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PV06: Urgent Safety Restrictions

PV06: Urgent Safety Restrictions

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Highlights

  • On-Demand course

  • 45 minutes

  • Intermediate level

Description

An Urgent Safety Restriction (USR) is a regulatory action taken, in response to a safety signal, to make an interim change to the terms of the marketing authorisation for a medicinal product in Europe. This module describes the principles and procedures for USRs.

course Content

1 section•1 lesson
Contents1 lesson
  1. PV06: Urgent Safety Restrictions

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