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MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)

On 29 September 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Northern Ireland MHRA Authorised Route (NIMAR)" that provides detailed instructions on this new route for supply, which became operational 1 January 2022.

Northern Ireland (NI) MHRA Authorised Route (NIMAR) allows the lawful delivery of prescription-only medicines (POMs) in compliance with UK and EU legislation, when NI has a risk of the product not being able to meet its clinical needs.


The design of this supply route aims to guarantee continued access to prescription-only medicines (POMs) for people in Northern Ireland (NI) in case clinical requirements cannot be fulfilled via authorized products or other established regulatory pathways.


In order to get a medicine on the NIMAR list, there is no application process, and MAHs should notify the DHSC when they intend to discontinue a product in Northern Ireland or if a shortage is forecast for a product.


To know more details on the Medicines eligible for supply via NIMAR, etc. click this LINK.



Also, UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released another updated guidance on "Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework" that provides Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.


To know more exclusively about the timelines etc about this guideline, click this LINK.




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