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Center OF Product AND COSMETIC EVALUATIONBIOEQUIVALENCE STUDY REPORT SUBMISSION CHECKLISTGeneral Instructions Please submit this checklist together with the bioequivalence study report (including
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How to fill out guideline on triggers regarding

01
Review the guideline on triggers to understand the purpose and requirements.
02
Identify the specific triggers that need to be documented.
03
Fill out the guideline sections with the relevant information for each trigger.
04
Cross-check the filled-out guideline for accuracy and completeness.
05
Submit the completed guideline for review and approval.

Who needs guideline on triggers regarding?

01
Healthcare professionals
02
Researchers studying trigger factors
03
Organizations developing protocols for managing triggers

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The guideline on triggers provides a framework for identifying events or circumstances that require further regulatory reporting or action.
Entities and organizations that are subject to regulatory oversight and are involved in activities that may meet the trigger criteria are required to file.
To fill out the guideline, entities must provide specific information related to the triggers, including descriptions of events, dates, and any relevant documentation as required by the regulations.
The purpose is to ensure that relevant stakeholders are aware of significant changes or risks that could impact regulatory compliance or operational stability.
Information such as the nature of the trigger event, its impact, mitigation measures taken, and any actions required must be reported.
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