On October 23, 2015, a very brief resolution was published in the Official Diary of the Union (Diário Oficial da União) (Brazil’s equivalent to the U.S. Federal Register) which formally suspends the 3-lot track and trace pilot that drug registration-holders were formerly required to complete by December 10 of this year (see “Brazil Suspends Pharma Serialization And Tracing Requirements”). Apparently, that makes it official. The new resolution is numbered RDC-45 and it is dated October 22, 2015. Of course, this new resolution is only available officially in Portuguese, but here is an unofficial translation of its core contents in English:
“The effectiveness of item II of article 23 of the Resolution of the Board of Directors – RDC No. 54 of December 10, 2013, published in Official Gazette No. 240, Section 1 of December 11, 2013, is suspended.”
That’s basically it. What is missing from this new official resolution is any mention of the possible reconsideration of the entire tracing model that is necessary to meet the remaining provisions of RDC 54—something that was hinted at in the news article that appeared on ANVISA’s website shortly a few weeks ago. That article was an unofficial report of the actions taken by the ANVISA board of directors at their October 1, 2015 meeting. Of course, suspending the closest approaching deadline could be just the first step in adjusting the regulation to something that is easier to implement. Adjustments of that kind will take more time and effort than simply suspending the first milestone.
Also related to meeting the Brazil requirements, GS1 Brazil, the local Member Organization (MO) of GS1, the global supply chain standards organization, posted the final version (in English) of their documents called “Brazilian Medicine Traceability using GS1 EPCIS”, Parts 1 and 2. Pre-release versions have been floating around for months, but this is apparently the final version (oddly dated both August 2015 and May 2015). Unfortunately I cannot find any URL that will allow you to download it for free. I received a copy because I am a paid member of GS1 Healthcare but I am not allowed to share their documents with non-members. I will update this post with the URL if I am provided one.
This new publication from GS1 Brazil comes on the heels of their earlier “Support Guide for Codification of Medicines”, which I discussed in “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages” back in May. In that essay I pointed out an error in one of their sample barcode images. I was surprised to see that the new document repeats the same error.
Part 1 is the implementation guide, Part 2 contains actual examples and choreographies. Part 1 contains an explanation of these important standards, and shows how to apply them to meet the regulation. Part 2 contains pages and pages of example XML showing how to implement specific supply chain scenarios using EPCIS and GS1’s Core Business Vocabulary (CBV). I’ll have to take their word for it that these examples would keep you in compliance with the law.
My concern about these documents is that they appear to have been written in English and I assume will be translated into Portuguese, rather than the other way around. Is it reasonable to expect that every member of the Brazil domestic pharma supply chain will implement their compliance solution using GS1 standards and following these translated documents without ANVISA instructing them to do so? If a single company, or a group of companies decides to implement a solution with a different approach, they would not be interoperable with companies who are using the GS1 Brazil recommended approach. That would be a disaster.
The suspension of the 3-lot pilot could be just the beginning of the changes we could see in that country’s requirements. I am hopeful that there are more meaningful changes to come.