Licensing of a Pharmaceutical Facility

Service completion duration

  • Categories: Pharmacies, warehouses, marketing offices, warehouses for re-exp...

Service fees

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

Service Rating

Average Rating : From 0 users

About the Service

This service allows customers to apply 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 app using the UAE PASS to apply for the service.

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

      • 3
        An approval will be issued for the local citizen owner.

        • 4
          Submit the request for initial inspection and pay the inspection fee.

          • 5
            Once the initial inspection is approved, an initial approval request must be submitted by the applicant.

            • 6
              Proceeded 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 fee.

                  • 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 email. It can also be downloaded via the website.

                        Conditions & Requirements

                        1. For 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.

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

                          • In case of applying 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. Click the link to view the circular:https://mohap.gov.ae/app_content/legislations/php-law-ar-55/mobile/index.html

                          • In case of applying for a medical warehouse license, the applicant should follow Circular No. (90) of 2021 of Federal Law No. (8) of 2019 on Medical Products the Profession of Pharmacy and Pharmaceutical Facilities.

                        FAQ’s

                          • Yes, provided that the local authority to which the facility belongs issues an approval letter regarding the percentage of foreign ownership.

                          • To obtain the final approval for the license, the facility should appoint a licensed experienced pharmacist in the following roles:

                            • Technical manager

                            • Quality manager

                            • Production manager

                        Service completion duration

                        Categories: Pharmacies, warehouses, marketing offices, warehouses for re-export:

                        3 working days

                        Manufacturing facilities of pharmaceuticals and medical device:

                        Handling the first licensing step (primary approval):

                        Within 5 working days from the application receiving date

                        Assigning inspection team to audit the compliance with good manufacturing practice (GMP):

                        10 days from the date of receiving the request

                        Issuance of the certificate of compliance with current good manufacturing practice (c-GMP):

                        5 working days from the date of generation of the visit report. It is recommended to issue a GMP certificate.

                        Issuing MOHAP facility license upon completing the required fees\documents:

                        3 working days from the date of receiving the last requirement

                        Service fees

                        Application fee: AED 100

                        Fees for initial inspection, according to the type of facility:

                        Warehouses, pharmacies and marketing offices: AED 1,000 per inspection

                        Final inspection fees, according to the type of facility:

                        Warehouses, pharmacies and marketing offices: AED 1,000 per inspection

                        Final license fees, according to the type of facility:

                        Pharmacies and warehouses: AED 7500
                        Marketing offices: AED 10,000
                        Warehouses for export: AED 10,000

                        Manufacturing facilities of pharmaceuticals and medical device:

                        Application fee: AED 100
                        Final inspection fee: AED 3000 per inspection
                        Approval fee for architectural plans and drawings: AED 2000
                        Fees for final licensing of manufacturing facilities of pharmaceuticals and medical device: AED 50000
                        Service channels
                        • MOHAP Website: www.mohap.gov.ae

                        • MOHAP Smart App

                        Service locations

                        • MOHAP Website: www.mohap.gov.ae  
                        • MOHAP Smart App
                        Payment channels
                        • E- Payment

                        Target audience
                        • Pharmacies

                        • Warehouses

                        • Manufacturers of medicines and medical devices

                        • Marketing Offices

                        • Warehouses for re-export

                        Department name

                        Licensing and Accreditation

                        Sector name

                        Health Regulation

                        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
                        • Pharmacies, warehouses, marketing offices, warehouses for re-export:

                        • Manufacturing facilities of pharmaceuticals and medical device:

                        Service Bundle

                        This service is not linked to any bundles

                        Number of Users

                        213

                        Number of Transactions

                        619

                        Notes

                        Manufacturing facilities of pharmaceuticals and medical device:

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

                        • Ministry of Interior - Obtaining the Approval for the Introductory Statement of the Subjected Facility's Owner(s)
                        • Departments of Economic Development - Registration of Trade Name
                        • Ministry of Health and Prevention - Licensing of Medical Professionals and Pharmacists
                        • Departments of Economic Development - Issuance of Trade License
                        • Civil Defense - Issuance of Civil Defense Certificate
                        • MOCCAE- Issuing the Environmental Compliance Certificate

                        This service accepts documents authenticated with the UAE PASS Digital Seal.

                        Required Documents
                        • Documents required for pharmacies, warehouses, marketing offices, warehouses for re-export:

                          • Initial approval (owner profile check & primary inspection):

                            • A copy of owner's passport

                            • A copy of owner's family book

                            • A copy of valid ID card

                            • A recent color photograph

                            • An introductory statement filled out exclusively by the owner and the responsible pharmacist (the statement is available at any Customer Happiness Center)

                            • The site’s architectural drawing approved by an engineering consultant office

                          • Registration in Tatmeen:

                            • Location photos

                          • License initial approval:

                            • Affection plan attested by the municipality

                            • A copy of the establishment lease agreement

                            • A copy of the trade name

                          • Final inspection and final approval of the license:

                            • A copy of trade license issued by the Department of Economic Development

                            • A copy of license of the pharmacist responsible for pharmaceutical facility

                            • A copy of a certificate of conformity with preventive safety requirements issued by the civil defense

                            • A list of partners

                        • Additional documents for marketing offices:

                          • Documents required for initial approval:

                            • A copy of the marketing office’s memorandum and articles of association

                            • A document representing the marketing authorization holder registered with the ministry (the licensed applicant must be a representative of a medical product company registered with MOHAP)

                            • A copy of the project’s feasibility study

                            • The partnership contract, which includes the owners' right to the capital in accordance with the UAE Companies’ Law

                            • Initial inspection report of the marketing office

                          • Documents required for final approval:

                            • Approval regarding the pharmacist responsible for the marketing office

                            • Final inspection report

                          • 1. Initial approval of the manufacturing facility

                            • A copy of the memorandum and articles of association

                            • A copy of the project's feasibility study

                            • The partnership contract, which includes the owners' right to the capital in accordance with the UAE Companies’ Law

                            • A copy of the partners’ passports

                            • A copy of the family book (for UAE national partner(s))

                            • A copy of the national ID card of each partner

                            • Photos for each partner

                            • This step also includes security approval of each partner separately, and this will be done by filling an 'introductory statement' and attaching a copy of the passport, the family book, the ID card and photos.

                            • Note: The requirements are submitted to the Ministry of Health and Prevention and the initial approval is issued by the Pharmaceutical Licensing Committee after completing security clearances and document submission. The approval granted is valid for 6 months and can be extended upon request.

                          • 2. Manufacturing facility construction and preparation

                            • After obtaining the initial approval in step (1), the manufacturing facility must submit detailed engineering drawings of the facility - including the drawings that demonstrate material flow, personnel flow and other technical requirements for good manufacturing practices (GMP) - and obtain approval of drawings from the technical committee concerned within the drug department prior to construction.

                            • After obtaining the technical committee’s approval on the drawings, this step also includes submission of the following documents:

                            • After submitting the above-mentioned required documents, the manufacturing facility is ready for inspection (GMP certification inspection) through coordination with the drug department to set an appointment for inspection.

                          • 3. Final licensing of the manufacturing facility and good manufacturing practice certificate issuance

                            • After obtaining approval for the construction and preparation stage in step (2), the manufacturing facility must appoint technicians and issue licenses for technicians working in the following jobs: production manager / quality assurance manager / quality control manager.

                            • Note: Pharmacists' license may be replaced by a biomedical engineer license if the manufacturing facility is limited to medical equipment production only.

                            • To obtain the final approval, the following documents must be submitted:

                            • After submitting all documents, the manufacturing facility becomes eligible for the final inspection. After final inspection by the inspection team and submission of documents, the final license is issued to the facility.

                        Sustainable Goals
                        Good Health And Well-Being

                        Did you find the content useful ?

                        Give us your feedback so we can improve your experience


                        Help us improve MOHAP website

                        Give us your feedback so we can improve your experience

                        Thank you for your feedback.