The MHRA and Northern Ireland partners are working together to support innovation, enhance patient safety and ensure people in Northern Ireland benefit from world-class regulation.
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MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
Updated MHRA guidance will help health institutions, such as NHS Trusts and Boards, safely design and make general medical devices for patients.
Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
Field Safety Notices: 23 to 27 June 2025
List of Field Safety Notices from 23 to 27 June 2025.
Guidance: Custom-made medical devices in Great Britain
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer
As with all products, we will keep its safety under close review
Field Safety Notices: 8 – 12 December 2025
List of Field Safety Notices from 8-12 December 2025