The Brazilian Health Regulatory Agency (ANVISA) is implementing a comprehensive nationwide serialization solution. Pharmaceutical companies manufacturing in or importing into Brazil are required to follow the regulations set forth in the National Medicine Control System (SNCM). The regulations are scheduled to go into effect in May 2022.
At its core, SNCM is a modernization scheme: Every supply chain actor must be able to capture, store, and exchange data electronically. All products will be required to have a GS1 Data Matrix barcode that houses a Global Trade Item Number (GTIN), an ANVISA Medicine Registry Number, a unique serial number, an expiration date, and a lot/batch number. These internationally accepted measures will enable Brazil to protect its almost 190 million citizens against common problems in the drug supply chain, such as counterfeit pharmaceuticals and cargo theft.
ANVISA also aims to prepare Brazil’s pharma industry to meet global standards. By doing so, when Brazilian companies decide to export to developed countries, they will have no issues complying with local regulations because they follow global standards.
Let’s look back at the most important SNCM deadlines so far and what to expect between now and 2022.
December 28, 2016
ANVISA signs the SNCM into law (Law No. 13.410). It establishes the serialization requirements and timelines for the entire Brazil pharmaceutical supply chain.
September 2017–August 2018: Pilot Phase
In the first phase of the SNCM, regulations were completed/finalized, a management committee was formed to oversee implementation, and preparations began for the next phase (evaluation). ANVISA selected industry stakeholders (e.g., importers, distributors, and retailers) to disseminate data about at least three batches of medicines in a pilot.
September 2018–May 2019: Evaluation Phase
This included analysis, correction, and validation tasks to further streamline the pharma compliance process. The management committee assessed results from the experimental phase and the next phase (implementation) was defined.
April 2019–April 2022: Implementation Phase
Serialization requirements are rolled out and finalized. ANVISA will monitor and evaluate results and work to correct any problems. The key serialization deadlines are listed below. Public discussions concerning the deadlines below have ended, and there might be changes. ANVISA hasn’t made any announcements yet; we’ll keep you updated about its decisions.
- October 2020: Pharma stakeholders must serialize 25% of their products
- April 2021: Pharma stakeholders must serialize 50% of their product
- September 2021: Pharma stakeholders must serialize 75% of their product
- April 2022: Pharma stakeholders must serialize 100% of their product
Final thoughts: rfxcel Brazil serialization solutions
rfxcel has fine-tuned its traceability software to help manufacturers operating in the Brazilian market achieve SNCM compliance, and we are prioritizing assisting Brazilian companies to prepare for all the deadlines between now and May 2022. Our entire team of supply chain experts is here to help you be ready. If you have questions or concerns about the SNCM regulations, email Commercial Director for Latin America Vinicius “Vinnie” Bagnarolli or contact us here.