Minimum Stockholding Requirement Breaches
Definition
Failure to maintain minimum stock levels or disclose accurately for PBS Designated Brands triggers breaches under MSR, with mandatory notifications for likely or actual non-compliance.
Key Findings
- Financial Impact: AUD 50,000+ in tied-up inventory capital per Designated Brand (4-6 months stock) plus AUD 20,000-100,000 estimated penalties per breach
- Frequency: Twice-yearly disclosures; ongoing monitoring
- Root Cause: Manual Lot Number and NDC tracking fails to provide real-time visibility into stock levels
Why This Matters
The Pitch: Wholesale Drugs players in Australia waste AUD 100,000+ annually on tied-up capital and breach risks from manual inventory. Automation of Lot Number tracking ensures MSR compliance.
Affected Stakeholders
Inventory Manager, Responsible Person, Compliance Officer
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.
Related Business Risks
Wastage from Oversupply and Expired Lots
S4R and S8 Medicines Inventory Discrepancies
Chargeback Fraud Claims
Chargeback Processing Errors
Manual Chargeback Reconciliation
PBS Wholesaler Supply Penalties
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