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Forms

Form For CA : of biological and innovative products and clinical studies

Form for CA of Biological and Innovative products and clinical studies.

Type Issue date Dec
    تهعد بظروف التخزين المقترحه
Form - Application form for new product submission
Form - ِِِِApplication form for renewal product submission
Form - Stability Summary Sheet(New_Re-reg)
Form - Stability Summary Sheet(Variations)
Form - Variation application form
Form   Yearly biologic product report (YBPR) Check list
Form - main and summary appeal for scientific file
Form 2023 المستندات المطلوبة لملف تسجيل مستحضر مبتكر
Form 01/2023 Applicant request to the Egyptian Drug Authority For Clinical Trial Authorization  
Form 01/2023 Progress Follow Up Report Template
Form 2023 Request inquiry for registration of innovative product
Form 2023 المستندات المطلوبة لملف تسجيل مستحضر مبتكر
  06/2025 Application Form of Pre-clinical and Clinical Technical Support Request
Form 09/2025 Corrective Action Preventive Action Template 
Form 09/2025 Applicant Request by the researcher “postgraduate or investigator initiated” for submission of the clinical medical research to the Egyptian Drug Authority
Form 09/2025 Progress Follow up Report for Researchers Template
Form 11/2025 Application Form For Scientific Advice 
Form 12/2025 APPLICATION FORM FOR RE-REGISTRATION PRODUCT SUBMISSION
Form 12/2025 Safety reporting for investigational medical devices
Form 12/2025 Investigational medicinal product (IMP) Identification Form
Form 12/2025 Template for scientific evaluation of innovative product

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