Investigation of organizational and normative regulations of pharmaceutical quality control abroad

  • V.M. Tolochko -
  • I.V. Shishkina -
  • Y.P. Medvedyeva -
  • A.V. Kaidalova -
Keywords: medicines, quality control, organizational and normative regulations

Abstract

The international experience in regulatory policy for monitoring of drug quality has been studied. The followed analysis of the normative and legislative base of the pharmaceutical activity of the European Union countries and some other developed countries of the world displayed clear systematization of requirements complex, taking into account the vertical and horizontal administration.

It has been established, that international experience can be used for the national pharmaceutical quality control system.

References

1. Gerasimchuk T. // Medicines of Ukraine. - 2001. - № 11. - P. 12-13.
2. AV Govorkov // Post-vaccination reactions and complications. - 2000. - № 4 (10). - mode of access to information: http://medi.ru/doc/15bl003.htm
3. Legislation of Ukraine on Health // Ministry of Health of Ukraine. - Unicom Inter, 2000. - 526 p.
4. Health and enlargement of the European Union. European Observatory on Health Systems and Policies: Open University Press, 2004, 292 p.
5. Koristov IL Pharmaceutical business in the EU: distinctive features and characteristics [Electronic resource]. - mode of access to information: http://www.lawmix.ru
6. Ukraine. Cabinet of Ministers of Ukraine. Some issues of public administration in the field of quality control of medicines. Resolution No. 1121 of 20.12.2008 // Pharmacy audit. - 2009. - № 2. - P. 11-15.
7. Ukraine. Cabinet of Ministers of Ukraine. Issues of state quality control of medicinal products. Resolution No. 837 of 10.09.2008 // Legal aspects of pharmacy. - 2008. - № 17. - P. 5-11.
8. RU Habriev, SV Kopachevskaya Pharmaceutical activity in foreign countries [Electronic resource]. Information access mode: - http://www.rusvrach.ru/articles/farm-2-2007str38-40
9. Arzneimittelrech und Grundlegende Dokumente [Online resource]. - information access mode: - http://www.zlg.de/
10. Arzneimittelgesetz (Österreich) [Online resource]. - information access mode: - http: // de.wikipedia.org/wiki/ Arzneimittelgesetz_ (Osterreich)
11. Das deutsche Arzneimittelgesetz [Online resource]. - Information access mode: - http: II de.wikipedia.org/wiki/ Arzneimittelgesets_ (Deutschland)
12. Das Gesetzgebung [Electronic resource]. - information access mode: - http: //www.admini. ch / index.html? lang = de
13. How to develop and implement a national drug policy. - Geneva: World Health Organization, 2001. - 84 p.
14. Pharmaceutical quality. - DHI Publishing, 2004. - 758 p.
15. Regulating pharmaceuticals in Europe: driving for efficiency, equity and quality. - Open University Press, 2004. - 395 p.
16. Schweizerisches Heilmittelinstitut [Electronic resource]. - information access mode: - http: //www.swissmedic.ch/
17. www.agenziafarmaco.it
18. www.dari.kz/index.php?lang=rus&uin=l 187780987 & id = l 222266703
19. www.dslz.gov.ua/files/normdocs/PIC_EMEAE_ ICH.doc
Published
2020-07-09
How to Cite
Tolochko, V., Shishkina, I., Medvedyeva, Y., & Kaidalova, A. (2020). Investigation of organizational and normative regulations of pharmaceutical quality control abroad. Farmatsevtychnyi Zhurnal, (6), 44-49. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/893
Section
Issues of quality control of medicines abroad