{"id":12499,"date":"2023-04-10T13:01:48","date_gmt":"2023-04-10T13:01:48","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12499"},"modified":"2026-03-02T10:10:58","modified_gmt":"2026-03-02T10:10:58","slug":"brazil-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/brazil-regulatory\/","title":{"rendered":"Brazil Regulatory"},"content":{"rendered":"
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Brazil Regulatory\n<\/h2>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory For<\/h5>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Brazil<\/span><\/p>\n\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Brazil Regulatory Requirements<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory Agency<\/strong><\/td>Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA)<\/td><\/tr>
Regulation Name<\/strong><\/td>
  • Law No. 13.410\/2016<\/b> \u2013 Establishes the National Medicine Control System (SNCM)<\/li>
  • RDC 319\/2019<\/b> \u2013 Serialization and traceability technical requirements<\/li>
  • RDC 591\/2021<\/b> \u2013 Implementation timeline updates System Name: SNCM \u2013 Sistema Nacional de Controle de Medicamentos
    <\/b><\/li><\/ul><\/td><\/tr>
Compliance Dates<\/strong><\/td>April 28, 2022 <\/b>\u2013 Manufacturers and importers required to serialize and
report medicine data to SNCM.

Phased implementation originally planned earlier; current framework
mandates serialization and event reporting for applicable medicines.<\/td><\/tr>
Applies to<\/strong><\/td>All prescription medicines<\/b> and regulated pharmaceutical products
intended for commercial distribution in Brazil.

Applies to manufacturers, importers, distributors, and dispensers
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Secondary Packaging<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Barcode Symbology <\/strong><\/td>\n GS1 2D DataMatrix<\/td>\n <\/tr>\n
Barcode Content<\/strong><\/td>\n \n
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  • GTIN (AI 01)<\/li>\n
  • Serial Number (AI 21)<\/li>\n
  • Expiry Date (AI 17)<\/li>\n
  • Batch\/Lot (AI 10)<\/li>\n <\/ul>\n <\/td>\n <\/tr>\n
Serial Number Randomization<\/strong><\/td>\n Yes \u2013 unique, randomized serial per unit<\/td>\n <\/tr>\n
Serial Number Reuse<\/strong><\/td>\n Not permitted.<\/td>\n <\/tr>\n
Human Readable Expiry Date Format <\/strong><\/td>\n \n Printed in standard Brazilian labeling format (typically MM\/YYYY or\n DD\/MM\/YYYY as applicable)\n <\/td>\n <\/tr>\n
Barcode Data Encoding<\/strong><\/td>\n GS1 Application Identifiers (01, 17, 10, 21)<\/td>\n <\/tr>\n
Product Code Notes<\/strong><\/td>\n \n GTIN required; must align with GS1 Brazil registration and ANVISA\n product registration.\n <\/td>\n <\/tr>\n
Free Samples must be marked?<\/strong><\/td>\n \n Yes \u2013 must comply with SNCM serialization if entering the supply chain\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Tertiary Packaging<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Barcode Symbology<\/strong><\/td>\n GS1-128 (SSCC \u2013 AI 00)<\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n SSCC and aggregation hierarchy<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Aggregation Data Capture<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n Parent-Child Mapping Aggregation Capture?<\/strong>\n <\/td>\n Yes \u2013 linking units to cases\/pallets must be reported<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Data Exchange<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Send Unit Data to Government Repository? <\/strong><\/td>Yes \u2013 manufacturers\/importers must report serialized unit data to SNCM<\/td><\/tr>
Send Unit Data to Third-Party Repository? <\/strong><\/td>Optional (internal systems), not regulator-mandated<\/td><\/tr>
Send Unit Data to Trading Partner? <\/strong><\/td>Commercially expected (EPCIS-based exchange possible)<\/td><\/tr>
Send Aggregation Data to Government Repository? <\/strong><\/td>Yes<\/b><\/td><\/tr>
Send Aggregation Data to Third-Party Repository?<\/strong><\/td>Optional<\/td><\/tr>
Send Aggregation Data to Trading Partner?<\/strong><\/td>Commercially expected<\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Authentication<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n Who Offers Data Repository for Authentication?<\/strong>\n <\/td>\n SNCM \u2013 managed by ANVISA<\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n \n Yes \u2013 commissioning and movement events must be reported\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Government Reporting<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacturer Activity Reported?<\/strong><\/td>\n Yes<\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported? <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\tSource and Credit<\/strong>: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t
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Disclaimer\n<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\tThis information is being provided \u2018As Is\u2019 with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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About Kevision Systems<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kevision Systems,<\/strong> a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision\u2019s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.<\/p>

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.<\/p>

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.<\/p>

For Further Information, please contact our Compliance Team at\u00a0info@kevision.in<\/a><\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Brazil Regulatory Regulatory For Brazil Brazil Regulatory Requirements Regulatory Agency Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA) Regulation Name Law No. 13.410\/2016 \u2013 Establishes the National Medicine Control System (SNCM) RDC 319\/2019 \u2013 Serialization and traceability technical requirements RDC 591\/2021 \u2013 Implementation timeline updates System Name: SNCM \u2013 Sistema Nacional de Controle de Medicamentos Compliance Dates […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":12422,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-12499","page","type-page","status-publish","hentry"],"rankMath":{"parentDomain":"kevision.in","noFollowDomains":[],"noFollowExcludeDomains":[],"noFollowExternalLinks":false,"featuredImageNotice":"La imagen destacada debe tener al menos 200 por 200 p\u00edxeles para que Facebook y otros sitios de redes sociales puedan 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