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Adverse Experience Reporting Program (ARP) Periodic Summary Update (PSU) For Veterinary Medicines Registrants Reporting Form KP83F05 Registrant Name:Reporting Period:/ / to/ / AP VMA Product Number:Total
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Adverse experience reporting program is a system designed to collect and evaluate information on adverse experiences related to drugs or medical products.
Manufacturers, distributors, and importers of drugs or medical products are required to file adverse experience reporting program.
Adverse experience reporting program can be filled out electronically through the FDA's MedWatch program or by submitting a paper form.
The purpose of adverse experience reporting program is to monitor the safety and effectiveness of drugs and medical products in the market.
Information such as the type of adverse event, date of occurrence, patient demographics, and product details must be reported on adverse experience reporting program.
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