For smaller items, there is an actual physical real estate issue. You have to add a GTIN and serial number, and it has to be readable to a human and to a scanner.
Many smaller packages have just enough space for lot number and expiration date, but the remaining blank area is not sufficient for adding a unique serial number or a 2D barcode. That could necessitate the addition of a new outer carton.
For primary packages consisting of folding cartons, in order for them to be read in a post-aggregation situation, such as inside a case before the flaps are sealed, the location of the 2D DataMatrix code may need to be relocated to a side panel or end flap to maintain line-of-sight visibility while in the case.
The longevity and readability of the codes becomes an issue as the product moves through multiple steps in the supply chain. The code-printing surface must be resistant to environmental conditions, and codes may have to be relocated to a place on the package that is free from abrasion that can occur on conveyors, cartoners, and palletizers.
These artwork and structural changes can take up to six months to implement.
And of course, any change in labeling (either on the primary package or on the case) means refiling an NDA with the FDA. Typically FDA handles these quickly, but if hundreds of thousands of labels are being filed in a race to comply with looming deadlines, one could expect slowdowns in approvals.
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