{"id":7484,"date":"2022-11-04T11:12:51","date_gmt":"2022-11-04T11:12:51","guid":{"rendered":"https:\/\/cinmed.me\/farmakovigilanca\/osnovni-pojmovi\/"},"modified":"2023-03-03T06:28:15","modified_gmt":"2023-03-03T06:28:15","slug":"general-information","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/pharmacovigilance\/general-information\/","title":{"rendered":"General information"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7484\" class=\"elementor elementor-7484 elementor-664\" 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-24bc737 elementor-widget elementor-widget-image\" data-id=\"24bc737\" 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=\"1024\" height=\"580\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/1.opste-informacije-finalna-slika-1024x580.png\" class=\"attachment-large size-large wp-image-8803\" alt=\"opste informacije PhV\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/1.opste-informacije-finalna-slika-1024x580.png 1024w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/1.opste-informacije-finalna-slika-300x170.png 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/1.opste-informacije-finalna-slika-768x435.png 768w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/1.opste-informacije-finalna-slika.png 1175w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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><strong>Pharmacovigilance <\/strong>is a set of activities related to collection, identification, evaluation, understanding, <strong>prevention and response to adverse reactions to medicines<\/strong>, as well as other problems relating to their use. <strong>Adverse reaction to a medicine <\/strong>is harmful and unintentionally caused reaction to a medicine, while an <strong>adverse event i<\/strong>s unwanted experience created in the period of medicine administration for which the causality \u00a0with medicine use does not have to be proven and represents any unwanted and unintended sign (e.g. an abnormal laboratory finding), symptom or disease, timely associated with medicine administration.<\/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-bd69b1e elementor-widget elementor-widget-text-editor\" data-id=\"bd69b1e\" 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><strong>Unexpected adverse reaction of medicine<\/strong> is any harmful adverse reaction to the medicine that is not listed in the approved summary of product \u00a0characteristics. <strong>Serious adverse reaction to a medicine<\/strong> is any adverse reaction that can cause death, is life-threatening, hospitalization or prolongation of hospitalization if for that there was no need before the usage of medicine, persistent or significant impairment or disability, congenital anomalies or distortions during nursing and other medically significant condition.<\/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-1ebc2a4 elementor-widget elementor-widget-text-editor\" data-id=\"1ebc2a4\" 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><strong>Pharmacovigilance system<\/strong> is a system established by marketing authorisation holder and the Institute, with the aim of monitoring the safety of medicines on the market and detecting any change in the benefit-risk ratio of their use. The benefit-risk ratio is an assessment of positive therapeutic effects of a medicine in view of the risk associated with its use.<\/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-6e260e1 elementor-widget elementor-widget-text-editor\" data-id=\"6e260e1\" 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><strong>Development and continuous improvement of the pharmacovigilance system<\/strong> is necessary since not all adverse reactions that can manifest during premarketing phase of development of the may be foreseen in the period before placing the medicine in question on the market. Reasons to it are as follows:<\/p><ul><li>Studies in animals cannot fully foresee safety of the medicine administered in humans.<\/li><li>Subjects who participate in clinical trials are selected, conditions for the administration of the medicine in clinical trials are different from those in common clinical practice, the duration of clinical trials is limited and a relatively small number of subjects is included.<\/li><li>Given that examined medicine is usually administered in less than 5000 patients prior to placing on the market, only adverse reactions that commonly occur may be noticed.<\/li><li>At least 30,000 patients should take the medicine to make sure that we have not failed to notice adverse reactions whose incidence is 1 in 10000 (very rare)<\/li><li>Information about rare adverse reactions, toxic effects of long-term use of the medicine, use in special patient groups (such as children, the elderly and pregnant women) or medicines interactions are either incomplete or unavailable. <\/li><\/ul>\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-c455ef2 elementor-widget elementor-widget-text-editor\" data-id=\"c455ef2\" 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>Post-marketing safety monitoring of the medicine is particularly important for the detection of serious adverse reactions whose incidence is low and for adverse reactions that occur after long-term medicine administration, or after a certain period of time.<\/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-5748ded elementor-widget elementor-widget-text-editor\" data-id=\"5748ded\" 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>Owing to the information from the post-marketing period of the lifecycle of the medicine (spontaneous reporting, clinical trials, relevant literature, scientific journals, registers, etc.) we obtain true picture of safety profile of a certain medicine.<\/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-51b6af3 elementor-widget elementor-widget-text-editor\" data-id=\"51b6af3\" 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>Based on collected information which are to be analyzed and assessed, the Institute, with the aim of protecting public health, may take certain measures prescribed by the Law on Medicines.<\/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-214c950 elementor-widget elementor-widget-image\" data-id=\"214c950\" 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 decoding=\"async\" width=\"630\" height=\"647\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Medicines-safety-cycle-eng.jpg\" class=\"attachment-medium_large size-medium_large wp-image-10361\" alt=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Medicines-safety-cycle-eng.jpg\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Medicines-safety-cycle-eng.jpg 630w, https:\/\/cinmed.me\/wp-content\/uploads\/2023\/03\/Medicines-safety-cycle-eng-292x300.jpg 292w\" sizes=\"(max-width: 630px) 100vw, 630px\" \/>\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-2bb6663 elementor-widget elementor-widget-text-editor\" data-id=\"2bb6663\" 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>More information about pharmacovigilance and CInMED activities with the aim of promoting this scientific discipline is available in the section <a href=\"https:\/\/cinmed.me\/publikacije\/\" target=\"_blank\" rel=\"noopener\"><u>Publications<\/u><\/a> and on our <a href=\"https:\/\/www.youtube.com\/@cinmed3571\/featured\" target=\"_blank\" rel=\"noopener\"><strong>YouTube<\/strong><\/a>\u00a0 channel<strong>.<\/strong><\/p><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/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<p>More information about the WHO Programme for international monitoring of safe use of medicines, which Montenegro has been a full member of since 2009, is available on the website of Uppsala Monitoring Centre in Sweden, independent organization that coordinates mentioned Programme: <a href=\"https:\/\/who-umc.org\/\">https:\/\/who-umc.org\/<\/a>.<\/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-e991f61\" data-id=\"e991f61\" 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-dcdb386 elementor-widget elementor-widget-shortcode\" data-id=\"dcdb386\" 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-f4f6c46 elementor-widget elementor-widget-text-editor\" data-id=\"f4f6c46\" 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<div class=\"relative pt-10 rounded bg-primary pb-72\">\n\t<h1 class=\"ml-10 text-4xl text-white \">Search <span class=\"font-bold\">register<\/span><\/h1>\n\t<div class=\"mt-8 \">\n\t\t<h3 class=\"mb-4 ml-10 text-secondary text-medium \">Here you can search for medicines in our register<\/h3>\n\t\t<div class=\"relative inline-block w-4\/5 ml-10 text-left\" style=\"width:80%\">\n\t\t\t<div>\n\t\t\t\t<select onchange=\"javascript:handleSelect(this)\" class=\"block h-[52px] text-[18px] text-light appearance-none w-full bg-white py-3 px-4 pr-8 rounded leading-tight focus:outline-none focus:bg-white focus:border-none\">\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\">Choose register<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-medicines-for-human-use\/\">Register of medicines for human use<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-veterinary-medicines\/\">Register of veterinary medicines<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/medical-devices\/register-of-medical-devices\/\">Register of medical devices<\/option>\n\t\t\t\t<\/select>\n\n\t\t\t\t<script type=\"text\/javascript\">\n\t\t\t\t\tfunction handleSelect(elm) {\n\t\t\t\t\t\twindow.location = elm.value;\n\t\t\t\t\t}\n\t\t\t\t<\/script>\n\t\t\t\t<img decoding=\"async\" style=\"top:22px;\" 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