Answer:
Under the Product Data Elements, simply change the “Marketing Status” to “Completed” and then enter in a “Marketing End Date”. The Marketing End Date is the date you no longer plan to market the product. Save and then create a new submission to send to the FDA indicating that this product is to be delisted. This is also the date that it will be archived on the Daily Med.
If you are trying to delist an older R3 product that is on the Daily Med, you will need to create a new submission file and update it to R4. When you enter the information for the Manufactured product, enter in a marketing start date (the day you started marketing the product to the public) AND a marketing end date (the date you plan to stop marketing this product). Create the submission files as normal and then submit to the FDA.
If this product has been discontinued for a long amount of time or you genuinely cannot find a principal display panel, you may create your own image with the words “Product Discontinued” prominently displayed and use it as the principal display panel. This is only to be used if you cannot find the principal display panel.
Establishments will not be required by the SPL Portal validation logic when all associated manufactured products have a status of “Complete” and a date populated in the “Marketing End Date” field.
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