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Product overview

Comply with Brazil’s serialization and reporting requirements

TraceLink Brazil Pharmaceuticals enables multinational and Brazilian domestic pharmaceutical manufacturers to meet ANVISA requirements for product serialization and compliance reporting to the centralized SNCM (Systema Nacional de Controle de Medicamentos) system.

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With Brazil Pharmaceuticals, you can:

Confidently meet Brazil traceability requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from regional compliance demands

Industry challenges

New compliance requirements demand new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges in managing regulatory compliance requirements emerging in the Brazilian market. These challenges include:

Complex serialization and reporting requirements

Brazil’s complex end-to-end traceability regulations affect manufacturers, importers, distributors, and dispensers alike, and each segment has unique reporting requirements.

Complex serialization and reporting requirements
Siloed compliance processes and reporting

The central government system does not connect trade partners to work on multienterprise processes, such as tracking and resolving shipping and receiving errors.

Siloed compliance processes and reporting
Incorrect compliance data

Reporting and data errors can lead to product delays if they aren’t resolved quickly between trading partners.

Incorrect compliance data

Product benefits

How TraceLink Brazil Pharmaceuticals drives efficiency

Simplify SNCM system integration

Create and trigger reports for key compliance events

Report on serialized inventory operations

Comply with internal transfers of product

Manage operational exceptions

For Internal 34

Product benefits

Simplify SNCM system integration

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

Digital_Documents

Product benefits

Create and 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.

Pharmacy

Product benefits

Report on serialized inventory operations

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

Logistics

Product benefits

Comply with internal transfers of product

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

For Internal 5

Product benefits

Manage operational exceptions

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

Capabilities

TraceLink Brazil Pharmaceuticals

This solution provides the full compliance data management capabilities companies need to build a secure and flexible Brazil serialization and traceability compliance infrastructure. You can:

Manage compliance data

Create and manage compliance reports

Automate compliance reporting process

Digital documents

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).

serial

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)

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Integrate with and trigger automated submission of reports to the Brazil SNCM compliance system based on configured operational triggers.

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.

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Related resources

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