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OTC generic and originator medicines

29 November 2015

The following describes 'generic' and 'originator' medicines in the context of OTC medicine applications.

OTC generic medicine

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; and
  2. has the same pharmaceutical form; and
  3. is bioequivalent; and
  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 Generic topical (locally acting, locally applied) medicines

OTC originator medicine

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.