{"id":1470,"date":"2022-06-29T13:33:25","date_gmt":"2022-06-29T10:33:25","guid":{"rendered":"https:\/\/3keys.com\/?page_id=1470"},"modified":"2024-03-04T11:43:19","modified_gmt":"2024-03-04T08:43:19","slug":"pharma-saudi-arabia","status":"publish","type":"page","link":"https:\/\/3keys.com\/de\/expertise\/regulations\/pharma\/pharma-saudi-arabia\/","title":{"rendered":"Pharma (Saudi Arabia)"},"content":{"rendered":"<p><\/p>\n<p>March 2017 \u2013 Serialization SSU \u2013\u00a0All Products must be labeled in compliance with Legislative Decree No. 41 of 2017.<\/p>\n<p>February 2018 \u2013 Registration DENR \u2013\u00a0All local manufacturers and warehouses have to register their GLN\u2019s in the DENR authority portal. Do not apply for overseeing suppliers.<\/p>\n<p>7 January 2019 \u2013 Reporting DTTS \u2013\u00a0Stakeholders start reporting SNs through the new authority platform called DTTS, Drug Track &amp; Trace System.<\/p>\n<p>August 2020 \u2013 Aggregation \u2013\u00a0All Companies representing Manufacturers\/MAHs are required to be compliant with Aggregation reporting requirements.<\/p>\n<h2>Who is affected?<\/h2>\n<ul>\n<li>Manufacturers<\/li>\n<li>Warehouses<\/li>\n<li>Pharmacies<\/li>\n<li>Medical and Dispense Centers<\/li>\n<\/ul>\n<div>Local manufacturers and importers\/distributers have to notify the authorities through DTTS about all activities done to the drug packs.<\/div>\n<p>The external manufacturers (oversee suppliers with production outside the KSA) have the possibility to provide their agents with a flat list of SN.<\/p>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>March 2017 \u2013 Serialization SSU \u2013\u00a0All Products must be labeled in compliance with Legislative Decree No. 41 of 2017. February 2018 \u2013 Registration DENR \u2013\u00a0All<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":466,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"page_regulations.php","meta":{"inline_featured_image":false},"categories":[20],"tags":[],"class_list":["post-1470","page","type-page","status-publish","hentry","category-saudi_arabia"],"_links":{"self":[{"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/pages\/1470","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/comments?post=1470"}],"version-history":[{"count":4,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/pages\/1470\/revisions"}],"predecessor-version":[{"id":2141,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/pages\/1470\/revisions\/2141"}],"up":[{"embeddable":true,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/pages\/466"}],"wp:attachment":[{"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/media?parent=1470"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/categories?post=1470"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/3keys.com\/de\/wp-json\/wp\/v2\/tags?post=1470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}