Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF)

11 May 2023 – the UK MHRA published updated guidance on pharmacovigilance system requirements.

New guidance has replaced the previous section; 'Notification of QPPV and PSMF details to the MHRA by existing holders of UK marketing authorizations'. This guidance replaces the previous requirement to submit a Type IA(IN) variation and an accompanying eCTD sequence to make these changes. This has been simplified and only an update notification is required, there is no requirement to submit an eCTD sequence.

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