Starting a pharmaceutical company in the UAE requires multiple regulatory approvals from federal and emirate health authorities. Here is a complete guide to UAE pharmaceutical company setup in 2025.
UAE Pharmaceutical Regulatory Authorities
Pharmaceutical businesses in the UAE are regulated by: MOHAP (Ministry of Health and Prevention) at the federal level (product registration, wholesale distribution, manufacturing). DHA (Dubai Health Authority) in Dubai for pharmacies and healthcare-related businesses. DOH (Department of Health) in Abu Dhabi for Abu Dhabi-based pharma businesses. ESMA (Emirates Authority for Standardisation and Metrology) for product quality standards. The UAE has one of the most rigorous pharmaceutical regulatory frameworks in the Arab world.
UAE Pharmaceutical Import and Distribution
To import and distribute pharmaceutical products in the UAE: MOHAP wholesale distributor licence (required for any company importing or distributing medicines in the UAE). Requirements: UAE mainland company (free zone companies cannot hold MOHAP wholesale distributor licences), qualified pharmacist on staff (minimum: a MOHAP-licensed pharmacist employed by the company), temperature-controlled storage facility (GDP-compliant), and a clear chain of custody and cold-chain documentation system. Drug registration: every pharmaceutical product sold in the UAE must be registered with MOHAP. Product registration takes 6-24 months and requires: product dossier (CTD format), stability data, and bioequivalence data (for generic medicines).
UAE Pharmacy Licence (Retail)
Retail pharmacies in Dubai: licensed by DHA. Requirements: DAST-licensed pharmacist in charge (responsible pharmacist), DHA-approved location (not within 200m of another pharmacy in some cases), and inspection and fit-out approval from DHA. In Abu Dhabi: licensed by DOH. Similar requirements. There are approximately 1,000+ pharmacies in Dubai and 500+ in Abu Dhabi. The market is growing, driven by a large expat population accustomed to pharmacy-based healthcare in their home countries.