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Regulatory Guidelines

Regulatory Guideline Central Administration For Inspection of Pharmaceutical Institutions

Regulatory Guideline Central Administration For Inspection of Pharmaceutical Institutions

النوع تاريخ الإصدار الوصف رقم الأصدار
Guideline 2022   الإجراءات والقواعد المنظمة لعملية التفتيش على مصانع المستلزمات الطبية المحلية 01
Guideline 2024

Regulatory Guideline for the Regulation of Dispensing Reserve Antibiotics

Arabic version

01
Guideline 2024

Regulatory Guideline for Inspection and Follow-up Procedures of Corrective Action Plans Submitted by Pharmaceutical Establishments (Warehouses, Depots, and Pharmacies)

Arabic version

02
Guideline 2025

Regulatory Guideline for Decree of the Chairman of the Egyptian Drug Authority No. 47 of 2025 on the Recall of Expired Pharmaceutical Products

Arabic version

 01
Guideline 2025

Regulatory Guideline for Dispensing Instructions for Products Containing Pseudoephedrine

Arabic version

02
Guideline 10/2025 GUIDELINES ON RECALL & RAPID ALERT SYSTEM For Medicinal Products 05
Guideline 11/2025 Guideline for Conducting Risk-Based Post Market
Surveillance Plan within the Egyptian Market
For Pharmaceutical and Biological Products
05
Guideline 12/2025

Regulatory Guideline for the Establishment and Operation of the Unified National Electronic Track-and-Trace System for Human and Biological Medicinal Products

Arabic version

01
Guideline 12/2025 Regulatory Guideline for Good Distribution and Storage Practices 05
Guideline 05/2026

Regulatory Guideline No. (239) of 2023 Concerning the Release of Human and Veterinary Pharmaceutical Products, Pesticides, Disinfectants, Cosmetic Preparations, Raw Materials, Biological Products, and Medical Devices.

Arabic version

03
Guideline 06/2026 Annex Of Products and Substances with Misuse Potential
Arabic version
01

 

منشورات وكتب دورية

النوع تاريخ الإصدار الوصف
منشور دوري  2020 منشور دوري رقم 1 لسنة 2020 بتحديد مواصفات السيارات المستخدمة لنقل الأدوية
منشور  2024 منشور رقم (2) لسنة 2024 بشأن التفتيش على المؤسسات الصيدلية من الجهات الأجنبية

 

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