Version history

Update of ARGOM Chapter 6A Efficacy and safety

Re-formatting of Chapter 6A as Appendix 1 - Guidelines on efficacy and safety aspects of OTC applications.

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