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Registration of a Conventional Pharmaceutical Product

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Service completion duration

  • 45 working days
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Service fees

  • Application: AED 100
  • Registration of a conventional pharmaceutical prod...
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About the Service

This service enables clients to submit applications to register conventional, biological or other human pharmaceutical products for importation and trading within the UAE.

Service Process

  • 1
    Register in the e-services, create a user name and password (if not already registered), and access the electronic system.

  • 2
    Submit the request through the electronic service and complete the payment to meet all conditions and required fees.

  • 3
    After submitting online, registration dossier is studied and discussed by the concerned technical committee and then submit report to the concerned ministerial committee.

  • 4
    Study registration file and discuss the pricing of product by the concerned technical committee and then submit report to the concerned ministerial committee.

  • 5
    Follow up to be done online to complete the Stability, Bioequivalence (if required) & Pharmacovigilance section and Analysis through Quality Control Lab.

  • 6
    Completion of the file requirements and submission on agreed date.

  • 7
    Re-discuss the registration of products that have been previously delayed on completion of requirements by the relevant technical and ministerial committees.

  • 8
    Price approval letter will be issued after committee approval and Price decree after sign by HE The Minister.

  • 9
    Issuing certificates of registration of products that have been approved for registration after satisfying all conditions and requirements valid for five years from the date of committee approval.

  • 10
    Pharmaceutical certification (for local pharmaceutical products) is valid for one year from the date of issue.

Conditions & Requirements

  1. Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.

  2. The applicant must be a medical warehouse licensed by the Ministry of Health and have a valid license.

FAQ’s

  1. What are the fees for obtaining a registration service for a conventional pharmaceutical product?

    • Application: AED100.

    • Registration of a conventional or biological medicine product etc.: AED7,000.

    • Analysis or re-analysis of a medical product: AED3,500.

    • Pricing certificate after committee approval: AED500.

    • For PV plan evaluation – AED1000.

  2. What is the average length of time for the registration of a conventional pharmaceutical product?
    45 working days.
  3. What is the target group for a conventional pharmaceutical product registration service?

    • Drug warehouses.

    • Local pharmaceutical manufacturers.

    • Marketing officers.

  4. What channels are available to apply for a conventional pharmaceutical product registration service?
    The Applications can be submitted through MOHAP Website and Smart Application.
Service completion duration
  • 45 working days
Service fees

Application: AED 100

Registration of a conventional pharmaceutical product: AED 7,000

Analysis or re-analysis of a medical product: AED 3,500

Pricing certificate after committee approval: AED 500

For PV plan evaluation: AED 1000

Service channels
  • MOHAP Website

  • MOHAP Mobile App

Payment channels
  • E- Payment

Target audience
  • Medical warehouses

  • Local pharmaceutical manufacturers

  • Marketing officers

Department name

Drug

Sector name

Health Regulation

Main service

Medical, Pharmaceutical and Drug Licencing and Registration

Service Code

110-04-007-000

Service Classfication

Transactional

Service Type

Government to Business

Sub Service Type

Variation

Related Services
  • Medical Store licensing: related to licensing Department

  • Local Manufacturer licensing

  • Registration of a conventional pharmaceutical product is a pre-requisite for import service.

Service Bundle

This service is not linked with any service packages

Number of Users

46

Number of Transactions

673

Notes

Marketing Authorization Holder companies must be registered by MOHAP before they could register their products.

Required Documents
  • The required documents are to be submitted in accordance with the requirements of the standard technical file eCTD (Electronic Common Technical Document)

Sustainable Goals
Good Health And Well-Being

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