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Get the free Annex IV Product Recall Completion Form - Ministry of Health

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Annex IV PRODUCT RECALL COMPLETION Forth filled Product Recall Completion Form and any other accompanying documents must be submitted to Pharmacovigilance Section, Department of Pharmaceutical Services, Ministry of Health via hard copy or email at productdefect.pharmacy@moh.gov.bn. 1Details
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How to fill out annex iv product recall

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How to fill out annex iv product recall

01
Identify the product that needs to be recalled, including the specific batch or lot number.
02
Determine the reason for the recall, such as safety concerns or quality issues.
03
Notify the appropriate regulatory authorities about the recall.
04
Prepare a recall strategy outlining the communication plan with customers and the public.
05
Issue a press release or public announcement about the recall, including instructions on how customers can return the product.
06
Monitor the recall process to ensure that all affected products are removed from the market.

Who needs annex iv product recall?

01
Manufacturers, distributors, and retailers of products that have been identified as potentially harmful or defective may need to fill out annex iv product recall.
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Annex IV product recall refers to a specific regulatory document that outlines the procedures and requirements for recalling products that may pose a risk to health or safety.
Manufacturers, importers, and distributors of products that are subject to recall are required to file Annex IV product recall.
To fill out Annex IV product recall, provide detailed information on the product, the reason for recall, the risk assessment, and the corrective actions taken.
The purpose of Annex IV product recall is to ensure the identification, removal, and reporting of unsafe or defective products to protect consumers and public health.
The information that must be reported includes product details, batch numbers, distribution details, reason for the recall, and any health risks associated with the product.
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