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Brazil Compliance

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Description

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


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 who have business and compliance demands as Brazil traceability requirements phase in. With Brazil Compliance, companies can:

  • Confidently connect to the SNCM system with an application and platform designed to meet Brazil's digital certificate and other security protocols
  • Ensure the creation and submission of compliance reports based on key transactional events (shipment, receipt, etc.) as defined in the regulations 
  • Ensure that internal serialized inventory operations which result in compliance events are appropriately reported upon 
  • Enable compliance for internal transfers of product between organization and sites with different CNPJs that trigger SNCM reporting requirements
  • Effectively and efficiently manage operational exceptions (receipt/shipment errors, data issues, etc.) which need rectification and corrective actions with the SNCM system

Capabilities and Features

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.

  • 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 for a product)
    • 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 depending if products were produced outside Brazil and imported, or 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 through the rich UL
  • Archive and enable search for and retrieval of information, events, and reports sent to the SNCM system for up to 1 year after product expiry


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Related Product Information

Brazil Compliance Brief

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Related Applications
Serial Number Manager
Serial Number Exchange
Serialized Operations Manager
Master Data Exchange
Serialized Traceability
Related Content
2-Minute Video: What You Need to Know About Brazil Compliance
In this video, TraceLink experts explain why Brazil may be your biggest compliance challenge.
Brazil Compliance: A Step-by-Step Approach to Serialization
Begin your Brazil serialization journey and see why you need to start today to meet the April 2022 ANVISA deadline. Download the infographic.
5 Risk Factors of Using Your LMS Provider to Meet Brazil Compliance Requirements
Learn why Line Management System (LMS) vendors can’t compare to TraceLink’s enterprise-level data management capabilities for Level 4 - Level 5 serialization.
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