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Food and Drug Authority of Ethiopia (EFA)Guideline for Emergency Use
Authorization of COVID-19 VaccineAddis ABBA, Ethiopia
January, 2021Table of Contents
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What is guideline for emergency use?
Guidelines for emergency use are regulatory frameworks established to facilitate the rapid development and deployment of medical products, like drugs and vaccines, during public health emergencies.
Who is required to file guideline for emergency use?
Manufacturers of medical products intending to use their products under emergency circumstances are required to file guidelines for emergency use.
How to fill out guideline for emergency use?
To fill out guidelines for emergency use, companies must provide comprehensive information about the product, including its intended use, production processes, and data on safety and efficacy.
What is the purpose of guideline for emergency use?
The purpose of guidelines for emergency use is to ensure that there is a clear and efficient process for bringing necessary medical products to market quickly in response to public health crises.
What information must be reported on guideline for emergency use?
Reports must include product specifications, safety data, clinical trial results, and any adverse effects observed during the use of the product in emergency situations.
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