Tga pv guidelines

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pharmacovigilance reporting requirements

Your pharmacovigilance responsibilities outlined in this guidance is underpinned by legislation. Under subsection 28(5)(e) of the Therapeutic Goods ActYour pharmacovigilance reporting requirements (i.e. what, how and when you MUST report) are summarised in the table below. The TGA applies a risk management approach to ensuring that medicines included on the Australian Register of Therapeutic Goods (ARTG) meet acceptable standards The Therapeutic Goods Administration (TGA) collects and evaluates information related to the benefit-risk balance of medicines in Australia to monitor their