Tag Archives: ukqppv

MHRA Guidance on UK QPPV and PSMF in the Event of a No Deal Brexit

The MHRA has published guidance on the UK qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF), if the UK leaves the EU without a deal. This is a must read for all UK Marketing Authorisation Holders; please contact us if you would like to discuss how Purple Vigilance can help with these requirements. The full guidance can be found by following the link below:

https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-if-the-uk-leaves-the-eu-w