Brazil Publishes Its Serialization Plan

Industry has been closely following Brazil's law 11.903 requiring serialization for all pharmaceuticals sold in the country. The law and the original ANVISA guidelines detailed a program of serialized code in 2-D Data Matrix format on a security label printed by the national mint that was to be rolled out in June 2010. Subsequent ANVISA announcements delayed the timeline, but in November, ANVISA indicated that it will require all pharmaceuticals sold in Brazil to comply with its program by January 2012.

In September, Peter Schmitt, founder of Montesino Associates, provided an update on Brazil's law in the live Webcast, "Update: Brazil Law 11.903—An "Emerging" Regulation for Traceability & Serialization." Schmitt has continued to follow the evolution of the law, and he has translated the most recent ANVISA notice to educate the industry.

On November 3, ANVISA posted a Normative Instruction detailing its decision to move forward with the self-adhesive security labels supplied by the Brazilian Mint (known by its Portuguese initials: CMB-Casa da Moeda). According to Schmitt's translation, ANVISA states in the Instruction that "the self-adhesive labels shall contain an individual, unique, and non-repetitive identifier, called the IUM (Brazilian Initials for Unique Drug Identifier), printed in legible characters, and consisting of a two dimensional bar code. . . . The other specifications of self-adhesive labels are the responsibility of the Mint of Brazil and will be published by that entity."

The self-adhesive labels, often called "Safety Labels" or "Stamps" by ANVISA, "will be supplied by the CMB to each company with drug registration in Brazil, regularized with ANVISA."

The labels will feature an "invisible marker" for authentication that can only be recognized by the special readers. Measuring 19 x 25 mm, the labels will feature "micro fibers and colored beads visible only under ultraviolet light" along with "micro cuttings to protect against attempted tampering," Schmitt reports.

Over the next seven months, ANVISA will be supplying readers to pharmacies at no cost to them, which will enable them to authenticate the labels.

"Data from the security labels will be connected via the IUM and Brazil's Electronic Invoice system and will be the responsibility of the Treasury Secretary of Brazil," Schmitt explains.

"Pharmaceutical companies have 60 days to enroll in the program (not to implement) by signing a contract with the CMB," Schmitt adds. "Shipment of the labels to the pharmaceutical company must begin within 60 days after the contract has been signed."

Companies will have six months to start using the label for products produced in Brazil and 12 months for products imported into Brazil, Schmitt reports. After January 15, 2012, all pharmaceutical products sold in Brazil are required to have the safety label on their packaging.

During the PMP News Webcast, Schmitt addressed a number of questions on meeting the law's requirements. We have included answers to those questions on our Web site.

And Schmitt will continue to track developments in Brazil, so please stay tuned to www.pmpnews.com for further updates or e-mail Schmitt directly at peter.schmitt@montesino.com.

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