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We are planning to do shelf life extension labeling in China at both the CMO depot and clinical sites, and we are having trouble understanding the requirements to reflect in the shelf life extension label.
According to NMPA GMP Article 33 (in effect since July 2022), “if the expiry date needs to be changed, the drug for clinical trial shall be affixed with an additional label, and the additional label shall be marked with the new expiry date and at the same time cover the original expiry date. The original lot number or drug code must not be covered when affixing additional labels.
In the original Chinese text, “cover” is written as “覆盖,” which is interpreted as “completely masked.” Therefore, the question was raised on whether we need to completely redact the original expiry date with the shelf life extension label, or use the more familiar strike-out line.
Does anyone have experience preparing or performing shelf life extension labeling in China? If yes, we would like to know a) how we manage the cover up of the original expiry date according to Article 33; b) whether this requirement would be applicable to both site and depot relabeling.
Thank you in advance!