In Australia, the Therapeutic Goods Administration (TGA) approves medicines and medical devices for specific indications based on clinical evidence submitted at the time of registration. When a prescriber orders a medicine outside those approved conditions , for a different disease, a different patient age group, a different dose, or a different route , that use is described as off-label. The term carries no inherent judgment about safety or efficacy; it is a regulatory classification, not a clinical one.
Off-label prescribing is lawful in Australia under the Therapeutic Goods Act 1989 (Cth). A registered medical practitioner may prescribe an approved medicine off-label at their professional discretion, provided they have clinical justification and obtain informed consent from the patient. This differs from unapproved goods, which are not on the ARTG at all and require separate TGA authorisation , such as the Special Access Scheme (SAS) or an Authorised Prescriber arrangement; before supply is permitted.
Off-label use is well-documented across many therapeutic areas, including paediatric medicine (where approved paediatric formulations are often absent), oncology, and neurology. The absence of an on-label indication does not mean evidence is lacking; it commonly reflects that a manufacturer has not pursued a formal indication variation with the TGA, which is a commercial decision separate from clinical evidence.
Prescribers, patients, and pharmacists should be aware that off-label use shifts elements of prescribing responsibility toward the individual clinician. Professional indemnity considerations, documentation of informed consent, and adherence to relevant state and territory poisons legislation all apply. Regulatory bodies including the TGA publish guidance on responsibilities when prescribing outside approved indications.
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