Tag Archives: barcode

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 nearly that easy.

The problem is that every regulation requires something different.  The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name).  But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same.  It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

Idea for a barcode that might meet ANVISA requirements
Idea for a barcode that might meet ANVISA requirements

Last week I wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month I wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  Today I will take a look at drug package identifiers under the SNCM as regulated there by the National Agency of Sanitary Surveillance (ANVISA).  Most of the factual information included here is based on Continue reading The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

UDI Deadline For Class III Medical Devices Quickly Approaching

UDIexample.small.ucm368901There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline:  the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching