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Guidance

Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.

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  • OTC medicines - Safety and efficacy data

    Guidance
    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 or vary the safety and/or efficacy aspects of a registered OTC medicine. (Formerly ARGOM Appendix 1)

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