Monday, May 11, 2015

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages - Dirk Rodgers

Last week Dirk wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month he wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  In this article Dirk takes a look at drug package identifiers under the SNCM as regulated by the National Agency of Sanitary Surveillance (ANVISA).  Dirk is a member of the GS1 Healthcare group - Contact GS1 Healthcare for more information.

An excerpt from Dirk's article:
"Under the SNCM, manufacturers must apply a Unique Medicine Identifier (IUM) to all drug packages imported or sold into the Brazilian supply chain and trace them through the supply chain by December 11, 2016.  By December 11 of 2015, manufacturers must apply the IUM to the packages of at least three lots of drugs and trace them to the dispensing points.  And you thought compliance with the DSCSA was going to be hard to achieve!

Let’s focus on the IUM.  According to the English translations of various ANVISA resolutions and the GS1 Healthcare Q&A with ANVISA from last year, the IUM must be composed of, and in this specific order when printed in human readable on the drug label:
  • The ANVISA medication registry number for the drugThis 13-digit code is comparable to the NDC in the US.
  • A serial numberThis must be 13 digits chosen by the manufacturer and must be unique to the specific package it is printed on and unique across all products marketed in Brazil by that manufacturer. This is different from the definition of a GS1 serial number because it is not tied to a specific Global Trade Item Number (GTIN) or even the medication registry number.
  • The expiration date of the drugWhen printed in human readable form, this must appear as “MM/YY”.
  • The lot/batch number of the productThis may be up to 20 alphanumeric characters and is assigned by the manufacturer.
This data must also be encoded into a 2-dimensional (2D) Datamatrix barcode.  GS1 standard encoding is acceptable, which includes the formatting of the encoded date as “YYMMDD” and the use of GS1 standard application identifiers (AIs).  GS1 Brazil has confirmed that ANVISA does not mind if the barcode and the human readable includes a GS1 GTIN in addition to the four required elements listed above.  However, in the human readable portion, the GTIN should appear either first, or last.  That is apparently because ANVISA does not consider the GTIN to be a part of the IUM and they want to keep the IUM intact."

Read Dirk's full article here.