Organizational and legal regulation procedure for circulation of extemporal medicines based on pharmaceutical law

Authors

  • V.Jr. V. Shapovalov Kharkiv medical Academy of Postgraduate Education, https://orcid.org/0000-0002-9329-0195
  • S Zbrozhek Committee of the healthcare of the Verkhovna Rada of Ukraine,
  • V Shapovalova Kharkiv medical Academy of Postgraduate Education,
  • V V Shapovalov Department of Health Kharkiv Regional State Administration,

Keywords:

the legal procedure, circulation, extemporal medicines, pharmaceutical law.

Abstract

Introduction.The paper studied the situation regarding the production of medicines in pharmacies. Established that the presence of the pharmacy manufacture of medicines, patients entitled to receive medicines made to the needs of individuals. Goalto study the organizational and legal procedure of regulation of extemporal medicines by developing of the algorithm for determining the legal act used in the event of conflict based on the law pharmaceutical law. Materialsandmethods. The materials of the study were legal acts of Ukraine: Laws of Ukraine, Decrees of the Cabinet of Ministers of Ukraine, Orders of the Ministry of Healthcare of Ukraine. The research methods were legal, documentary and comparative analyzes.Results and discussion. However, production of extemporaneous preparations in the pharmacy requires a production base and the appropriate staff. Therefore, the authors based on pharmaceutical law proposed organizational and legal procedure regarding the regulation of extemporaneous preparations by developing the algorithm for determining the legal act which should follow in the event of conflicts concerning the law. Conclusions. Based on pharmaceutical law held organizational and legal procedure for the regulation of circulation of extemporal medicines. Proposed the algorithm for determining of the legal act used in the practice of pharmacy professionals. Considered the professional status of an authorized person on the stage of quality control of extemporal medicines in their treatment in healthcare institutions of private property.

References

Vasіna, Ju. V., Shapovalova, V. O., Shapovalov, V. V., Koval’ova, K. І. (26.01.15). Certificate of autoship 58295 (Ukraine). «Organіzacіjno-pravovі osnovi pripinennja farmacevtichnoї dіjal’nostі z obіgu ekstemporal’nih lіkars’kih zasobіv» (Ukraїna). 58715; derclared 27.11.14.

Vasіna, Ju. V. Pharmaceutical Law: historical aspects of the distribution of medicines for groups nomenklatura-law on the basis of the pharmaceutical legislation, court evidence-based pharmacy and pharmacy. Ukraїns’kij zhurnal klіnіchnoї ta laboratornoї medicini. 2010. 5, 2, 4–9.

Vasina, J. V., Shapovalov, V. V., Shapovalova, V. А., Kovalyova, K. I. The principles of the pharmaceutical law in solving problems of supplying patients with mental health problems with extemporal medicines. Research result. 2015, 1 (3), 18–29. Available at: http://rr.bsu.edu.ru/images/issue3/medicine/medicine.pdf.

Shapovalova, V. O., Shapovalov, V. V., Vasіna, Ju. V., Koval’ova, K. І. The composition and mode of control of extemporaneous preparations for the treatment of dermatological diseases: a newsletter on innovation. Ust.-rozrobn.: HMAPO MOZ Ukraїni, Ukrmedpatentіnform MOZ Ukraїni. K.: Ukrmedpatentіnform MOZ Ukraїni. 164–2015, 3, 4.

Shapovalov, V. V., Vasіna, Ju. V., Omel’chenko, V. O. Pharmaceutical Law of Ukraine: the distribution of medicines for groups nomenklatura legal. Zbіrnik naukovih prac’ spіvrobіtnikіv NMAPO іmenі P. L. Shupika. 2011. 20, 3, 419–423.

Vasіna, Ju. V. Pharmaceutical Law: determination control regime extemporal formulation comprising potent substances. Farmacevtichnij zhurnal. 2013. 2, 37–43.

Shapovalova V. V. ed. Pharmaceutical and medical law: a tutorial. 2011. Kharkіv , Skorpion, 208.

Shapovalov, V. V., Zbrozhek, S. І., Shapovalova, V. O., Vasіna, Ju. V. Features of the legal procedures for licensing of medical drugs in Ukraine and the EU: 2011. metod. rekom. Kiїv, 48.

Shapovalov, V. V. (Jr.), Vasina, Ju. V., Kovaleva, K. I., Shapovalova, V. A., Shapovalov, V. V. Combating trafficking in counterfeit medicines from pharmacy forensic positions based pharmaceutical law. Farmacija Kazahstana. 2016. 1 (176), 19–25.

Vasіna, Ju. V., Omel’chenko, V. O. Forensic Pharmacy: improvement of state control in the implementation extemporal recipe for solving the problem of combating the counterfeit drugs. Farmacevtichnij zhurnal. 2011. 2, 39–42.

Vasіna, Ju. V., Shapovalova, V. O., Shapovalov, V. V., Koval’ova, K. І. Pharmaceutical Law: study of turnover extemporaneous preparations at regional level. Farmakom. 2014. 4, 78–84.

Shapovalov, V. V., Shapovalova, V. A., Shapovalov, V. V. (Jr.), Vasina, Ju. V., Komar, L. A. Forensic study of pharmaceutical risks associated with the availability of the medication of the population and extemporaneous compounding. Nauchnye vedomosti Belgorodskogo gosudarstvennogo universiteta (Medicina. Farmacija). 2015.16 (213), 31, 210–218.

Vasіna, Ju. V., Shapovalov, V. V., Shapovalova, V. O., Hmelevs’kij, M. O. Forensic study of pharmaceutical violations handling controlled drugs in health facilities in rural areas]. Sbornik nauchnyh trudov Sworld. Ivanovo: Markova AD, 2015, 30, 3 (36), 59–70.

Vasіna, Ju. V. The standardization and organization of drug production, subject-quantitative account of extemporaneous preparations of different legal classification groups in health care. Ukraїns’kіj vіsnik psihonevrologії. 2013. 21, 2 (75), 18–21.

Shapovalova V. O., Shapovalov V. V. (Jr.), Shapovalov V. V., Vasіna Ju. V., Konєva V. Ju. (04.08.11). Certificate of authorship 39511, Ukraїna. Navchal’nij posіbnik «Legislation in pharmacy, forensic pharmacy and evidence-based pharmacy» (Ukraїna). 39779; declared. 31.05.11.

Downloads

Published

2019-12-23

How to Cite

Shapovalov, V. V., Zbrozhek, S., Shapovalova, V., & Shapovalov, V. V. (2019). Organizational and legal regulation procedure for circulation of extemporal medicines based on pharmaceutical law. Annals of Mechnikov’s Institute, (4), 33–37. Retrieved from https://journals.uran.ua/ami/article/view/188930

Issue

Section

Research Articles