ANVISA Reveals Draft Serialization Regulation and Asks For Comments

Last week, the National Agency of Sanitary Surveillance (ANVISA), the healthcare regulator in Brazil, published a draft of their proposed pharma serialization regulations aimed at meeting the requirements of the new law number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”).  The purpose of this new publication is to solicit comments from interested parties.  It is called “Public Consultation No. 311 of February 15, 2017”.  This is not a final regulation—the public consultation ends on March 17, 2017, after which changes to the text, based on the feedback collected, are likely before it becomes final—but it provides us with a solid view of ANVISA’s thinking, and that amounts to a big win for the industry, and for Brazil.  Now is the time to read it over and submit your comments to help make it even better.

Here are the URLs you will need (URLs have been shortened):


Original URL

Google Translate URL

The full draft of the proposed modifications to RDC-54

ANVISA Public consultation 311 comment submission form

Tutorial on responding to Brazil Public Consultations

Too large to translate

Up-to-the-minute results of the Public Consultation!

A note about these translations.  They are raw Google Translate output, which can result in some sentences being translated poorly.  Unlike these translations, when I provide a translation in a PDF, those are built from the output of Google Translate, but I carefully feed that service with one paragraph at a time.   I make sure the cut-and-paste from the source does not result in the insertion of extra carriage returns, which frequently causes ill effects in the translation.  I also adjust the formatting to more closely resemble the original.  And I sometimes manually adjust a small number of words.  For example, I changed the word “experiment” to “pilot” in the Russian translation I provided a few essays back, because I believe it is closer to the meaning.  In the translation links above, none of that has been done.  These are “raw” automated translations, so beware.  In fact, no automated translation—including my earlier “adjusted” Google Translated PDF’s—should be used for planning compliance.  Always get a professional translation of these documents for that purpose.  Check with the local industry associations for those.


Probably the thing that stands out the most to me is the fix ANVISA has made to the contents of the Unique Medicine Identifier (IUM).  This is the contents of the Datamatrix barcode and the human readable on each package.  The draft IUM contents now officially includes a GS1 Global Trade Item Number (GTIN), which is described as a “presentation GTIN”.  That is, the GTIN that is “presented” on the package.  Previously, the GTIN was not officially included in the IUM, although ANVISA did not mind of you chose to put one in (see “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).

Now, once they made that change, it allows the serial number element of the IUM to be unique within the GTIN, and not some other arbitrary (non-GS1) limitation.  Previously, ANVISA defined the serial number to require uniqueness across all products registered in Brazil by the market authorization holder.  Here is how Google Translate translates the new requirement:

“It is forbidden to repeat the serial code between units of the same drug presentation.”

This should conform with the GS1 General Specification.  The folks at GS1 should be very happy with this significant change—and so will the industry and their solution providers.

Interestingly, a part of the old RDC-54 definition of the serial number was that they must be “non-repetitive”.  That is, they were to be randomized.  The new draft does not include that language.

The new draft regulation does not seem to mandate the collection of aggregation data, but would require registration holders to put a unique serial number on each transport package that “…allows the relation with the IUM of the medicines contained therein.”  That is, the mandated serial number on the transport package would allow the collection of aggregation data, but that language doesn’t seem to say aggregation data is required.  Could that just be a bad translation?

Another huge improvement is the adoption of a centralized, government run data repository that all members of the pharma supply chain must deposit data into—the National Medicine Control System (SNCM).  Each company handling drugs in the supply chain must keep a copy of all event data for at least one year after expiration of the drug, and deposit that data into the government repository.  In the previous RDC-54, each market authorization holder was expected to receive this data from downstream members of the supply chain and store it for that length of time.  They were expected to analyze it for any “anomalies” and report them to ANVISA.  In the new draft, it will be up to ANVISA to analyze the supply chain event data for “anomalies” (which is actually not mentioned in the draft).  This takes a huge weight off of the shoulders of manufacturers and importers.  In fact, I understand this obsolete feature of the old design was the cause of lawsuits against ANVISA in the past.

Now that every member of the supply chain would need to pass IUM event data to the same central repository, this draft regulation would allow a more relaxed update schedule.  Updates would not need to be “real-time”.  Authorization holders would have up to 3 days to upload their event records, wholesale distributors would have 5 days, and dispensers would have 7 days to upload.  Clearly these would likely be batch uploads rather than online transactions.

The technical specification necessary to build and operate the SNCM would be published within four months after the publication of the final regulation.  Finally, once this new regulation is approved, RDC No. 54 of December 10, 2013, and RDC No. 114 of September 29, 2016, would be repealed (RDC-54 is currently “suspended”, see “Brazil Suspends Pharma Serialization And Tracing Requirements“).

Those are the things I saw in this new draft.  Did you see anything that excited you?