Drug Serialization Requirements in Brazil

On December 28, 2016, after lengthy discussions and a temporary suspension of already active legislation related to pharmaceutical serialization, the Brazilian President signed the law 13.410, thus amending the ones dating back to 2009 and 2013. Published in the Official Gazette on December 29, 2016, law 13.410 is not officially in force.

While certain requirements related to pharmaceutical serialization are already fixed, the exact scope of the law is yet unclear. However, in Brazil, the Agência Nacional de Vigilância Sanitária or ANVISA, is scheduled to clarify this within four months of the publication of law 13.410.

Serialization at both the unit and case (transport packing container) levels will be mandatory in Brazil for all pharmaceutical products. Cases will have to include information as to which units they contain. Tracking will be required at each level of the supply chain, including certain events beyond entry/exit at manufacturer/importer, wholesaler, distributor, and pharmacy levels. Pharmaceutical products manufactured outside of Brazil may be serialized upon entering the Brazilian market.

The 2D barcode or Datamatrix must be encoded with ANVISA registration number, Serial number, Lot number and Expiry date. Brazilian coding standards are similar to GS1 standards but not exactly the same. Batch number and, obviously, a GTIN follows the same format required by GS1. However, there are differences regarding the (numerical) serial number (13, not 20 digits), the production and expiration date (MM/AAAA format). The numerical ANVISA registration number contains 13 digits.

Each player within the drug supply chain will have to report when a product passes through their facility. This has previously been the case, however, until now, pharmacies, distributors and other trading partners fed supply chain information back to the Marketing authorization Holder (MAH). In the future, information will be reported to a centralized reporting authority established by ANVISA. This centralized system will store and better analyze all information related to pharmaceutical products covered by the new law.

From the signature of Law 13.410, ANVISA has 4 months to define the scope of the pharmaceutical products covered under the law and specify detailed instructions. Pharmaceutical companies and CMOs then have one year to put prototype testing of three batches in place. Results will need to be communicated to ANVISA. ANVISA then has 8 months to analyze industry feedback and serialization prototypes. Once reports are validated, players in the pharmaceutical industry will have three additional years to fully implement serialization which will result in a December 2021 deadline. We can therefore expect that by 2022, all pharmaceutical products will have to be serialized and traced throughout the supply chain.

Similar in other countries, serialization and aggregation implementation will happen gradually in Brazil. Although technically required since 2015, serialization will have to be fully implemented and processes operational within the next five years. Until then, players of the drug supply chain, as well as authorities both have their part to play.