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PSMF – Pharmacovigilance system master file and QPPV – Qualified person for pharmacovigilance

In which way and by what deadline is it possible to submit the pharmacovigilance system summary of a marketing authorisation holder?

Requirement for a MAH to be obliged to immediately provide information about changes in the PSMF in accordance with Section 91, Sub-section 2, Letter b). Does this mean that each change in the PSMF must be reported to SÚKL?