Problems of legal regulation of the simplified registration of veterinary medicinal products in Ukraine

  • I. A. Berezovska Institute of International Relations of the Kyiv National Taras Shevchenko University, Kyiv, Ukraine
Keywords: European Union, veterinary medicinal products, harmonization of legislation, registration of veterinary medicines, simplified registration

Abstract

The article is devoted to the legal regulation study of simplified registration of veterinary medicinal products in the light of harmonization of Ukrainian legislation with EU legislation. It is noted that due to complexity of preparing a complete registration dossier, legislation of many countries, including EU countries have a number of possibilities for simplified registration of veterinary medicines by submitting a shortened list of registration dossier materials.

The analysis of the relevant EU legislation has been carried out, in particular the provisions of Directive 2001/82/EC of the European Parliament related to simplified registration of veterinary medicines. It is determined that the EU law provides for the possibility of incomplete dossier submission in cases of registration of generic or hybrid veterinary medicinal products, veterinary medicinal products with well-studied veterinary use, veterinary medicines with a fixed combination, and veterinary medicinal products, that are registered with informed consent.

It is noted that as a result of EU-Ukraine Association Agreement signing a new stage in the development of Ukrainian legislation regarding the turnover of veterinary medicinal products has begun, which is characterized by the increased impact of EU law on the legal regulation of this industry. It is proved that today legal regulation of simplified registration in Ukraine needs to be updated. Although Ukrainian system of veterinary medicinal products registration in general is similar to European system, level of legal regulation in EU is much higher.Further harmonization of veterinary legislation in Ukraine requires adoption of essential legal acts for regulation of veterinary medicines’ trade and improvement of existing institutional mechanisms. At the same time, a balance between high quality, efficiency and safety of products with guaranteed business opportunities for legal manufacturers of veterinary medicinal products must be established.

References

Barbara K. Immel A Brief History of the GMPs for Pharmaceuticals. Available at: https://www.scribd.com/document/358469747/A-Brief-History-of-GMP.

Uhoda pro asotsiatsiiu mizh Ukrainoiu ta Yevropeiskym Soiuzom i yoho derzhavamy-chlenamy // Ofitsiinyi visnyk Ukrainy vid 26.09.2014, № 75, tom 1, stor. 83, stattia 2125.

Berezovska I.A. Reformuvannia ukrainskoho zakonodavstva shchodo vyrobnytstva veterynarnykh preparativ u svitli asotsiatsii Ukrainy z YeS // Naukovo-tekhnichnyi biuleten Derzhavnoho naukovo-doslidnoho kontrolnoho instytutu veterynarnykh preparativ ta kormovykh dobavok i instytutu biolohii tvaryn – Lviv, 2017. – Vyp.18, №2, s.503 – 510.

Directive 2001/82 EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products // Official Journal L 311, 28.11.2001, p. 1–66.

Metodychni rekomendatsii «Suchasni pryntsypy otsinky ekvivalentnosti likarskykh zasobiv v Ukraini» 77.17/119.17. Kyiv, 2017 Available at: https://www.apteka.ua/article/431229

Rozporiadzhennia Kabinetu Ministriv Ukrainy vid 24 liutoho 2016 r. № 228-r «Pro skhvalennia Vseokhopliuiuchoi stratehii implementatsii Hlavy IV (Sanitarni ta fitosanitarni zakhody) Rozdilu IV “Torhivlia i pytannia, poviazani z torhivleiu” Uhody pro asotsiatsiiu mizh Ukrainoiu, z odniiei storony, ta Yevropeiskym Soiuzom, Yevropeiskym Spivtovarystvom z atomnoi enerhii i yikhnimy derzhavamy-chlenamy, z inshoi storony» // Uriadovyi kurier vid 06.04.2016 № 65.

Regulation (Eu) 2019/6 оf the European Parliament аnd of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC // Official Journal L/43 , 7.01.2019.

Zakon Ukrainy "Pro veterynarnu medytsynu" vid 25.06.1992 № 2498-XII // Holos Ukrainy ofitsiine vydannia vid 24.07.1992.

Postanova Kabinetu ministriv Ukrainy vid 21.11.2007 N 1349 «Pro zatverdzhennia polozhen pro derzhavnu reiestratsiiu veterynarnykh preparativ, kormovykh dobavok, premiksiv ta hotovykh kormiv» //Ofitsiinyi visnyk Ukrainy vid 03.12.2007 r., № 89, stor. 46, stattia 3273, kod akta 41573/2007.

Nakaz Derzhavnoho komitetu veterynarnoi medytsyny Ukrainy №133 vid 14.07.2008 roku «Pro zatverdzhennia form zaiav, pereliku materialiv reiestratsiinoho dosie ta poriadku yoho formuvannia» Ofitsiinyi visnyk Ukrainy vid 22.08.2008 r., № 60, stor. 50, stattia 2044, kod akta 43987/2008.

Published
2019-09-18
How to Cite
Berezovska, I. A. (2019). Problems of legal regulation of the simplified registration of veterinary medicinal products in Ukraine. Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology, 20(2), 417-425. https://doi.org/10.36359/scivp.2019-20-2.53