🇦🇺Australia

TGA Non-Reporting Penalties

2 verified sources

Definition

Mandatory reporting for sponsors (pharmaceutical companies including complementary medicine sponsors) of serious adverse events; non-compliance exposes to civil penalties. Alternative medicine providers treat CAM as listed medicines requiring pharmacovigilance.

Key Findings

  • Financial Impact: AUD 100,000 to 500,000+ civil penalty per serious breach
  • Frequency: Per unreported serious adverse event
  • Root Cause: Manual documentation delays and failure to meet mandatory reporting deadlines

Why This Matters

The Pitch: Alternative Medicine providers in Australia 🇦🇺 risk AUD 500,000+ fines per violation on adverse reaction reporting. Automation of documentation and TGA submission eliminates this risk.

Affected Stakeholders

Business Owners, Compliance Officers, Product Sponsors

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

AEFI Under-Reporting Costs

2-5% annual revenue loss from recalls and claims; 20-40 hours/month manual reporting burden

State AEFI Reporting Fines

AUD 5,000-20,000 fine per unreported statutory AEFI

Verzögerter Geldeingang bei Selbstzahler-Abonnements

Quantified: ≈ 39 % higher receivables without optimised billing; for AUD 100,000 monthly sales this can mean ≈ AUD 39,000 extra outstanding plus ≈ 1–3 % of annual revenue (AUD 12,000–36,000) in bad‑debt write‑offs.

Überhöhte Verwaltungskosten durch manuelle Paket- und Mitgliedsabrechnung

Quantified: ≈ 20–40 admin hours per month on manual cash‑pay billing; at AUD 35–45/hour this is ≈ AUD 8,400–21,600 per year in excess wage costs.

Kundenabwanderung durch intransparente Paket- und Mitgliedsabrechnung

Quantified: Estimated 5–10 % of package and membership revenue lost to churn, refunds and cancellations; for AUD 500,000 annual revenue this is ≈ AUD 25,000–50,000 per year.

Steuerrisiko und Strafzuschläge durch fehlerhafte Abrechnung von Paketleistungen

Quantified: ATO administrative penalties commonly 25–50 % of the tax shortfall; e.g. on an AUD 8,000 GST shortfall, penalties of ≈ AUD 2,000–4,000 plus interest.

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