Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit

MHRA updated this guidance on October 11, 2019. Pharmacovigilance system requirements if there is a no-deal Brexit.

The MHRA has updated the Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit by adding new section about the temporary exemption in relation to the pharmacovigilance system master file and adding information about requesting a UK PSMF number via the MHRA Submissions portal.

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