Brazil Compliance

TraceLink’s Brazil Compliance application enables multinational and Brazilian domestic pharmaceutical manufacturers—or organizations such as agents or 3PLs that support them in managing compliance data and related reporting—to meet ANVISA requirements for product serialization and compliance reporting to the centralized SNCM (Systema Nacional de Controle de Medicamentos) system.

Challenges

Brazil represents one of the world’s largest pharmaceutical markets, with end-to-end traceability regulations that affect manufacturers, importers, distributors, and dispensers. Complying with Brazil serialization / traceability regulations means meeting a complex set of business rule and data management requirements which will be highly connected to your supply network operations.

While each segment has reporting requirements, the central system does not connect trade partners in order to confirm order accuracy or track and resolve shipping and receiving errors. This puts the burden on each stakeholder to ensure the exchange of critical serialized product and operational data with supply network partners. Failure to do so can result in reporting errors, compliance issues, and potential product delays.

2022
Government Reporting, Serialization

Benefits

Brazil Compliance will help enable the critical data management and operational process needs of MAHs/pharmaceutical manufacturers, agents of MAHs, 3PLs, wholesale distributors, and other entities with Brazil traceability and business requirements. With Brazil Compliance, companies can:

Connect to the SNCM System

Connect to the SNCM system with an application and platform designed to meet Brazil's digital certificate and other security protocols.

Create & Trigger Reports for Key Events

Create & Trigger Reports for Key Compliance Events

Ensure the creation and submission of correct compliance reports, informed by the necessary business, product, and operational data, based on key transactional events (shipment, receipt, etc.) as defined in the regulations. Fully automate compliance reporting based on unique internal or partner operations, or manually trigger reports to support unusual situations.

Report on Serialized Inventory Operations

Ensure that internal serialized inventory operations which result in compliance events are appropriately reported upon.

Comply with Internal Transfers of Product

Enable compliance for internal transfers of product between organization and sites with different CNPJs that trigger SNCM reporting requirements.

Manage Operational Exceptions

Effectively and efficiently manage operational exceptions (receipt/shipment errors, data issues, etc.) which need rectification and corrective actions with the SNCM system.

Capabilities

Brazil Compliance will provide a full compliance data management system for companies needing to build a secure and flexible Brazil serialization and traceability compliance infrastructure. With Tracelink’s Brazil Compliance solution, companies can:

Create and configure Brazil compliance reports based on in-depth business rules and data management capabilities for event transactions which are required to be reported by ANVISA to the SNCM system including:
- Activation (creation of a unique medicine identifier)
- Shipping
- Receiving
- Finalization (multiple different types)
- Replacement and Revocation (to correct and cancel previous event reports)
Manage master data and transactional event data which is unique to Brazil serialization and traceability regulations.
Configure specific rules and data management for unique report requirements (products produced outside Brazil and imported through customs, products domestically manufactured).
Integrate with and trigger automated submission of reports to the Brazil SNCM compliance system based on configured operational triggers or submit and manage reports with rich user experience tools.
Archive, search for, retrieve information, events, and reports sent to the SNCM system for up to 1 year after product expiry.