Licensing of a Pharmaceutical Facility

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.