{"id":550,"date":"2019-11-24T22:19:09","date_gmt":"2019-11-24T20:19:09","guid":{"rendered":"http:\/\/cratia.com\/?post_type=countries&#038;p=550"},"modified":"2020-11-18T17:27:33","modified_gmt":"2020-11-18T15:27:33","slug":"farmakonadzor","status":"publish","type":"countries","link":"https:\/\/cratia.com\/en\/countries\/turkmenistan\/farmakonadzor\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"<p><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The legislation of Turkmenistan on pharmacovigilance is being established. The draft Order for Monitoring the Safety of Medicinal Products has been developed, but not officially approved.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The competent authority of the pharmacovigilance system is the Ministry of Health and Medical Industry of Turkmenistan.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">At the legislative level, the Applicant (Marketing Authorization Holder) is not required to establish and maintain a pharmacovigilance system, to appoint an authorized person responsible for pharmacovigilance.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Requirements for the submission of the periodic safety update report (summarized data on the adverse effects of the medicinal product \u2013 PSUR):<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Once every 6 months \u2013 within 2 years after receiving a Marketing Authorization;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Annually over the next 3 years;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Subsequently \u2013 once every 5 years (in case of re-registration of the product).<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><strong>Cratia provides professional services on the establishment and maintenance of pharmacovigilance in Turkmenistan. We have an excellent knowledge of national legislation, necessary experience and resources.<\/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":121,"menu_order":2,"template":"","class_list":["post-550","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/550","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\/121"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=550"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}