Keeping Up with Brazil

In September, Peter Schmitt, founder of Montesino Associates, provided an update on Brazil’s law requiring serialization for pharmaceuticals in the live Webcast, “Update: Brazil Law 11.903—An “Emerging” Regulation for Traceability & Serialization.” 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.

On November 3, ANVISA posted a Normative Instruction to the Daily Journal (Brazil's equivalent to the United States's Federal Register) 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 × 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 an edited transcript below, updated by Schmitt as needed.

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.

Q: Does Law 11.903 apply to medical devices, specifically stent delivery catheters?

Schmitt: To the best of my knowledge, to date, the law reads “medicines,” so the emphasis has been on the distribution of medicine.
    But there has been a lot of discussion about whether medical devices will be affected. Some expect that they may not be far behind. For now, to the best of my knowledge, combination products that contain a drug will have to comply with this law. In addition, my speculation is that kits that contain a pharmaceutical product will have to comply as well with a security label on the secondary packaging of that kit.
 
Q: Is there, at least potentially, the desire to print the 2-D Data Matrix on the actual blister package and NOT on the secondary package?

Schmitt: Right now the focus has been on the secondary package.

Q: Will we need two labels, one pasted on top of each other, for each layer of packaging?

Schmitt: No. A tamper-evident security label containing the serial number will need to be applied to the secondary packaging. This label will be provided by the CMB.

Q: Have you heard of any rumors to replace the IUM with a more global serialized standard such as SGTIN (Application Identifiers 01 and 21 in a 2-D code)?

Schmitt: Some have suggested using only the IUM in the security label and using additional printing to deal with other required data points. As of now this is speculation. ANVISA has not given any encouragement that this is a possibility.

Q: Could you please speak further to the use of strict control systems for the security labels and integration with production systems. Are you suggesting that these labels may be shipped to the packager outside of Brazil?

Schmitt: The Brazilian government has no intention to allow these labels to be shipped outside of Brazil. The commercial value of these labels will truly be priceless. The mint will have the responsibility to deliver these labels securely, perhaps even via armored car just like they would for currency. A robust control system to ensure
all labels are accounted for will be
necessary.

Q: As an importer of Rx products, we receive packaging that already includes the GTIN, Registration Number, Batch Number, and Expiration Date. Will the line we set up to apply the label with the new serial numbers require the added coding of the above noted items in 2-D format?

Schmitt: Yes. Drug companies importing into Brazil will have to provide this information to the Mint ahead of time who will include this information in the security label. Among the major concerns of the industry are the obvious logistical and infrastructural challenges. Even in a normal blister packaging operation, tracking blister-to-carton relationships and handling rejects are challenges. Under this new system, tracking security labels will add yet another challenge.

Q: What exactly is primary versus secondary packaging? Example, please?

Schmitt: Primary packaging is the package that comes into direct contact with the drug, such as a blister package or a bottle, and secondary packaging surrounds the primary package, typically taking the form of a carton.

Q: Upon import, will the products have to be broken down to the selling unit, then the label be applied to that unit, and then those units be repacked to the case and pallet levels?

Schmitt: My understanding is that, yes, this sounds like ANVISA’s intention with the law.

Q: Is serialization at the unit level and will this include aggregation?

Schmitt: Again, my understanding is yes, serialization will need to occur at the saleable unit level, and the unit information will
need to be conveyed to the Brazilian mint for it to produce the security labels. As such, drug manufacturers would not be
serializing items themselves through their own printing operations and then aggregating those items as they print/package into parent-to-child (carton-to-case) relationships. Those relationships would have to be captured through inspection of preserialized labels applied to units or predetermined and verified through inspection operations.

As ANVISA stated on November 3, “the CMB is the institution responsible, under the Drug Tracking System, to develop technology, produce, deliver, and monitor the distribution of self-adhesive labels for security.”