Brazil : ANVISA Update and Track & Trace Requirements

Brazil is the largest economy in Latin America. As per Law No. 13.410, In May 2022, it will join USA, EU, Russia and many other counties in mandating serialization in its pharma supply chain. All the Pharma companies manufacturing or importing in Brazil will be required to follow the regulations set forth in SNCM (National Medicine Control System).

In its initial step towards serialization implementation, the SNCM was signed into law by the Brazilian Health Regulatory Agency (ANVISA) on December 28, 2016.

Brazil Serialization Deadlines:

As per the plan, the serialization requirements were rolled out in 3 phases –

• In Stage 1 i.e. In September 2017, a 1-year pilot phase was initiated.
• In Stage 2 i.e. From September 2018 to May 2019, a pilot review and the finalization of technical guidelines were done.
• Stage 3 was initially set for May 2019 to May 2022 and included unit-level serialization implementation.

The SNCM requires unit-level serialization, track and trace of products and monitoring supply chain events. These serialization requirements state that every item must be visible at the unit level, and all products must have a list of the following specifications:

• GS1 2D data matrix bar code containing Global Trade Item Number (GTIN)
• ANVISA Medicine Registry Number
• Unique serial number
• Expiration date
• Lot/batch number

ANVISA Update :

In November 2019, a report was published which stated that there would be changes in the deadline and later the proposed changes stipulate that every pharma stakeholder should be able to serialize 25 percent of its products by October 2020. The other deadlines didn’t change. 50 percent of the Products should be serialized by April 2021, 75 percent by September 2021, and 100 percent of Product serialization and reporting should be done by April 2022. The proposal was put forward for public review and an update regarding the results of the proposal is awaited.

For complying with all these regulations Pharmaceutical companies will need a Level 4&5 provider who understands these regulations and on whom companies can rely, tracekey solutions GmbH being the best in the business is favourite amongst the customers.

 Why tracekey solutions GmbH and how it can help you in this :

Tracekey is one of the leading Serialization Solution Provider in Europe. We handle complex Russian Track and Trace needs for number of companies present worldwide.

• Tracekey being No.1 in market for small and mid-sized businesses will prove to be a reliable partner for your Global compliance needs.
• Tracekey develop SaaS (Software as a service) solution that simplify the lives of their Customers.
• Tracekey's traceability system mytracekey PHARMA is perfect for Brazilian market needs.
• Well renowned Customer Success and Development Team always dedicated towards Customer needs.
• Fast on-boarding and easy validation.
• Ready-to-use software including connectors to common serialization systems.
• With footprint in over 12+ countries it is one of the best Serialization Solution provider in the Pharmaceutical market today.

"Tracekey makes you happy. One-stop solution for all your Compliance needs."