Australian regulatory guidelines for OTC medicines (ARGOM)

Supporting information

These guidance materials provide information about the application process, specific technical requirements and types of OTC medicines.

In this section: Application process for OTC medicines | Application levels for OTC medicines | Specific technical guidance for OTC medicines | TGA medicines guidance | European union and ICH guidance

Application process for OTC medicines

• OTC medicines advisory committee process

• Changing an OTC medicine: using the Changes Tables

• 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

European union and ICH guidance

• Scientific guidelines - European Union and ICH guidelines adopted in Australia