Monday, May 18, 2015

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? - By Dirk Rodgers

Dirk Rodgers of RxTrace.com has written another great article on ANVISA... Read below for an excerpt  or read the full article here. Serialization is a challenge and with this interpretation from the Brazilian authorities it certainly complicates matters for manufacturers if their goods land up in Brazil...
"In Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards. They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific. But there is one GS1 standard they steer clear of: the GS1 serial number. Why is that?

I’m not sure, but I think I have a pretty good theory. See if you agree.

But first, let’s review how GS1’s serial numbers are defined (see the GS1 General Specifications for more details and specifics). GS1 serial numbers can be any length, up to 20 characters. The allowed character set includes 82 distinct characters, including digits 0-9, the upper and lower case English alphabet, and a set of 20 symbols and punctuation characters. Most applications, trading partners and regulations limit the serial numbers used within their closed domain to something shorter and often limit the allowed character set by written agreement or guidance. But the feature of GS1 serial numbers most pertinent to this discussion is that they must always refer to a specific GS1 GTIN. That is, any reference to a GS1 serial number without including its associated GTIN is, by definition, totally ambiguous and meaningless.

WHY DOES THAT NOT APPEAL TO ANVISA?

ANVISA wants the serial number (held within AI 21 in the barcode) to be unique across all GTINs registered by the registrant, not just the one GTIN referenced along with it on the product. See the difference? GS1 says the serial number must be unique only for that GTIN, but ANVISA says serial numbers used in their supply chain must be unique to the manufacturer (more accurately, the registration holder). That really complicates things for larger manufacturers, inside and outside Brazil, because it means they have to coordinate the serial number assignment across all of their products that are targeted for the Brazilian market. For large multi-national corporations, that could involve dozens—perhaps hundreds—of packaging facilities around the globe and include a wide diversity of products." - Continue reading at RxTrace.com