Update of APS per new boxed warning in PM
-
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?
-
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?
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
