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Australian regulatory guidelines for OTC medicines (ARGOM)
The Australian Regulatory Guidelines for over the counter medicines (ARGOM) assist applicants and sponsors with the process of applying to either register new OTC medicine or make changes to the registry details of a registered OTC.
OTC medicines registration basics
Supporting information
These guidance materials provide information about the application process, specific technical requirements and types of OTC medicines.
Application process for OTC medicines
Application levels for OTC medicines
Specific technical guidance for OTC medicines
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OTC medicines - Safety and efficacy data (was Appendix 1 of ARGOM)
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ARGOM Appendix 2: Guidelines on Quality Aspects of OTC medicines
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ARGOM Appendix 3: Guidelines on Presentation aspects of OTC medicines
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ARGOM Appendix 4: Guidelines on OTC medicines applications for new substances
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ARGOM Appendix 5: Guidelines on OTC medicines applications for specific substances
TGA medicines guidance
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Systemic literature searches for literature based submissions
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Guidance 17: Microbial quality of prescription and over-the-counter medicines