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Biovigilance responsibilities of sponsors of biologicals

Australian requirements and recommendations

13 December 2017

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Your record-keeping requirements

You must retain records pertaining to the reporting requirements and safety of your biological (section 5 of the Therapeutic Goods (Biologicals - Conditions of Inclusion in Register) Determination 2017). Information relating to biovigilance activities and the safety of the biological include, but is not limited to:

  • all adverse event reports (serious, near-serious and non-serious)
  • information surrounding serious threats to public health
  • special situation reports including, but not limited to, reports:
    • from post-registration studies
    • from post-marketing initiatives
    • of exposure during pregnancy and breastfeeding
    • of use in paediatric or elderly populations
    • of lack of efficacy
    • of quality defect issues
    • of transmission of infectious agents
    • of overdose, abuse, off-label use, misuse, medication error or occupational exposure
    • of non-serious adverse reactions and reactions occurring overseas
    • relating to suspended or discontinued products
  • reference safety documents and non-valid reports containing biological-event pairs

These must be kept for as long as the product is approved for inclusion in the ARTG and for a period of 10 years after removal from the ARTG.

General safety information on your biological should also be retained for as long as the product is approved for inclusion in the ARTG. This includes, but is not limited to:

  • ongoing monitoring activities
  • PSURs
  • literature reviews
  • contracts with biovigilance providers
  • documentation regarding changes to reference safety information
  • biovigilance procedural documents
  • biovigilance training documents

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