Issue a License for a Medical Products Manufacturing Facility

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service-completion-duration

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 request receiving date Issuance of the certificate of compliance with current good manufacturing practice (c-GMP): 5 working days from generating the GMP report 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: 100 AED
Final Inspection fee: 3000 AED per inspection

about-the-service

This service allows obtaining the necessary license to establish a pharmaceutical institution for the manufacturing of Medical products

service-process

Log in using UAE PASS to start the service
Fill out the application form
Attach the required documents
Pay the fees of the initial Approval
After obtaining the initial approval, an application is submitted for the construction and factory setup stage upon approval of the plans.
Obtaining the initial approval to practice Good Manufacturing Practices (GMP) and assessing the qualified personnel.
Personnel licensing (licensing of personnel by the Ministry of Health and Prevention).
Submission of the factory’s final license application
Issuance of a License for a Medical Products Factory and Contractual Companies for Research and Development

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conditions-and-requirements

Adherence to the provisions of Ministerial Resolution No. 88 of 2023
Adherence to the Federal decree low No 38 Governing Medical product ,pharmacists and pharmaceutical Establishments

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required-documents

1. Initial Approval
A copy of the factory’s Memorandum of Association (MOA) or Articles of Association.
A copy of the project’s feasibility study.
The partnership agreement, clearly indicating the capital ownership of each partner in accordance with the UAE Companies Law.
Copies of valid passports and Emirates ID cards for all partners, and a copy of the Family Book for the UAE national partner.
This stage also requires completion of the Partner and Owner introductory statements Form
Step 2: Construction & Preparation
Submit detailed engineering drawings of the factory (material & personnel flow,) to be approved by EDE technical committee.
License from Ministry of Industry
A copy of the approval of the Planning Department or the municipality
Water & Electricity approval indicating the estimated water and electricity consumption
Environmental Pollution approval Certificate
A copy of the approval of the municipality regarding sanitation
Provide list of production lines planned to be established
List of equipment and devices for each production, packaging, and sterilization line to be used in the project
List of equipment used in the Quality Control Laboratory, where laboratory testing of raw materials, in-process materials, and finished products is conducted
Copy of technical agreement with international expertise house
Step 3: Initial GMP approval
Submission of GMP inspection by the applicant.
Evaluation the qualifications of key personals and issuing the qualification certificates.
Step 4 issuing facility license
Appoint licensed managers: Technical, Production, QA, QC (MOHAP license)
Submit Site Master File and staff licenses
GMP certificate
Civil Defense certificate.

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faqs

Is it possible for a non-citizen to own a pharmaceutical establishment?
Yes , after provide official approval from internal authority ( ECONOMIC DEPT ) for sharing percentage
Who should be licensed at the Manufacturing Facility?
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" PV officer Pharmacist in-charge

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