ANALYSIS OF THE LEGISLATIVE AND REGULATORY FRAMEWORK GOVERNING THE CIRCULATION OF BLOOD PRODUCTS IN UKRAINE
Abstract
The relevancy of the issue is substantiated on the modern principles of the public regulation of circulation and use of blood products in Ukraine In particular, it was demonstrated that uninterrupted supply of the health care facilities with donor blood and qualitative, safe and efficient blood products nowadays in terms of armed stand-off is one of the primary state priorities and deal with national security of the country as a general matter. The analysis was conducted on the scientific researches of this topic, which had shown that in Ukraine, if any high relevance of this issue - the scientific researches are essentially unavailable in that regard. The analysis of the state policy and current state of the blood product circulation sphere in Ukraine testified that regardless of the obligations undertaken by Ukraine as for adaptation of the national legislation to one of the European Union in part of quality and security provision of the human origin substance, human tissues and cells, there is no any unified nationwide policy and coordinated system of blood preparation and haemotherapy. In its turn, it negatively affects the provision of population with qualitative, safe and efficient blood products in sufficient quantity. The legal and regulatory framework regulating the blood products circulation in Ukraine. The main issues were demonstrated, in particular: non-conformance of terms; in-coordination of the issues on state registration of the blood products; lack of the relevant standards of quality and quality and risk management system in the institutions of blood service, etc. The current legal norms were processed in the sphere of the blood product circulation on licensing the establishments and institutions of blood service; state registration of the blood products as pharmaceutical products; ensuring control for compliance to the security and quality indicators of the blood products; regarding introduction the quality and risk management system in the institutions of blood service as well as introduction of the good practises of GMP/GPP, GLP. The main in-conformities of the legal norms were specified, which negatively affect the provision of population with qualitative, safe and efficient blood products in sufficient number. The following conclusions have been made. The scientifically grounded areas were offered regarding the improvement of legislation and regulatory framework in the sphere of the blood products circulation in Ukraine.
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References
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