{"id":10716,"date":"2026-04-28T14:27:10","date_gmt":"2026-04-28T12:27:10","guid":{"rendered":"https:\/\/sashagmann.de\/regularien-normen\/regulation-ec-no-726-2004\/"},"modified":"2026-05-04T12:42:32","modified_gmt":"2026-05-04T10:42:32","slug":"regulation-ec-no-726-2004","status":"publish","type":"regularien-normen","link":"https:\/\/sashagmann.de\/en\/regularien-normen\/regulation-ec-no-726-2004\/","title":{"rendered":"Regulation (EC) No 726\/2004"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10716\" class=\"elementor elementor-10716 elementor-10658\" data-elementor-post-type=\"regularien-normen\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3be836e e-flex e-con-boxed e-con e-parent\" data-id=\"3be836e\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2acb975 e-con-full e-flex e-con e-child\" data-id=\"2acb975\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-9e8f2d7 e-con-full e-flex e-con e-child\" data-id=\"9e8f2d7\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8363ddc elementor-widget elementor-widget-heading\" data-id=\"8363ddc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Regulation (EC) No 726\/2004<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-79a6eae e-flex e-con-boxed e-con e-parent\" data-id=\"79a6eae\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4692fef e-con-full e-flex e-con e-child\" data-id=\"4692fef\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-494ba24 e-con-full e-flex e-con e-child\" data-id=\"494ba24\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-81e015f elementor-widget elementor-widget-heading\" data-id=\"81e015f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Regulation (EC) No 726\/2004: Authorization and supervision of medicinal products for human use<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a32393 elementor-widget elementor-widget-heading\" data-id=\"1a32393\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Scope, objectives, and legal framework<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-16cfafe e-flex e-con-boxed e-con e-parent\" data-id=\"16cfafe\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-0fdadf6 e-con-full e-flex e-con e-child\" data-id=\"0fdadf6\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-025b2d6 elementor-widget elementor-widget-n-accordion\" data-id=\"025b2d6\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2470\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2470\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> EU Regulation and relationship to Union medicinal product law (EC\/EU) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2470\" class=\"elementor-element elementor-element-3740534 e-con-full e-flex e-con e-child\" data-id=\"3740534\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ec31f3d elementor-widget elementor-widget-text-editor\" data-id=\"ec31f3d\" 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\t\t<p>Regulation (EC) No 726\/2004 is a directly applicable EU regulation and constitutes a central legislative act in European pharmaceutical law. This regulation governs the centralized Community procedure for the authorization and licensing of medicinal products within the Union and establishes a uniform system for medicinal products for human use. The objective of the regulation is the harmonized assessment, authorization, supervision, and monitoring of medicinal products at the European Union level. By means of these provisions, it is ensured that innovative and safety-relevant medicinal products are evaluated according to identical regulatory requirements and that their placement on the market within the EU is based on a uniform legal framework.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1750258 e-con-full e-flex e-con e-child\" data-id=\"1750258\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fa71d0f elementor-widget elementor-widget-n-accordion\" data-id=\"fa71d0f\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2620\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2620\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Distinction from EU Directives and National Regulations <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2620\" class=\"elementor-element elementor-element-095b4d4 e-con-full e-flex e-con e-child\" data-id=\"095b4d4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9259404 elementor-widget elementor-widget-text-editor\" data-id=\"9259404\" 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\t\t<p>In contrast to a directive, a regulation has direct legal effect in all member states of the Union. While the Community code relating to medicinal products for human use contains fundamental requirements, Regulation (EC) No 726\/2004 defines the specific Community procedure for centralized EU authorization. National regulations remain applicable in a supplementary capacity but must not contradict the Union law requirements of this Regulation. This creates a clear hierarchy between the EU Regulation and national medicinal product law, thereby ensuring regulatory coherence within the EU.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\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<div class=\"elementor-element elementor-element-30ffb69 e-flex e-con-boxed e-con e-parent\" data-id=\"30ffb69\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-bcf3ae4 e-con-full e-flex e-con e-child\" data-id=\"bcf3ae4\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bac6c5a e-con-full e-flex e-con e-child\" data-id=\"bac6c5a\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d196fab elementor-widget elementor-widget-heading\" data-id=\"d196fab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Institutions &amp; Roles in the Procedure<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-1045d91 e-flex e-con-boxed e-con e-parent\" data-id=\"1045d91\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-aeaf047 e-con-full e-flex e-con e-child\" data-id=\"aeaf047\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fa97b39 elementor-widget elementor-widget-n-accordion\" data-id=\"fa97b39\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2620\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2620\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> The European Medicines Agency (EMA) \u2013 Establishment, Tasks, Supervision <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2620\" class=\"elementor-element elementor-element-20c6dfd e-con-full e-flex e-con e-child\" data-id=\"20c6dfd\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-586e772 elementor-widget elementor-widget-text-editor\" data-id=\"586e772\" 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\t\t<p>The European Medicines Agency (EMA) was established by the Regulation and serves as the central pharmaceutical agency of the EU. The organization coordinates the scientific evaluation process within the centralized Community procedure and manages the assessment of the quality, safety, and efficacy of medicinal products. The scientific review is primarily conducted by the Committee for Medicinal Products for Human Use (CHMP). In addition, the agency is responsible for European pharmacovigilance, including the EudraVigilance system, and undertakes the continuous monitoring of authorized medicinal products within the Union.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3e19b02 e-con-full e-flex e-con e-child\" data-id=\"3e19b02\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-8b64f48 e-con-full e-flex e-con e-child\" data-id=\"8b64f48\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1fd5e7d elementor-widget elementor-widget-n-accordion\" data-id=\"1fd5e7d\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-3330\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-3330\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> European Commission, Parliament, and Official Journal \u2013 Establishment and Publication of Decisions <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-3330\" class=\"elementor-element elementor-element-9ed1313 e-con-full e-flex e-con e-child\" data-id=\"9ed1313\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bd3da5e elementor-widget elementor-widget-text-editor\" data-id=\"bd3da5e\" 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\t\t<p>The legally binding authorization and licensing of a medicinal product is granted by the European Commission based on the scientific recommendation of the Agency. The European Parliament, together with the Council, is involved in the amendment of the Regulation. Every authorization, modification, or withdrawal of a marketing authorization is published in the Official Journal of the European Union. Upon publication in the Official Journal, the decision attains Union-wide validity and becomes a binding component of EU law.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-89fa9c9 e-flex e-con-boxed e-con e-parent\" data-id=\"89fa9c9\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-0d3c979 e-con-full e-flex e-con e-child\" data-id=\"0d3c979\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-324f839 e-con-full e-flex e-con e-child\" data-id=\"324f839\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba28bc9 elementor-widget elementor-widget-heading\" data-id=\"ba28bc9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Centralized Community Procedure (Centralised Procedure)<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-67d7b36 e-flex e-con-boxed e-con e-parent\" data-id=\"67d7b36\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5d16b2e e-con-full e-flex e-con e-child\" data-id=\"5d16b2e\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d177532 elementor-widget elementor-widget-n-accordion\" data-id=\"d177532\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2190\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2190\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Scope of Application for Medicinal Products for Human Use <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2190\" class=\"elementor-element elementor-element-f6fb8de e-con-full e-flex e-con e-child\" data-id=\"f6fb8de\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c0b846a elementor-widget elementor-widget-text-editor\" data-id=\"c0b846a\" 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\t\t<p>The centralized Community procedure is mandatory for certain medicinal products for human use, particularly for biotechnologically manufactured medicines, orphan medicinal products, advanced therapy medicinal products (ATMPs), specific oncological active substances, as well as other innovative products. Through the centralized procedure, an EU-wide authorization is granted, enabling simultaneous placement on the market in all Member States and creating a uniform regulatory status. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5069576 e-con-full e-flex e-con e-child\" data-id=\"5069576\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cd4c6b4 elementor-widget elementor-widget-n-accordion\" data-id=\"cd4c6b4\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2150\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2150\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Application, Dossier (CTD), Scientific Evaluation, and Authorization\/Licensing <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2150\" class=\"elementor-element elementor-element-dca75f2 e-con-full e-flex e-con e-child\" data-id=\"dca75f2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23be590 elementor-widget elementor-widget-text-editor\" data-id=\"23be590\" 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\t\t<p>The authorization begins with the submission of a complete CTD dossier to the Agency. The dossier contains structured data regarding the manufacture, quality control, preclinical testing, and clinical evaluation of the medicinal product. Following validation, the scientific evaluation is conducted within specified timelines. The assessment culminates in a benefit-risk analysis, on the basis of which the Commission grants or refuses the EU authorization. This procedure ensures a transparent and standardized decision regarding licensing within the Union.    <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cde0b68 e-con-full e-flex e-con e-child\" data-id=\"cde0b68\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-a733119 e-con-full e-flex e-con e-child\" data-id=\"a733119\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9616c40 elementor-widget elementor-widget-n-accordion\" data-id=\"9616c40\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1570\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1570\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Placing on the Market in the EU: Validity, Conditions, Requirements, and Regulations <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1570\" class=\"elementor-element elementor-element-02f48c0 e-con-full e-flex e-con e-child\" data-id=\"02f48c0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9ac4823 elementor-widget elementor-widget-text-editor\" data-id=\"9ac4823\" 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\t\t<p>With the EU authorization, placing the medicinal product on the market is permitted in all Member States. The authorization may be subject to specific conditions, such as additional studies, risk minimization measures, or special monitoring requirements. National pricing and reimbursement decisions remain unaffected by the authorization. However, the Union-wide validity of the authorization creates a uniform legal basis for distribution within the EU.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-9b2fe54 e-flex e-con-boxed e-con e-parent\" data-id=\"9b2fe54\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ff26505 e-con-full e-flex e-con e-child\" data-id=\"ff26505\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-be93719 e-con-full e-flex e-con e-child\" data-id=\"be93719\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e727ba6 elementor-widget elementor-widget-heading\" data-id=\"e727ba6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pharmacovigilance &amp; Market Surveillance<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-f044d0e e-flex e-con-boxed e-con e-parent\" data-id=\"f044d0e\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-40af4ed e-con-full e-flex e-con e-child\" data-id=\"40af4ed\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-80ea8d2 elementor-widget elementor-widget-n-accordion\" data-id=\"80ea8d2\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1350\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1350\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Safety Monitoring\/Pharmacovigilance, Risk Management, and Periodic Reports <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1350\" class=\"elementor-element elementor-element-ce3ff81 e-con-full e-flex e-con e-child\" data-id=\"ce3ff81\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d6e3e61 elementor-widget elementor-widget-text-editor\" data-id=\"d6e3e61\" 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\t\t<p>The Regulation obligates marketing authorization holders to establish a comprehensive pharmacovigilance system. This includes an approved Risk Management Plan (RMP), the submission of Periodic Safety Update Reports (PSURs), and the reporting of adverse reactions via EudraVigilance. These regulatory provisions serve the continuous monitoring of medicinal products post-authorization and enable an ongoing assessment of the benefit-risk balance within the EU.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f0f2dd8 e-con-full e-flex e-con e-child\" data-id=\"f0f2dd8\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-d24f0c9 e-con-full e-flex e-con e-child\" data-id=\"d24f0c9\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-38ba9a4 elementor-widget elementor-widget-n-accordion\" data-id=\"38ba9a4\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-5940\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-5940\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Measures in Case of Changes to the Benefit-Risk Assessment <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-5940\" class=\"elementor-element elementor-element-51c7015 e-con-full e-flex e-con e-child\" data-id=\"51c7015\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-55ca5e1 elementor-widget elementor-widget-text-editor\" data-id=\"55ca5e1\" 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\t\t<p>If safety monitoring yields new findings, regulatory changes may become necessary. These changes can include updates to the Summary of Product Characteristics (SmPC), additional warnings, restrictions on use, or the suspension of the authorization. The decision is coordinated Union-wide to ensure a consistent risk assessment across all Member States.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-f0ec1e4 e-flex e-con-boxed e-con e-parent\" data-id=\"f0ec1e4\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-26d20be e-con-full e-flex e-con e-child\" data-id=\"26d20be\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-93d1133 e-con-full e-flex e-con e-child\" data-id=\"93d1133\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-90beef6 elementor-widget elementor-widget-heading\" data-id=\"90beef6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Lifecycle-Management<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-6fec3b2 e-flex e-con-boxed e-con e-parent\" data-id=\"6fec3b2\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-719946f e-con-full e-flex e-con e-child\" data-id=\"719946f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-632a35d elementor-widget elementor-widget-n-accordion\" data-id=\"632a35d\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1030\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1030\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Variations, Renewal, and Determination of Changes <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1030\" class=\"elementor-element elementor-element-6bb992b e-con-full e-flex e-con e-child\" data-id=\"6bb992b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1f404ed elementor-widget elementor-widget-text-editor\" data-id=\"1f404ed\" 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\t\t<p>Following authorization, every medicinal product is subject to structured lifecycle management in accordance with the Variations Regulation (EC) No 1234\/2008. Variations concern, for example, changes in manufacturing, new indications, or adjustments to quality parameters. Prior to the expiry of the initial authorization period, a renewal is carried out based on updated safety and efficacy data. Any determination of changes requires formal approval by the competent EU authorities.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c0cde8c e-con-full e-flex e-con e-child\" data-id=\"c0cde8c\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-f5dd28e e-con-full e-flex e-con e-child\" data-id=\"f5dd28e\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9992e77 elementor-widget elementor-widget-n-accordion\" data-id=\"9992e77\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1610\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1610\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Batch Releases, Supply Obligations, and Supply Interruptions <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1610\" class=\"elementor-element elementor-element-1094da1 e-con-full e-flex e-con e-child\" data-id=\"1094da1\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-57a5952 elementor-widget elementor-widget-text-editor\" data-id=\"57a5952\" 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\t\t<p>Manufacturers and marketing authorization holders are obligated to ensure proper manufacturing, batch release, and market supply. Supply interruptions must be reported at an early stage. These regulatory requirements serve to secure stable supply chains and the continuous availability of authorized medicinal products within the Union.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-610505c e-flex e-con-boxed e-con e-parent\" data-id=\"610505c\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-fab30e9 e-con-full e-flex e-con e-child\" data-id=\"fab30e9\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bd7c201 e-con-full e-flex e-con e-child\" data-id=\"bd7c201\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f2631d elementor-widget elementor-widget-heading\" data-id=\"2f2631d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Special Areas<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-925e3a2 e-flex e-con-boxed e-con e-parent\" data-id=\"925e3a2\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c5edba0 e-con-full e-flex e-con e-child\" data-id=\"c5edba0\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-9d61a6f e-con-full e-flex e-con e-child\" data-id=\"9d61a6f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93668e8 elementor-widget elementor-widget-n-accordion\" data-id=\"93668e8\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1540\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1540\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Medicinal Products for Paediatric Use \u2013 Requirements, Study Plans, and Exemptions <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1540\" class=\"elementor-element elementor-element-7e17066 e-con-full e-flex e-con e-child\" data-id=\"7e17066\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b2825aa elementor-widget elementor-widget-text-editor\" data-id=\"b2825aa\" 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\t\t<p>Specific Union law requirements apply to medicinal products for paediatric use, in particular the submission of an approved Paediatric Investigation Plan (PIP). Study plans must be coordinated with the medicines agency prior to authorization. The objective of these regulations is to promote safe and effective medicinal products for human use for the paediatric population within the EU.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-33faca3 e-flex e-con-boxed e-con e-parent\" data-id=\"33faca3\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5f93355 e-con-full e-flex e-con e-child\" data-id=\"5f93355\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d338741 e-con-full e-flex e-con e-child\" data-id=\"d338741\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0c90832 elementor-widget elementor-widget-heading\" data-id=\"0c90832\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Interfaces with Other Legal Acts<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-a5226de e-flex e-con-boxed e-con e-parent\" data-id=\"a5226de\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4fbaceb e-con-full e-flex e-con e-child\" data-id=\"4fbaceb\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5bd491a elementor-widget elementor-widget-n-accordion\" data-id=\"5bd491a\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-9620\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-9620\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Reference to Directive 2001\/83\/EC and other EU Regulations <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-9620\" class=\"elementor-element elementor-element-781710d e-con-full e-flex e-con e-child\" data-id=\"781710d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-65edf7e elementor-widget elementor-widget-text-editor\" data-id=\"65edf7e\" 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\t\t<p>The Regulation supplements Directive 2001\/83\/EC as well as other EU regulations in pharmaceutical law. While the Directive defines basic requirements for manufacturing and distribution, the Regulation governs the centralized authorization procedure at the EU level. This interplay ensures a systematic integration of Union law provisions.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5a24bcf e-con-full e-flex e-con e-child\" data-id=\"5a24bcf\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1cc3a06 e-con-full e-flex e-con e-child\" data-id=\"1cc3a06\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4dfc611 elementor-widget elementor-widget-n-accordion\" data-id=\"4dfc611\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-8170\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-8170\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Transitions, Updates, and Official Notices in the Official Journal <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-8170\" class=\"elementor-element elementor-element-443cdb6 e-con-full e-flex e-con e-child\" data-id=\"443cdb6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0168ce1 elementor-widget elementor-widget-text-editor\" data-id=\"0168ce1\" 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\t\t<p>Amendments to the Regulation, updates to regulatory requirements, and new authorizations are published in the Official Journal. Transitional arrangements define deadlines for the implementation of new requirements. Publication ensures that market participants are informed of the current legal status at all times.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-6641461 e-flex e-con-boxed e-con e-parent\" data-id=\"6641461\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5570051 e-con-full e-flex e-con e-child\" data-id=\"5570051\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-fc666a2 e-con-full e-flex e-con e-child\" data-id=\"fc666a2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1933b3b elementor-widget elementor-widget-heading\" data-id=\"1933b3b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Obligations of Economic Operators<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-302910e e-flex e-con-boxed e-con e-parent\" data-id=\"302910e\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8840eca e-con-full e-flex e-con e-child\" data-id=\"8840eca\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-01b0eab elementor-widget elementor-widget-n-accordion\" data-id=\"01b0eab\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1770\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1770\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Manufacturers, Authorization Holders, Importers \u2013 Responsibilities <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1770\" class=\"elementor-element elementor-element-2031a77 e-con-full e-flex e-con e-child\" data-id=\"2031a77\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e47937 elementor-widget elementor-widget-text-editor\" data-id=\"7e47937\" 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\t\t<p>Manufacturers, importers, and authorization holders bear the responsibility for compliance with all regulatory requirements of the Regulation. This includes GMP-compliant manufacturing, quality assurance, documentation obligations, and ensuring full regulatory conformity throughout the entire product lifecycle. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1f4338f e-con-full e-flex e-con e-child\" data-id=\"1f4338f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-5d5445a e-con-full e-flex e-con e-child\" data-id=\"5d5445a\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bf7d1fd elementor-widget elementor-widget-n-accordion\" data-id=\"bf7d1fd\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2000\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2000\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Quality Management, Documentation, Reporting and Information Obligations <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2000\" class=\"elementor-element elementor-element-1513b8d e-con-full e-flex e-con e-child\" data-id=\"1513b8d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-25fe188 elementor-widget elementor-widget-text-editor\" data-id=\"25fe188\" 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\t\t<p>A robust quality management system is a prerequisite for maintaining the authorization. Companies must keep regulatory documentation up to date, fulfill reporting obligations, and transmit relevant information to the competent authorities without delay. These requirements ensure transparency, traceability, and compliance within the European pharmaceutical sector.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-320fcaf e-flex e-con-boxed e-con e-parent\" data-id=\"320fcaf\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b66aada e-con-full e-flex e-con e-child\" data-id=\"b66aada\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-f73ad71 e-con-full e-flex e-con e-child\" data-id=\"f73ad71\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0e9554e elementor-widget elementor-widget-heading\" data-id=\"0e9554e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Testing and Verification Reference (Our Services)<\/h2>\t\t\t\t<\/div>\n\t\t\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<div class=\"elementor-element elementor-element-320eb66 e-flex e-con-boxed e-con e-parent\" data-id=\"320eb66\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f2c0ac1 e-con-full e-flex e-con e-child\" data-id=\"f2c0ac1\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-83052bc elementor-widget elementor-widget-n-accordion\" data-id=\"83052bc\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1370\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1370\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Analytical Support for Non-clinical Development, Lead Discovery <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1370\" class=\"elementor-element elementor-element-7f7eb61 e-con-full e-flex e-con e-child\" data-id=\"7f7eb61\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-193054a elementor-widget elementor-widget-text-editor\" data-id=\"193054a\" 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\t\t<p>The search for target molecules and structures for the development of new active ingredients requires analytical support for extraction processes, the identification and discovery of metabolites, and chemical structure elucidation. SAS hagmann supports pharmaceutical companies within the framework of R&amp;D partnerships with services in the field of chemical analysis. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6eb18c e-con-full e-flex e-con e-child\" data-id=\"c6eb18c\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-435c662 e-con-full e-flex e-con e-child\" data-id=\"435c662\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a16aae4 elementor-widget elementor-widget-n-accordion\" data-id=\"a16aae4\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1690\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1690\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Quality\/Safety\/Efficacy: Analytical Testing, Stability, Vigilance Support <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1690\" class=\"elementor-element elementor-element-030ecdb e-con-full e-flex e-con e-child\" data-id=\"030ecdb\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d13569 elementor-widget elementor-widget-text-editor\" data-id=\"2d13569\" 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\t\t<p>Analytical testing, monitoring of delivery systems regarding critical analytes, stability studies, and regulatory vigilance support ensure the sustained assurance of quality, safety, and efficacy. These services assist companies in complying with Union legal regulations, in amending existing authorizations, and in the long-term regulatory monitoring of their medicinal products within the EU. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\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>\n\t\t","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false},"class_list":["post-10716","regularien-normen","type-regularien-normen","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/sashagmann.de\/en\/wp-json\/wp\/v2\/regularien-normen\/10716","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sashagmann.de\/en\/wp-json\/wp\/v2\/regularien-normen"}],"about":[{"href":"https:\/\/sashagmann.de\/en\/wp-json\/wp\/v2\/types\/regularien-normen"}],"version-history":[{"count":1,"href":"https:\/\/sashagmann.de\/en\/wp-json\/wp\/v2\/regularien-normen\/10716\/revisions"}],"predecessor-version":[{"id":10717,"href":"https:\/\/sashagmann.de\/en\/wp-json\/wp\/v2\/regularien-normen\/10716\/revisions\/10717"}],"wp:attachment":[{"href":"https:\/\/sashagmann.de\/en\/wp-json\/wp\/v2\/media?parent=10716"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}