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About this service

This service enables customers to apply for a release certificate for a shipment of pharmaceutical products extracted from biological sources, in order to facilitate the issuance of an import permit, ensure the conformity of documents and certificates, and ensure that the product is safe for treatment.

Service process

  • Login to the MoHAP website or smart app using the UAE PASS

  • The applicant must submits the application online and pay the service fee

  • The certificate will be issued within 3 working days

  • The applicant should courier the original / legalized documents to Drug Department, MOHAP HQ, Dubai

Required documents

  • Required documents for the products derived from Human Blood and Vaccines:

    • Original batch release certificate issued by OMCL in country of origin / Legalized copy

    • Original Certificate of Final Product Analysis signed, stamped and duly authenticated / Legalized copy

    • Invoice

    • Report of the production process flow, from beginning to final product (Protocol of manufacturing and Analysis)

    • LPO, Declaration and Technical report about consumption from end user

    • Copy of pharmacist's and warehouse licenses

    • Certificate of Pharmaceutical Product

    • WHO prequalification certificate for Vaccines

  • Required documents for the products of Human Tissue Origin:

    • Valid Tissue Bank Certificate of the exporter

    • FDA/Authority License for the manufacturer and Product

    • Storage and Handling temperature details

    • Invoice

    • Copy of pharmacist's and warehouse licenses

Conditions and requirements

  • * Registration Certificate must be submitted if the final product is registered with the Ministry.

  • * Registration certificate in the country of origin and Purchase orders from the end users must be submitted by the applicant where the product is not registered in the UAE.

Service completion duration

3 working days

Service fees

  • Fees for the release of a shipment of pharmaceutical products derived from biological sources: AED500

SDGs goals

Service locations

MOHAP website

Support

import.export@mohap.gov.ae

Payment channels

  • E-payment

Target audience

  • Drug Stores, Local pharmaceutical factories, Government Hospitals

Resources

Service category

Business services

Sub service category

Pharmaceutical enterprises services

Main service

Clearance, Import and Export Permits

Service code

110-02-025-000

Service classification

  • Government to business

Service type

Transactional

Sub service type

Variation

Number of transactions

5064

Notes

This service accepts documents authenticated with the UAE PASS Digital Seal.

Start service

Service completion duration

3 working days

Service fees

  • Fees for the release of a shipment of pharmaceutical products derived from biological sources: AED500

Average rating

0 from 0 users

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