{"id":12521,"date":"2023-04-10T13:11:55","date_gmt":"2023-04-10T13:11:55","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12521"},"modified":"2026-02-26T05:10:03","modified_gmt":"2026-02-26T05:10:03","slug":"indonesia-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/indonesia-regulatory\/","title":{"rendered":"Indonesia Regulatory"},"content":{"rendered":"
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Indonesia 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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Indonesia<\/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>National Agency of Drug and Food Control (Badan Pengawas Obat dan
Makanan \u2014 BPOM)<\/strong> \u2014 the authority that oversees pharmaceutical
serialization and traceability in Indonesia<\/td><\/tr>
Regulation Name<\/strong><\/td>Peraturan BPOM Nomor 22 Tahun 2022<\/strong> \u2013 \u201cPenerapan 2D Barcode dalam
Pengawasan Obat dan Makanan\u201d (Implementation of 2D Barcode in Drug and
Food Monitoring).<\/td><\/tr>
Compliance Dates<\/strong><\/td>
Requirement<\/b><\/th>Deadline<\/b><\/th><\/tr>
Identification barcode mandatory<\/b><\/td>7 Dec 2023<\/b> – all eligible products must have QR code for
identification.<\/td><\/tr>
Authentication (serialization) barcode<\/b><\/td>7 Dec 2025<\/b> – narcotics, psychotropics & high-risk medicines.<\/td><\/tr>
Full serialization for all prescription drugs<\/b><\/td>7 Dec 2027<\/b> – all “hard drugs” must carry authentication barcode.<\/td><\/tr><\/tbody><\/table><\/td><\/tr>
Applies to<\/strong><\/td>Domestic and imported pharmaceutical medicines<\/b>, including prescription, OTC, traditional medicines, cosmetics, supplements & processed foods under BPOM regulations.<\/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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Pharmaceutical 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>
  • Identification Barcode: QR Code <\/b>on products like OTC,
    traditional medicines, cosmetics, etc.<\/li>
  • Authentication Barcode: GS1 2D DataMatrix<\/b> for serialized
    products.<\/li><\/ul><\/td><\/tr>
Barcode Contents<\/strong><\/td>Identification Barcode <\/u>
QR Code

\u00a0<\/p>

  • Marketing Authorization Number, NIE Number<\/li><\/ul>

    \"\"<\/p>

    * Authentication Barcode<\/span><\/p>

    QR Code\/2D Datamatrix<\/p>

    • GTIN\/Marketing Authorization Number<\/li>
    • Expiry Date<\/li>
    • Batch\/Lot Number<\/li>
    • Serial Number<\/li><\/ul>

      \"\"<\/p><\/td><\/tr>

Serial Number Randomization<\/strong><\/td>Not Specified<\/td><\/tr>
Serial Number Reuse<\/strong><\/td>Not Specified<\/td><\/tr>
Human Readable Expiry Date Format <\/strong><\/td>Must appear on packaging per GS1\/DataMatrix standards (e.g.,
YYMMDD<\/b>), consistent with serialization best practice.<\/td><\/tr>
Barcode Data Encoding<\/strong><\/td> GS1 standard encoding<\/b> (DataMatrix & QR) for serialized DM.<\/td><\/tr>
Product Code notes <\/strong><\/td>
  • Printed on the packaging with the black ink and base is
    white color or other color<\/li>
  • In case there are two 2D Barcode that included on the
    packaging of drug and food product, therefore one of the 2D
    Barcode must contain wording \u201cBPOM RI\u201d<\/li>
  • 2D Barcode that printed on the packaging must be easy to be
    scanned and can be read by BPOM track and trace application<\/li>
  • The barcode must be put proportionally on the packaging with
    minimum size 0,6 x 0,6 cm<\/li><\/ul><\/div><\/div><\/div><\/div><\/td><\/tr>
Free Samples must be marked?<\/strong><\/td>
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Case 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 \n
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\n GS1-128<\/b> recommended for logistic\/aggregation levels per GS1\n aggregation standards.\n <\/p>\n <\/div>\n <\/div>\n <\/td>\n

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Barcode Contents<\/strong><\/td>\n \n
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\n SSCC <\/b>(serial shipping container code) on cases & pallets\n to link parent-child.\n <\/p>\n <\/div>\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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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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Parent-Child Mapping Aggregation Capture?<\/strong><\/div>
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 Mandatory <\/b>for serialized products under authentication requirements<\/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<\/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>Unit serialization data must be reported to BPOM via TTAC (Track & Trace Anti-Counterfeit Control) System.
<\/b><\/td><\/tr>
Send Unit Data to Third-Party Repository? <\/strong><\/td>Not explicitly required outside BPOM\u2019s system; third-party repositories
may be used by companies but are not mandated <\/b>by regulation.<\/td><\/tr>
Send Unit Data to Trading Partner? <\/strong><\/td>Yes<\/td><\/tr>
Send Aggregation Data to Government Repository? <\/strong><\/td>Yes<\/td><\/tr>
Send Aggregation Data to Third-Party Repository? <\/strong><\/td> Optional:<\/b> Industry may store in external partners, but not explicitly
mandated.<\/td><\/tr>
Send Aggregation Data to Trading Partner? <\/strong><\/td>Common in supply chain best practices; not a strict BPOM rule<\/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 \n BPOM\u2019s TTAC System is the centralized government repository for\n serialization reporting and authentication.\n <\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n Yes<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n \n Downstream partners (distributors\/wholesalers) are expected to scan and\n report product receipt to TTAC.\n <\/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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Master Data Upload?<\/strong><\/td>Master product data (GTIN, NIE, batch, expiry) must be uploaded into BPOM\u2019s TTAC system as part of serialization setup.<\/td><\/tr>
Manufacturer Activity Reported? <\/strong><\/td> Yes:<\/b> Activation, packing, distribution, and return\/recall events must be reported.<\/td><\/tr>
Downstream Trading Partner Activity Reported? <\/strong><\/td> Yes: <\/b>Receipts, shipments, returns, and distribution events are part of TTAC reporting.<\/td><\/tr><\/tbody><\/table>\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<\/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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Indonesia Regulatory Regulatory For Indonesia Regulatory Agency National Agency of Drug and Food Control (Badan Pengawas Obat danMakanan \u2014 BPOM) \u2014 the authority that oversees pharmaceuticalserialization and traceability in Indonesia Regulation Name Peraturan BPOM Nomor 22 Tahun 2022 \u2013 \u201cPenerapan 2D Barcode dalamPengawasan Obat dan Makanan\u201d (Implementation of 2D Barcode in Drug andFood Monitoring). Compliance […]<\/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-12521","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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