Since 30.10.2017, the obligatory provision for applicants in drug registration and re-registration is to provide a Risk management plan (read more details in s\u0435ction Pharmacovigilance) and clinical data addenda (DCRA, see more details in section Drug clinical review addendum (DCRA). Nowadays, a 2-year transitional period is provided to applicants for preparation of the documents.
\nUp to 30.10.2017, all and any drug distributors and manufacturers in Ukraine should have a developed Pharmacovigilance system (master file), qualified person in Pharmacovigilance, Risk management plan on each of drug submitted for registration or re-registration. Periodic Safety Update Reports (PSUR). Our company provides all the service, see more details in section Pharmacovigilance.<\/p>\n","protected":false},"excerpt":{"rendered":"
Since 30.10.2017, the obligatory provision for applicants in drug registration and re-registration is to provide a Risk management plan (read more details in s\u0435ction Pharmacovigilance) and clinical data addenda (DCRA, see more details in section Drug clinical review addendum (DCRA). Nowadays, a 2-year transitional period is provided to applicants for preparation of the documents. Up \u0447\u0438\u0442\u0430\u0442\u044c \u0434\u0430\u043b\u044c\u0448\u0435…<\/a><\/p>\n","protected":false},"author":1,"featured_media":226,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[10],"tags":[],"class_list":["post-183","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"translation":{"provider":"WPGlobus","version":"3.0.0","language":"en","enabled_languages":["uk","ru","en"],"languages":{"uk":{"title":true,"content":true,"excerpt":false},"ru":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"acf":[],"_links":{"self":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/183","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/comments?post=183"}],"version-history":[{"count":11,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/183\/revisions"}],"predecessor-version":[{"id":505,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/posts\/183\/revisions\/505"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/media\/226"}],"wp:attachment":[{"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/media?parent=183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/categories?post=183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sertlicensing.com.ua\/en\/wp-json\/wp\/v2\/tags?post=183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}