Tag Archives: RDC 54

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. Continue reading ANVISA Reveals Draft Serialization Regulation and Asks For Comments

Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54

iqpc-serial-labeling-playbook-2016Apparently, the National Agency of Sanitary Surveillance (ANVISA), Brazil’s pharma regulatory body, has passed a resolution that finally suspends all remaining serialization deadlines that were left over in their old RDC-54 regulation.  Remember that they suspended the deadline for the 3-lot pilot from RDC-54 last year (see “The Official Suspension of the Three-Lot Pilot in Brazil“).  I consider this news to be a “rumor” only because I have not yet seen the official word, despite having heard it from a very reliable source.

This is not Continue reading Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54

Proposed Pharma Serialization Regulation Progresses in Brazil

395px-Coat_of_arms_of_Brazil.svgThe government of Brazil is trying to recover from the poor design of their first attempt at a pharma serialization and tracing regulation, RDC-54/2013.  That first regulation was at least partially suspended (see “Brazil Suspends Pharma Serialization And Tracing Requirements” and “The Official Suspension of the Three-Lot Pilot in Brazil”).  Everyone seems to be operating under the assumption that the entire RDC-54-2013 will be replaced with a new regulation.  Legislation to do exactly that has been slowly churning its way through the Legislature for the last 9 months.  Word came last week that Continue reading Proposed Pharma Serialization Regulation Progresses in Brazil

More Thoughts On FDA and ANVISA

More ThoughtsOne of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out.  And in the ensuing days you find out what you should have included in those original essays.  That’s what happened with my two essays from last week:  “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.

So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA

Brazil Suspends Pharma Serialization And Tracing Requirements

ANVISA logoLast week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice.  Thank you to all who forwarded the link to the official announcement.  I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link.  Apparently shortly after that essay was published, ANVISA  Continue reading Brazil Suspends Pharma Serialization And Tracing Requirements