Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
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Designated standards prioritisation
The MHRA invite feedback on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices to help shape future initiatives.
Field Safety Notices: 24 to 28 November 2025
List of Field Safety Notices from 24 to 28 November 2025.
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 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29
A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentration of 40mg/ml of methylprednisolone acetate).
Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): updated safety and educational materials to support patient discussion on reproductive risks
Updated safety and educational materials are now available to support the implementation of the regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. They also include previous updates to product information on the risk of low birth weight in children exposed to valproate during pregnancy.
Medicines recall of all quetiapine oral suspension batches from Eaststone Limited due to incorrect amount of active ingredient
Batches of quetiapine oral suspension from Eaststone Limited are being recalled due to the active content being twice the amount it should be. Patients should not stop taking this medicine without consulting their healthcare professional.