Brazil Serialization and Compliance Reporting Law Officially Signed and Published
In early September, Brazil’s serialization and compliance reporting bill, PL 4069, Brazil Track and Trace Bill Passes Committee Vote after roughly seven months of debate and revision. That bill has now officially been signed and published as a
Summary of the Law
13.410 officially amends the original 11.903 law for the SNCM (National Medicines Control System).
The 3-phase implementation schedule is confirmed (starting after regulatory rules)
- 1 year pilot of at least 3 batches of product (It is believed ANVISA will select pilot participants and that not everyone in the industry will need to execute a pilot).
- 8-month analysis of pilot results.
- 3 years for full implementation.
At a minimum, the four data elements contained will include:
- ANVISA registration number.
- Serial number.
- Lot number.
- Expiry date.
Additional data may be included based on ANVISA rules (ANVISA has been discussing this in the RDC rulemaking).
ANVISA is given authority to determine the scope of the medicines covered under the law, and a governmental system/database shall be established for the storage and analysis of the information relating to the medicines covered.
Each stakeholder/supply chain member must capture and communicate the required regulatory information to the governmental system.
ANVISA has up to four months to complete regulatory rules for the operational aspects of the law, and this time period may be extended.
Industry stakeholders will review and begin discussing planned actions while ANVISA rule-making continues – this rule-making will determine details such as final data elements, traceability events, data formats, and reporting requirements. As always, we'll keep you updated as information becomes available.