{"id":7487,"date":"2022-11-04T13:08:41","date_gmt":"2022-11-04T13:08:41","guid":{"rendered":"https:\/\/cinmed.me\/farmakovigilanca\/uputstva-za-nosioca-dozvole-za-lijek\/"},"modified":"2026-06-01T14:34:54","modified_gmt":"2026-06-01T12:34:54","slug":"instructions-for-marketing-authorisation-holders","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/pharmacovigilance\/instructions-for-marketing-authorisation-holders\/","title":{"rendered":"Instructions for marketing authorisation holders"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7487\" class=\"elementor elementor-7487 elementor-665\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-668816e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"668816e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b031b8f\" data-id=\"b031b8f\" data-element_type=\"column\" data-e-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-e3486b7 elementor-widget elementor-widget-image\" data-id=\"e3486b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"915\" height=\"477\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika.png\" class=\"attachment-large size-large wp-image-8805\" alt=\"uputstva za nosioca dozvole - Rules\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika.png 915w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika-300x156.png 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/3.uputstva-za-nosioca-dozvole-za-lijek-finalna-slika-768x400.png 768w\" sizes=\"(max-width: 915px) 100vw, 915px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb5dca3 elementor-widget elementor-widget-text-editor\" data-id=\"cb5dca3\" data-element_type=\"widget\" data-e-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>Responsibilities of marketing authorization holders in the area of pharmacovigilance are defined by the <a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/02\/Law-on-medicinal-products_-eng.pdf\"><u>Law on Medicinal Products<\/u><\/a>\u00a0and <a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Rulebook_on_pharmacovigilance_oct-2014.pdf\" target=\"_blank\" rel=\"noopener\"><u>Rulebook on the manner of collecting of data and reporting and monitoring adverse reactions to medicines for use in human medicine<\/u><\/a>. In line with the Law on medicines, <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/good-pharmacovigilance-practices\">Guidelines on Good Pharmacovigilance Practice<\/a> are applied in this area and they are available on the website of the European Medicines Agency (EMA).<\/p><p>Additionally, responsibilities of marketing authorization holders are more closely defined by the following instructions:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-966e376 elementor-widget elementor-widget-text-editor\" data-id=\"966e376\" data-element_type=\"widget\" data-e-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<ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2026\/06\/Instruction-on-the-manner-of-submitting-the-summary-of-PSMF_.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting the summary of PSMF\u00a0<\/a><i>(updated 1.6.2026.)<\/i><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-submitting-ADR-report.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting ADR report <\/a> (<i>updated <\/i> 13.12.2021.)<\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-sending-letters-to-health-professionals.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of sending letters to health professionals <\/a> (<i>updated<\/i> 13.12.2021.)<\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/Instruction-on-the-manner-of-submitting-periodic-safety-update-report.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting periodic safety update report <\/a>\u00a0 (<i>updated<\/i> 13.12.2021.)<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2025\/06\/Instruction-on-the-manner-of-submitting-RMP-june-2025.pdf\" target=\"_blank\" rel=\"noopener\">Instruction on the manner of submitting risk management plan (RMP)\u00a0<\/a> (<i>updated<\/i> 16.6.2025.)<\/li><\/ul>\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-09c494f\" data-id=\"09c494f\" data-element_type=\"column\" data-e-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-a168863 elementor-widget elementor-widget-shortcode\" data-id=\"a168863\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t    <div class=\"sidebar-menu-wrapper\">\r\n        <div class=\"sidebar-menu-header\">\r\n            <img decoding=\"async\" class=\"sidebar-menu-header-icon\" src=\"\/wp-content\/uploads\/2022\/11\/4.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Pharmacovigilance<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-farmakovigilanca-container\"><ul id=\"menu-farmakovigilanca\" class=\"list-none\t\"><li id=\"menu-item-7342\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7342 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/osnovni-pojmovi\/\">General information<\/a><\/li>\n<li id=\"menu-item-7343\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7343 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/prijava-nezeljenog-dejstva-lijeka\/\">Adverse reactions to medicines reporting<\/a><\/li>\n<li id=\"menu-item-7344\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7344 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/uputstva-za-nosioca-dozvole-za-lijek\/\">Instructions for marketing authorisation holders<\/a><\/li>\n<li id=\"menu-item-7345\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7345 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/pisma-zdravstvenim-radnicima\/\">Direct Healthcare Professional Communication<\/a><\/li>\n<li id=\"menu-item-7346\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7346 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/mjere-minimizacije-rizika\/\">Risk minimisation measures<\/a><\/li>\n<li id=\"menu-item-7348\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7348 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/lista-ozbiljnih-nezeljenih-dejstava\/\">List of serious adverse reactions<\/a><\/li>\n<li id=\"menu-item-7349\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7349 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/lista-ljekova-pod-dodatnim-pracenjem\/\">List of medicines under additional monitoring<\/a><\/li>\n<li id=\"menu-item-7350\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7350 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/farmakovigilanca\/godisnji-izvjestaji\/\">Annual reports<\/a><\/li>\n<\/ul><\/div>            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n\t\t<div class=\"elementor-shortcode\"><\/div>\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-5bf21fb elementor-widget elementor-widget-shortcode\" data-id=\"5bf21fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<div class=\"overflow-hidden relative p-6 text-white rounded-2xl shadow-md bg-primary\">\n\t<div class=\"mb-5\">\n\t\t<div class=\"flex gap-3 justify-between items-center mb-2\">\n\t\t\t<h2 class=\"text-2xl font-bold tracking-tight leading-tight text-white\">\n\t\t\t\tFind medicines <span class=\"font-normal text-[#fbf2db]\"> and medical devices<\/span>\t\t\t<\/h2>\n\t\t\t<div class=\"flex relative z-20 flex-shrink-0 gap-1.5 items-center\">\n\t\t\t\t<button type=\"button\" class=\"flex relative z-10 justify-center items-center w-8 h-8 text-white rounded-full transition-all duration-200 cursor-pointer sidebar-register-prev bg-white\/20 hover:bg-white hover:text-primary shadow-xs focus:outline-none\" aria-label=\"Previous register\">\n\t\t\t\t\t<svg class=\"w-4 h-4 pointer-events-none\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" viewBox=\"0 0 24 24\"><path stroke-linecap=\"round\" stroke-linejoin=\"round\" d=\"M15 19l-7-7 7-7\"\/><\/svg>\n\t\t\t\t<\/button>\n\t\t\t\t<button type=\"button\" class=\"flex relative z-10 justify-center items-center w-8 h-8 text-white rounded-full transition-all duration-200 cursor-pointer sidebar-register-next bg-white\/20 hover:bg-white hover:text-primary shadow-xs focus:outline-none\" aria-label=\"Next register\">\n\t\t\t\t\t<svg class=\"w-4 h-4 pointer-events-none\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2.5\" viewBox=\"0 0 24 24\"><path stroke-linecap=\"round\" stroke-linejoin=\"round\" d=\"M9 5l7 7-7 7\"\/><\/svg>\n\t\t\t\t<\/button>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<p class=\"text-sm leading-relaxed text-white\/90\">\n\t\t\tQuick and easy access to databases of approved medicines and medical devices.\t\t<\/p>\n\t<\/div>\n\n\t<!-- Swiper Slider -->\n\t<div class=\"overflow-hidden relative z-10 w-full swiper sidebarRegisterSwiper\">\n\t\t<div class=\"flex items-stretch swiper-wrapper\">\n\t\t\t\t\t\t\t<div class=\"flex flex-col h-auto swiper-slide\">\n\t\t\t\t\t<div class=\"flex flex-col flex-1 p-6 h-full text-left bg-white rounded-xl border shadow-sm transition-shadow duration-300 border-surface-variant hover:shadow-md\">\n\t\t\t\t\t\t<div class=\"w-14 h-14 bg-[#FDF5E6] rounded-xl flex items-center justify-center mb-4 flex-shrink-0\">\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-7 h-7\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/medical_services.png\" alt=\"Database of medicines for human use\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/register-of-medicines-for-human-use\/\">\n\t\t\t\t\t\t\t\tHuman medicines database\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search authorised human medicines<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" href=\"\/en\/register-of-medicines-for-human-use\/\">\n\t\t\t\t\t\t\t<span>Search database<\/span>\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-4 h-4 transition-transform duration-200 group-hover:translate-x-1\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/arrow_forward.png\" alt=\"Arrow forward\">\n\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\t\t<div class=\"flex flex-col h-auto swiper-slide\">\n\t\t\t\t\t<div class=\"flex flex-col flex-1 p-6 h-full text-left bg-white rounded-xl border shadow-sm transition-shadow duration-300 border-surface-variant hover:shadow-md\">\n\t\t\t\t\t\t<div class=\"w-14 h-14 bg-[#FDF5E6] rounded-xl flex items-center justify-center mb-4 flex-shrink-0\">\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-7 h-7\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/pets.png\" alt=\"Database of veterinary medicines\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/register-of-veterinary-medicines\/\">\n\t\t\t\t\t\t\t\tVeterinary medicines database\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search authorised veterinary medicines<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" href=\"\/en\/register-of-veterinary-medicines\/\">\n\t\t\t\t\t\t\t<span>Search database<\/span>\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-4 h-4 transition-transform duration-200 group-hover:translate-x-1\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/arrow_forward.png\" alt=\"Arrow forward\">\n\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\t\t<div class=\"flex flex-col h-auto swiper-slide\">\n\t\t\t\t\t<div class=\"flex flex-col flex-1 p-6 h-full text-left bg-white rounded-xl border shadow-sm transition-shadow duration-300 border-surface-variant hover:shadow-md\">\n\t\t\t\t\t\t<div class=\"w-14 h-14 bg-[#FDF5E6] rounded-xl flex items-center justify-center mb-4 flex-shrink-0\">\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-7 h-7\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/science.png\" alt=\"Register of medical devices\">\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h3 class=\"mb-2 text-xl font-bold leading-snug\" style=\"color: rgb(221, 111, 16);\">\n\t\t\t\t\t\t\t<a class=\"relative z-20 transition-colors duration-200 hover:!text-[#c25e1a] !no-underline hover:!no-underline\" style=\"color: inherit;\" href=\"\/en\/medical-devices\/register-of-medical-devices\/\">\n\t\t\t\t\t\t\t\tRegister of medical devices\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/h3>\n\t\t\t\t\t\t<p class=\"flex-grow mb-6 text-sm leading-relaxed text-gray-600\">Search medical devices registered with CInMED<\/p>\n\t\t\t\t\t\t<a class=\"relative z-20 inline-flex items-center gap-2 mt-auto font-semibold text-sm !text-[#E37222] hover:!text-[#c25e1a] !cursor-pointer transition-colors duration-200 !no-underline hover:!no-underline group\" href=\"\/en\/medical-devices\/register-of-medical-devices\/\">\n\t\t\t\t\t\t\t<span>Search register<\/span>\n\t\t\t\t\t\t\t<img decoding=\"async\" class=\"object-contain w-4 h-4 transition-transform duration-200 group-hover:translate-x-1\" src=\"https:\/\/cinmed.me\/wp-content\/themes\/cinmed\/images\/arrow_forward.png\" alt=\"Arrow forward\">\n\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<\/div>\n<\/div>\n\n<div class=\"relative px-10 pt-10 pb-72 mt-10 rounded bg-light-yellow\">\n\t<div class=\"mt-8 md:mt-0\">\n\t\t<h1 class=\"text-3xl text-primary\">Sign up for<\/h1>\n\t\t<h1 class=\"mb-5 text-3xl font-bold text-primary\">Newsletter<\/h1>\n\t\t  \n  \n  <div class=\"\n    mailpoet_form_popup_overlay\n      \"><\/div>\n  <div\n    id=\"mailpoet_form_1\"\n    class=\"\n      mailpoet_form\n      mailpoet_form_shortcode\n      mailpoet_form_position_\n      mailpoet_form_animation_\n    \"\n      >\n\n    <style type=\"text\/css\">\n     #mailpoet_form_1 .mailpoet_form {  }\n#mailpoet_form_1 .mailpoet_column_with_background { padding: 10px; }\n#mailpoet_form_1 .mailpoet_form_column:not(:first-child) { margin-left: 20px; }\n#mailpoet_form_1 .mailpoet_paragraph { line-height: 20px; margin-bottom: 20px; }\n#mailpoet_form_1 .mailpoet_segment_label, #mailpoet_form_1 .mailpoet_text_label, #mailpoet_form_1 .mailpoet_textarea_label, #mailpoet_form_1 .mailpoet_select_label, #mailpoet_form_1 .mailpoet_radio_label, #mailpoet_form_1 .mailpoet_checkbox_label, #mailpoet_form_1 .mailpoet_list_label, #mailpoet_form_1 .mailpoet_date_label { display: block; font-weight: normal; }\n#mailpoet_form_1 .mailpoet_text, #mailpoet_form_1 .mailpoet_textarea, #mailpoet_form_1 .mailpoet_select, #mailpoet_form_1 .mailpoet_date_month, #mailpoet_form_1 .mailpoet_date_day, #mailpoet_form_1 .mailpoet_date_year, #mailpoet_form_1 .mailpoet_date { display: block; }\n#mailpoet_form_1 .mailpoet_text, #mailpoet_form_1 .mailpoet_textarea { width: 200px; }\n#mailpoet_form_1 .mailpoet_checkbox {  }\n#mailpoet_form_1 .mailpoet_submit {  }\n#mailpoet_form_1 .mailpoet_divider {  }\n#mailpoet_form_1 .mailpoet_message {  }\n#mailpoet_form_1 .mailpoet_form_loading { width: 30px; text-align: center; line-height: normal; }\n#mailpoet_form_1 .mailpoet_form_loading > span { width: 5px; height: 5px; background-color: #5b5b5b; }#mailpoet_form_1{border-radius: 0px;text-align: left;}#mailpoet_form_1 form.mailpoet_form {padding: 20px;}#mailpoet_form_1{width: 100%;}#mailpoet_form_1 .mailpoet_message {margin: 0; padding: 0 20px;}#mailpoet_form_1 .mailpoet_paragraph.last {margin-bottom: 0} @media (max-width: 500px) {#mailpoet_form_1 {background-image: none;}} @media (min-width: 500px) {#mailpoet_form_1 .last .mailpoet_paragraph:last-child {margin-bottom: 0}}  @media (max-width: 500px) {#mailpoet_form_1 .mailpoet_form_column:last-child .mailpoet_paragraph:last-child {margin-bottom: 0}} \n    <\/style>\n\n    <form\n      target=\"_self\"\n      method=\"post\"\n      action=\"https:\/\/cinmed.me\/wp-admin\/admin-post.php?action=mailpoet_subscription_form\"\n      class=\"mailpoet_form mailpoet_form_form mailpoet_form_shortcode\"\n      novalidate\n      data-delay=\"\"\n      data-exit-intent-enabled=\"\"\n      data-trigger-mode=\"\"\n      data-click-trigger-selector=\"\"\n      data-font-family=\"\"\n      data-cookie-expiration-time=\"\"\n    >\n      <input type=\"hidden\" name=\"data[form_id]\" value=\"1\" \/>\n      <input type=\"hidden\" name=\"token\" value=\"754242d876\" \/>\n      <input type=\"hidden\" name=\"api_version\" value=\"v1\" \/>\n 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class=\"mailpoet_submit\" value=\"Subscribe!\" data-automation-id=\"subscribe-submit-button\" style=\"width:100%;box-sizing:border-box;padding:5px;margin: 0 auto 0 0;border-color:transparent;\" \/><span class=\"mailpoet_form_loading\"><span class=\"mailpoet_bounce1\"><\/span><span class=\"mailpoet_bounce2\"><\/span><span class=\"mailpoet_bounce3\"><\/span><\/span><\/div>\n\n      <div class=\"mailpoet_message\">\n        <p class=\"mailpoet_validate_success\"\n                style=\"display:none;\"\n                >Thank you for subscribing!\n        <\/p>\n        <p class=\"mailpoet_validate_error\"\n                style=\"display:none;\"\n                >        <\/p>\n      <\/div>\n    <\/form>\n\n      <\/div>\n\n  \t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-0 left-0 w-[380px]\" src=\"\/wp-content\/uploads\/2022\/11\/newsletter.png\" alt=\"Newsletter\" \/>\n<\/div>\n\t\t<div class=\"elementor-shortcode\"><\/div>\n\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Responsibilities of marketing authorization holders in the area of pharmacovigilance are defined by the Law on Medicinal Products\u00a0and Rulebook on the manner of collecting of data and reporting and monitoring adverse reactions to medicines for use in human medicine. 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