UDI requirements vs Japanese Barcode Marking guideline

[HelviReg]

Hello everyone,

According to the Japanese Barcode Marking Guideline, 3 information could be required to be encoded in a MD barcode: its product code (e.g. GTIN), its serial number and its expiration date, if applicable.

Looking at US FDA UDI requirements in terms of labeling, the product code must be encoded, as 5 other information if present on the label: the LOT number, the serial number, the expiration date, the manufacturing date and the HCT/P code.

So according to the product type, the barcodes respectively required by the Japanese regulation and the US FDA can be identical, or not, since 4 more information can be expected by the latter.

Do you think that a UDI barcode can be accepted by Japan, even if it encodes non required information, such as the manufacturing date ? Does someone have experienced such case ? (my question here is about encoded information only, the format is another concern).

Thank you very much for your help,

Vivien

 

[miken99]

This may or may not help.

The U in UDI stands for Unique. To make that Unique the US FDA and other regulators around the world are leveraging existing numbering system that are mature and used to uniquely identify their countries products. So, I would suspect that US and Japan would have similar views on UDI implementations.

The rule regarding what is supposed to be in the barcode is quite logical. Product ID (the DI) and any or all of the other required human readable found on the package (PI) are to be in machine readable format. So, I think that the first question would be 'Are there different requirements for human readable info on the packages for Japan vs. the US?' If not, then they aare the same and you do not have a problem. If so, then here in the US there is nothing to prevent a mfgr. to encode additional data in the barcode as long as it follows the data fields required for UDI compliance. That might be the case in Japan as well.

Hope that helps!