Bußgelder wegen TGA- und ARTG-Verstößen bei Ergänzungs- und Kräuterprodukten
Definition
The TGA requires that medicines, including complementary and herbal products, are entered in the ARTG and display an AUST L or AUST R number on their label before they can be legally sold in Australia.[3] Failure to comply can lead to infringement notices and court action under the Therapeutic Goods Act 1989, with civil penalties for unlawful import, supply or advertising. LOGIC: In a supplement and herbal dispensary environment, products are frequently added, repacked or relabelled. Without systematic checks, manual processes can result in non‑ARTG products being stocked or supplied, incorrect labels being printed, or claims on labels/online listings that breach TGA advertising requirements. A single TGA infringement notice for unlawful advertising or supply can run to tens of thousands of dollars, and a recall of affected inventory can destroy much or all of the batch value plus disposal and communication costs. For a small operator, one enforcement action combined with stock destruction can easily exceed AUD 50,000–200,000 in total direct and indirect losses. Larger chains with multiple SKUs and higher throughput can face far higher aggregate losses if systematic inventory‑labelling issues are uncovered across many products and stores.
Key Findings
- Financial Impact: Logic-based: AUD 13,000–60,000+ per TGA infringement notice under the Therapeutic Goods Act, plus AUD 20,000–200,000 per recall in destroyed or written‑off stock and operational costs; total exposure AUD 50,000–250,000+ per major non‑compliance incident.
- Frequency: Low to medium frequency but high‑impact events, typically triggered by TGA investigations following complaints, audits or market surveillance of complementary medicine suppliers.
- Root Cause: Lack of integrated compliance checks in the inventory system (no automatic verification of ARTG status or AUST number at product setup), manual label creation for herbal and supplement lines, poor control over product data when adding new SKUs, and fragmented responsibility between practitioners, front‑of‑house staff and suppliers.
Why This Matters
The Pitch: Alternative medicine retailers and dispensaries in Australia 🇦🇺 waste AUD 10,000–250,000+ per incident on TGA compliance breaches tied to inventory and product management (unregistered lines, mislabelled batches, supply of expired stock). Automation of product master data, batch/expiry tracking and TGA‑status checks in the inventory system eliminates most of this risk.
Affected Stakeholders
Inhaber von Naturheilpraxen mit eigenem Dispensary, Apothekenleiter mit alternativmedizinischem Sortiment, E-Commerce-Leiter für Nahrungsergänzungsmittel, Qualitäts- und Compliance-Manager für komplementäre Medizin
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Financial Impact
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Current Workarounds
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Methodology & Sources
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Related Business Risks
Vernichtung von Beständen durch Qualitäts- und Lagerfehler bei Nahrungsergänzungsmitteln
Umsatzverlust durch Bestandsfehler und Fehlbestände im Supplement- und Kräuterhandel
Produktivitätsverlust durch manuelle Bestandsführung und Kommissionierung von Nahrungsergänzungsmitteln
Kunden- und Patientenabwanderung durch Lieferverzögerungen und Fehlmengen bei alternativen Therapien
TGA Non-Reporting Penalties
AEFI Under-Reporting Costs
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