{"id":7548,"date":"2022-11-14T00:38:29","date_gmt":"2022-11-14T00:38:29","guid":{"rendered":"https:\/\/cinmed.me\/o-cinmed-u\/strucna-misljenja-i-cpp\/"},"modified":"2023-06-14T10:34:43","modified_gmt":"2023-06-14T10:34:43","slug":"expert-opinions-and-cpp","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/about-cinmed\/expert-opinions-and-cpp\/","title":{"rendered":"Expert Opinions and CPP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7548\" class=\"elementor elementor-7548 elementor-914\" 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=\"1024\" height=\"684\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Strucnomisljenje-1200x849-1-1024x684.jpg\" class=\"attachment-large size-large wp-image-5516\" alt=\"Strucna misljenja CInMED\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Strucnomisljenje-1200x849-1-1024x684.jpg 1024w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Strucnomisljenje-1200x849-1-300x200.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Strucnomisljenje-1200x849-1-768x513.jpg 768w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Strucnomisljenje-1200x849-1.jpg 1058w\" 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>Institute for Medicines and Medical Devices has the authority to issue expert opinions within areas of its jurisdiction. For this purpose, Application form for the issuance of expert opinion within competences of the Institute for medicines and medical devices shall be submitted to the Institute. \u00a0<\/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-1d23717 elementor-widget elementor-widget-text-editor\" data-id=\"1d23717\" 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>Application for expert opinion may refer only to one of the areas listed on the form. In case that applicant intends to apply for expert opinion referring to more than one area, it is necessary to submit separate application form for each one. In case of more questions on a single application, only one of them will be answered.<\/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-19d00a9 elementor-widget elementor-widget-text-editor\" data-id=\"19d00a9\" 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>Institute has the competence in issuing expert opinion on classification of a product into a medicine or group of medicines. For this purpose, it is necessary to submit documentation in line with the instruction &#8211; Documentation required for issuance of expert opinion on classification of a product into a medicine or group of medicines.<\/p><p>\u00a0<\/p><p>Documentation shall be submitted and expert opinion on classification shall be issued for each product separately.<\/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-3f166ad elementor-widget elementor-widget-text-editor\" data-id=\"3f166ad\" 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>Application for issuance of expert opinion on the exemption from approved packaging shall be submitted to the Institute in accordance with the instruction &#8211; Documentation required for issuing expert opinion on the exemption from approved packaging.<\/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-db6bea1 elementor-widget elementor-widget-text-editor\" data-id=\"db6bea1\" 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>Application for issuance of the certificate for the purpose of export of medicines in line with WHO recommendations (Certificate of Pharmaceutical Product, CPP) shall be submitted on the Form for issuance of the Certificate of Pharmaceutical Product (CPP). This application shall be submitted to the Institute in accordance with the instruction &#8211; Manner of submitting application for issuance of the Certificate of Pharmaceutical Product (CPP certificate).<\/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-10f68ba elementor-widget elementor-widget-text-editor\" data-id=\"10f68ba\" 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>For the purpose of issuance of expert opinion on the classification of products as medical devices, it is necessary to submit an application in line with the instructions &#8211; Required documentation for issuance of expert opinion on classification of medical devices. One application for an expert opinion may be submitted for several medical devices if medical devices are manufactured by the same manufacturer and belong to the same class, or category.<\/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-ae34a96 elementor-widget elementor-widget-text-editor\" data-id=\"ae34a96\" 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>Instructions and Forms<\/strong><\/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-639a17f elementor-widget elementor-widget-text-editor\" data-id=\"639a17f\" 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=\"\/wp-content\/uploads\/2022\/11\/Obrazac_zahtjeva_za_izdavanje_strucnog_misljenja-1.docx\" target=\"_blank\" rel=\"noopener\">Application form for the issuance of expert opinion within competences of the Institute for medicines and medical devices<\/a><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/06\/Documentation-required-for-issuing-expert-opinion-on-the-exemption-from-approved-packaging.pdf\" target=\"_blank\" rel=\"noopener\">Documentation required for issuing expert opinion on the exemption from approved packaging<\/a><em> (updated 6.6.2023.)<\/em><\/li><li><a href=\"\/wp-content\/uploads\/2022\/11\/Za851.46-04-IMS-Obrazac-zahtjeva-za-izdavanje-sertifikata-o-farmaceutskom-proizvodu-CPP.docx\" target=\"_blank\" rel=\"noopener\">Application form for issuance of the Certificate of a Pharmaceutical Product (CPP certificate)<\/a><em> (updated 15.4.2022.)<\/em><\/li><li><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/06\/Manner-of-submitting-application-for-issuance-of-the-CPP-certificate.pdf\" target=\"_blank\" rel=\"noopener\">Manner of submitting application for issuance of the CPP certificate<\/a> <em>(updated 6.6.2023.)<\/em><\/li><li><u><a href=\"http:\/\/cinmed.me\/wp-content\/uploads\/2023\/02\/REQUIRED-DOCUMENTATION-FOR-ISSUANCE-OF-EXPERT-OPINION-ON-CLASSIFICATION-OF-MEDICAL-DEVICES.pdf\" target=\"_blank\" rel=\"noopener\">Required documentation for issuance of expert opinion on classification of medical devices <\/a> <\/u><em>(updated 25.1.2023.)<\/em><\/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-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-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<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;\" class=\"absolute right-[15px] top-[22px] \" src=\"\/wp-content\/uploads\/2022\/11\/strelca-copy-8.png\" \/>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-[30px] w-[380px]\" src=\"\/wp-content\/uploads\/2022\/11\/nele.png\" \/>\n<\/div>\n\n\n<div class=\"relative px-10 pt-10 mt-10 rounded pb-72 bg-light-yellow\">\n\t<div 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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\" \/>\n<\/div>\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>Institute for Medicines and Medical Devices has the authority to issue expert opinions within areas of its jurisdiction. For this purpose, Application form for the issuance of expert opinion within competences of the Institute for medicines and medical devices shall be submitted to the Institute. \u00a0 Application for expert opinion may refer only to one [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7540,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cinmed-template-custom.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-7548","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Expert Opinions and CPP - Cinmed<\/title>\n<meta name=\"description\" content=\"Expert Opinions and CPP expert opinion on the exemption from approved packaging Certificate of Pharmaceutical Product, CPP \u2022 Documentation required for issuing expert opinion on the exemption from approved packaging\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cinmed.me\/o-cinmed-u\/strucna-misljenja-i-cpp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Expert Opinions and CPP - 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