ARGOM Appendix 2: Guidelines on quality aspects of OTC applications

The Therapeutic Goods Act 1989 (the Act) requires that applications for a product registration be evaluated "having regard to whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established".

All applications for over-the-counter (OTC) medicine registration must be supported by evidence to substantiate the quality of the product. This part of the guidance document describes the information regarding the quality of the product should be submitted for OTC medicine applications. It is divided into eleven sections as follows:

1. Application format and content
2. Active substance
3. Description and composition of the medicines (finished product)
4. Development pharmaceutics and formulation
5. Manufacture of the medicines
6. Control of excipients
7. Control of finished product
8. Finished product container
9. Stability of the finished product
10. Microbiological testing
11. Checklist for submission of stability data