Tag Archives: Application Identifier

The New GS1 Digital Link Standard

There is competition in the 2D barcode world between Data Matrix, QR Code and PDF417.  Which do you like?  Why?  Before you choose, do you know the features and benefits of each so you can make an intelligent choice?  Now that I’ve asked all those questions, I need to take a step back. For meeting the U.S. Drug Supply Chain Security Act (DSCSA), Congress already made the choice for you.  It’s the same in the E.U., the European Commission made the same choice.  They both picked Data Matrix.  You can’t use QR Code or PDF417 or any other kind of barcode or RFID on prescription drug packages in those markets, or you won’t be compliant and your trading partners won’t want to do business with you.  Does that bother you?  It shouldn’t.  The problem is, some countries around the world are flirting with mandating QR-Codes for drugs rather than Data Matrix. 

Let’s take a look at these three types of barcodes, and in the process, we’ll take a closer look at GS1’s new Digital Link Standard.

Continue reading The New GS1 Digital Link Standard

I’ve Changed My Mind, Follow GS1’s HRI Specification

HRI zoomThat’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation.  Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).  Why have I changed my mind?  GS1 modified their specification to accommodate most of the objections I had over it.  Let me explain.

The new specification for HRI is in the latest version of Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification

ANVISA And The SSCC Controversy

ANVISA logoGS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations.  I’ll cover these controversies in multiple essays—in this one, Brazil.

This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).

The problem is, a homogeneous case of product can Continue reading ANVISA And The SSCC Controversy