{"id":7499,"date":"2022-11-18T13:24:15","date_gmt":"2022-11-18T13:24:15","guid":{"rendered":"https:\/\/cinmed.me\/inspektorat\/dobra-praksa-u-farmakovigilanci\/"},"modified":"2023-02-24T09:37:42","modified_gmt":"2023-02-24T09:37:42","slug":"good-pharmacovigilance-practice","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/inspectorate\/good-pharmacovigilance-practice\/","title":{"rendered":"Good Pharmacovigilance Practice"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7499\" class=\"elementor elementor-7499 elementor-1082\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" 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-b11a068\" data-id=\"b11a068\" 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-ce4b035 elementor-widget elementor-widget-image\" data-id=\"ce4b035\" 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=\"669\" height=\"438\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Dobra-praksa.jpg\" class=\"attachment-large size-large wp-image-6264\" alt=\"dobra praksa PhV\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Dobra-praksa.jpg 669w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Dobra-praksa-300x196.jpg 300w\" sizes=\"(max-width: 669px) 100vw, 669px\" \/>\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-81f4de1 elementor-widget elementor-widget-text-editor\" data-id=\"81f4de1\" 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>Pharmacovigilance system is organized in line with Guidelines of Good Pharmacovigilance Practice.<\/p><p>\u00a0<\/p><p>Good Pharmacovigilance Practice represents guidelines of quality assurance in planning, organization and implementation of procedures related to collecting, processing and evaluating safety data on a medicine with the aim of protecting the health of the population and animals <a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-9_en\">(EudraLex-<\/a> <a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-9_en\">Volume 9-Pharmacovigilance guidelines).<\/a><\/p><p>\u00a0<\/p><p>Institute shall conduct control of the pharmacovigilance system of marketing authorisation holder in the implementation of Good pharmacovigilance practice. Inspection supervision is performed by competent inspectors for medicines for human and veterinary use as follows: pharmaceutical inspector in relation to medicines in the manufacturing, wholesale of medicines for human use, clinical trials of medicines, as well as application of guidelines of Good manufacturing practice, Good distribution practice, <a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-9_en\">Good Pharmacovigilance Practice<\/a> and Good clinical practice.<\/p>\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-c99dd92\" data-id=\"c99dd92\" 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-fddc2e7 elementor-widget elementor-widget-shortcode\" data-id=\"fddc2e7\" 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\/5.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Inspectorate<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-inspektorat-container\"><ul id=\"menu-inspektorat\" class=\"list-none\t\"><li id=\"menu-item-14222\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-14222 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\/inspektorat\/opste-informacije\/\">General information<\/a><\/li>\n<li id=\"menu-item-7408\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7408 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\/inspektorat\/proizvodnja-dobra-proizvodacka-praksa\/\">Manufacturing\/GoodManufacturing Practice<\/a><\/li>\n<li id=\"menu-item-7409\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7409 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\/inspektorat\/promet-na-veliko-dobra-distributivna-praksa\/\">Wholesale\/Good Distribution Practice<\/a><\/li>\n<li id=\"menu-item-7410\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7410 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\/inspektorat\/dobra-praksa-u-farmakovigilanci\/\">Good Pharmacovigilance Practice<\/a><\/li>\n<li id=\"menu-item-7411\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7411 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\/inspektorat\/dobra-klinicka-praksa\/\">Good Clinical Practice<\/a><\/li>\n<li id=\"menu-item-19604\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-19604 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\/inspektorat\/proizvodnja-uvoz-i-distribucija-aktivnih-supstanci\/\">Manufacture\/import and distribution of active substances<\/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-d1b992c elementor-widget elementor-widget-shortcode\" data-id=\"d1b992c\" 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\" 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<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>Pharmacovigilance system is organized in line with Guidelines of Good Pharmacovigilance Practice. \u00a0 Good Pharmacovigilance Practice represents guidelines of quality assurance in planning, organization and implementation of procedures related to collecting, processing and evaluating safety data on a medicine with the aim of protecting the health of the population and animals (EudraLex- Volume 9-Pharmacovigilance guidelines). 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