Issue a Certificate of Compliance with the good Practice Standards of a Pharmaceutical Establishment
About this service
Service process
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Login to the MoHAP website or smart app using the UAE PASS
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Submit a request for inspection and pays the fees
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Reviewing the application to ensure fulfilling the requirements
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Performing the inspection
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Obtaining the inspection report
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In case of passing the inspection successfully, the customer will pay the certificate issuance fees
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The customer downloads the certificate from the website
Required documents
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First: To obtain the Good Storage and Distribution Practice (GSDP) Certificate for the purpose of exporting to the UAE market and outside:
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The agreement between the Marketing Authorization Holder or the manufacturer and the logistic warehouse
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The manufacturing Site registration certificate (Mandatory) and the product registration (in case it's registered) in the MOHAP
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A valid Good Manufacturing Practice (GMP) Certificate for all relevant manufacturing sites issued by the competent authority in the country of origin and legalized by the Embassy of the UAE in the country of origin
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A copy of the Free Sale Certificate (FSC) and the Certificate of Pharmaceutical Products (CPP) for all products that are un-registered or having marketing authorization approval by the MOHAP, issued by the competent authority in the country of origin and legalized by the Embassy of the UAE in the country of origin, along with the countries planning to export to
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An authorization letter from a licensed pharmaceutical establishment with a valid license authorizing the pharmacist to be the pharmacist incharge of the assigned storage area in the logistic warehouse
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A valid license for the pharmacist in charge of the assigned storage area in the logistic warehouse
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The applicant's commercial license issued by the Free Zone Authority
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The commercial license of the logistic warehouse issued by the Free Zone Authority
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The marketing office license (formerly the scientific office) issued by the MOHAP
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License of the pharmacist in charge of the marketing office
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Biomedical engineer qualification certificate legalized by the UAE Ministry of Education in case dealing only with non-pharmaceutical medical equipment
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List of the products that will be stored in the logistic warehouse (registered and un-registered in the MOHAP)
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Second: To obtain the GSDP Certificate for the purpose of exporting only (outside) the country:
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All of the above applies, plus:
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A copy of the marketing approval for medical products
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Conditions and requirements
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Providing all requirements and documents
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Passing the inspection successfully
Service completion duration
Service fees
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AED 1,000 Inspection fee
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AED 2,000 certificate issuance fees
Service channels
- MOHAP website: www.mohap.gov.ae
- MOHAP smart app
SDGs goals
Service locations
- MOHAP Website - www.mohap.gov.ae
- MOHAP Smart App
Support
- Import & export regulation section: import.export@mohap.gov.ae
- Call Center: 80011111
Payment channels
- E-payment
Target audience
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Companies desire to store their products in the logistic warehouses in the free zones as per MOHAP regulations.
Service category
Sub service category
Pharmaceutical enterprises services
Main service
Medical Establishment Licencing and Registration
Service code
110-03-026-000
Service classification
- Government to business
Service type
Transactional
Sub service type
Variation
Number of transactions
0
Notes
This service accepts documents authenticated with the UAE PASS Digital Seal.
Service completion duration
Service fees
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AED 1,000 Inspection fee
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AED 2,000 certificate issuance fees
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