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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
- OTC medicines advisory committee process
- Changing an OTC medicine: using the Changes Tables
- Changing paracetamol solid-dose products affected by the 2023 scheduling decision
- Guidelines on OTC new N1 applications
- Assurances to accompany N1 applications
- N2 applications and OTC medicine monographs
- Requirements for OTC new medicines N2 applications
- Publishing OTC medicine PIs and CMIs on the TGA website
Application levels for OTC medicines
- Determining your application level
- OTC Medicines categorisation framework
- OTC application placement flowchart
- Application route for umbrella branded medicines
Specific technical guidance for OTC medicines
- OTC medicines - Safety and efficacy data (was Appendix 1 of ARGOM)
- ARGOM Appendix 2: Guidelines on Quality Aspects of OTC medicines
- ARGOM Appendix 3: Guidelines on Presentation aspects of OTC medicines
- ARGOM Appendix 4: Guidelines on OTC medicines applications for new substances
- ARGOM Appendix 5: Guidelines on OTC medicines applications for specific substances
TGA medicines guidance
- Pathways to a scheduling decision
- Australian regulatory guidelines for sunscreens
- Colourings used in medicines for topical and oral use
- Systemic literature searches for literature based submissions
- Guidance 10: Adventitious agent safety of medicines
- Guidance 11: Drug master files and certificates of suitability or a monograph or the European pharmacopoeia for drug substances
- Guidance 15: Biopharmaceutic studies
- Guidance 17: Microbial quality of prescription and over-the-counter medicines
- Inhalation and nasal spray registered medicines
- Guidance 21: Medicines produced by genetic manipulation