http://repository.iphce.org/xmlui/handle/123456789/5310 2026-05-20T18:16:20Z http://repository.iphce.org/xmlui/handle/123456789/5372 አዲስ ዘመን ከኢትዮጵያ የምግብና መድኃኒት ባለሥልጣን ጋር በመተባበር የታተም Ethiopian Food and Drug Authority የምግብ ክለሳ እና ጉዳቶቹ; የወባ መድኃኒት አግባባዊ አጠቃቀም፤ የመድኃኒት አግባባዊ አጠቃቀም ለስኬታማ ሕክምና ያለው ፋይዳ፤ የወባ መድኃኒት አግባባዊ አጠቃቀም፤ የመድኃኒት አግባባዊ አጠቃቀም፤ ለስኬታማ ሕክምና ያለው ፋይዳ: የመድኃኒት ጠቀሜታ ምንድን ነው?፤ የምግብ ዘይትና ዱቄትን በማበልፀግ አስገዳጅ ደረጃን እውን የማድረግ ጅማሮ 2025-01-01T00:00:00Z http://repository.iphce.org/xmlui/handle/123456789/5353 Inspection manual for good storage, distribution and dispensing practices Ethiopian Food and Drug Authority The Ethiopian Food and Drug Authority (EFDA) is committed to strengthening the national pharmaceutical regulatory system to ensure the safety, quality, and effectiveness of medical products throughout their lifecycle. In line with its legal mandate under Proclamation No. 1112/2019 and Regulation No. 531/2023, EFDA regulates and oversees a range of functions, including the inspection of pharmaceutical storage, distribution, and dispensing operations. 2025-01-01T00:00:00Z http://repository.iphce.org/xmlui/handle/123456789/5352 iLicenese user manual: A practical guide on how to use eRIS- iLicense to manage licensing activities for the Ethiopian Food and Drug Authority Ethiopian Food and Drug Authority This document is a manual designed to provide a step-by-step guide on how to use the iLicense application. iLicense is a web-based tool that allows importers, exporters, wholesalers, and manufacturers to apply for a certificate of competency and for EFDA to approve these applications. iLicense is a component of the Electronic Regulatory Information System (eRIS). eRIS was designed and implemented to facilitate the licensing, inspection, registration, and import permit processes for medicines, food, cosmetics, and medical devices. eRIS is the umbrella system at EFDA and is composed of sub-systems that work together:iLicense, iInspect, iRegister, iImport, iClearance, and iVerify. Fully online, both applicants and EFDA use eRIS and its sub-component systems to manage the licensing, registration, and import application processes using this shared portal. 2023-01-01T00:00:00Z http://repository.iphce.org/xmlui/handle/123456789/5332 GMP inspection manual, edition no. 03 Ethiopian Food and Drug Authority The Government of Ethiopia has been actively working to strengthen the regulatory system at both the national and regional levels. Ensuring the comprehensive regulation of all aspects related to the safety, efficacy, and quality of pharmaceutical products is a key priority. Effective medicines regulation encompasses various critical activities, including the inspection of pharmaceutical facilities such as manufacturers. These inspections play a vital role in safeguarding public health by ensuring compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Storage Practice (GSP) and Good dispensing practices other regulatory standards.