The normative legal adjusting in the sector of the quality assurance of medicinal products in Ukraine: retrospective analysis

  • N. A. Vetiutneva P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
  • S. G. Ubogov P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
  • T. N. Budnikova P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
  • L. B. Pilipchuk P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
  • L. A. Fedorova P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
  • V. I. Todorova P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
  • A. P. Radchenko P.L. Shupyk National Medical Academy of Post-Graduate Education, Kyiv
Keywords: medicinal products, quality assurance, normative legal base, eurointegration, harmonization

Abstract

The research on determination of priority ways of development of the system of the normative legal adjusting in the sector of the quality management of medicinal products is to one of actual and necessary tasks of pharmaceutical science.

Aim of work – the retrospective analysis of dynamics and features of development of normative legal base of Ukraine in the sector of the quality assurance of medicinal products.

Subjects: scientific publications, analytical materials, public information, normative legal acts, normative documents.

Methods: system overview, bibliographic, historical, logical, retrospective analysis, graphic modeling.

A dynamics, features of development and harmonization with the European and international legislation of normative legal base of Ukraine in the sector of the quality assurance of medicinal products in the period of 1991–2012 years is investigational.

A common amount, maintenance, application domains and annual dynamics of acceptance of normative legal acts and normative documents is analysed. Four stages of development of normative legal base of Ukraine in the sector of the quality assurance of medicinal products are distinguished. The peak of legislative activity (2001) is set. The legislative activity of different subjects in the sector of the quality assurance of medicinal products is analysed. The most (53 %) of normative legal acts and normative documents is entered by Ministry of Public Health of Ukraine. It is set that the process of updating and addition of normative legal base in the sector of the quality assurance of medicinal products is characterized by high rates, that it contingently deepening of her harmonization with the European and international legislation in accordance with strategy of eurointegration of Ukraine.

References

1. State Pharmacopoeia of Ukraine / State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicinal Products". - 1st kind. - Kharkov, 2001. - 556 p. (Supplement 1 - 2004 - 520 s; Supplement 2. - 2008 - 620 s; Supplement 3. - 2009 - 280 s. Supplement 4. - 2011. - 540 p.).
2. The Ethical Code of Pharmaceutical Workers of Ukraine, approved by the VII National Congress of Pharmacists of Ukraine on September 15-17, 2010.
3. Law of Ukraine "On Medicines" of 04.04.1996 № 123 / 96ВР (as amended).
4. Normative-policy documents of the Ministry of Health of Ukraine. - Mode of access: http://mozdocs.kiev.ua.
5. Normative Documents and Legislative Assurance of the Quality of Medicines in Ukraine: Collection of Legislative Acts / Ed. SV Garnaya. - Kharkiv - View of NFaU. - 2011. - 186 p.
6. The site "Legislation of Ukraine". - Mode of access: http://zakon4.rada.gov.ua.
7. Lyapunov M., Bezugla O., Solovyov O. and others. Standardization of pharmaceutical products. - Kharkiv: Morion, 2012. - 728 c.
8. Tovmasyan E.K. International cooperation of the Pharmacopoeia Center: history, routine and prospects // Farmakom. - 2012. - No. 1/2. - P. 18-24.
Published
2019-02-12
How to Cite
Vetiutneva, N. A., Ubogov, S. G., Budnikova, T. N., Pilipchuk, L. B., Fedorova, L. A., Todorova, V. I., & Radchenko, A. P. (2019). The normative legal adjusting in the sector of the quality assurance of medicinal products in Ukraine: retrospective analysis. Farmatsevtychnyi Zhurnal, (4), 9-18. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/382
Section
Management, marketing and logistics

Most read articles by the same author(s)