{"id":349,"date":"2019-11-03T16:41:47","date_gmt":"2019-11-03T14:41:47","guid":{"rendered":"http:\/\/cratia.com\/?post_type=countries&#038;p=349"},"modified":"2023-04-27T15:23:28","modified_gmt":"2023-04-27T12:23:28","slug":"pharmacovigilance","status":"publish","type":"countries","link":"https:\/\/cratia.com\/en\/countries\/azerbajdzhan\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"<p><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The pharmacovigilance system is actively developing.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The competent authority responsible for monitoring adverse events is the Analytical Expertise Center (AEC) of the Ministry of Health of the Republic of Azerbaijan.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">To date, the Applicant is not required by law to appoint a local person responsible for pharmacovigilance in Azerbaijan. However, certain requirements for safety monitoring and submission of information about adverse reactions to medicinal products are being put forward.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">National legislation establishes the following cases of reporting:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">all adverse reactions to new medicinal products (medicinal products are considered as new within 5 years after their registration);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">all unexpected adverse reactions;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">all serious adverse reactions;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">undesirable effects of drug interactions;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">unexpected therapeutic effects (previously unknown);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">results of observations in which there is clear evidence that the medicinal product causes adverse reactions (for example, the similar reaction to the repeated administration of the medicinal product);<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">laboratory abnormalities, the consequences of an overdose (accidental or intentional).<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">National legislation provides for different deadlines for reporting depending on the nature and characteristics of the adverse event. For example, information about all serious and unexpected adverse effects of the medicinal product should be sent to the ACE as soon as possible, but not later than 3 days.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><b>Cratia provides professional services on the establishment and maintenance of pharmacovigilance in Azerbaijan. We have an excellent knowledge of national legislation, necessary experience and resources.\u00a0<\/b><\/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":122,"menu_order":2,"template":"","class_list":["post-349","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/349","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\/122"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}