Category Pharmacovigilance

TGA Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey for medicine sponsors

The TGA is conducting a Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey for medicine sponsors. The survey is now open for medicine sponsors to complete.  Background to the survey The survey is designed to inform the TGA about the following…

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Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities

The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. About Commission Implementing Regulations A Commission Implementing Regulation is a legally binding act of the European Union. It is…

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