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Pharmacovigilance responsibilities of medicine sponsors

Australian recommendations and requirements

27 June 2018

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Your record-keeping requirements

Under paragraph 28(5)(ca) of the Act, you MUST retain records pertaining to the reporting requirements and safety for your medicine. Information relating to pharmacovigilance activities and the safety of the medicine include, but is not limited to, all adverse reaction reports (serious and non-serious), information surrounding significant safety issues, special situation reports, reference safety documents and non-valid reports containing drug-event pairs. These MUST be retained indefinitely for the life of the medicine and for:

  • a period of 10 years after removal from the ARTG for registered medicines, and
  • a period of 5 years after removal from the ARTG for listed medicines.

General safety information on your medicine including but not limited to ongoing monitoring activities, PSURs, literature reviews, contracts with pharmacovigilance providers, documentation regarding changes to reference safety information, pharmacovigilance procedural documents and pharmacovigilance training documents should also be retained indefinitely for the life of the medicine. We may also ask to review these records on request, or as part of the Pharmacovigilance Inspection Program.

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