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(1) Is the English/French label HC requirement HC for both a primary and secondary packaging label?
IMP being used of my clinical trial is configured in a 2mL cryovial and primary package label is ENG only. I would like to confirm if an overlabel operation is needed to comply with ENG/FR requirements. Secondary packaging will include ENG/FR label.
(2) for expiry extensions, is HC following the CTR or can the expiry update solely be applied to secondary label on carton vs updating primary label?