On May 11, 2017, ANVISA formally published RDC-157/2017 that will serve as the regulations for their 3-Lot Pilot that is to take place in 2017. We’ve been expecting this new RDC around this time because they were required by the recent Law Number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”). ANVISA also held a “public consultation” to allow the public to review and comment on an earlier draft of what is now RDC-157/2016 (see “ANVISA Reveals Draft Serialization Regulation and Asks For Comments”). The newly adopted RDC-157 is clearly intended to guide the pilot and then ANVISA intends to update it as part of their analysis of the pilot results. They will likely go through another public consultation before they make it a final regulation that all companies will need to follow. Bottom line, if you are not part of the 3-Lot Pilot, don’t start implementing a solution until they publish the absolute final regulations after the pilot analysis is complete.
I have used Google Translate to generate a translation that appears to be fairly good. I made just a few changes to reflect terminology we use here in the United States and elsewhere, and one particular word that Google Translate cannot interpret, for some reason, but a friend of mine from Brazil has helped with. Despite being fairly easy to read, please do not use this automated translation for compliance, or even to design your participation in the pilot. Get a professionally translated version for that. Check with the local industry associations in Brazil.
I see that Google shutdown the links I created and used in my last Brazil essay for the Google Translate URLs for the previous draft version of this regulation. Apparently I can’t post a URL that causes Google Translate to re-translate a given document every time the URL is clicked. So this time I took the time to actually generate a PDF that contains the translation of this new final pilot version. You can downloaded it from RxTrace here.
The changes made to the regulation as the result of the public consultation are fairly minor. It appears they simply provide a little more clarity around the intention of ANVISA in individual provisions.
I wish they had provided more clarity around the need for aggregation data. I’m sure that some people still think the language in Article 7 is intended to mean that aggregation data must be captured and reported, but to me, it is confusing. Here is the final Article 7 as translated by Google:
“Art. 7. Every transport package containing at least one medicinal product included in the SNCM pilot phase, from the registration holder’s dispatch event instance, must have a unique identifier code that allows the relationship with the IUM of the medicinal products contained therein.”
To me, this article is simply saying that transport packages must be identified with a unique identifier (a serialized code). This would allow the relationship with the IUM of the products contained inside to be documented if someone chose to do that. At least the regulation requires the registration holder to put that serial number on the transport package to make that possible, but it doesn’t seem to say that anyone MUST document those relationships. Could just be a bad translation, or maybe I’m missing something somewhere else. This is one important reason not to rely entirely on this machine-translation.
Article 17 gives ANVISA four months to publish the “normative instructions”—the technical specifications—for the operation of the SNCM pilot phase. That brings us out to September before the pilot can start. Article 19 states that after the pilot evaluation is complete, a new normative act will be published for the full implementation of the SNCM.
That’s the one everyone will need to follow. Odds are, it will have a lot of similarities to the requirements in RDC-157/2017.
We are now a little more than a week away from the 180 day cutoff date for the FDA to allow companies to apply for waivers, exceptions and exemptions from the DSCSA. The clock is ticking. What are they going to do about it? (see “FDA Tea Leaves: Are They About To Delay The November Deadline?” and “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance”.)
It won’t be long now. Next Monday is Memorial Day so there won’t be an RxTrace essay that week, but if the FDA makes any announcements, you can bet I’ll interrupt my holiday to let you know. So no essay means no announcement…yet. Have a great holiday!