🇦🇪UAE

غرامات عدم الامتثال للقانون الاتحادي رقم 38 لسنة 2024

4 verified sources

Definition

The new UAE pharmaceutical law imposes harsher penalties for violations including fines up to 1 million AED ($270,000 USD) and increased imprisonment terms. The EDE gains expanded enforcement powers to conduct inspections, seize non-compliant products, and shut down establishments. Retail pharmacies administering vaccines must ensure full compliance with vaccine handling, storage temperature controls, and immunization registry documentation within the one-year grace period (through January 2, 2026).

Key Findings

  • Financial Impact: Up to 1,000,000 AED per violation; additional risk of license revocation (total revenue loss). Typical compliance costs estimated at 50,000-150,000 AED per pharmacy for system upgrades and staff training.
  • Frequency: One-time penalty per violation; ongoing compliance risk until grace period expires (January 2026)
  • Root Cause: New regulatory framework consolidates scattered requirements under centralized EDE authority. Existing manual immunization registries and vaccine administration records may not meet expanded documentation and traceability standards required by Federal Decree-Law No. 38 of 2024.

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Retail Pharmacies.

Affected Stakeholders

Pharmacy managers, Pharmacists administering vaccines, Compliance officers, Warehouse/storage managers

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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 الإيرادات من تقارير السجلات اليدوية للتطعيم

Estimated 2-5% of vaccine administration revenue per pharmacy; for typical UAE retail pharmacy administering 100-200 vaccines/month at 50-150 AED per service = 5,000-45,000 AED annual leakage per location.

نقص المخزون والتناقضات في تسجيل المخدرات

2–5% of narcotic inventory value annually (typical retail pharmacy: 100,000–500,000 AED annual narcotic stock); estimated loss 2,000–25,000 AED per year; detection delays add 20–40 hours/month reconciliation labor at 200 AED/hour

هدر الأدوية منتهية الصلاحية

2-8% of pharmaceutical inventory value; estimated AED 50,000-500,000+ annually per pharmacy network depending on inventory size

عدم الامتثال لمتطلبات تسجيل الأدوية والمراقبة

MOHAP compliance fines estimated AED 10,000-100,000+ per violation; license suspension risk; Corporate Tax penalties for unreconciled inventory discrepancies estimated 2-5% of unreported stock value

أخطاء في قرارات إعادة الترتيب والتنبؤ بالطلب

3-5% revenue loss from preventable stockouts; 2-4% capital waste from overstocking; estimated AED 100,000-500,000 annually for mid-size UAE pharmacy network

تقليص المخزون والسرقة وعدم المراقبة

1-3% inventory shrinkage; estimated AED 75,000-300,000 annually per mid-size pharmacy network; plus potential MOHAP penalties for unaccounted controlled substances (fines AED 50,000+)

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