Issue a License for a Medical Products Manufacturing Facility

Service Description

This service enables the issuance of the licence required to establish a pharmaceutical facility for the manufacture of medical products.

Service Process

• 1. Log in using UAE PASS to start the service
• 2. Fill out the application form
• 3. Attach the required documents
• 4. Pay the fees
• 5. Submit the application
• 6. Obtain Initial Approval for a medical products manufacturing facility license
• 7. Submit the construction and fit-out phase application by obtaining approval for the engineering plans
• 8. Obtain Initial Approval for Good Manufacturing Practice and evaluation of qualified staff
• 9. Issue a Certificate of Compliance with Good Practice Standards
• 10. License the staff (through the Ministry of Health and Prevention (MOHAP))
• 11. Submit the final license application for the manufacturing facility
• 12. Issue a Medical Products Manufacturing Facility License

Conditions & Requirements

• • Compliance with Ministerial Resolution No. (88) of 2023 on the conditions and procedures for licensing medical products manufacturing plants
• • Compliance with Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession, and Pharmaceutical Entities

Required Documents

• 
  Section 1: Initial Approval for the Manufacturing Facility
• 1. Copy of the manufacturing facility's articles of incorporation or memorandum of association
• 2. Copy of the project's economic feasibility study
• 3. Partnership agreement specifying the shareholders entitled to capital in accordance with the UAE Companies Law
• 4. Copy of valid passports and National IDs for all partners, and Family Book (Khulasat Al Qaid) for UAE national partners
• 5. Completed Identification Form for all partners and the owner
• 
  Section 2: Construction and Fit-Out Phase
• 1. Detailed engineering drawings approved by the EDE Technical Committee
• 2. Copy of the Ministry of Industry's approval for the manufacturing facility project
• 3. Copy of the approval from the Water and Electricity Authority — according to the relevant emirate — or the relevant department of the free zone authority — for the estimated water and electricity consumption
• 4. Copy of the municipality's approval confirming the adequacy of the sewage disposal method
• 5. Copy of approvals from the relevant authorities regarding environmental pollution
• 6. Copy of the technical agreement with international expert firms (if applicable)
• 7. Environmental permit
• 8. List of pharmaceutical dosage forms or medical devices and the production lines planned for establishment
• 9. List of equipment and devices for each production, packaging, and sterilisation line
• 10. Statement of equipment and devices used in the quality control laboratory in which laboratory tests are conducted on raw materials, finished products, or during production
• 
  Section 3: Good Manufacturing Practice (GMP) Inspection Phase
• 1. Submit a Good Manufacturing Practice (GMP) inspection request
• 2. Evaluate the qualification of key personnel and issue their qualification certificates
• 3. Conduct the Good Manufacturing Practice (GMP) inspection
• 
  Section 4: Final Approval Requirements and Manufacturing Facility Licence Issuance
• 1. Copy of the licences of manufacturing facility staff and their appointment decisions (Production Manager, Quality Assurance Manager, Quality Control Manager)
• 2. List of staff in each department and the responsibilities of each
• 3. Civil Defence Certificate confirming compliance with fire prevention and safety requirements

FAQ’s

• Q1: Can a non-UAE national own a pharmaceutical facility?
• Yes, provided that approval is obtained from the relevant local authority specifying the permitted foreign ownership percentage.
• Q2: Who must be licensed in the manufacturing facility?
• To obtain final license approval, the facility must appoint a licensed and experienced pharmacist in the following roles: