General information

March 13, 2019

Legislation of Ukraine on the above mentioned issues:

 

1. Law of Ukraine “Licensing of Different Types of Economic Activities”

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

 

2. Law of Ukraine “On Medicines”

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

 

3. Law of Ukraine “Basic Principles of State Supervision (Control) of Economic Activities”

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

 

4. Law of Ukraine “The Fundamentals of Legislation on Health Care”

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

 

5. Law of Ukraine “On Fundamentals of Social Protection of Disabled Persons in Ukraine”

http://zakon3.rada.gov.ua/laws/show/875-12

 

6. Law of Ukraine “On the Defense of Ukraine”

http://zakon3.rada.gov.ua/laws/show/1932-12

 

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. Resolution of the Cabinet of Ministers of Ukraine of September 14, 2005 No. 902 “On Approval of the Procedure for the State Control of the Quality of Medicinal Products Imported to Ukraine”

http://zakon3.rada.gov.ua/laws/show/902-2005-%D0%BF

 

9. Order of the Ministry of Health of Ukraine of September 29, 2014 No.677 “On Approval of the Procedure for Quality Control of Medicinal Products during Wholesale and Retail Trade”, registered by the Ministry of Justice of Ukraine of November 26, 2014 No. 1515/26292

http://zakon5.rada.gov.ua/laws/show/z1515-14

 

10. Order of the Ministry of Health of Ukraine of July 6, 2012 No. 498 “On Approval of the List of Goods Which Have the Right to Acquire and Sell Pharmacy Institutions and Their Structural Divisions”

http://zakon5.rada.gov.ua/laws/show/z1231-12

 

11. Order of the Ministry of Health of Ukraine of October 1, 2014 No. 698 “On Approval of the Procedure to Control the Compatibility of Immunobiological Preparations, Applied in Medical Practices, with the Requirements of the National and International Standards”, registered by the Ministry of Justice of Ukraine of October 29, 2014 No. 1356/26133

http://zakon2.rada.gov.ua/laws/show/z1356 -14

 

12. Order of the Ministry of Health of Ukraine of July 19, 2005 No. 360 “On approval of the Rules for prescribing for medical products, the Procedure for the dispatch of medicinal products and medical products from pharmacies and their structural units, Instructions on the order of storage, registration and destruction of prescription forms”, with amendments and additions

http://zakon5.rada.gov.ua/laws/show/z0782-05

 

13. Order of the Ministry of Health of Ukraine of April 24, 2015, No. 242 “On Approval of the Rules for Utilization and Destruction of Medicinal Products”

http://zakon2.rada.gov.ua/laws/show/z0550-15

 

14. Order of the Ministry of Health of Ukraine of May 15, 2006 No.275 “On Approval of Instructions on Sanitary-Epidemiological mode of Pharmacy Establishments”

http://zakon0.rada.gov.ua/laws/show/z0642-06

 

15. Order of the Ministry of Health of Ukraine of October 17, 2012 No. 812 “On Approval of the Rules of Production (Manufacturing) and Quality Control of medicines in Pharmacies”

http://zakon2.rada.gov.ua/laws/show/z1846-12

 

16. Order of the Ministry of Health of Ukraine of December 12, 2006 No. 818 “On Improving Certification of Pharmacists” 

https://zakon.rada.gov.ua/laws/show/z1366-06?lang=en

 

17. Order of the Ministry of Health of Ukraine of October 28, 2002 No. 385 “On Approval of Lists of Health Care Institutions, medical, pharmacist positions and positions of junior specialists in pharmaceutical education in Health Care Institutions”

http://zakon2.rada.gov.ua/laws/show/z0892-02

 

18. СТ-Н МОЗУ 42-4.0:2016 “Guideline. Medicinal products. Good manufacturing practice”

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

 

19. СТ-Н МОЗУ 42-5.0:2014 “Guideline. Medicinal products. Good distribution practice”

 

20. СТ-Н МОЗУ 42-5.1:2011 “Guideline. Medicinal products. Good storage practice”