General information

May 28, 2019

List of normative legal acts, the compliance of which requirements are verified during the implementation of measures of state supervision (control), and other regulatory acts in the field of state supervision (control)

 

1. Law of Ukraine “On Medicines”

https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80?lang=en

 

2. Law of Ukraine “Fundamentals of the Legislation of Ukraine on Health Care”

https://zakon.rada.gov.ua/laws/show/2801-12?lang=en

 

3. Law of Ukraine “On the Main Principles of State Supervision (Oversight) in the Area of Commercial Activity”

https://zakon.rada.gov.ua/laws/show/877-16?lang=en

 

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

https://zakon.rada.gov.ua/laws/show/222-19?lang=en

 

5. Law of Ukraine “On the Fundamentals of Social Security of the Disabled in Ukraine”

https://zakon.rada.gov.ua/laws/show/875-12?lang=en

 

6. 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

 

7. Resolution of the Cabinet of Ministers of Ukraine of February 3, 2010 No. 260 “Some Issues of State Quality Control of Medicinal Products”

https://zakon3.rada.gov.ua/laws/show/260-2010-%D0%BF?lang=en

 

8. Resolution of the Cabinet of Ministers of Ukraine of October 31, 2007, No. 1280 “On Approval of the Procedure for Sampling for the Determination of Its Quality Indicators and the Form of a Sample Product Sample”

https://zakon3.rada.gov.ua/laws/show/1280-2007-%D0%BF?lang=en

 

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

https://zakon.rada.gov.ua/laws/show/z1515-14?lang=en

 

10. Order of the Ministry of Health of Ukraine of October 17, 2012 No. 812 “On Approval of the Rules for Production (Manufacturing) and Quality Control of Medicines in Pharmacies” (as amended), registered by the Ministry of Justice of Ukraine of November 2, 2012 No. 1846/22158, 

https://zakon3.rada.gov.ua/laws/show/z1846-12?lang=en

 

11. Order of the Ministry of Health of Ukraine of October, 01, 2014, No. 698 “On Approval of the Procedure for Controlling the Compliance of Immunobiological Preparations Applied in Medical Practice, with the Requirements of the National and International Standards», registered by the Ministry of Justice of Ukraine on October 29, 2014 No. 1356/26133

https://zakon.rada.gov.ua/laws/show/z1356-14?lang=en

 

12. Order of the Ministry of Health of Ukraine of July 19, 2005 № 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

https://zakon3.rada.gov.ua/laws/show/z0782-05?lang=en

 

13. Order of the Ministry of Health of Ukraine of May 15, 2006 N 275 “On Approval of Instructions on Sanitary-Epidemiological mode of Pharmacy Establishments”

https://zakon.rada.gov.ua/laws/show/z0642-06?lang=en

 

14. Order of the Ministry of Health of Ukraine of April 24, 2015, No. 242  “On Approval of the Rules for the Utilization and Destruction of Medicinal Products”, registered by the Ministry of Justice of Ukraine on May 18, 2015 No. 550/26995

https://zakon.rada.gov.ua/laws/show/z0550-15?lang=en

 

15. Order of the Ministry of Health of Ukraine of July 06, 2012, No. 498 “On Approval of the List of Goods Which Have the Right to Acquire and Sell Pharmacy Institutions and Their Structural Divisions”

https://zakon.rada.gov.ua/laws/show/z1231-12?lang=en

 

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

 

17. СТ-Н МОЗУ 42-5.1:2011 «Guideline. Medicinal products. Good storage practice»

 

18. Order of the Ministry of Health of Ukraine of December 16, 2003, No. 584″ On approval of the Rules for Storage and Control of the Quality of Medicinal Products in Health Care Institutions”, registered by the Ministry of Justice of Ukraine on March 03, 2004 No. 275/8874

https://zakon.rada.gov.ua/laws/show/z0275-04?lang=en

 

19. Order of the Ministry of Health of Ukraine of September 16, 2011, No. 595″ On the Procedure for Prophylactic Vaccinations in Ukraine and Quality Control and Circulation of Medical Immunobiological Medicines”

https://zakon.rada.gov.ua/laws/show/z1159-11?lang=en

 

20. Order of the Ministry of Health of Ukraine of November 22, 2011 No. 809 “On Approval of the Procedure for Prohibiting (Stoppage) and Renewing the Market Circulation of Medicinal Products on the Territory of Ukraine”, registered by the Ministry of Justice of Ukraine of January 30, 2912 No. 126/20439

https://zakon3.rada.gov.ua/laws/show/z0126-12?lang=en

 

21. 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

 

22. СТ-Н МОЗУ 42-4.1:2011 “Guideline. Medicinal products. Dosier of Manufacturing site”