This therapeutic good cannot be advertised to the public. To do so would be unlawful under:
- Ss. 42DL(12) (criminal), and
- Ss. 4DLB (9) (civil) penalties for advertising.
Regulatory status of the good
The responses you have given indicate that there may not be an exemption in place that would allow the good to be supplied in Australia without being included in the ARTG. If there is no such exemption, the supply of the therapeutic good itself may be illegal.
Other possible exemptions
Some goods are exempt from entry in the ARTG on the basis that they are only accessible through specific pathways under the Act for unapproved therapeutic goods. These pathways include:
- Special Access Scheme A
- Special Access Scheme B
- Authorised Prescriber
- Clinical Trial Approval (CTA)
- Clinical Trial Notification (CTN)
- Personal importation
Medicines accessed through the approved therapeutic goods pathways generally are, or are likely to meet the requirements for scheduling as, prescription medicines. In any case, such goods cannot be advertised to consumers.
Other types of therapeutic goods exempt from the requirement to be entered in the ARTG include:
- Blood and blood components manufactured by the holder of a licence to manufacture such products
- Some disinfectants
- Allergens for skin patch testing on unbroken skin
Illegal therapeutic goods
A therapeutic good that is not entered in the ARTG and is not subject to an exemption from the requirement to be entered in the ARTG is an illegal therapeutic good.
In addition to advertising penalties, the Act provides for criminal and civil penalties for the supply of illegal therapeutic goods and courts can impose heavy fines or even terms of imprisonment:
- Medicines - s.19B (criminal offences) and s.19D (civil penalties)
- Biologicals - s.32BD (criminal offences) and s.32BF (civil penalties)
- Medical devices - s.41MI (criminal offences) and s.41MIB (civil penalties)
Illegal medicines can be contaminated with prescription-only substances or harmful adulterants and are often made in unapproved places. The TGA regularly issues alerts about illegal therapeutic goods that represent safety risks to alert the public not to buy or use such goods. See the TGA's Alerts page for examples.