General information

March 13, 2019

Legislation of Ukraine on the above mentioned issues:

 

1. Law of Ukraine «On Medicines»

http://zakon3.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80

 

2. Law of Ukraine «The Fundamentals of Legislation on Health Care»

http://zakon5.rada.gov.ua/laws/show/2801-12

 

3. Law of Ukraine «Licensing of Different Types of Economic Activities»

http://zakon5.rada.gov.ua/laws/show/222-19

 

4. Law of Ukraine «Basic Principles of State Supervision (Control) of Economic Activities»

http://zakon3.rada.gov.ua/laws/show/877-16

 

5. Resolution of the Cabinet of Ministers of Ukraine of August 5, 2015 No. 609 «On Approval of the List of the state licensing authorities and Recognition of some invalid Decisions of the Cabinet of Ministers of Ukraine»

https://zakon.rada.gov.ua/laws/show/609-2015-%D0%BF?lang=en

 

6. Resolution of the Cabinet of Ministers of Ukraine of September 10, 2008 No. 843 «On Approval of the Criterion for Assessing the Risk of Activities in the Health Care for the Safety of Life and Health of the Population and Determining the Periodicity of Implementation of Planned Measures of State Supervision (Control)»

https://zakon.rada.gov.ua/laws/show/843-2008-%D0%BF?lang=en

 

7. Resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 «On approval of Licensing conditions for conducting economic activities for the production of medicinal products, wholesale and retail trade in medicinal products, import of medicines (except for active pharmaceutical ingredients)»

https://zakon.rada.gov.ua/laws/show/929-2016-%D0%BF/paran12?lang=en

 

8. Order of the Ministry of Health of Ukraine of December 27, 2012 No. 1130 «Procedure for conducting confirmation of conformity of manufacturing conditions with good manufacturing practice requirements», registered by the Ministry of Justice of Ukraine on January 21, 2013 No.133/22665

https://zakon.rada.gov.ua/laws/show/z0133-13/ed20121227?lang=en

 

9. Order of the Ministry of Health of Ukraine of December 07, 2012 No.1008 «On Approval of the Procedure for Quality Certification of Medicinal Products for International Trade and Validation for Active Pharmaceutical Ingredients Exported»

https://zakon.rada.gov.ua/laws/show/z2218-12?lang=en

 

10. ST-N МОHU 42-4.0:2016 «Guideline. Medicines. Good manufacturing practice»

http://dls.gov.ua/wp-content/uploads/2018/10/GMP-1_2016.pdf

 

11. 42-01:2003 «Guideline. Medicines. Technological process. Documentation»

https://zakon.rada.gov.ua/rada/show/v0107282-03/sp:max100?sp=:max100&lang=en

 

12. ST-N МОHU 42-4.1:2011 «Guideline. Dossier of manufacturing site»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%94%D0%BE%D1%81%D1%8C%D0%B5-%D0%92%D0%94.pdf

 

13. ST-N МОHU 42-3.0:2011 «Guideline. Pharmaceutical Development»

 

14. ST-N МОHU 42-4.2:2011 «Guideline. Risk Management for Quality»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%A3%D0%BF%D1%80%D0%B0%D0%B2%D0%BB%D1%96%D0%BD%D0%BD%D1%8F-%D1%80%D0%B8%D0%B7%D0%B8%D0%BA%D0%B0%D0%BC%D0%B8-ICH-Q9.pdf

 

15. ST-N МОHU 42-4.3:2011 «Guideline. Pharmaceutical Quality System»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%A4%D0%B0%D1%80%D0%BC%D0%B0%D1%86%D0%B5%D0%B2%D1%82%D0%B8%D1%87%D0%BD%D0%B0-%D1%81%D0%B8%D1%81%D1%82%D0%B5%D0%BC%D0%B0-%D1%8F%D0%BA%D0%BE%D1%81%D1%82%D1%96.pdf

 

16. ST-N МОHU 42-4.4:2011 «Guideline. International Harmonized Certification Requirements Series»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%9C%D1%96%D0%B6%D0%BD%D0%B0%D1%80%D0%BE%D0%B4%D0%BD%D1%96.pdf

 

17. ST-N МОHU 42-5.1:2011 «Guideline. Good storage practice»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97%D0%9D%D0%9F%D0%97.pdf

 

18. ST-N МОHU 42-4.5:2012 «Guideline. Good practice of cultivating and harvesting raw materials of plant origin»

https://zakon.rada.gov.ua/rada/show/v0118282-13?lang=en

 

19. ST-N МОHU 42-3.7:2013 «Guideline. Quality of water for use in pharmacy»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%AF%D0%BA%D1%96%D1%81%D1%82%D1%8C-%D0%B2%D0%BE%D0%B4%D0%B8.pdf

 

20. ST-N МОHU 42-3.8:2013 «Guideline. Medicines. Pharmaceutical quality of medicines for inhalation and nasal preparations»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%A4%D0%B0%D1%80%D0%BC%D1%8F%D0%BA%D1%96%D1%81%D1%82%D1%8C.pdf

 

21. ST-N МОHU 42-4.6:2016 «Medicines. Some provisions regarding active substances exported to Ukraine for the manufacture of medicinal products»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%94%D0%B5%D1%8F%D0%BA%D1%96-%D0%BF%D0%BE%D0%BB%D0%BE%D0%B6%D0%B5%D0%BD%D0%BD%D1%8F.pdf

 

22. ST-N МОHU 42-4.7:2016 «Medicines. Establishing the boundaries of health effects for use in identifying risk in the case of the production of various medicinal products through technical means of general use»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%9C%D0%B5%D0%B6%D1%96-%D0%B2%D0%BF%D0%BB%D0%B8%D0%B2%D1%83.pdf

 

23. ST-N МОHU 42-4.8:2016 «Medicines. Formalized general risk assessment to establish appropriate manufacturing practices for auxiliary substances used in human medicines»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%9E%D1%86%D1%96%D0%BD%D1%8E%D0%B2%D0%B0%D0%BD%D0%BD%D1%8F-%D1%80%D0%B8%D0%B7%D0%B8%D0%BA%D1%96%D0%B2.pdf

 

24. ST-N МОHU 42-3.5:2016 «Medicines. Validation of processes»

http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97-%D0%92%D0%B0%D0%BB%D1%96%D0%B4%D0%B0%D1%86%D1%96%D1%8F-%D0%BF%D1%80%D0%BE%D1%86%D0%B5%D1%81%D1%96%D0%B2.pdf