Pharmacovigilance system master file – PSMF, periodic safety reports – PSUR/PBRER/DSUR regular and including as per Decision 1583, risk management plans (RMP) in EAEU/EU format and harmonization.
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Pharmacovigilance Agency
Pharmacovigilance system master file – PSMF, periodic safety reports – PSUR/PBRER/DSUR regular and including as per Decision 1583, risk management plans (RMP) in EAEU/EU format and harmonization.