Understanding over-the-counter (OTC) generic and originator medicines

The Therapeutic Goods Regulations 1990, Regulation 2, defines a generic medicine as a medicine that, in comparison with a registered medicine:

1. has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine or previously registered medicine
2. has the same pharmaceutical form
3. is bioequivalent
4. has the same safety and efficacy properties.

In the context of OTC generic medicine applications, the following also apply:

• the comparator medicine is the 'originator medicine'
• for point (b) above, the various immediate release oral dosage forms, e.g. tablets, capsules, oral liquids or suspensions, can be considered to be one and the same 'pharmaceutical form'
• for point (c) above, for locally acting, locally applied medicines replace 'bioequivalent' with 'therapeutically equivalent' - see the information on generic topical (locally acting, locally applied) medicines at OTC medicines - safety and efficacy data for more.

An OTC originator medicine (sometimes referred to as the 'innovator' medicine) is one that has been approved for marketing in Australia on the basis of a full dossier which may include chemical, biological, pharmaceutical, pharmacological-toxicological, and clinical data.