Licensing of a Pharmaceutical Facility

Service completion duration

  • 5 working days

Service fees

  • Application fee: AED 100
  • Fees for initial inspection, a...
  • Final inspection fees, accordi...
  • Fees for accrediting the geome...
  • Final license fees, according ...

Service Rating

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About the Service

This service enables applications for a license to establish a pharmaceutical facility to sell pharmaceutical products and medical supplies, to register, import and distribute pharmaceutical products and medical supplies, to represent companies, pharmaceutical factories and international medical supplies registered in the country, to export and re-export pharmaceutical products and medical supplies, or to manufacture pharmaceutical products and medical supplies.

Service Process

  • 1
    Register in e-services, create a user name and password, and access the e-service

    • 2
      Submit an application for a facility license and pay fees

      • 3
        Submit application for initial inspection

        • 4
          Once initial inspection is approved, submit request to study the geometric plan and pay fees

          • 5
            Once site plan is approved, the initial approval for inspection will be issued

            • 6
              Proceed with finalizing the license requirements from relevant government departments, such as Civil Defense

              • 7
                Apply for licensing of medical staff (pharmacists)

                • 8
                  Apply for final inspection

                  • 9
                    Once final inspection is approved, pay the final licensing fees and submit the remaining documents

                    • 10
                      The license will be issued through the e-system, sent via email and can also be downloaded from the website

                      * With respect to factories and warehouses for the purpose of re-export, this service is provided through Customer Happiness Centers following the same procedures and steps.

                      Conditions & Requirements

                      1. In respect of pharmacies, warehouses and scientific offices, the majority owner of 51% of the capital share must be a UAE national as per the Companies Law.

                      2. The client must not own more than two pharmacies in the UAE.

                      3. The area of ​​the pharmacy or scientific office must cover a minimum of 30 square meters, the area covered by internal pharmacies in hospitals should be of reasonable size, and that of a warehouse area must cover a minimum of 50 square meters excluding administrative offices and toilets.

                      4. The pharmaceutical facility must not be linked with any other commercial activity.

                      5. The pharmacy location must be more than 200 meters from the nearest pharmacy.

                      6. The pharmacy must be located on the ground floor, with the exception of pharmacies in commercial centers.

                      7. Initial approval will be valid for six months only, during which time the pharmacy owner is required to meet all technical requirements and conditions to obtain the license from the Ministry of Health. There is no fixed period for factories. *In addition, the following requirements apply to pharmacies and medical warehouses:

                      8. There must be shelves and storage tanks to preserve medicines.

                      9. There must be an air-tight locker to preserve controlled medicines.

                      10. There must be a refrigerator with a digital thermometer.

                      11. There must be adequate air conditioning for the area size.

                      12. There must be adequate lighting.

                      13. There must be working fire extinguishers.

                      14. There must be signage (Arabic and English with all characters in one standard size) conforming to the technical conditions, with the name approved by the Pharmaceutical Licensing Committee.

                      15. The shift schedule must be displayed.

                      16. There must be a first aid kit.

                      17. There must be curtains for glass facades exposed to the sun.

                      18. There must be devices to deter insects

                      19. There must be a thermometer in the pharmaceutical facility

                      Service completion duration
                      • 5 working days
                      Service fees

                      Application fee: AED 100

                      Fees for initial inspection, according to facility:

                      Warehouses, pharmacies and scientific offices: AED 1,000 per inspection
                      Drug manufacturers and medical devices: AED 3,000 per inspection

                      Final inspection fees, according to facility:

                      Warehouses, pharmacies and scientific offices: AED 1,000 per inspection
                      Drug manufacturers and medical devices: AED 3,000 per inspection

                      Fees for accrediting the geometric plans for factories of medicines and medical devices: AED 2,000

                      Final license fees, according to facility: - Pharmacies and warehouses: AED 7,500

                      Factories of medicines and medical devices: AED 50,000
                      Scientific offices: AED 10,000
                      Stock for export: AED 10,000
                      Service channels
                      • MOHAP Website

                      • Service Centers

                      • Printing Offices

                      Service locations

                      • Mohap Website (application, payment and service) 24-hour service
                      • Printing offices (application, payment and service) as per the working hours of the centers
                      • Customer Happiness Centers ( Dubai, Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah, Fujairah) as per the working hours of the centers
                      Payment channels
                      • E- Payment

                      Target audience
                      • Pharmacies

                      • Warehouses

                      • Manufacturers of medicines and medical devices

                      • Scientific laboratories

                      • Stock exporters

                      Department name

                      Regulation, Licensing & Advertisement Department

                      Sector name

                      Health Regulation Sector

                      Main service

                      Medical Establishment Licencing and Registration

                      Service Code

                      110-03-020-000

                      Service Classfication

                      Transactional

                      Service Type

                      Government to Business

                      Sub Service Type

                      Variation

                      Number of Users

                      213

                      Notes

                      This service is linked to various services from other government agencies, including:

                      1. Ministry of Interior - for obtaining the owner's security clearance
                      2. Economic Development Departments - for registration of trade name
                      3. Ministry of Health and Prevention - for licensing of medical professionals and pharmacists
                      4. Economic Development Departments - for issuance of trade license
                      5. Civil Defense - for issuance of Civil Defense Certificate
                      Required Documents
                      • Copy of owner's valid passport

                      • Copy of owner's family book

                      • Copy of valid ID card

                      • Site geometric plan approved by the engineering consulting office

                      • Land planning map for the facility site approved by the municipality

                      • Recent color photograph

                      • Copy of valid lease

                      • Character reference documents of the owner and the pharmacist in charge (document available from a Customer Happiness Center)

                      • Copy of valid trade license issued by Department of Economic Development

                      • Copy of license of the pharmacist responsible for pharmaceutical facility * In addition, for pharmaceutical factories and medical products:

                      • Copies of passports of factory partners

                      • Partnership contract guaranteeing shareholders rights

                      • Copy of the Memorandum of Association

                      • Copy of the feasibility study

                      • Copies of the appointments of the technical director, the director of production and quality, and heads of departments * For stock intended for re-export:

                      • Copy of valid free zone license for import and export warehouses

                      • Good manufacturing certificate valid for products

                      • Contract between company and warehouse

                      Sustainable Goals
                      Good Health And Well-Being

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