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Testing of biological medicines

Applicable to biological medicines, excluding vaccines, anti-venoms and toxins

19 July 2019

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Risk assessment tool for biological medicines

To assess the potential risks posed by a therapeutic good objectively, we use an internal risk assessment tool to address:

  • consequences, which are inherent risks in the product and its use
  • likelihood, which are risks posed by manufacturing, distribution and marketing

Post-market monitoring program - determining time intervals

The risk assessment tool is also used to assign:

  • testing intervals for the post-market monitoring program
  • risk assessment intervals for reviewing a product's risk rating

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