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

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

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2 thoughts on “Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?”

  1. The only way I can see this working is if ANVISA issues a unique registration for each potential labeler. While this is not contained in any of the documentation I have seen, the translations are not forthcoming (English) and have had to rely on 3rd parties (not ideal, to say the least). Nothing that I have read implies this is the case; ANVISA only references the manufacturer. Perhaps our Brazilian colleagus can shed some light; my Brazilian team seems as confused than I am…

  2. I can not see your point why only this would enable parallel importing. From my point of view having several importers of the same product would also be possible with a uniqueness per GTIN. As taking parts from the whole production amount and spread it to different ANVISA Medication Registry Number (related to registration holder and the product) would still end up in a uniqueness of serial number per AMRN (for sure with “gaps”(if you will call it like this in a randomized environment in serial numbers which are used by the other parallel importers).
    Or differently said: split an amount of Products where you have a bijective assignment to a serialnumber in subsets will end up in a mapping which is still bijective.

    Or did I get your point wrong Drik?

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