Historical preconditions of the creation of pharmacovigilance system in
Journal Title: Фармацевтичний журнал - Year 2017, Vol 3, Issue 3
Abstract
The system of pharmacovigilance in the world appeared in response to series of tragedies related to the use of medicines. The largest of these were «sulfanilamide boom», «thalidomide tragedy» and «bomb with time mechanism». In Ukraine, the pharmacovigilance system has existed since 1996, and since 2002 Ukraine has been a member of the WHO international monitoring program for side effects. In 2000–2001 appeared the first orders of the Ministry of Health of Ukraine that regulated the implementation of pharmacovigilance in Ukraine, and in 2007, when the Order of the Ministry of Health of Ukraine № 898 came into force, the legislative framework in the pharmacovigilance system has been radically changed. This is connected with the reflection of the provisions of Directive 2001/83 / EC of the European Parliament and of the Council on the Community code relating to medicinal products in the order № 898. Today, the development of pharmacovigilance in Ukraine is carried out through adaptation to European legislation, which is stipulated by the Law of Ukraine «On the National Program of Adaptation of Ukrainian Legislation to the Law of the European Union».
Authors and Affiliations
N. V. Sholoiko, O. V. Matvieieva, K. S. Haiduk
Keywords
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- EP ID EP556042
- DOI 10.32352/0367-3057.3-4.17.01
- Views 86
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