Regulatory classification
Launch blocker
Substantial Gap
Product contains active ingredients at concentrations exceeding AICIS industrial chemical thresholds. At assessed concentrations, the product meets the definition of a therapeutic good under the Therapeutic Goods Act 1989 and requires TGA registration prior to supply in Australia. AICIS listing is insufficient. Regulatory pathway must be amended before any supply or marketing activity.
Market registration
Launch blocker
Substantial Gap
No ARTG listing exists for this product in Australia. Supply of a therapeutic good without a valid ARTG entry is a criminal offence under the Therapeutic Goods Act 1989. No supply, commercial importation, or advertising may occur until an AUST L number is issued. Estimated processing time is 3–6 months from a complete submission.
Labelling and packaging
Actionable Gap
Current label does not meet TGO 92 requirements for listed therapeutic goods. Required elements absent include: AUST L number (obtainable only post-registration), advisory statements for specified ingredients, dosage instructions in the mandatory format, and required warning statements. The existing label must be fully revised before supply.
Safety testing and certification
Actionable Gap
Existing safety data is adequate for AICIS purposes but does not meet TGA listed medicine standards. Microbiological testing to TGO 100 standards and heavy metals testing to Ph. Eur. standards are required for the ARTG application dossier. Existing data should be reviewed; additional testing commissioned where gaps are identified.
Ingredient and formulation compliance
Compliant
All ingredients assessed against TGA listed medicines permitted ingredients list (ARTG Ingredients Database). Each active ingredient is eligible for inclusion in a listed medicine at the formulated concentration. No prohibited or scheduled substances identified. Formulation is suitable for the listed medicine pathway subject to documentation requirements above.