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
