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ETHIOPIAN FOOD AND DRUG AUTHORITY Medicine Evaluation and Marketing Authorization Lead Executive office Guideline for Renewal of Marketing AuthorizationDocument No.:EFA/GDP/018Version No:002Date of
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How to fill out guidelines for conditional approval

01
Review the requirements and criteria for conditional approval.
02
Provide all necessary information and documentation as outlined in the guidelines.
03
Address any specific concerns or issues raised by the approver.
04
Submit the application for conditional approval according to the specified timeline.
05
Follow up on any additional requirements or modifications requested by the approver.

Who needs guidelines for conditional approval?

01
Individuals or entities seeking approval for a project or program that does not meet all criteria upfront but may be eligible for conditional approval upon meeting certain conditions.
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Guidelines for conditional approval outline the criteria and requirements that must be met by entities seeking provisional approval for certain processes or products under specific conditions.
Entities such as businesses, organizations, or individuals seeking provisional approval for their projects or products are required to file guidelines for conditional approval.
To fill out guidelines for conditional approval, applicants must gather necessary information, complete the required forms accurately, include all supporting documentation, and ensure compliance with the specified criteria.
The purpose of guidelines for conditional approval is to provide a structured framework for entities to obtain temporary permission while meeting specific conditions, ultimately leading to full approval upon satisfaction of those conditions.
Information that must be reported includes applicant details, project or product description, conditions for approval, timelines for compliance, and any relevant supporting documentation.
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