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What is SNCM?
SNCM is an abbreviation for Sistema Nacional de Controle de Medicamentos, which is Brazil's national drug control system that establishes drug tracking and serialization criteria. The National Drug Control System (SNCM) was established to regulate the traceability of pharmaceutical products and prevent counterfeit drugs and cargo theft. The SNCM includes unit-level serialization, product tracking and tracing, and environmental monitoring as products move through the supply chain.
In Brazil, the purpose of SNCM is to build a National Drug Control System that sets the procedures for drug tracking and serialization. The SNCM defined serialization standards and timelines for the entire Brazilian pharmaceutical supply chain.
The SNCM is a centralized government database that follows the flow of pharmaceutical items from the point of manufacture to the point of consumption, including the stages of manufacture, import, distribution, transport, storage, and dispensation.
All importers and producers must have a "serialization plan" on the SNCM portal, and all product event reports must be reported to SNCM by supply chain players.
The Brazilian Health Regulatory Agency (ANVISA) signed the SNCM into law on December 28, 2016, and it was the first step toward serialization implementation.
On April 12, 2022, the Brazilian Federal Senate enacted Bill 3846. The measure proposed was to incorporate a QR code for a digital package insert and revoke the necessity to serialize drugs individually. The Bill additionally revoked the necessity for ANVISA to establish the National Drug Control System (SNCM) itself.
The SNCM strived to prevent counterfeit medications and pharmaceutical trafficking, which are prevalent, across the nation.
Are you willing to ensure compliance with Brazilian pharmaceutical regulations? Contact Freyr, wherein our team of experts can provide comprehensive support, including guidance on ANVISA, product registration assistance, and compliance and monitoring for the National Pharmaceutical Track and Trace system.