How to Get a UAE Pharmaceutical Import Licence Guide 2026
UAE pharmaceutical imports are regulated by the Ministry of Health and Prevention (MOHAP) at the federal level, with DHA (Dubai Health Authority) and DOH (Department of Health Abu Dhabi) at the emirate level. Importing pharmaceuticals to UAE without the correct licences is a serious regulatory offence. This guide covers UAE pharmaceutical import licensing for 2026.
In this guide:
UAE Pharmaceutical Regulatory Framework
- Federal authority: Ministry of Health and Prevention (MOHAP) is the primary federal regulator for pharmaceutical imports; all drugs must be registered in the UAE Drug Register (Yadawee) before import
- Emirate regulators: Dubai DHA and Abu Dhabi DOH have additional requirements for pharmaceutical distribution within their emirate; alignment with MOHAP but sometimes additional approvals needed
- Controlled substances: Schedule I and II controlled medicines have additional import permit requirements from MOHAP; strict quotas and record-keeping
- SFDA alignment: UAE aligns with Gulf Health Council (GHC) and Saudi Food and Drug Authority (SFDA) standards for some pharmaceutical approvals
UAE Pharmaceutical Import Licence — Prerequisites
- UAE trade licence with pharmaceutical activity: must have a UAE company (mainland or free zone) with “pharmaceutical products trading” as a licensed activity
- MOHAP pharmaceutical company registration: the importing company must be registered with MOHAP as a pharmaceutical entity; requires a qualified pharmacist as the Responsible Person (UAE Pharmacist Licence required)
- Product registration (Yadawee): each drug product must be registered individually in Yadawee (UAE Drug Database); import of unregistered drugs is not permitted (except for compassionate use with special MOHAP approval)
- Manufacturer GMP compliance: the manufacturing facility must hold a GMP (Good Manufacturing Practice) certificate issued by a recognised regulatory authority (EMA, US FDA, UK MHRA, PIC/S member authority)
UAE Drug Registration Process (Yadawee)
- Apply via Yadawee (yad.mohap.gov.ae): create an account; submit new drug registration application
- Required documents: full dossier (CTD format preferred); product information (SPC, PIL); GMP certificates; stability data; clinical data or bioequivalence study (for generics); manufacturing site information
- MOHAP review: MOHAP evaluates safety, efficacy, and quality; review takes 6-24 months depending on product type (new molecular entities take longest)
- Registration approval: MOHAP issues a Drug Registration Certificate; product can then be imported
- Annual renewal: drug registration must be renewed annually; re-submission required if formulation or manufacturer changes
UAE Pharmaceutical Import Cost Estimate
- Trade licence with pharma activity: AED 20,000-35,000/year (mainland DED)
- MOHAP company registration: AED 5,000-10,000 one-time
- Drug registration per product: AED 5,000-15,000 per product; multiple products = significant upfront investment
- Qualified pharmacist: AED 10,000-20,000/month UAE salary for a licensed pharmacist serving as Responsible Person
- Total first-year cost (1 product): AED 70,000-130,000 excluding inventory