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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
- Overview of OTC medicines registration
- OTC medicines registration process
- Process to change a registered OTC medicine
- Changing an OTC medicine: using the Changes Tables
- Fees and payments
- Target evaluation times
- 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
OTC medicines - Safety and efficacy data (was Appendix 1 of ARGOM)