{"id":18858,"date":"2023-11-27T09:54:24","date_gmt":"2023-11-27T09:54:24","guid":{"rendered":"https:\/\/kevision.in\/?page_id=18858"},"modified":"2026-02-02T09:32:11","modified_gmt":"2026-02-02T09:32:11","slug":"russia-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/russia-regulatory\/","title":{"rendered":"Russia Regulatory"},"content":{"rendered":"
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Russia 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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Russia Pharma<\/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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Regulatory Agency<\/strong><\/td>\nCenter for Research in Perspective Technologies (CRPT) <\/b>\u2014 a public-private partnership that operates Russia\u2019s national track and trace system Chestny ZNAK (Honest Sign)<\/b>, under the authority of Russian law. CRPT issues codes and manages the reporting infrastructure for tracked products including medicines.<\/td>\n<\/tr>\n
Regulation Name<\/strong><\/td>\nFederal Law No. 425-FZ \u201cOn Amendments to the Law on the Circulation of Medicines\u201d<\/b> (December 28, 2017) established mandatory digital marking and traceability for pharmaceuticals.\nGovernment Decree No. 1557 of December 2018 defined implementation specifics for medicines in the Chestny ZNAK Monitoring of Drug Circulation (MDLP)<\/b> system.<\/td>\n<\/tr>\n
Compliance Dates<\/strong><\/td>\nMandatory marking introduced:<\/b> January 1, 2020 (general deadline) with extension to July 1, 2020<\/b> as the legal enforcement date for all medicines.\nOngoing system updates continue through 2026<\/b>, including enhanced pharmacy scanning and offline verification.<\/td>\n<\/tr>\n
Applies to<\/strong><\/td>\nAll pharmaceuticals <\/b>\u2014 including prescription and over-the-counter medicines \u2014 manufactured in or imported into Russia must be serialized and tracked.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Free Samples must be marked?<\/strong><\/td>\nNo<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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SECONDARY PACKAGING\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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(A carton containing one or more primary packs and includes a \u201cmono carton\u201d containing one primary pack)<\/p>\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>		\u2022 2D Data Matrix is mandated for unit-level marking.<\/b>
\u2022 Codes are cryptographically-secured and issued through CRPT.<\/td><\/tr>
Barcode Content<\/strong><\/td>Russian Data Matrix codes include:

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  • GTIN (Global Trade Item Number)<\/b><\/li>
  • Serial Number<\/b><\/li>
  • Batch\/Lot Number<\/b><\/li>
  • Expiry Date<\/b><\/li>
  • Foreign Economic Activity Common Nomenclature (FEACN)<\/b><\/li>
  • Verification key\/crypto code<\/b> (44 or 88 characters depending on version).<\/li><\/ul><\/td><\/tr>
Serial Number Randomization<\/strong><\/td>Serial numbers are unique and cryptographically protected; they are typically non-predictable due to associated encryption and issuance processes.<\/b><\/td><\/tr>
Serial Number Reuse<\/strong><\/td>

Russia\u2019s system does not support reuse of serial numbers within the same GTIN scope because each code is unique and requires registration in the central system.<\/b><\/p><\/div><\/div><\/td><\/tr>

Human Readable Expiry Date Format
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Human readable interpretation (HRI) of expiry dates typically follows a YYMMDD format adjacent to the 2D Data Matrix.<\/b><\/p><\/div><\/div><\/td><\/tr>

Barcode Data Encoding<\/strong><\/td>

Encoded using GS1 standards and Russian crypto code specifications supplied by CRPT to ensure authenticity and anti-counterfeiting protection.<\/b><\/p><\/div><\/div><\/td><\/tr>

Product Code Notes
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Canada\u2019s roadmap calls for unique GTINs at primary and secondary levels.<\/b>
The roadmap supports alignments with global standards and data capture for patient safety, but does not currently mandate aggregation or reporting.<\/p><\/div><\/div><\/td><\/tr>

Free Samples must be marked?<\/strong><\/td>

Yes, if the unit enters regulated circulation, it must carry the required marking; no special exemption for samples is defined in law.<\/b><\/p><\/div><\/div><\/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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AGGREGATION DATA CAPTURE\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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Parent-Child Mapping Aggregation Capture?<\/strong><\/p><\/div>

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 Yes.<\/b> Aggregation is required in Russia. Participants must account for unit, bundle, and logistics level relationships, and report movements of both individual units and aggregated batches.<\/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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DATA EXCHANGE\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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Send Unit Data to Government Repository?
<\/strong><\/td>		Yes.<\/b> Serialized data and event records must be reported to the Federal State Information System for Monitoring Drug Circulation (FSIS MDC)<\/b> \u2014 part of Chestny ZNAK.<\/td><\/tr>
Send Unit Data to Third-Party Repository?
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As applicable<\/p><\/div><\/div><\/td><\/tr>

Send Unit Data to Trading Partner?
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As applicable<\/p><\/div><\/div><\/td><\/tr>

Send Aggregation Data to Government Repository?
<\/strong><\/td>		Yes.<\/td><\/tr>
Send Aggregation Data to Third-Party Repository?
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As applicable<\/p><\/div><\/div><\/td><\/tr>

Send Aggregation Data to Trading Partner?
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As applicable<\/p><\/div><\/div><\/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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Who Offers Data Repository for Authentication?<\/strong><\/td>Federal State Information System for Monitoring Drug Circulation (FSIS MDC)<\/b> \u2014 the centralized government repository operated under the Chestny ZNAK framework handles authentication and verification.<\/td><\/tr>
Manufacturers Must Register Shipments in Repository?
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Yes<\/p><\/div><\/div><\/td><\/tr>

Downstream Trading Partners Must Authenticate on Receipt?
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Yes<\/p><\/div><\/div><\/td><\/tr>

Downstream Trading Partners Must Authenticate on Shipment?
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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>Yes<\/b><\/td><\/tr>
Downstream Trading Partner Activity Reported?
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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\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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Kevision Systems, 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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Russia Regulatory Regulatory For Russia Pharma Regulatory Agency Center for Research in Perspective Technologies (CRPT) \u2014 a public-private partnership that operates Russia\u2019s national track and trace system Chestny ZNAK (Honest Sign), under the authority of Russian law. CRPT issues codes and manages the reporting infrastructure for tracked products including medicines. Regulation Name Federal Law No. […]<\/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-18858","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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