Welcome to the new version of the Patents Manual. Please note there are changes to the numbering and sequence of the chapters and pages in the manual. You are encouraged to take the time to explore and familiarise yourself with this new structure. Meaning of Pharmaceutical Substance

Date Published

Schedule 1 defines a pharmaceutical substance as follows:

"pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

(a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or

(b) action on an infectious agent, or on a toxin or other poison, in a human body;

but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing”.

From this definition, the substance must have at least one therapeutic use, which is defined in schedule 1 as follows:

"therapeutic use means use for the purpose of:

(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

(b) influencing, inhibiting or modifying a physiological process in persons; or

(c) testing the susceptibility of persons to a disease or ailment”.

If a substance is listed in the ARTG, there is a prima facie assumption that the substance is a pharmaceutical substance, and therefore the Commissioner is unlikely to query whether a substance is a pharmaceutical substance within the meaning of the Act without good reason.

Amended Reasons

Amended Reason Date Amended
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