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Tech alert: TGA Pharmacovigilance Inspection Program Risk Assessment Survey

18 Oct 2022 7:39 AM | Anonymous member (Administrator)

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey, open until 18 December 2022, is designed to inform the TGA about a sponsors medicine portfolio, pharmacovigilance system, inspection history and compliance with Australian pharmacovigilance legislation and guidelines, and will serve as a tool to help prioritise and schedule pharmacovigilance inspections of sponsors.

Please note: Any sponsors who has at least one medicine included on the Australian Register of Therapeutic Goods (ARTG) should complete this survey. medicine sponsors that do not complete this survey will be assigned the highest survey risk score, meaning you will have a very high chance of receiving a Pharmacovigilance Inspection under the TGA's PVIP.

The survey questions relate only to medicines (not medical devices or biologicals) in the ARTG including all listed, registered and provisionally registered medicines.

Sponsors are directed to complete and submit their survey responses online; the survey consists of 24 questions and must be completed in one attempt only. Partially completed surveys will not be recorded and cannot be retrieved for later use.

The TGA request that stakeholders answer the questions carefully and truthfully as they may ask for evidence of responses during a pharmacovigilance inspection. A copy of the survey questions is available to assist stakeholders prepare their responses prior to submission.

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