
This includes supply of medicines that are unlicensed in NI, but which are licensed and approved in GB (PLGB Products). There is a list of medicines which can be supplied in this way. To be included on the list, there must be a clinical need for the medicine, with no suitable, licensed alternative available on the NI Market.
Product Eligibility for inclusion on the list
- The product is classified as a Prescription Only Medicine (POM).
- Pharmacy (P) medicines and General Sales List (GSL) medicines are not eligible for supply to NI via NIMAR.
- The medicine has a valid GB licence (GBPL)
The list is managed by DHSC in partnership with the MHRA and the Northern Ireland Executive. For some products the brand is specified, for others it is not; where no brand is specified, wholesalers can supply the given product, in a POM presentation at the listed strength.
Distribution of NIMAR medicines to NI
There are two methods by which NIMAR listed products may be supplied to end users in Northern Ireland:
- Directly from marketing authorisation holders and wholesale dealers based in Great Britain
- Via wholesale dealers based in Northern Ireland
NI Wholesalers should ensure that any medicines they receive which are not authorised for NI are on the NIMAR List. The list is regularly reviewed and updated to accurately represent the medicines available for supply to in the NI market via NIMAR.
Dispensing medicines on the NIMAR list
NIMAR products can be supplied to patients on the same terms as medicines with a marketing authorisation valid in Northern Ireland (PL and PLNI). Registered health professionals do not need to do anything differently.
Medicines on the NIMAR list do not need to be serialised for FMD. There is no requirement to decommission these products as required by EU Delegated Regulation 2016/161.
CLICK HERE TO SEE THE CURRENT LIST
Want to keep up to date with changes like this?
Check out our training offerings. Come to one of our GDP Training sessions, our Cogent Gold Standard RP Training, or join us at our Monthly Forum