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    Update of APS per new boxed warning in PM

    PAAB Q&A
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    • K
      karen.taylor last edited by

      Can you please clarify what the manufacturer's responsibility is regarding updating approved APS when a new boxed warning has been added to a product's TMA? Does this need to be done proactively, i.e., materials updated prior to expiry? Or can they be updated as each piece expires?

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @karen.taylor last edited by

        Good morning @karen-taylor

        It is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. The addition of a new boxed warning would be considered significant and require the proactive update of all pieces in a timely manner. See also Q&A 337

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