{"id":12729,"date":"2023-04-10T16:29:08","date_gmt":"2023-04-10T16:29:08","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12729"},"modified":"2026-02-03T09:53:12","modified_gmt":"2026-02-03T09:53:12","slug":"ecuador-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/ecuador-regulatory\/","title":{"rendered":"Ecuador Regulatory"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"12729\" class=\"elementor elementor-12729\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5f71cb85 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5f71cb85\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3b495233\" data-id=\"3b495233\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-5d59c40f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5d59c40f\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-7bf7cb4\" data-id=\"7bf7cb4\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-35ed0c79 elementor-widget elementor-widget-spacer\" data-id=\"35ed0c79\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e94982 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"49e94982\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220cce5dd7\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h2 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h2\"  > Ecuador Regulatory\n<\/h2>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16e0a381 elementor-widget elementor-widget-spacer\" data-id=\"16e0a381\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b4ba30e elementor-widget elementor-widget-ld_button\" data-id=\"2b4ba30e\" data-element_type=\"widget\" data-widget_type=\"ld_button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t\t<a\n\t\t\t\tclass=\"elementor-button btn btn-naked btn-icon-block btn-no-label\" data-localscroll=\"1\" data-localscroll-options=\"{&quot;scrollBelowSection&quot;:true}\" href=\"#\"\t\t\t>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"btn-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"lqd-icn-ess icon-ion-ios-arrow-down\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-195daf67 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"195daf67\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"lqd-css-sticky-column elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1d57449a\" style=\"--lqd-sticky-offset:30px\" data-id=\"1d57449a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4e7549b elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"4e7549b\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220cce7b1d\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h5 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h5\"  > Regulatory For<\/h5>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1387c70f elementor-align-left elementor-widget elementor-widget-ld_icon_box\" data-id=\"1387c70f\" data-element_type=\"widget\" data-widget_type=\"ld_icon_box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t\t<div id=\"ld_icon_box_1387c70f\" class=\"iconbox d-flex flex-grow-1 pos-rel align-items-center iconbox-side\"   >\n\n\t\t\t\t\n\t\t\t\t<div class=\"iconbox-icon-wrap\"><div class=\"iconbox-icon-container d-inline-flex\"><\/div><\/div>\n\t\t\t\t\n\t\t\t\t<div class=\"contents\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t<p><span style=\"font-size: 15px\">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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6128dc7a\" data-id=\"6128dc7a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f4be3f3 elementor-widget elementor-widget-spacer\" data-id=\"4f4be3f3\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-669781e0 elementor-widget elementor-widget-text-editor\" data-id=\"669781e0\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table><tbody><tr><td width=\"350\"><strong>Regulatory Agency<\/strong><\/td><td width=\"400\">ARCSA is the legal authority that issues and enforces traceability and<br \/>serialization regulations for medicines, biological products, and<br \/>medical devices in Ecuador.<\/td><\/tr><tr><td width=\"350\"><strong>Regulation Name<\/strong><\/td><td width=\"400\">ARCSA traceability directives.<\/td><\/tr><tr><td width=\"350\"><strong>Compliance Dates<\/strong><\/td><td width=\"545\"><p class=\"get-company-address\">Although staged implementation deadlines were initially proposed<br \/>(starting from late 2022 into 2024), various industry sources indicate<br \/>that the formal enforcement of serialization infrastructure and<br \/>reporting to a live national system may still be pending or evolving.<br \/>Actual deployment of ARCSA\u2019s database and national reporting backbone<br \/>remains a work in progress.<\/p><\/td><\/tr><tr><td width=\"213\"><strong>Applies to<\/strong><\/td><td width=\"545\">The regulation applies to the entire pharmaceutical supply chain \u2014<br \/>including:<p>\u00a0<\/p><ul><li><b>Manufacturers (local and foreign products entering Ecuador)<\/b><\/li><li><b>Importers and distributors<\/b><\/li><li><b>Pharmacies and public healthcare entities<\/b><\/li><li><b>Logistics and transportation operators<\/b><\/li><\/ul><p>All medicines, biological products, and certain related healthcare goods<br \/>must comply with traceability requirements when distributed within the<br \/>Red P\u00fablica Integral de Salud (RPIS) and other sectors of the national<br \/>healthcare system.<\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a592e28 elementor-widget elementor-widget-spacer\" data-id=\"4a592e28\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d1b9efe elementor-widget elementor-widget-text-editor\" data-id=\"3d1b9efe\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table>\n  <tbody>\n    <tr>\n      <td width=\"350\"><strong>Free Samples must be marked? <\/strong><\/td>\n      <td width=\"400\">No<\/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<div class=\"elementor-element elementor-element-2c244a59 elementor-widget elementor-widget-spacer\" data-id=\"2c244a59\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6141ff1a elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"6141ff1a\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220ccea4d5\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > 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<div class=\"elementor-element elementor-element-30b64f66 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"30b64f66\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220cceabc5\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<p class=\"ld-fh-element d-inline-block pos-rel  lqd-highlight-classic lqd-highlight-grow-left p\"  > (A carton containing one or more primary packs and includes a \u201cmono carton\u201d containing one primary pack)\n\n<\/p>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-219c1e39 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"219c1e39\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39d0e1c2 elementor-widget elementor-widget-spacer\" data-id=\"39d0e1c2\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-747c745e elementor-widget elementor-widget-text-editor\" data-id=\"747c745e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table><tbody><tr><td width=\"350\"><strong>Barcode Symbology <\/strong><\/td><td width=\"400\"><b> Two-dimensional barcodes (e.g., GS1 DataMatrix) are required to encode the CUT on primary and\/or secondary packaging, ensuring visibility and readability. When package size does not permit direct barcode placement, tamper-evident stickers carrying the CUT may be used. <\/b><\/td><\/tr><tr><td width=\"290\"><strong>Barcode Content<\/strong><\/td><td width=\"545\"><p><b>Each medicinal product must carry a Unique Traceability Code (CUT) which includes the following key elements:<\/b><\/p><ul><li>GTIN (Global Trade Item Number)<\/li><li>Batch \/ Lot Number<\/li><li>Expiration Date<\/li><li>Unique Serial Number (where applicable)<\/li><\/ul><\/td><\/tr><tr><td width=\"290\"><strong>Serial Number Randomization<\/strong><\/td><td width=\"545\"><b>NA<\/b><\/td><\/tr><tr><td width=\"290\"><strong>Serial Number Reuse<\/strong><\/td><td width=\"545\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>No<\/b><\/p><\/div><\/div><\/td><\/tr><tr><td width=\"290\"><strong>Human Readable Expiry Date Format <\/strong><\/td><td width=\"545\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>YYMMDD<\/b><\/p><\/div><\/div><\/td><\/tr><tr><td width=\"213\"><strong>Barcode Data Encoding<\/strong><\/td><td width=\"545\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>GS1 Standard<\/b><\/p><\/div><\/div><\/td><\/tr><tr><td width=\"213\"><strong>Product Code Notes <\/strong><\/td><td width=\"545\"><b>NA<\/b><\/td><\/tr><tr><td width=\"213\"><strong>Free Samples must be marked?<\/strong><\/td><td width=\"545\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>No<\/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<div class=\"elementor-element elementor-element-4365be49 elementor-widget elementor-widget-spacer\" data-id=\"4365be49\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d05d973 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"4d05d973\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220ccec89e\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > 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<div class=\"elementor-element elementor-element-3ca53291 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3ca53291\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5572ed82 elementor-widget elementor-widget-spacer\" data-id=\"5572ed82\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15b10158 elementor-widget elementor-widget-text-editor\" data-id=\"15b10158\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table>\n  <tbody>\n    <tr>\n      <td width=\"350\">\n        <div class=\"icon-main-div\">\n          <strong>Parent-Child Mapping Aggregation Capture?<\/strong>\n        <\/div>\n        <div class=\"text-main-div\"><\/div>\n      <\/td>\n      <td width=\"400\">\n        Yes \u2014 Ecuador mandates parent-child (aggregation) capture to maintain\n        hierarchical packaging relationships as part of ARCSA\u2019s pharmaceutical\n        traceability requirements.\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<div class=\"elementor-element elementor-element-3e95ff2f elementor-widget elementor-widget-spacer\" data-id=\"3e95ff2f\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ad33241 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"2ad33241\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220cceec62\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > 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<div class=\"elementor-element elementor-element-d942224 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d942224\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-109d49ef elementor-widget elementor-widget-spacer\" data-id=\"109d49ef\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65d79727 elementor-widget elementor-widget-text-editor\" data-id=\"65d79727\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table><tbody><tr><td width=\"350\"><strong>Send Unit Data to Government Repository? <\/strong><\/td><td width=\"400\">Yes \u2014 required , The National Traceability System mandates that all<br \/>logistical movements of products, including unit tracking data, be<br \/>recorded in ARCSA\u2019s traceability information system.<\/td><\/tr><tr><td width=\"350\"><strong>Send Unit Data to Third-Party Repository? <\/strong><\/td><td width=\"400\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\">Not specifically mandated. The official regulation only defines<br \/>the national traceability system with ARCSA\u2019s database as the<br \/>platform for traceability records. It does not require reporting<br \/>to third-party commercial repositories.<\/p><\/div><\/div><\/td><\/tr><tr><td width=\"350\"><strong>Send Unit Data to Trading Partner? <\/strong><\/td><td width=\"545\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>Not mandated by ARCSA itself.<\/b><\/p><\/div><\/div><ul><li>The regulation requires capturing unit traceability information, but<br \/>does not explicitly require exchange of unit data with trading<br \/>partners under the law; partners are expected to manage their own<br \/>internal records.<\/li><\/ul><\/td><\/tr><tr><td width=\"213\"><strong>Send Aggregation Data to Government Repository? <\/strong><\/td><td width=\"545\"><p><b><br \/>Yes \u2014 through the traceability system.<\/b><\/p><ul><li>All operations and movements \u2014 including those involving aggregated<br \/>packaging levels (pallets, cartons, etc.) \u2014 must be registered in<br \/>the traceability system.<\/li><\/ul><\/td><\/tr><tr><td width=\"350\"><strong>Send Aggregation Data to Third-Party Repository? <\/strong><\/td><td width=\"400\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>Not required by regulation.<\/b><\/p><\/div><\/div><ul><li>The law does not prescribe third-party database submission; focus is<br \/>on capturing aggregation within the ARCSA traceability framework.<\/li><\/ul><\/td><\/tr><tr><td width=\"350\"><strong>Send Aggregation Data to Trading Partner? <\/strong><\/td><td width=\"400\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>Not a statutory requirement.<\/b><\/p><\/div><\/div><ul><li>As with unit data, internal aggregation data sharing with partners<br \/>is a business practice, not a mandated legal obligation under<br \/>Ecuador regulations.<\/li><\/ul><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41c94429 elementor-widget elementor-widget-spacer\" data-id=\"41c94429\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f0af0f7 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"5f0af0f7\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220ccf1039\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > AUTHENTICATION<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60ba50a3 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"60ba50a3\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32a71a50 elementor-widget elementor-widget-spacer\" data-id=\"32a71a50\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-520523cf elementor-widget elementor-widget-text-editor\" data-id=\"520523cf\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table><tbody><tr><td width=\"350\"><strong>Who Offers Data Repository for Authentication?<\/strong><\/td><td width=\"400\"><p><b><br \/>ARCSA is the central authority.<\/b><\/p><ul><li>Ecuador\u2019s traceability rules establish a <b>national traceability<br \/>system <\/b>managed by <b>ARCSA<\/b>, which functions as the central traceability<br \/>database.<\/li><\/ul><\/td><\/tr><tr><td width=\"350\"><strong>Manufacturers Must Register Shipments in Repository? <\/strong><\/td><td width=\"400\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b><br \/>Yes \u2014 they must record traceability events.<br \/><\/b><\/p><\/div><\/div><ul><li>The regulation requires that all supply chain actors (manufacturers,<br \/>importers, etc.) <b>record movements <\/b>in the system, which includes<br \/>shipment events.<\/li><\/ul><\/td><\/tr><tr><td width=\"350\"><strong>Downstream Trading Partners Must Authenticate on Receipt?<br \/><\/strong><\/td><td width=\"545\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b><br \/>The regulation requires registering receipt movements.<br \/><\/b><\/p><\/div><\/div><ul><li>Downstream partners must <b>capture and record the reception of<br \/>products<\/b> in the traceability system. While not called \u201cauthenticate\u201d<br \/>in those terms, reception events are part of traceability logging.<\/li><\/ul><\/td><\/tr><tr><td width=\"213\"><strong>Downstream Trading Partners Must Authenticate on Shipment?<br \/><\/strong><\/td><td width=\"545\"><p><b><br \/>Yes \u2014 as part of movement logging.<\/b><\/p><ul><li>Similarly, <b>shipment (dispatch) events must be recorded<\/b> by<br \/>logistics\/receiving partners as part of ongoing traceability.<\/li><\/ul><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a95816a elementor-widget elementor-widget-spacer\" data-id=\"2a95816a\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64f50a42 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"64f50a42\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220ccf27e6\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > GOVERNMENT REPORTING<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5b1c65 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a5b1c65\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2483ccef elementor-widget elementor-widget-spacer\" data-id=\"2483ccef\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba2882d elementor-widget elementor-widget-text-editor\" data-id=\"ba2882d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<table><tbody><tr><td width=\"350\"><strong>Manufacturer Activity Reported?<\/strong><\/td><td width=\"400\"><b> Yes \u2014 operational activities logged.<\/b><p>\u00a0<\/p><ul><li>All logistical operations throughout the supply chain \u2014 including<br \/>manufacturing, storage, distribution \u2014 are logged in the system<\/li><\/ul><\/td><\/tr><tr><td width=\"350\"><strong>Downstream Trading Partner Activity Reported? <\/strong><\/td><td width=\"400\"><div class=\"media-contact-div\"><div class=\"text-main-div\"><p class=\"get-company-address\"><b>Yes \u2014 required.<\/b><\/p><\/div><\/div><ul><li>All entities in the national traceability system (distributors,<br \/>pharmacies, logistics) must register traceability events for<br \/>products as they move through the supply chain.<\/li><\/ul><\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-61e8249b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"61e8249b\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1636c245\" data-id=\"1636c245\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-512d68a3 elementor-widget elementor-widget-text-editor\" data-id=\"512d68a3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<strong>Source 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<div class=\"elementor-element elementor-element-5a79f5c1 e-flex e-con-boxed e-con e-parent\" data-id=\"5a79f5c1\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a3efc41 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"2a3efc41\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220cd01033\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > DISCLAIMER\n<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57fa061 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"57fa061\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ab39a35 elementor-widget elementor-widget-spacer\" data-id=\"6ab39a35\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-287dc99a elementor-widget elementor-widget-text-editor\" data-id=\"287dc99a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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<div class=\"elementor-element elementor-element-3353fe82 elementor-widget elementor-widget-spacer\" data-id=\"3353fe82\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-565e2f85 elementor-widget elementor-widget-hub_fancy_heading\" data-id=\"565e2f85\" data-element_type=\"widget\" data-widget_type=\"hub_fancy_heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\n\t\t<div id=\"ld-fancy-heading-69e220cd0246b\" class=\"ld-fancy-heading pos-rel\">\n\t\t\t<h3 class=\"ld-fh-element d-inline-block pos-rel  elementor-heading-title lqd-highlight-classic lqd-highlight-grow-left h3\"  > 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<div class=\"elementor-element elementor-element-1fbf1412 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"1fbf1412\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3bb7be94 elementor-widget elementor-widget-spacer\" data-id=\"3bb7be94\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-558705d8 elementor-widget elementor-widget-text-editor\" data-id=\"558705d8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products &amp; services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision\u2019s Track &amp; Trace Software &amp; related equipment provide a fully integrated solution to the traceability of pharmaceutical products &amp; Supply Chain Integrity.<\/p><p>Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality &amp; reliability.<\/p><p>Kevision Systems is dedicated and driven to provide the finest &amp; 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><p><strong>For Further Information, please contact our Compliance Team at\u00a0<a href=\"mailto:info@kevision.in\" target=\"_blank\" rel=\"noopener\">info@kevision.in<\/a><\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f7ee024 elementor-widget elementor-widget-spacer\" data-id=\"2f7ee024\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Ecuador Regulatory Regulatory For Pharma Regulatory Agency ARCSA is the legal authority that issues and enforces traceability andserialization regulations for medicines, biological products, andmedical devices in Ecuador. Regulation Name ARCSA traceability directives. Compliance Dates Although staged implementation deadlines were initially proposed(starting from late 2022 into 2024), various industry sources indicatethat the formal enforcement of serialization [&hellip;]<\/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-12729","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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