Tag Archives: Brazil

ANVISA

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 →

ANVISA

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 →

Predictions

RxTrace Preview of 2016

It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability.  As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  You don’t have to be a subscriber  to respond and the results will also be open to everyone in the coming months.

So what about 2016?  I think Continue reading RxTrace Preview of 2016 →

ANVISA

The Official Suspension of the Three-Lot Pilot in Brazil

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395px-Coat_of_arms_of_Brazil.svgOn 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: Continue reading The Official Suspension of the Three-Lot Pilot in Brazil →

ANVISA, FDA

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 →

SAP

SAP Makes Bold Move Into Pharma Traceability

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sap-erp-graphicLast week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP.  Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module.  The same issue contained a sponsored article from SAP about the module.  As long-term readers of RxTrace know, I do not endorse specific products and I rarely even write about specific products.  This essay is not an endorsement— Continue reading SAP Makes Bold Move Into Pharma Traceability →

ANVISA

Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?

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Brazil Ministry of Health logoIn Brazil, the National Agency of Sanitary Surveillance (ANVISA) has built their pharma serialization regulation around GS1 standards.  They embrace the GS1 Datamatrix and GS1-128, both encoded with GS1 Application Identifiers (AI) and using GS1 Human Readable Interpretation (HRI) (see my previous essay, “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”, for my thoughts on HRI), the GS1 Global Trade Item Number (GTIN) and the GS1 Serial Shipping Container Code (SSCC) to be specific.  But there is one GS1 standard they steer clear of:  the GS1 serial number.  Why is that? Continue reading Why Does ANVISA Embrace GS1 Standards, Except The Serial Number? →

ANVISA

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages

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Idea for a barcode that might meet ANVISA requirements
Idea for a barcode that might meet ANVISA requirements

Last week I wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month I wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  Today I will take a look at drug package identifiers under the SNCM as regulated there by the National Agency of Sanitary Surveillance (ANVISA).  Most of the factual information included here is based on Continue reading The ANVISA Unique Medicine Identifier (IUM) on Drug Packages →