Issue of a Certificate of Amendment of Registered Pharmaceutical Products
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 the request online and complete the payment to meet all conditions
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The officer concerned will review the application and notify the applicant online
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The company should complete the requirements requested by the officer
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The customer will follow up with the Pharmacological Analysis Section of at the Drug Department
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The certificate shall be issued, provided that all the conditions and requirements are met
Required documents
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Application of minor variation of the pharmaceutical product for each type signed and stamped by the company.
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Documents required for minor variations in:
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Human pharmaceutical products (traditional, biological, … etc.).
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Pharmaceutical products derived from natural sources (herbal medicines, homeopathic medicines.
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Pharmaceutical products for general sale (supplements, disinfectants, medical cosmetics substances, miscellaneous).
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Medical equipment and reagents.
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Conditions and requirements
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The application for minor variations to pharmaceutical products will not be accepted if the registration date has expired.
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All submitted documents should be provided on official papers holding the name and logo of the concerned company.
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The company should provide a valid proof that these proposed changes have been approved by the competent authorities of the country of origin.
Service completion duration
22 working days
Service fees
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Certificate of amendment to any registered medical product data: AED 1000
SDGs goals
Service locations
- MOHAP Website
- MOHAP Smart Application
Target audience
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Medical warehouses
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Local pharmaceutical manufacturers
Resources
Drug Registration - External User Manual-966
Infographic_Issue of a Certificate of Amendment of Registered Pharmaceutical Products
Service category
Sub service category
Factories & companies services
Main service
Medical, Pharmaceutical and Drug Licencing and Registration
Service code
110-04-033-000
Service classification
- Government to business
Sub service type
Variation
Number of transactions
0
Notes
This service accepts documents authenticated with the UAE PASS Digital Seal.
Service completion duration
22 working days
Service fees
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Certificate of amendment to any registered medical product data: AED 1000
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