Analysis / Re-Analysis of a Medical Product for a Pharmaceutical Establishment and Its Subsidiaries

Service Description

This service enables the analysis of medical and healthcare products to verify their components, active ingredients, preservatives, and suitability for use.

Service Process

• Log in using UAE PASS to start the service.
• Pay the applicable fees
• Submit the application
• Upload the required documents
• File review by laboratory specialists
• Customer notification of analysis requirements through the electronic platform
• Submit samples to the Research Quality Control Laboratory for Medical and Healthcare Products
• If the sample complies with specifications, a Certificate of Analysis is issued
• If the sample does not comply with specifications, a Certificate of Non-Compliance is issued, and re-analysis may be requested

Conditions & Requirements

• The technical file must consist of three main sections: analytical studies, stability studies, and bioavailability and bioequivalence studies (for chemical and biological medicines only). The file must be submitted to the Emirates Drug Establishment.
• The purpose of use for unidentified medicines must be clarified.
• The submitted sample quantity must be sufficient and consistent with the pharmaceutical dosage form of the product.

Required Documents

• Application Form
• Electronic application form
• Documents to Be Uploaded on the Portal
• Certificate of analysis for the final product for three batches
• Certificate of analysis for reference standards (if the product contains a therapeutic substance)
• Composition statement certificate including active and inactive ingredients, their concentrations, and specifications
• Final product specification certificate
• Final product analysis method and validation reports for test methods
• Certificate of analysis for active and inactive ingredients at the finished product manufacturer
• If the analytical method is pharmacopoeial, a copy of the latest edition of the pharmacopoeia must be attached
• If High-Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC) is used, the chromatogram must be attached. In other cases such as FTIR, TLC, and UV Spectrum, supporting evidence must be provided
• Samples and Reference Materials
• (Sufficient quantities of final product samples must be provided to allow the product to be analyzed three times.)
• Primary Reference Standard such as USP or EP
• Working Standard accompanied by a certificate of analysis with full details
• Related Substance & Degradation Product Standard for active ingredients or preservatives
• In cases where a Special Type of HPLC Column is used, it must be submitted to the laboratory
• The outer packaging and package insert must include all required information, including: Batch number Manufacturing and expiry dates Storage conditions Trade name of the product Manufacturer’s name and country of origin Directions for use Capacity or volume Applicable pharmacopoeia (if required) Necessary warnings (if applicable)
• Copy of the outer packaging
• Copy of the package insert