We have an approved IMP single panel label and would like to move to a booklet style label to allow for use in multi-national trials. Would the English version of the booklet label need to be resubmitted for approval if only the format is changing?
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We have an approved IMP single panel label and would like to move to a booklet style label to allow for use in multi-national trials. Would the English version of the booklet label need to be resubmitted for approval if only the format is changing?