Search Results for: RFID

DSCSA, EUDR

Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not.  That’s probably what the legislatures and regulators who create the requirements think.  RxTrace readers know it’s not … Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution →

GS1 General Specification

GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market.  The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose.  So far, three organizations have … Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care →

Predictions

RxTrace Preview of 2016

It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability.  As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  You don’t have to be a subscriber  to respond and the … Continue reading RxTrace Preview of 2016 →

Barcodes

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

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That’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 … Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification →

Brand Protection

Your Plain Old Package: Unlock Its Built-in Brand Protection Capability

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When serialization of drugs was first being considered for pharmaceuticals back in the mid-2000s, I recall that it seemed to rattle the traditional brand protection vendors who offered package-level authentication technologies.  They were more than a little worried that drug companies would end up using serial numbers in place of their more traditional offerings, like … Continue reading Your Plain Old Package: Unlock Its Built-in Brand Protection Capability →

ANVISA

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?

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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 … Continue reading Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? →

ANVISA, SSCC

ANVISA And The SSCC Controversy

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GS1’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 … Continue reading ANVISA And The SSCC Controversy →