Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
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Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
Class 4 Medicines Defect Notification: Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus Pharmaceuticals UK Ltd, EL(25)A/39
Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution (pack size 150ml and 280ml bottles).
Health Institution Exemption – Stakeholder survey
The MHRA invites health institutions in Great Britain to share their experience of the health institution exemption (sometimes referred to as an in-house manufacturing exemption).
MHRA updates guidance for semaglutide prescribers and patients
MHRA updates product information regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide.
MHRA Safety Roundup: September 2025
Summary of the latest safety advice for medicines and medical device users
MHRA smashes major illicit weight loss medicine production facility in record seizure
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