{"id":413,"date":"2019-11-03T20:52:13","date_gmt":"2019-11-03T18:52:13","guid":{"rendered":"http:\/\/cratia.com\/?post_type=countries&#038;p=413"},"modified":"2020-11-18T17:20:39","modified_gmt":"2020-11-18T15:20:39","slug":"farmakonadzor","status":"publish","type":"countries","link":"https:\/\/cratia.com\/en\/countries\/moldova\/farmakonadzor\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"<p><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The pharmacovigilance system in Moldova is organized taking into account the norms used in the international practice, namely, the Guidelines of the International Conference on Harmonization (ICH) and Directive of the Council of the European Economic Community on Pharmacovigilance No. 75\/319.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The Agency for medicinal products and medical devices is the competent authority of Moldova, overseeing adverse events, registration, systematization and analysis of data on adverse reactions.\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Information on adverse reactions\/effects of medicinal products is submitted to the Department of registration of medicinal products, clinical evaluation and pharmacovigilance by:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">doctors and pharmacists of all medical institutions of the Republic of Moldova, regardless of the form of ownership;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">manufacturers\/owners of the Registration Certificate or their authorized representatives;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">authorized international organizations (WHO: World Health Organization, EC: European Community, etc.);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">medical information sources and scientific publications;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">public organizations that represent the interests of consumers of medicinal products, as well as citizens;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Ethics Committees (during clinical trials of medicinal products);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">investigators of clinical sites involved in conducting clinical trials of medicinal products.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Marketing Authorization Holder must designate the Local Contact Person (LCP) responsible for pharmacovigilance in Moldova. The Application for registration or renewal is accompanied by the curriculum vitae of such authorized person.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">To change such authorized person, it will be required to submit the application for variations type IB.\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Manufacturers and MAHs of the medicinal products authorized for use in Moldova are required to provide the Pharmacovigilance department with information on any adverse event of the medicinal product, during the first 5 years after obtaining the Registration certificate.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The report on an unexpected serious adverse drug reaction registered in the territory of Moldova and other countries is submitted within 15 days from the receipt of the information.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">During the validity period of the Registration certificate of the medicinal product, the Holder should provide the Agency for medicinal products and medical devices with the periodic safety update reports (PSURs) for the registered medicinal product.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The Agency for medicinal products and medical devices may require inspection of the pharmacovigilance system of MAH or it\u2019s LCP.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><strong>Cratia provides professional services of establishment and maintenance of pharmacovigilance system in Moldova. We have an excellent knowledge of national legislation, necessary experience and resources.\u00a0<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: <a href=\"mailto:info@cratia.ua\">info@cratia.ua<\/a>, or visit <a href=\"\/en\/contacts\/\">our office<\/a>.\u00a0<\/span><\/p>","protected":false},"featured_media":0,"parent":145,"menu_order":2,"template":"","class_list":["post-413","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/413","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/countries"}],"up":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/145"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}