Some aspects of analysis of the Ukrainian legislation regulating the production of veterinary medicines

Authors

DOI:

https://doi.org/10.14739/2409-2932.2021.2.233932

Keywords:

legislation, veterinary drugs, licensing, production

Abstract

The aim of the work was to study the current state of domestic legislation of state regulation in the field of licensing the activities of business entities manufacturing veterinary medicinal products and its harmonization with the requirements of the European Union.

Materials and methods. The research materials were regulatory and legislative acts, regulations and principles of the state policy of Ukraine connected with licensing the activities of business entities manufacturing veterinary medicinal products, in force from 2015 to the present. To carry out this study, the methods of information retrieval, systematization, analytics, graphic, comparison, and data generalization were used.

Results. The article presents the main results of the analysis of the Ukrainian legislation which regulates the production of veterinary medicines and preparations. According to the results of the analysis, it was found that in the period from 2015 to 2018, Ukrainian manufacturers of veterinary medicinal products worked in such conditions that did not require a license for this type of activity. By the decree of the President of Ukraine, the program of sustainable strategic development of the country “Ukraine-2020” was approved which provided for reforms in the format of deregulation and the development of entrepreneurship and excluded the necessity of licenses for veterinary drugs production.

Conclusions. Based on the study, it can be concluded that the Law of Ukraine “On Licensing of Types of Economic Activities” dated March 3, 2015 No. 222-VIII was actually aimed at reducing the governmental influence and regulatory pressure on the activities of business entities involved in the production of veterinary medicinal preparations.

Author Biographies

I. V. Bushuieva, Zaporizhzhia State Medical University, Ukraine

PhD, DSc, Professor, Head of the Department of Management and Economics of Pharmacy and Pharmaceutical Technology

K. V. Petrova, Bogomolets National Medical University, Kyiv, Ukraine

PhD student of the Department of Pharmacy and Industrial Technology of Drugs

Zh. M. Polova, Bogomolets National Medical University, Kyiv, Ukraine

PhD, DSc, Professor, Head of the Department of Pharmacy and Industrial Technology of Drugs

References

Verkhovna Rada of Ukraine. (2014, November 27). Uhoda pro Koalitsiiu deputatskykh fraktsii "Yevropeiska Ukraina" [Agreement on the Coalition of European Ukraine parliamentary factions]. http://zakon4.rada.gov.ua/laws/show/n0001001-15

Cabinet of Ministers of Ukraine. (2014, December 24). Deiaki pytannia Derzhavnoi rehuliatornoi sluzhby Ukrainy. Postanova Kabinetu Ministriv Ukrayiny vid 24.12.2014 r. No.724 [Some issues of the State Regulatory Service of Ukraine (No.724)]. http://zakon4.rada.gov.ua/laws/show/724-2014-%D0%BF

Verkhovna Rada of Ukraine. (2015, January 12). Pro Stratehiiu staloho rozvytku "Ukraina – 2020". Ukaz Prezydenta Ukrayiny vid 12.01.2015 r. No. 5/2015 [About the Sustainable Development Strategy "Ukraine - 2020" (No. 5/2015)]. http://zakon4.rada.gov.ua/laws/show/5/2015

Verkhovna Rada of Ukraine. (2015, March 2). Pro litsenzuvannia vydiv hospodarskoi diialnosti. Zakon Ukrayiny vid 02.03.2015 No. 222-VIII [On Licensing of Types of Economic Activity (No. 222-VIII)]. https://zakon.rada.gov.ua/laws/show/222-19?lang=en#Text

Verkhovna Rada of Ukraine. (2000, June 1). Pro litsenzuvannia pevnykh vydiv hospodarskoi diialnosti. Zakon Ukrayiny vid 01.06.2000 No. 1775-III [On Licensing of Certain Types of Economic Activity (No. 1775-III)]. http://zakon4.rada.gov.ua/laws/show/1775-14

Kostin, I., Modlenko, N. (2016, August 15). Evropeiskie normy registratsii lekarstvennykh sredstv. Dva puti dlya Ukrainy [European standards for registration of drugs]. Evropeiskaya Pravda. https://www.legalalliance.com.ua/rus/publikacii/evropejskie-normy-registracii-lekarstvennyh-sredstv-dva-puti-dla-ukrainy/

Polyakova D. (2009). Farmakonadzor v Ukraine: novyi etap razvitiya [Pharmacovigilance in Ukraine: a new stage of development]. Apteka online, (50). https://www.apteka.ua/article/22238

Ministry of Agrarian Policy and Food. (2017, November 10). Pro zatverdzhennia Polozhennia pro osnovni vymohy do vyrobnytstva veterynarnykh preparativ ta Pravyl nalezhnoi vyrobnychoi praktyky veterynarnykh preparative [On approval of the Regulations on the basic requirements for the production of veterinary drugs and the Rules of good manufacturing practice of veterinary drugs (No. 606)]. https://zakon.rada.gov.ua/laws/show/z0106-18?lang=en#Text

(2018, February 19). Ukraina sdelala shag k sozdaniyu zakonodatel'noi bazy dlya proizvodstva vetpreparatov [Ukraine has taken a step towards creating a legal framework for the production of veterinary drugs]. AgroPortal. http://agroportal.ua/news/ukraina/ukraina-sdelala-shag-k-sozdaniyu-zakonodatelnoi-bazy-dlya-proizvodstva-vetpreparatov/

Cabinet of Ministers of Ukraine. (2018, October 3). Pro zatverdzhennia Litsenziinykh umov provadzhennia hospodarskoi diialnosti z vyrobnytstva veterynarnykh preparativ [About the statement of Licensing conditions of carrying out economic activity on production of veterinary drugs (No. 808)]. https://zakon.rada.gov.ua/laws/show/808-2018-%D0%BF?lang=en#Text

Published

2021-06-01

How to Cite

1.
Bushuieva IV, Petrova KV, Polova ZM. Some aspects of analysis of the Ukrainian legislation regulating the production of veterinary medicines . Current issues in pharmacy and medicine: science and practice [Internet]. 2021Jun.1 [cited 2024Nov.23];14(2):245-50. Available from: http://pharmed.zsmu.edu.ua/article/view/233932

Issue

Section

Original research