If you do business in Brazil then you know that everything is published there in Portuguese, including ANVISA’s documents. It is necessary to translate everything unless you can read Portuguese. I can’t, so whenever something comes out I have to do a quick translation to get an idea of how significant it is. Last week, ANVISA published two new documents related to their future pharma serialization and traceability mandate. They are important, because they relate directly to the schedule and some of the requirements of Brazil’s pharma serialization and traceability mandate.
One of the two documents is RDC 319/2019 and it went into effect on the day it was published, November 12, 2019. This new RDC amends some of the provisions of RDC 157/2017. When published in May 2017, RDC 157 established the plan for the 3-lot pilot and what would happen leading up to the full mandate (see “Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot”). The changes made by this new RDC eliminates every mention of the word “pilot”, so the effect is to convert the entire RDC 157 into regulation for the full deployment. With RDC 319, the pilot is officially over. You can download my Google Translate translation of this document here.
One the changes to RDC 157 made by this new RDC is Article 2 which originally established that ANVISA would publish a “normative instruction” (guidance document) containing a list of medicines that the SNCM system would apply to. The new RDC changes content of the future normative instruction to “deadlines and conditions” for sending data to the system.
And, surprise, the other document, Public Consultation No. 747, is a public consultation (request for comments) on a proposed normative instruction that would set the deadlines and some conditions for serialization and tracing, which is exactly the modification that RDC 319 (discussed above) inserted into RDC 157 Article 2. You can download my Google Translate translation of this document here. The proposed normative instruction in this new public consultation will fulfill the updated intent of RDC 157 Article 2.
It proposes the following list and associated deadlines:
“I – at least 25% of the marketed production of each establishment by 1 October 2020;
“II – at least 50% of the marketed production of each establishment until April 1, 2021;
“III – at least 75% of the marketed production of each establishment until September 1, 2021; and
“IV – 100% of the marketed production of each establishment until April 1, 2022;”
Of course, because of RDC 319 above, these are no longer referring to the pilot but are the full deployment so every company would have to meet these dates if finalized. Remember, the original law 13,410, signed by the Brazil President in the last few days of 2016 that set the whole program in motion, established the following goals for the program as I characterized in “Brazil Gets Rational With Their New Pharma Traceability Law”:
- April 29, 2017: ANVISA to publish proposed regulations that meet the requirements of the new law (this date could get pushed out a little if it takes ANVISA longer than expected to complete the draft, and if it does, then the succeeding dates may also get pushed by a comparable amount);
- April 29, 2018: Selected members of the supply chain must complete a 3-lot pilot that follows the proposed regulations;
- December 29, 2018: ANVISA to publish final regulations after considering the results of the 3-lot pilots;
- December 29, 2021: Deadline for all regulated drugs being serialized and traced through the supply chain;
They were a little late with the completion of the pilot and in May of 2019 ANVISA published their final pilot report that would be the basis of modifications to the regulations (see “Brazil: The Anvisa 2019 Pilot Report”) but these newly proposed deadlines represent an acceleration of the original intent of the law. Yes, the full 100% of production isn’t until April 1, 2022 but members of the supply chain will have to start dealing with full tracing of 25% of each manufacturer’s production by October 1, 2020. That’s not far away. Apparently the original law did not anticipate a phased approach but the lessons learned from just about every pilot and full deployment of regulations around the world have shown that a phased approach is the only smart way to roll out a regulation like this. Once a regulator decides to do a phased rollout, and the one deadline given previously was for the full deployment, you have to set your initial deadlines earlier than the final date in order to meet that final one. This set of phases misses the original goal for full deployment, but only by 3 months.
The comment period for this proposed normative instruction runs until just after the new year. Watch for the publication of the final guidance shortly after that.
There will be no essay next week due to Thanksgiving and the essay scheduled for Monday, December 2nd will probably come out on the 3rd. Happy Thanksgiving everyone!