{"id":110408,"date":"2018-04-16T15:00:36","date_gmt":"2018-04-16T12:00:36","guid":{"rendered":"https:\/\/eba.com.ua\/?p=110408"},"modified":"2018-05-11T16:06:10","modified_gmt":"2018-05-11T13:06:10","slug":"onovleno-nastanovu-z-nalezhnoyi-praktyky-farmakonaglyadu","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/onovleno-nastanovu-z-nalezhnoyi-praktyky-farmakonaglyadu\/","title":{"rendered":"[:ua]\u041e\u043d\u043e\u0432\u043b\u0435\u043d\u043e \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0437 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u0444\u0430\u0440\u043c\u0430\u043a\u043e\u043d\u0430\u0433\u043b\u044f\u0434\u0443[:en]Good Pharmacovigilance Practice Guideline Updated[:]"},"content":{"rendered":"<p>In accordance with Order of the Ministry of Health of Ukraine of No. 620 as of April 5<sup>th<\/sup>, 2018, a new edition of the standard &#8220;Guideline. Medicines. Good Pharmacovigilance Practices &#8220;(hereinafter referred to as the &#8220;Guideline&#8221;) has been issued.<\/p>\n<p>The Guideline has been adopted based on the relevant guideline of the European Union \u201cGuideline on Good Pharmacovigilance Practices\u201d (hereinafter \u2013 GVP), which contains technical approaches to planning and carrying due pharmacovigilance practice. It has been developed based on the following modules:<\/p>\n<ul>\n<li>Module \u0406 \u2014 Pharmacovigilance and its quality system;<\/li>\n<li>Module \u0406\u0406 \u2014 Pharmacovigilance master file;<\/li>\n<li>Module \u0406\u0406\u0406 \u2014 Audit of the pharmacovigilance system of the applicant (registration certificate owner) which is carried by an authorized specialized expert institution in the area of pharmacovigilance;<\/li>\n<li>Module \u0406V \u2014 Pharmacovigilance audit;<\/li>\n<li>Module V \u2014 Risk management systems;<\/li>\n<li>Module VI \u2014 Management and reporting of side effects of medicines;<\/li>\n<li>Module VII \u2014Regularly updated security report;<\/li>\n<li>Module VI\u0406\u0406 \u2014 Post-registration security research;<\/li>\n<li>Module IX \u2014 Signal management;<\/li>\n<li>Module X \u2014 Additional monitoring;<\/li>\n<li>Module XV \u2014 Security communication process;<\/li>\n<li>Module XVI \u2014Risk minimization measures: selection of tools and effectiveness indicators.<\/li>\n<\/ul>\n<p>Part XII\u0406 \u2013 Special issues on drugs or population II: biological medicines.<\/p>\n<p>Moreover, additional structural elements such as \u201cPreface\u201d, \u201cNational Introduction\u201d, \u201cScope\u201d, \u201cNormative Links\u201d, \u201cTerms and Definitions\u201d, \u201cMarkings and Abbreviations\u201d, and \u201cBibliography\u201d are also included in the Guideline.<\/p>\n<p>Please pay attention that the Guideline, same as GVP of the European Union, has a status of a technical document to provide recommendations to applicants and owners of registration certificates, competent authorized bodies and other persons concerned with respect to the best and the most acceptable way of performing the legislation of Ukraine governing the pharmaceutical sphere.<\/p>\n<p>It is planned to review the Guideline regularly in line with the changes and amendments made to GVP of the European Union.<\/p>\n<p><i>Contact the author: Natalia Spivak, associate at Legal Alliance Company,\u00a0<\/i><a href=\"mailto:spivak@l-a.com.ua\"><i>spivak@l-a.com.ua<\/i><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>In accordance with Order of the Ministry of Health of Ukraine of No. 620 as of April 5th, 2018, a new edition of the standard &#8220;Guideline. Medicines. Good Pharmacovigilance Practices &#8220;(hereinafter referred to as the &#8220;Guideline&#8221;) has been issued. The Guideline has been adopted based on the relevant guideline of the European Union \u201cGuideline on [&hellip;]<\/p>\n","protected":false},"author":4489,"featured_media":110409,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[24,23],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Good Pharmacovigilance Practice Guideline Updated - European Business Association<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eba.com.ua\/onovleno-nastanovu-z-nalezhnoyi-praktyky-farmakonaglyadu\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Good Pharmacovigilance Practice Guideline Updated - European Business Association\" \/>\n<meta property=\"og:description\" content=\"In accordance with Order of the Ministry of Health of Ukraine of No. 620 as of April 5th, 2018, a new edition of the standard &#8220;Guideline. 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