{"id":870,"date":"2020-02-17T14:57:44","date_gmt":"2020-02-17T14:57:44","guid":{"rendered":"https:\/\/newsite.osmr.ro\/?page_id=870"},"modified":"2026-08-04T12:47:36","modified_gmt":"2026-08-04T12:47:36","slug":"alerte-snvm","status":"publish","type":"page","link":"https:\/\/osmr.ro\/en\/alerte-snvm\/","title":{"rendered":"NMVS Alerts"},"content":{"rendered":"<div class=\"clearfix\">\n<div class=\"vc_row wpb_row vc_row-fluid\">\n<div class=\"wpb_column vc_column_container vc_col-sm-12\">\n<div class=\"wpb_wrapper\">\n<div class=\"wpb_text_column wpb_content_element \">\n<div class=\"wpb_wrapper\">\n<p><img decoding=\"async\" class=\"lazyload aligncenter\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27854%27%20height%3D%27546%27%20viewBox%3D%270%200%20854%20546%27%3E%3Crect%20width%3D%27854%27%20height%3D%27546%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/osmr.ro\/wp-content\/uploads\/2023\/08\/Imagine-Modificata_EN.png\" width=\"854\" height=\"546\" alt=\"\" title=\"-\"><\/p>\n<p>&nbsp;<\/p>\n<p>For technical details regarding Alerts generated by the National Medicines Verification System (NMVS), according to the obligations stipulated by the Ministerial Order 1.473 \u2013 Art. 20 paragraph (3), OSMR can be contacted at the following email addresses: <strong>alerte.dapp@osmr.ro<\/strong> (for MAH\/OBP) and <strong>alerte.eu@osmr.ro<\/strong> (for End-Users).<\/p>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-margin-bottom-large:30px;--awb-width-medium:100%;--awb-width-small:100%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-margin-bottom-large:30px;--awb-width-medium:100%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-transform:none;\"><h2 style=\"text-align: center;\"><strong>NAMS<\/strong><\/h2>\n<p>To support users of the <strong>National Alerts Management System (NAMS)<\/strong>, we have prepared the <strong>User&#8217;s Manual<\/strong> and <strong>two video tutorials<\/strong>. By accessing the links below, you can learn how to log in to the system and how to manage alerts in NAMS.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-margin-bottom-large:30px;--awb-width-medium:100%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-2 fusion_builder_column_inner_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-margin-bottom-large:30px;--awb-width-medium:100%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-button-wrapper fusion-align-block fusion-align-inline-medium\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_text_transform:none;--button_font_size:14px;--button_typography-font-family:&quot;Plus Jakarta Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;\" target=\"_self\" href=\"https:\/\/osmr.ro\/wp-content\/uploads\/docs\/Manualul_Utilizatorilor_NAMS_OSMR-MAN-02_vs._1.0.pdf\"><i class=\"fa-file-download fas awb-button__icon awb-button__icon--default button-icon-left\" aria-hidden=\"true\"><\/i><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Download User&#8217;s Manual<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-3 fusion_builder_column_inner_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-margin-bottom-large:30px;--awb-width-medium:100%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-4 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-margin-bottom-large:30px;--awb-width-medium:100%;--awb-order-medium:0;--awb-width-small:100%;--awb-order-small:0;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><div class=\"video-shortcode\"><iframe class=\"lazyload\" title=\"Gestionare Alerte SNVM\" width=\"1200\" height=\"675\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271200%27%20height%3D%27675%27%20viewBox%3D%270%200%201200%20675%27%3E%3Crect%20width%3D%271200%27%20height%3D%27675%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.youtube.com\/embed\/KUdF2g1ZXCw?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<div class=\"video-shortcode\"><iframe class=\"lazyload\" title=\"Logare NAMS\" width=\"1200\" height=\"675\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271200%27%20height%3D%27675%27%20viewBox%3D%270%200%201200%20675%27%3E%3Crect%20width%3D%271200%27%20height%3D%27675%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/www.youtube.com\/embed\/kTJBvCIvHXM?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<div class=\"wpb_wrapper\">\n<h3><strong>NMVS Alerts<\/strong><\/h3>\n<\/div>\n<p><img decoding=\"async\" class=\"lazyload aligncenter\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27559%27%20height%3D%27578%27%20viewBox%3D%270%200%20559%20578%27%3E%3Crect%20width%3D%27559%27%20height%3D%27578%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-orig-src=\"https:\/\/osmr.ro\/wp-content\/uploads\/2021\/05\/Imagine-Alerts.png\" alt=\"\" title=\"-\"><\/p>\n<div class=\"wpb_wrapper\">\n<p style=\"text-align: center;\">Managing alerts generated by the National Medicines Verification System (NMVS)<\/p>\n<ul>\n<li>OSMR is taking the necessary steps to minimize the large number of L5 alerts that are generated the NMVS. This entails an active communication with the stakeholders, emphasising the importance of the correct scanner and software configuration, as well as the accuracy and quality of the data uploaded to the European Hub.<\/li>\n<li>The final result of the alert analysis is communicated by OSMR to the software provider and\/or the End-User.<\/li>\n<li>The NMVS information on the respective product is analysed and evaluated, compared to the data received \u00a0from the End-User\/MAH\/OBP at the time of the transaction.<\/li>\n<li>The emails to which End-Users\/MAH\/OBP can request information regarding the root cause of an alert generated by the NMVS, as well as details about the internal investigation are: <a href=\"mailto:alerte.dapp@osmr.ro\">alerte.dapp@osmr.ro<\/a> (for MAH\/OBP) and <a href=\"mailto:alerte.eu@osmr.ro\">alerte.eu@osmr.ro<\/a> (for End-Users).<\/li>\n<li>OSMR supervises Arvato in maintaining the technical functionality of the NMVS.<\/li>\n<\/ul>\n<p>For more information on managing NMVS Alerts, \u00a0 <strong><a class=\"emd_dl_red_darker\" href=\"https:\/\/osmr.ro\/wp-content\/uploads\/2019\/09\/Gestionarea-Alertelor_EN_v02.pdf\" target=\"_self\" rel=\"noopener\">Download PDF<\/a><\/strong><\/p>\n<p style=\"text-align: center;\"><strong>Alerts within the European Medicines Verification System<\/strong><\/p>\n<p style=\"text-align: left;\">The European Medicines Verification System is designed as such that when a medicine pack is scanned at<br \/>\nthe point of dispense, it will be checked and verified for authenticity against a national repository.<\/p>\n<p style=\"text-align: left;\">If the Unique Identifier (UI) &#8211; which is encoded in a 2D data matrix holding information related to the pack<br \/>\n&#8211; on the pack matches the UI in the repository, the pack is dispensed to the patient. At the same time, the<br \/>\nstatus of the serial number of the pack is set to \u201cdecommissioned\/supplied\u201d, enabling thus a record of the<br \/>\ndispense of the pack to be kept, to check against potential future falsifications.<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 On the other hand, should the information taken from the UI differ from the information held in the<br \/>\nsystem, the medicine pack\u2019s authenticity cannot be verified, and an alert will be raised.<\/p>\n<p style=\"text-align: left;\">An exception describes a situation where the normal operation of the EMVS is interrupted; as per EMVO<br \/>\nUser Requirements Specifications. Within EMVS &#8211; NMVS there are 5 levels of exceptions, going from level<br \/>\n1, in which the system can handle the situation by itself, to level 5, in which system administrators and<br \/>\nexternal stakeholders are informed of the situation:<br \/>\n&#8211; Level 1: the system can handle the exception on its own. The deviation does not appear to the<br \/>\nuser in any way;<br \/>\n&#8211; Level 2: the initiator of a transaction\/the operator is informed about the exception;<br \/>\n&#8211; Level 3: the system administrator (EU or national) is informed about the exception;<br \/>\n&#8211; Level 4: more than one system administrator is informed about the exception;<br \/>\n&#8211; Level 5: in addition to the initiator of a transaction\/the operator and system administrators,<br \/>\ndisclosure of information to other stakeholders is required.<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 The external stakeholders who are informed in the event of a level 5 alert are the NMVO, the OBP,<br \/>\nEMVO and the National Competent Authority (NCA).<\/p>\n<p style=\"text-align: left;\">An alert describes the process of informing actors other than the one who was interacting with the<br \/>\nsystem when the exception was triggered.<\/p>\n<p>The information in EU Hub and NMVS is organized on 3 levels:<br \/>\n&#8211; Product Level;<br \/>\n&#8211; Batch Level;<br \/>\n&#8211; Pack Level.<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Each level has a certain status in NMVS, and the decommissioning\/verification operation can only be<br \/>\nconsidered successful when the status is set as \u201cActive\u201d for all of them.<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Thus, when interrogating NMVS, the following information should be received:<br \/>\nProduct Status (Product Code, GTIN)<br \/>\n&#8211; Active;<br \/>\n&#8211; Recall;<br \/>\n&#8211; Product Code (PC) Unknown.<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Batch Status (Batch):<br \/>\n&#8211; Active;<br \/>\n&#8211; Recall;<br \/>\n&#8211; Expired;<br \/>\n&#8211; Batch Unknown (when PC is unknown);<br \/>\n&#8211; Different expiry date (between the 2D data matrix on the pack and the information in NMVS);<br \/>\n&#8211; Different batch number (between the 2D data matrix on the pack and the information in NMVS).<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0Pack Status (Serial Number, SN):<br \/>\n&#8211; Active;<br \/>\n&#8211; Decommissioned;<br \/>\n&#8211; Unknown Serial Number.<\/p>\n<p style=\"text-align: left;\">\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0It should be mentioned that the system is interrogated in a certain order: from PC level towards SN level,<br \/>\nthus if the PC is unknown, NMVS cannot check the information on Batch, Expiry date or SN. Furthermore,<br \/>\nif Batch in unknown, NMVS cannot verify Expiry date or SN.<\/p>\n<p style=\"text-align: left;\">There are 3 major transaction types in NMVS:<br \/>\n&#8211; Verification (the medicine\u2019s status in NMVS is not modified);<br \/>\n&#8211; Decommissioning (the medicine\u2019s status in NMVS is modified from Active to Inactive);<br \/>\n&#8211; Undo decommissioning (the medicine\u2019s status in NMVS is modified from Inactive to Active).<br \/>\nInstances which do not raise an Alert in the NMVS:<br \/>\n&#8211; Batch Expired \u2013 the local procedures in place will be applied;<br \/>\n&#8211; Batch Recalled \u2013 the local procedures in place will be applied;<br \/>\n&#8211; Product Code Recalled \u2013 the local procedures in place will be applied.<br \/>\nIn all the above-mentioned cases, the End User will be notified by the IT system which connects to the<br \/>\nNMVS about the situation occurred.<\/p>\n<p>Scenarios from the NMVS which can indicate an Alert:<br \/>\n&#8211; The Product Code cannot be identified in NMVS or EMVS;<br \/>\n&#8211; Batch not found;<br \/>\n&#8211; Expiry date differs from the information found in NMVS;<br \/>\n&#8211; Batch number differs from the Serial Number after interrogating NMVS;<br \/>\n&#8211; Serial Number inactive;<br \/>\n&#8211; Serial Number unknown;<br \/>\n&#8211; The scanner is not used\/configured correctly, there are errors with the IT system of the End User;<br \/>\n&#8211; Medicines not in the scope of the FMD (no prescription);<br \/>\n&#8211; Medicines which are not manufactured in the EU\/do not have packaging elements according to<br \/>\nthe EU legal requirements;<br \/>\n&#8211; Data on the product or the product batches have been incorrectly uploaded to the EU Hub, or the<br \/>\nrespective data is invalid;<br \/>\n&#8211; Errors generated by the EMVS when data is withdrawn by the NMVS, invalid data after uploading<br \/>\nit to the EU Hub by the OBP\/MAH.<\/p>\n<p style=\"text-align: left;\">Level 5 Alert Messages \u2013 10 situations identified according to EMVO User Requirements Specifications:<br \/>\n&#8211; NMVS_NC_PC_01 \u2013 Unknown Product Code;<br \/>\n&#8211; NMVS_FE_LOT_03 \u2013 Failed to find a batch for the given data;<br \/>\n&#8211; NMVS_FE_LOT_12 \u2013 Expiry date does not match the date held in the NMVS;<br \/>\n&#8211; NMVS_FE_LOT_13 \u2013 The Batch ID does not match the Serial Number in the NMVS;<br \/>\n&#8211; NMVS_NC_PCK_22 \u2013 Pack is already Inactive;<br \/>\n&#8211; NMVS_NC_PCK_19 \u2013 Property is already set on pack;<br \/>\n&#8211; NMVS_NC_PC_02 \u2013 Unknown Serial Number;<br \/>\n&#8211; NMVS_NC_PCK_06 \u2013 Actual pack status doesn\u2019t match the undo transaction (set and undo status<br \/>\nmust be equivalent);<br \/>\n&#8211; NMVS_NC_PCK_20 \u2013 Defined timeframe between setting this property and undo was exceeded;<br \/>\n&#8211; NMVS_NC_PCK_21 \u2013 Undo can only be executed by the same user who previously set the<br \/>\nattribute.<\/p>\n<p style=\"text-align: left;\">L5 Alerts may strongly suggest a potential falsified medicine.<br \/>\nLevel 5 Alert message generated by NMVS is sent to the following recipients:<br \/>\n&#8211; The End User\u2019s IT system;<br \/>\n&#8211; EMVO, via the EU Hub;<br \/>\n&#8211; OBP\/MAH via EU Hub (except for the cases where the product is unknown in NMVS, then the<br \/>\nsystem cannot alert the OBP);<br \/>\n&#8211; OSMR (Romanian NMVO);<br \/>\n&#8211; ANMDMR (The Romanian National Agency for Medicines and Medical Devices).<\/p>\n<p style=\"text-align: left;\">Level 5 Alerts contain the following information:<br \/>\n&#8211; The hour and the date when the alarm was generated (Time stamp);<br \/>\n&#8211; Unique Alert Identification Code (ID);<br \/>\n&#8211; Product Code;<br \/>\n&#8211; Batch Identification Code;<br \/>\n&#8211; Expiry Date;<br \/>\n&#8211; Serial Number;<br \/>\n&#8211; GTIN;<br \/>\n&#8211; NMVS and\/or EU Hub Code corresponding to the product status at the moment the transaction<br \/>\nhad been undertaken by the End User;<br \/>\n&#8211; End User\/Client Identification Number.<\/p>\n<p>More information on Alerts within the European Medicines Verification System can be found here: <strong><a class=\"emd_dl_red_darker\" href=\"https:\/\/osmr.ro\/wp-content\/uploads\/2019\/04\/Alerts_EN.pdf\" target=\"_self\" rel=\"noopener\">Download PDF<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>[\/fusion_text][\/fusion_builder_column][\/fusion_builder_row][\/fusion_builder_container]<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; For technical details regarding Alerts generated by the National Medicines Verification System (NMVS), according <a href=\"https:\/\/osmr.ro\/en\/alerte-snvm\/\"> [&#8230;]<\/a><\/p>\n","protected":false},"author":9,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-870","page","type-page","status-publish","hentry"],"translation":{"provider":"WPGlobus","version":"3.0.3","language":"en","enabled_languages":["ro","en"],"languages":{"ro":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"_links":{"self":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/pages\/870","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/comments?post=870"}],"version-history":[{"count":99,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/pages\/870\/revisions"}],"predecessor-version":[{"id":8289,"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/pages\/870\/revisions\/8289"}],"wp:attachment":[{"href":"https:\/\/osmr.ro\/en\/wp-json\/wp\/v2\/media?parent=870"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}