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OTC medicines - Safety and efficacy data

30 November 2015

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This guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either:

  • register an OTC medicine in the ARTG
  • vary the safety and/or efficacy aspects of a registered OTC medicine.

For guidance on how to present clinical efficacy and safety data in the CTD format, see:

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