Brazil ANVISA Update: New Proposal for Serialization Implementation

(An Official publication of PharmaSecure)

As per Law No. 13.410, 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.

As per the plan, the serialization requirements were rolled out in 3 phases –
Stage 1: In September 2017, a 1-year pilot phase was initiated.
Stage 2: From September 2018 to May 2019, pilot review and the finalization of technical guidelines were done.
Stage 3: was planned for May 2019 to May 2022, including implementation of unit-level serialization.

In November 2019, a report was published which stated that there would be changes in the deadline. In order to protect Brazil’s citizens against prevalent issues in the drug supply chain like counterfeit drugs and theft, every supply chain stakeholder manufacturing or importing in Brazil was instructed to capture, store and exchange supply chain events electronically.

The law required unit-level serialization, track and trace and monitoring supply chain events. Serialization requirements stated that all items must be visible at the unit level, and products must have a GS1 2D data matrix barcode containing GTIN, ANVISA medicine registry number, unique serial number, expiry date, and lot/batch number.

As per the recent update, a proposal was put forward to implement serialization requirements for pharma stakeholders in 25 percent of its products by October 2020, 50 percent of its products by April 2021, 75 percent by September 2021 and 100 percent with reporting by April 2022.

The proposal was put forward for public review and an update regarding the results of the proposal is awaited.

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