Twenty Years of The State Pharmacopoeia of Ukraine: The Experience of Establishing the First National Pharmacopoeia in The Post-Soviet Area
DOI:
https://doi.org/10.53933/sspmpm.v1i2.22Abstract
The 1st October, 2021 marks 20 years since the introduction of the State Pharmacopoeia of Ukraine. The purpose of the study was to experience of creating the first national pharmacopoeia in the post-Soviet space. Ukraine, the first in the post-Soviet space, managed to create its own State Pharmacopoeia, which is fully harmonized with the European Pharmacopoeia and takes into account national specifics. The State Pharmacopoeia of Ukraine relies on its own National system of Pharmacopoeial standard samples and Pharmacopoeial program of professional testing of control laboratories as feedback from users. The State Pharmacopoeia of Ukraine is not funded by the state, and the Pharmacopoeia Center is a completely self-supporting structure. In general, the State Pharmacopoeia of Ukraine can be considered the best National Pharmacopoeia in the post-Soviet space.
References
European pharmacopoeia: Quality standards for medicines // EUPATI, URL: https://toolbox.eupati.eu/resources/european-pharmacopoeia-quality-standards-for-medicines/.
International harmonisation //Council of Europe, 2021. URL: https://www.edqm.eu/en/international-harmonisation
Wiggins J. M., Albanese J. A. A Brief History of Pharmacopoeias: A Global Perspective //BioPharm, 15.09.2019. URL: https://www.biopharminternational.com/view/brief-history-pharmacopoeias-global-perspective-2.
USP 43-NF 38. Last Print Edition // USP-NF, 04.10.2019. URL: https://www.uspnf.com/notices/usp-nf-final-print-edition.
Ukaz Prezydenta Ukrainy vid 11.06.1998 r. N 615/98 (615/98) «Pro zatverdzhennia Stratehii intehratsii Ukrainy do Yevropeiskoho Soiuzu». URL: https://zakon.rada.gov.ua/laws/show.
Ukaz Prezydenta N 398/2015 398/2015 vid 07.07.2015 / Verkhovna Rada Ukrainy, 07.07.2015 URL: https://zakon.rada.gov.ua/laws/show/615/98#Text.
Nakaz Ministerstva okhorony zdorovia Ukrainy vid 12.03.2001 N 95 «Pro zatverdzhennia i vvedennia v diiu Derzhavnoi Farmakopei Ukrainy (1 vydannia)» // Verkhovna Rada Ukrainy, 12.03.2001 URL: https://zakon.rada.gov.ua/rada/show/v0095282-01#Text.
Zvit pro vykonannia Uhody pro asotsiatsiiu mizh Ukrainoiu ta YeS u 2018 rotsi //Uriadovyi ofis koordynatsii yevropeiskoi ta yevroatlantychnoi intehratsii za pidtrymky Predstavnytstva YeS v Ukraini ta proektu Association4U, shcho finansuietsia Yevropeiskym Soiuzom. Kyiv, 2019. 44 s. URL: https://www.kmu.gov.ua/storage/app/sites/1/55-GOEEI/AA_report_UA.pdf.
Zakon Ukrainy «Pro likarski zasoby» // Vidomosti Verkhovnoi Rady Ukrainy (VVR), 1996, № 22, st. 86 (Iz zminamy, vnesenymy zghidno iz Zakonamy – ostannii № 1668-IX vid 15.07.2021). URL: https://zakon.rada.gov.ua/
European Pharmacopoeia (Ph. Eur.). 10th Edition. // Council of Europe, 01.01.2021. URL: https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-10th-edition/
Postanovleniye Kabineta Ministrov 19.03.1997 g. №244 «O merakh po poetapnomu vnedreniyu v Ukraine trebovaniy direktiv Evropeyskogo Soyuza. sanitarnykh. ekologicheskikh. veterinarnykh. fitosanitarnykh norm i mezhdunarodnykh i evropeyskikh standartov» // Verkhovna Rada Ukraїni. 19.03.1997. URL: https://zakon.rada.gov.ua/laws/show/244-97-%D0%BF/conv#Text.
Direktiva №98/34/ES Evropeyskogo parlamenta i Soveta ES o protsedure predostavleniya informatsii v oblasti tekhnicheskikh standartov i reglamentov. a takzhe pravil okazaniya uslug v informatsionnom obshchestve //Lyuksemburg. 22.06.1998 (red. 20.11.2006). URL: https://zakon.rada.gov.ua/laws/show/994_b11#Text.
British Pharmacopoeia 2020 // Pharmacopoeia. 2020. URL: https://www.pharmacopoeia.com/downloads/bp/2020/
Dorofeyev V.L. Farmakopei raznykh stran: obzor standartov kachestva lekarstvennykh sredstv. Remedium. 2011. № 3. URL: https://www.clinvest.ru/jour/announcement/view/1331
Organizational and legal regulation procedure for circulation of extemporal medicines based on pharmaceutical law / V.V. Shapovalov, S.I. Zbrozhek, V.O. Shapovalova, V.V. Shapovalov. Annals of Mechnikov Institute. 2017. № 4. P. 33-37. URL: http://www.imiamn.org.ua/journal/4_2017/zmist4_2017.html DOI: 10.5281/zenodo.1133771.
Concerning the importance of forensic and pharmaceutical researches to improve patients’ accessibility to medicines / V. Shapovalov (Jr.), А. Gudzenko, L. Komar, et al. Pharmacia. 2017. Vol. 65. N.2. P. 23–29.
Forensic pharmacy: some risk factors in the formation of addictive health disorders / V. A. Shapovalova, S. I. Zbrozhek, V. V. Shapovalov, V. V. Shapovalov. Acta Scientific Pharmaceutical Science. 2021. Vol. 4. Iss. 1. P. 7 – 12. DOI: 10.3180 / ASPS.2020.05.0651
Shapovalova V.O., Zbrozhek S.I., Shapovalov V.V., Shapovalov V.V. Sudovo-farmatsevtychni doslidzhennia prychynno-naslidkovykh zviazkiv mizh sotsialnymy ta medychnymy faktoramy ryzyku pry formuvanni adyktyvnykh rozladiv zdorovia. Zdorovia suspilstva. 2020. T. 9. № 6. S. 236 – 242. DOI: https://doi.org/10.22141/2306-2436.9.6.2020.226954. DOI: https://doi.org/10.22141/2306-2436.9.6.2020.226954
Organizational and legal analysis of the pharmaceutical provision for the most common diseases of society / V. Shapovalov (Jr.), S. Zbrozhek, A. Gudzenko, V. Shapovalova, V. Shapovalov. International Journal of Pharmaceutical Sciences Review and Research. 2018. Vol. 51. N. 1. P. 118-124.
Mizhnarodni standarty upravlinnia yakosti yak osnova dlia zapobihannia rozpovsiudzhennia neiakisnoi ta falsyfikovanoi produktsii: navchalno-metodychnyi posibnyk dlia samostiinoi roboty / V.V. Shapovalov, L.O. Komar – Kharkiv: KhMAPO, 2016. – 90 s.
Avtorske pravo № 69375, Ukraina. Orhanizatsiia kontroliu yakosti likarskykh zasobiv : navch.-metod. posibn. / V.O. Shapovalova, V.V. Shapovalov, Yu.V. Vasina, S.I. Zbrozhek (Ukraina). - №70018; zaiavl. 26.10.2016 ; opubl. 22.12.16.
Legislation in pharmacy, forensic pharmacy and evidence-based pharmacy: Study book (series: Pharmaceutical law) / V.A. Shapovalova, V.V. Shapovalov (Jr.), V.V. Shapovalov, et al. [3-rd ed.]. Kharkiv, 2011. 160 p.
Farmatsevtychne pravo: navch. posib. / V.O. Shapovalova, V.V. Shapovalov, V.V. Shapovalov (mol.), et al. [Elektronnyi resurs]: interakt. pidruch. [3-ye vyd.]. Kh., 2011. 1 elektron. optyk. dysk (CD-ROM). – System. vymohy: Windows XP, Vista, 7, Mac OS X, Ubuntu, 512 Mb RAM, CD-ROM. – Nazva z tytul. ekranu.
Farmatsevtychne zakonodavstvo: navch. posib. z hryfom MON Ukrainy (seriia: Farmatsevtychne pravo) / V.O. Shapovalova, V.V. Shapovalov, V.V. Shapovalov (ml.), et al. [2-e vyd.]. Kharkiv, 2010. 142 s.
Slobozhansky chytannya. Medical and pharmaceutical law of Ukraine: materials of the XIII International scientific and practical conference. Kharkiv, Ukraine, 17-18 November 2016. Eds. V.O. Shapovalova, V.V. Shapovalov, V.V. Shapovalov, A.O. Osyntseva. 200 p.
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