As of 1 September 2017 the TGA’s Pharmacovigilance Inspection Program (PVIP) will be commencing.

Pharmacovigilance refers to the monitoring and prevention of the adverse effects of medicines, after they have been approved for use. All sponsors are legally responsible for meeting pharmacovigilance reporting requirements for all medicines listed on the Australian Register of Therapeutic Goods (ARTG), regardless of their marketing status – that is, whether they are currently available for purchase, withdrawn from sale or otherwise.

It is expected that a system should be put in place by each sponsor, to ensure the acquisition of sufficient information for the scientific evaluation of adverse reactions and