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HomeRegulationsPHV-3

PHV-3

VERSION 4 in force from:

PHV-3 (ENG):

PHV-3 v. 4: Non-Interventional Post-Authorisation Safety Studies of Medicinal Products for Human Use

PHV-3 (CS): in process

NAME: Non-Interventional Post-Authorisation Safety Studies of Medicinal Products for Human Use

Introduction
Definitions
How to notify SÚKL/EMA of performing PASS
Notification forms to inform SÚKL
Documents for audit and inspection
Recommended sources of further information

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