Re-formatting of Chapter 6A as Appendix 1 - Guidelines on efficacy and safety aspects of OTC applications.
MAG - OTCME
Webpage format and changed structure
Moved definition of 'generic' to a standalone web page
Updated 'Standard reference texts' and moved to section 4 'Types of data'
Updated LBS guidance and linked to common TGA guidance
Revised 'bioequivalence data'
Added cases where bioequivalence data not required
Included ingredients which do not need bio data under 'Bioequivalence'
Included reference to generic combination medicines
Requirements for justification of biowaiver links to ARGPM Guidance 15
Updated 'Therapeutic equivalence data' for topicals
Added list of topical generics for which therapeutic equivalence data are not required
Revised 'Products with a new dosage form' section
Reworded Fixed combination guidance
Replaced Modified release guidance with reference to adopted EU guidance
OTC Medicines Regulatory Guidance
30 November 2015
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.