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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Legal basis for pharmacovigilance inspections

You must have suitable pharmacovigilance systems in place to fulfil your pharmacovigilance responsibilities as outlined in Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements.

We undertake pharmacovigilance inspections on the basis of the conditions in s28(5) of the Therapeutic Goods Act 1989 and the related powers in s.46A of the Act to ensure you comply with the legislation. This legislation allows an authorised person to enter premises where pharmacovigilance documents are kept and to inspect and make copies of any documents relating to pharmacovigilance activities, for the purpose of determining whether you are complying with the Act and regulations.

In addition, under s.47 of the Act, if an authorised person has reasonable grounds for suspecting that there is evidence of an offence under the Act on the premises (for instance, material that suggests noncompliance with regulation 15A resulting in a breach of reporting requirements), they can enter the premises with consent or a warrant, seize the evidence, and require answers to any questions they put.

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