Licensing of a Pharmaceutical Facility

Service completion duration

  • 5 working days

Service fees

  • Application fee: AED 100
  • Fees for initial inspection, according to facility...

Service Rating

Average Rating : From 0 users

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
    Login to the MOHAP website or smart application to apply for e-services, create an account, get username and password.

    • 2
      Apply to obtain a pre- licensing approval for a pharmaceutical facility

      • 3
        Issue the approval for the local citizen owner

        • 4
          Submit the request - initial inspection and pay inspection fees

          • 5
            Once the initial inspection is approved, a initial approval request will be submitted by the applicant

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

              • 7
                Apply for staff licensing "Pharmacists"

                • 8
                  Apply for final inspection and pay the visit fees

                  • 9
                    Once the final inspection is approved, submit the final approval request with the remaining documents

                    • 10
                      If the application is approved, the license fee will be paid

                      • 11
                        The license is issued electronically and sent via e-mail and can be downloaded via the website

                        Conditions & Requirements

                        1. In respect of pharmacies, warehouses and scientific offices the owner must be a UAE national as per the Companies Law. The client must not own more than two pharmacies in the UAE

                          • The following technical and health conditions must be met in pharmaceutical facilities:

                            • In case of submitting an application for a pharmacy license, the applicant should follow “Ministerial circular No. 932 regarding the health and technical conditions that must be met in private pharmacies” Ministerial circular can be viewed through the link below: https://mohap.gov.ae/app_content/legislations/php-law-ar-55/mobile/index.html

                          • In case of submitting an application for a scientific office license, the applicant should follow “Ministerial circular No. 1110 of 2016 regarding scientific offices” Ministerial circular can be viewed through the link below: https://mohap.gov.ae/app_content/legislations/php-law-en-44/mobile/index.html

                          • In case of submitting an application for a medical warehouse license, the applicant should follow “circular No. 90 of 2021 of Federal Law No. 8 of 2019 regarding medical products, the pharmacy profession, and pharmaceutical facilities.

                        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

                        • MOHAP Mobile App

                        Service locations

                        • Mohap Website
                        • MOHAP Smart Application
                        Payment channels
                        • E- Payment

                        Target audience
                        • Pharmacies

                        • Warehouses

                        • Manufacturers of medicines and medical devices

                        • Scientific laboratories

                        • Stock exporters

                        Department name

                        Licensing and Accreditation 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

                        Related Services
                        • This service is not linked with any service

                        Service Bundle

                        This service is not linked with any service Bundle

                        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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