Licensing of a Pharmaceutical Facility

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

when-applying-through-the-website

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Pay the fees.
• Submit the application.
• Upon passing the initial inspection, submit a request for initial approval.
• Complete licensing procedures with various government entities (e.g., Civil Defense, etc.).
• Submit licensing requests for medical staff (pharmacists).
• Submit the final inspection request and pay the final inspection fees.
• Upon passing and approval of the final inspection, submit the final approval request with the required documents attached.
• Upon approval of the request, pay the pharmaceutical facility licensing fees.
• Issue the pharmaceutical facility license.
• In case of security approval, the prescribed registration fees will be paid.
• Issue the registration certificate for the chemical precursors company according to the specified activity, valid for one year.

conditions-and-requirements

• Compliance with Federal Decree-Law No. (38) of 2024 Pharmaceutical establishments and manufacturing facilities must comply with all technical conditions and requirements stipulated in Federal Decree-Law No. (38) of 2024 concerning medical products, the pharmacy profession, and pharmaceutical establishments, ensuring adherence to the approved regulatory and technical standards.
• Adherence to Cabinet Resolution No. (90) of 2021 Compliance is required with the provisions of Cabinet Resolution No. (90) of 2021 regarding the Executive Regulations of Federal Law No. (8) of 2019 on medical products, the pharmacy profession, and pharmaceutical establishments, particularly with respect to the regulatory and procedural framework governing the sector.
• Observance of Ministerial Resolution No. (88) of 2023 Entities must fulfill the conditions and procedures necessary for licensing the establishment of medical product manufacturing plants in accordance with Ministerial Resolution No. (88) of 2023, ensuring full compliance with the associated technical and regulatory requirements for the establishment and operation of such facilities.
• Alignment with Related Legislation All relevant provisions under Federal Decree-Law No. (38) of 2024 and its related implementing regulations and guidelines must be observed, to ensure full compliance with the comprehensive legislative framework governing medical products, the pharmacy profession, and pharmaceutical establishments.

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 EDE).
• 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 EDE prior to construction.
• After obtaining the technical committee’s approval on the drawings, this step also includes submission of the following documents:
• A copy of the Ministry of Industry’s approval of the manufacturing facility’s project.
• A copy of the approval of the planning department or the municipality.
• A copy of the approval of the water and electricity department.
• A copy of the approval of the municipality regarding sanitation.
• A copy of the relevant authorities' approvals regarding environmental pollution.
• Copies of detailed engineering drawings of the manufacturing facility (approved by the technical committee).
• A copy of the technical agreement with international expertise houses.
• List of pharmaceutical forms or medical means and production lines to be established.
• A list of equipment and devices for each production, packaging and sterilization line used in the project.
• Explanation of the necessary equipment for the quality control laboratory.
• After submitting the above-mentioned required documents, the manufacturing facility is ready for inspection (GMP certification inspection) through coordination with the EDE 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:
• Site master file.
• Technical manager appointment letter and notarized employment contract + EDE license.
• Production manager appointment letter and notarized employment contract + EDE license.
• Quality control manager appointment letter and notarized employment contract + EDE license.
• A copy of the licenses of the staff working in the facility.
• List of employees in each department and their responsibilities.
• 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.