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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Compliance and enforcement

The Regulatory Compliance Framework sets out the TGA's overall approach to compliance.

Where the pharmacovigilance inspection process identifies deficiencies we will generally, in the first instance, work with you to address the deficiencies, for example by providing you with guidance and examples of best practice where available.

If we identify significant or critical deviations where you fail to comply with pharmacovigilance requirements we can:

  • cancel or suspend medicines from the ARTG for refusing or failing to comply with a condition of registration or listing, under subsections 29D(1)(b) and 30(2)(c) of the Act
  • prosecute offences related to not complying with conditions of registration or listing, under Section 21A of the Act
  • prosecute offences related to not complying with requirements to notify TGA of adverse effects, under Section 29A of the Act.

We publish information about regulatory compliance decisions and actions on our website.

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