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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Inspection follow-up

When non-compliance with Australian pharmacovigilance legislation and guidelines is identified during an inspection, follow-up will be required until a CAPA plan that appropriately addresses the non-compliance is completed. The following follow-up actions may be initiated, as appropriate:

  • meeting with you to discuss the deficiencies, their impact and your action plans
  • reviewing progress reports on the corrective actions
  • re-inspecting to assess appropriate implementation of the CAPA plan
  • asking you to provide us with data you have not yet submitted
  • requesting variations to amend product information document(s)
  • impact analyses, for example following a review of data that were not previously included
  • asking you to issue safety communications or amend marketing and/or advertising information
  • communicating the inspection findings to other regulatory authorities, where applicable under international agreements
  • taking other product-related actions depending on the impact of the deficiencies and the outcome of follow-up

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