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Brazil ANVISA Serialization


The recent focus has been on regulations relating to the Brazilian Brazilian Resolution No. 54 by the Joint Board of the National Health Surveillance Agency (ANVISA — Agencia Nacional de Vigilancia Sanitariar). The new law established rules and provisions for implementation of a national system of drug product identification and tracking throughout the pharmaceutical supply chain. Provisions adopted following a pubic comment period starting on April 2, 2013. The law was Published/Adopted on December 10, 2013.

Brazilian Resolution No. 54 and AVISA established that by December 10, 2015 (2 years from effective date) manufacturers must provide to ANVISA a set of complete tracking data for 3 lots of drug product including all transactions down to the point of dispensation. Likewise, by December 10, 2017 (3 years from effective date), all drug products must be serialized, tracked and reported and all supply chain participants must have required identification and tracking systems in place.

There are several very specific requirements for manufacturers and wholesalers that will be defined based on your company procedures and business systems.

Projects have delivered (1) strategy, (2) project roadmap and plans, (3) User Requirement Specification (URS) for (a) enterprise serialization, (b) packaging systems, (c) warehouse/shipping (referred to as EDGE), and (d) regulatory reporting such as e-pedigree, (4) contract manufacturer and logistics provider requirements and governance, (5) compliance with global regulatory requirements, (6) functional and design specifications, (8) business system and packaging designs and architectures, (9) pilot planning and scenarios, (10) GAMP based validation, and (11) vendor selection.

Projects have included solutions involving serialization, track and trace, electronic pedigree (e-Pedigree), country traceability reporting (i.e., Turkish Ministry of Health, China, etc.), radio frequency identification (RFID), barcoding and scanning, GS1 electronic product code information services (EPCIS), supply chain, warehousing and Electronic Data Interchange (EDI). Pharma Logic Solutions is a longstanding Solution Provider for GS1 US Healthcare.

Strategy, business and user requirements, designs and implementations have included solutions from SAP (ECC, SCM, Aii, OER, Aie), JD Edwards, Oracle (OPSM, OPM), Manhattan Associates, MAPICS, Acsis (ProducTrak), Axway, rfXcel, Frequentz, Systech, Optel Vision (TrackSafe, Line Master, PharmaProof), Cognex, Mettler Toledo, Seidenader (Körber Medipak), Antares Vision (Xyntek), Laetus, ROC-IT Solutions, TAKE Solutions, Uhlmann, Nosco, Werum PAS-X, Tracelink, Videojet and others.

Contact us to discuss your needs and contrast the Pharma Logic Solutions solutions against previous providers to see why our approach is the ideal solution. 


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Updated: Sunday June 23, 2024.