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Analyze Medical Product for A Pharmaceutical Company and Its Subsidiaries

Service completion duration

  • A maximum of 20 days from sample delivery

Service fees

  • Fee for analysis of a medical ...

Service Rating

About the Service

This service allows the analysis of medical products to ensure that their ingredients, active substance and preservatives are suitable for use.

Service Process

  • 1
    Register in e-services, obtain user name and password, access the electronic system, and submit the application electronically

  • 2
    Deliver sample to the customer service center

  • 3
    Submit an application for the examination of a medical or pharmaceutical product

  • 4
    Application and samples will be referred, first, to Drug Administration for approval, and then to the Department of Pharmaceutical Analysis (Laboratory)

  • 5
    Examination will be conducted and a certificate of the examination result will be issued

  • 6
    The applicant will be informed of the result

  • 7
    The product will be analyzed and a report sent to the laboratory supervisor for review

  • 8
    If the result of the analysis is conforming, a certificate of conformity will be issued through the systems and can be printed electronically

  • 9
    If the result of the analysis is non-conforming, it will be referred to the non-conformity committee for a decision on appropriate further action, such as analysis by a different analyst. The result will be submitted to the laboratory chairman for the issue of a certificate of conformity, if the product does conform, or a certificate of non-conformity if it does not conform, and will then be transferred for accreditation

Conditions & Requirements

  1. All data must be provided in Arabic and English

  2. The technical file should consist of three main parts: analysis, stability study, and bioavailability and equivalence study (for chemical and biopharmaceuticals only), and should be submitted to the Drug Registration Department. If the technical file is submitted to the laboratory, only the analysis section is required

  3. In case of re-registration of the product, full and long-term accelerated studies of two recent batches are required

  4. The drug's uses should be clarified

  5. The quantity of the sample should be sufficient, as per the requirements of the pharmaceutical form

Service completion duration
  • A maximum of 20 days from sample delivery
Service fees

Fee for analysis of a medical product for a pharmaceutical company and its subsidiaries: AED 3,000

Service locations

  • Drug registration: Ministry of Health website
  • Sample delivery: Quality Control Laboratory

Payment channels
  • E- Payment
Target audience
  • Drug warehouses
  • Local pharmaceutical factories
Department name

Drug Control Department

Sector name

Health Regulation Sector

Main service

Quality control of pharmaceutical products

Service Code

110-44-001-000

Service Type

Transactional

Sub Service Type

Variation

Service Classfication

Government to Business

Required Documents
  • Samples, and standard and reference materials for the product to be analyzed
  • Electronic application form
  • CD with all documents and information, such as eCTD
  • In the absence of eCTD of the product, the CD should contain:
    • Certificate of final product analysis for three batches
    • Certificate of analysis of standard substances if the compound contains a therapeutic substance
    • Statement of composition certificate, listing the active and inactive ingredients, their concentrations and specifications
    • Certificate of final product specifications
    • Statement of method of analysis of final product and test validation methods (validation report for test methods)
    • Analysis certificate of active and inactive ingredients in the finished product
    • If the analysis is constitutional, a copy of the most recent version of the constitution must be attached
    • When high-performance liquid chromatography (HPLC) or gas chromatography (GC) are used in analysis, the chromatogram must be provided, and evidence of other methods, such as FTIR, TLC and UV spectrum, should also be provided
  • Standard samples and materials:
    • A sufficient number of samples of the final product (enough to analyze the product three times) must be provided
    • Primary reference standard as USP and EP
    • Working standard with an attached certificate of analysis of all details
    • Related substance and degradation product standard for the active and preservative ingredients
    • If a special type of HPLC column was used, this must be provided to the laboratory
  • External packaging of the product and the enclosed leaflet, including all necessary data (batch number, date of manufacture and validity, storage conditions, name of commercial compound, name of manufacturer and country of origin, directions for use, capacity or volume, drug code if applicable, and any necessary warnings) must be provided
  • Copy of outer packaging
  • Copy of internal leaflet
Sustainable Goals
Good Health And Well-Being

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