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GUIDANCE ON VARIATIONS TO A PREQUALIFIED VACCINE V.7. July 2015 Vaccine Assessment Group, Prequalification Team (PUT), Regulation of Medicines and other Health Technologies (RAT) Department of Essential
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01
Start by carefully reviewing the guidance on variations to provided by the regulatory authority.
02
Identify the specific type of variation you need to fill out guidance on.
03
Gather all relevant information and documentation related to the variation.
04
Follow the instructions provided in the guidance on variations to for each section.
05
Provide accurate and detailed information for each point in the guidance.
06
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Submit the filled out guidance on variations to the appropriate authority for review and approval.
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Monitor the progress of your variation request and respond promptly to any queries or requests for additional information.
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Follow up with the regulatory authority for the outcome of your variation request.

Who needs guidance on variations to?

01
Pharmaceutical companies and drug manufacturers
02
Clinical research organizations (CROs)
03
Regulatory affairs professionals
04
Healthcare professionals involved in drug development and registration
05
Researchers and scientists
06
Anyone involved in the process of submitting and obtaining approvals for variations to a regulated product or process.
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Guidance on variations refers to the instructions or advice provided regarding changes or modifications to a specific process, procedure, or documentation.
The individuals or organizations directly involved in the process or procedure that is being modified are required to file guidance on variations.
To fill out guidance on variations, one must provide detailed information about the proposed changes, reasons for the variations, and potential impact on the existing system.
The purpose of guidance on variations is to ensure that any modifications made to a process or procedure are properly documented, reviewed, and implemented in a systematic manner.
The information that must be reported on guidance on variations includes the nature of the variation, reasons for the change, potential risks or benefits, and any relevant supporting documentation.
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