New guidance on Supply of Medicines into Northern Ireland

Following our previous post summarising the MHRA Medicines Supply to Northern Ireland Webinar, the JensonR+ team would like to share with you a brief overview of the Northern Ireland MHRA Authorised Route (NIMAR).

Unlike the points covered in our previous summary NIMAR is not directly linked to EU proposals related to the Northern Ireland Protocol. NIMAR is a mechanism by which specified medicines can be supplied to into Northern Ireland (NI) to meet patient need.

It is to be noted that this is not a “licensing” option that can be chosen by the Marketing Authorisation Holder (MAH) but a decision that rests with the Department of Health and Social Care (DHSC), Northern Ireland Executive and the MHRA. As medicines supplied in NI via NIMAR are not licensed in NI it is not permitted to promote these medicines in NI.

The DHSC will maintain a list of medicines that can be moved through NIMAR into Northern Ireland. The decision to place a medicine on the list is based on a consideration of patient need where there is not a suitable licenced (for NI) alternative. It is worth noting that where brands are not stipulated on the NIMAR list, any generic equivalent brand of the molecule at the specified strength can be supplied.

New guidance on Supply of Medicines into Northern Ireland

Once on the list, the medicines can be supplied to Northern Ireland with the following considerations:

  • They are not prohibited by virtue of requirements concerning medicines falling under the scope of the Centrally Authorised Procedure.

  • They will be considered Prescription Only Medicines in Northern Ireland

  • They have a UKMA(UK) or UKMA(GB)

  • PLGB MAs do not need to comply with the Falsified Medicines Directive, even when being supplied to Northern Ireland through NIMAR

  • That it is supplied from GB by the holder of an MIA or WDA

  • That it is distributed in NI by the holder of a WDA

  • That the MAH must comply with GDP requirements, including, maintaining a quality system, keeping records and having a means of batch recall, in relation to NIMAR stock in Northern Ireland

Medicines will be removed from the list when it is considered that medicinal products, not including listed NIMAR products, available in Northern Ireland are capable of meeting clinical need. When the medicine is removed from the list it can no longer be supplied to Northern Ireland (though our current understanding is that existing stock of a NIMAR medicine already in the NI supply chain can still be dispensed).

Here at JensonR+ we can help guide and support you on how best to make use of the new guidance to ensure you can continue supply of medicines into Northern Ireland.

To find out more contact us at consultancy@jensongroup.com.

Neil Prideaux
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