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 Continue reading Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot
Tag Archives: IUM
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
Brazil Gets Rational With Their New Pharma Traceability Law
Last week, Brazil President Michel Temer signed law number 13,410, which amends law number 11,903 from 2009, their original pharma serialization and tracing law. The effect of the new law on the old can be seen here. The problem for me is that I don’t read Portuguese, so I must rely on Google Translate to translate these texts. This results in an unofficial translation that has a few imperfections that are obvious, even to non-Portuguese readers, but it appears to be not bad. Continue reading Brazil Gets Rational With Their New Pharma Traceability Law
Why Does ANVISA Embrace GS1 Standards, Except The Serial Number?
In 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?
The ANVISA Unique Medicine Identifier (IUM) on Drug Packages
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