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:
- CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: EU Module 5 - Clinical Studies (CPMP/ICH/2887/99 Rev 1 Efficacy)
- CTD for the registration of pharmaceuticals for human use - Nonclinical overview and nonclinical summaries of Module 2 and organisation of Module 4: EU Module 4 - Nonclinical studies (CPMP/ICH/2887/99 Rev 1 Safety)
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