The modern state and development trends of the normative legal adjusting in the sector of the quality assurance of medicinal products
The one of important factors of creation and effective functioning of the quality assurance system of medicinal products is the normative adjusting of the questions related to her through normative legal acts, harmonized with corresponding international and European documents.
Aim of work – the analysis of the modern state and development trends of normative legal and normative technical base of Ukraine in the sector of quality assurance of medicinal products.
Subjects: scientific publications, analytical materials, public information, normative legal acts, normative documents.
Methods: system overview, bibliographic, historical, logical, graphic modeling.
The subjects of legislative and normative activity in the sector of quality assurance of medicinal products are certain. The operating legislative acts and normative documents, regulative different aspects of quality assurance of medicinal products, are analysed.
It is shown that the modern process of development of national pharmaceutical sector is characterized by active introduction of international standards of the Good Practices. It will allow to create the system of quality assurance of medicinal products on all stages of their life cycle. The complex of the Good Practices of medicinal products, accepted and pre-arranged to the acceptance in Ukraine is analysed.
The prospects of development of normative legal and normative technical base in the sector of quality assurance of medicinal products in the conditions of reformation of pharmaceutical sector of health protection of Ukraine and his adaptation to the requirements of European Union are certain.
2. Aiben G.S. Principles of functioning of the quality system of subjects of pharmaceutical activity: Dis ... Cand. farm Sciences, specialty: 15.00.01 - technology of medicines, organization of pharmaceutical business and judicial pharmacy. - K .: MH Ukraine, National. honey. acad. postgraduate education them. P. L. Shupika, 2011. - 208 p.
3. Лебединець В.О., Kovalenko S.М., Taktaulova N.O. Regulation of document circulation in the quality management system of the pharmaceutical enterprise // Management, economics and quality assurance in pharmacy. - 2011. - No. 5 (19). - P. 15-21.
4. Lyapunov M. O., Solovyov O. S., Stetsiv VV and others. Standardization of pharmaceutical products is the basis of the pharmaceutical sector in Ukraine // Pharmacy. - 2012. - No. 825 (4). - Mode of access: http://www.apteka.ua/article/120227
5. Draft Concept of the program for the development and implementation of the standardization system for the circulation of medicines by 2015. - Mode of access: http://www.apteka.ua/article/59432
6. Public information of the Ministry of Health of Ukraine. - Mode of access: http://www.moz.gov.ua
7. The site of the "Legislation of Ukraine". - Mode of access: http://zakon4.rada.gov.ua
8. System for the standardization of drug circulation: the State Inspection of the Ministry of Health of Ukraine proposes a European way. - Mode of access: http://www.apteka.ua/article/59424
9. Solovyov O. S. System Strategy and tactics of the legislative process of pharmacy development in Ukraine / Zb. sciences works of co-workers. NMAPO named after P. L. Shupyk. - 2013. - Issue 22, Kn. 4. - p. 408-415.
10. Solovyov O. S., Ponomarenko MS, Klymenko IV, and others. Scientific and practical substantiation, development, improvement and prevention of violations of the foundations of sectoral law. Pharmacy / Ibid. - 2013. - Issue 22, Kn. 2. - K., 2013. - P. 546-557.
11. Lyapunov M., Bezugla O., Solovyov O. and others. Standardization of pharmaceutical products. - Kharkiv: Morion, 2012. - 728 c.
12. Ubozhov SG On the Problems of Regulatory and Regulatory Issues of Quality Issues of Medicines in the Conditions of European Integration of Ukraine / Zb. sciences works of co-workers. NMAPO named after P. L. Shupyk. - 2013. - Issue 22, Kn. 2. - P. 557-565.
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