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  3. Terms of Market Authorization
  4. 530 - What is PAAB's position on proactively providing storage/stability information to customers that is different than what is in the Product Monograph, but which is supported by clinical data? We sell a product that requires refrigeration between 2-8 degrees. Our Med Info department receives many, many calls inquiring about temperature excursions outside of the labelled storage conditions. We have data to support the excursions. We would like to be able to proactively provide temperature excursion data to customers to make it easier for them to know what to do if they experience an excursion...and so that they would not always need to call us. Is this permitted?
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530 - What is PAAB's position on proactively providing storage/stability information to customers that is different than what is in the Product Monograph, but which is supported by clinical data? We sell a product that requires refrigeration between 2-8 degrees. Our Med Info department receives many, many calls inquiring about temperature excursions outside of the labelled storage conditions. We have data to support the excursions. We would like to be able to proactively provide temperature excursion data to customers to make it easier for them to know what to do if they experience an excursion...and so that they would not always need to call us. Is this permitted?

Scheduled Pinned Locked Moved Terms of Market Authorization
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    You cannot promote the excursions in advertising until you update the Product Monograph.

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