A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
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Field Safety Notices: 5 to 9 May 2025
List of Field Safety Notices from 5 to 9 May 2025.
Guidance: Operational Information Sharing
Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.
Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator device being contaminated with pathogens.
Statutory guidance: MHRA fees
Fees payable to the MHRA from 2025.
Class 4 Medicines Defect Notification: Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited, UK, EL(25)A/40
Accord Healthcare Limited, UK has informed the MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) do not contain all the required safety information.