How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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MHRA updates product information regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide.
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Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products.
Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Statutory guidance: MHRA fees
Fees payable to the MHRA from 2025.
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.
Decentralised manufacture: The designation step
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.