MHRA publishes guidance on NIMAR

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the Northern Ireland MHRA Authorised Route (NIMAR) to ensure that its citizens can continue to access prescription-only medicine (POM). NIMAR seeks to provide a route for the lawful supply of POMs, in accordance with UK and EU rules, where a risk exists that a clinical need for that product in Northern Ireland (NI) cannot be met. This includes the supply of medicines that are not licensed in NI, but approved and licensed within Great Britain (GB). MHRA outlines how the supply of medicines through NIMAR is essential on the grounds of public health and will be governed by the Human Medicines Regulations 2021, SI 2012/1916 where all medicines supplied to NI will meet MHRA’s robust standards for quality, safety and efficacy. MHRA outlines two methods of distribution that may be used to supply NIMAR listed products to end users in NI. This includes directly from marketing...