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Animal Care CommitteeProceduresforSickAnimalResponse PROC009 ApprovalDate:12JUL2018 EffectiveDate:12AUG2018ProceduresforSickAnimalResponse ProcedureNumber:PROC009 VersionNumber:02 Category:PostApprovalMonitoring Subject:Stepsforrespondingtosickanimals,
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Category post-approval monitoring refers to the ongoing assessment and oversight of products or services that have been approved by regulatory authorities to ensure compliance with established standards and regulations after they are on the market.
Manufacturers or entities that have products or services that have received regulatory approval are required to file category post-approval monitoring.
To fill out a category post-approval monitoring form, the required sections must be completed with relevant data regarding the product or service's performance, compliance with regulations, and any incidents or changes since approval.
The purpose of category post-approval monitoring is to ensure that approved products continue to meet regulatory standards, safeguard public health, and track any potential risks or adverse effects that may arise after market introduction.
Information reported must include product performance data, compliance with manufacturing standards, adverse event reports, updates on clinical studies, and any significant changes to the product.
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