Any relabeling operations are considered manufacturing by definition [ICH Q7, Section 20] and should be performed under appropriate GMP controls [ICH Q7, Section 17.40]. With appropriate justification, manufacturers including repackagers and relabellers may replace the original label. The new label should contain information as per [ICH Q7, Sections 9.42, 9.43]. However, distributors should not remove an original label, but only add additional labels. Information about the original manufacturer must be provided to the customers [ICH Q7, Section 17.61]. Overall, the traceability of the supply chain needs to be maintained [ICH Q7, Section 17.2].
