The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

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

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4 thoughts on “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”

  1. ….. And just to make fun so much better….. It’s not enough only to produce an xml file showing the complete tracking of the three batches…. It’s actually granting ANVISA access to Real Time Tracking of those test batches from manufacturing to dispensing. So if you haven’t done that already, you are facing a nearly impossible situation. Good luck with Brazil.

  2. The Brazil use of AI’s resembles very much the Saudi arrangement, where a misguiding Serialization requirement collides with both the requirement to follow the GS1 recommendation, as well as the GCC Labeling & Packaging standard. In this way creating a hybrid and a mix of all three standards/recommendations/guidelines for HRI. Strange, misguiding and creating mistakes, but durable anyway if you mix the advices correctly, as well as questioning local authorities. Looking forward to ANVISA elaboration and hope to meet up with them in Sao Paulo in mid-June where the ANVISA PM will speak at an ISPE event.

  3. Dirk,

    As always, very informative and clarifying. But as I read the Support Guide from GS1 Brazil, they show a “Layout suggestion for compliance with RDC 54/2013 when imprinting the manufacture date, expiration date and batch data” that splits the human readable IUM. The Serial number, Date of MANUFACTURE, Expiration Date and Batch number are positioned next to the DataMatrix, but the registration number and GTIN are pre-printed on the side of the carton. Doesn’t that contradict the ANVISA regulation for the IUM?

    1. Kevin,
      You are exactly right. I did not notice that characteristic of that example or I would have commented on it as well. This GS1 Brazil guide has quite a few holes in it. Is it possible we are looking at an old version? Has it been updated with better information and we just haven’t found the right copy???


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