🇦🇪UAE

غرامات عدم الامتثال لتتبع تتمين

2 verified sources

Definition

Failure to serialize and track via Tatmeen results in non-compliant products being barred from UAE market, causing direct revenue loss from unsellable inventory and penalties from MoHAP.

Key Findings

  • Financial Impact: AED 50,000+ per major violation (product rejection/audit failure); 20-40 hours/month manual compliance per facility
  • Frequency: Ongoing since Dec 2022; full enforcement by April 2025
  • Root Cause: Manual serialization, aggregation, and reporting without integrated software

Why This Matters

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

Affected Stakeholders

Marketing Authorization Holders (MAHs), Licensed Agents/Distributors, 3PL Providers

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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

فقدان القدرة بسبب التجميع اليدوي

10-20% capacity loss (AED 100,000+ monthly for mid-size wholesaler); 30-50 hours/week manual aggregation labor

تكاليف زائدة للالتزام بتتمين

AED 150,000-500,000 initial setup (GLN, software, training); AED 20,000/month ongoing manual reporting

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

تسريب الخصومات الـ 340B

1-3% margin erosion (AED 100,000-500,000 for AED 50M turnover)

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