ANVISA Update: Companies Must Accelerate Product Serialization throughout 2021
On December 15, 2020, Brazil’s health regulatory agency, ANVISA, met to discuss industry feedback on the current draft of the agency’s Normative Instruction for companies planning to serialize medicines for the Brazil market. The meeting resulted in several significant changes to earlier drafts that had, until recently, appeared to be close to finalization. Despite these changes, ANVISA still expects companies to be well underway in the technical planning and implementation of their serialization and reporting solutions in order to meet the April 2022 deadline.
Deadlines are no longer expected to be phased by product category
In previous discussions, it was proposed that only certain categories of drugs would have to comply with the April 2022 deadline, with additional drugs being added over time in a series of subsequent deadlines. That proposal was rejected by the ANVISA directorship in favor of a percentage-based approach: The April 2022 deadline remains in effect for at least 20% of a company’s serialized products. There were minor changes to the list of products that will be exempt from the serialization requirements.
The “Implementation Plan” has been replaced by “Assisted Implementation”
Toward the end of 2020, as ANVISA updated its website and launched its portal to the government reporting system, SNCM, it was expected that companies would be required to submit a comprehensive serialization implementation plan for any products that were not yet serialized by December 31, 2020.
The implementation plan requirement has been set aside in favor of what is referred to as “Assisted Implementation”, which would require Marketing Authorization Holders (MAHs) to report a specific percentage of serialized lots to the SNCM implementation system during a testing period from April 2021 to April 2022. A new “Assisted Implementation” system will be available for manufacturers and importers to begin reporting events to SNCM based on a set of graduated minimums:
- 0.5% of the lots released from April to May 2021
- 2% of the lots released in June 2021
- 4% of the lots released from July to October 2021
- 5% of the lots released from October 2021 to the end of the testing program (April 2022).
Once the SNCM production system is fully ready in April 2022, reporting deadlines will be based on the percentage of serialized packaging lines for MAHs:
- ≥ 20% by April 2022
- ≥ 60% by April 2023
- 100% by April 2024
Downstream entities—wholesalers and dispensers—will begin participating in “Assisted Implementation” in July 2021 following a graduated series of minimum requirements:
- One serialized lot (whole or partial) that has been received by the company as of July 2021.
- 2% of the lots (whole or partial) that have been received by the company from July to October 2021
- 5% of the lots (whole or partial) that have been received by the company from October to December 2021
- 10% of the lots (whole or partial) that have been received by the company from December 2021 at the end of the testing program
Planning your Brazil serialization strategy with TraceLink
Although the details of the Normative Instruction are still under review, any change to the April 2022 deadline would have to go through a new legislative process, so manufacturers and importers should continue to plan on meeting ANVISA serialization and reporting requirements for at least 20% of their products by April 2022. Stay up to date on Brazil’s compliance regulations with our weekly regulatory updates.
Although not part of the law, Horizontal Integration—data exchange with trading partners—will be a critical requirement for accurate Wholesaler and Dispenser reporting and will require a significant amount of time to implement. TraceLink’s Brazil Compliance Special Interest Group will continue to monitor updates from the GS1 Working Group on Horizontal Integration to help companies define their own data exchange requirements and prepare for onboarding their trading partners as soon as possible.
Because 3PL integration has traditionally been challenging and time-consuming, companies using a 3PL should start their integration discussions. 3PLs are managing multiple customer requirements and Tracelink can start working with them on your behalf. Learn more about TraceLink’s solutions for Brazil Compliance.
With a tight timeframe until the 2022 ANVISA deadline takes effect in Brazil, there is no time to start over if you choose a partner that does not have the local expertise—and the world’s largest integrated digital supply network—to onboard your business partners quickly and let you Integrate Once, Interoperate with Everyone™. From automated software validation and expert training to enterprise-wide exception management with TraceLink’s Serialized Product Intelligence application, TraceLink lets you transform local compliance operations into a center of operational excellence.