🇦🇪UAE

عقوبات انتهاك تتبع NDC و Tatmeen

2 verified sources

Definition

Tatmeen mandates serialization linking Lot Numbers and product codes; inaccurate manual inventory management leads to fines for circulating non-compliant drugs.

Key Findings

  • Financial Impact: AED 10,000 - 50,000 per violation (minimum FTA-equivalent penalties for serialization failures)
  • Frequency: Per imported batch or local trade shipment
  • Root Cause: Manual Lot Number and NDC data entry without GS1 validation

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Wholesale Drugs and Sundries.

Affected Stakeholders

Compliance Officer, Logistics Coordinator, Importer

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

غرامات مخالفات إدارة المخزون الدوائي

AED 50,000 - 200,000 annually in expired stock disposal for mid-sized wholesalers (industry standard 2-5% inventory value)

خسائر من تقليل المخزون بسبب سوء إدارة اللوت

1-3% annual inventory shrinkage (AED 100,000 - 500,000 for AED 10M+ stock)

تكاليف تخزين غير متوافقة للأدوية

AED 50-100 per pallet/day in excess storage + 20-40 hours/month manual rework

غرامات عدم الامتثال للـ VAT

AED 5,000-50,000 per violation; 2-5% revenue exposure from audit adjustments

مخاطر التسعير غير السليم للـ 340B

AED 50,000-500,000 annual inventory shrinkage (2-5% of drug stock); refund liabilities

تكاليف الامتثال الزائدة للـ 340B

40 hours/month manual tracking at AED 200/hour = AED 96,000/year

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