General Information

March 13, 2019

 

The Department of quality control of medicines  of the State Service of Ukraine on medicines and Drug Control (hereinafter – the Department) is guided by the Constitution of Ukraine, the laws of Ukraine, resolutions of the Verkhovna Rada of Ukraine, acts of the President of Ukraine, the Cabinet of Ministers of Ukraine, other normative legal acts, Regulation about the State Service on medicines and Drug Control , its orders, the Regulation on the Department of quality control of medicines (hereinafter referred to as the Regulations), as well as documents by the quality management systems of the State  Service of Ukraine on medicines and Drug Control .

 

The Department in accordance with the Regulation fulfills the following basic functions :

Participates in the development and discussion of draft regulatory acts on issues  on issues related to competence of the Department.

Prepares the decision (order) of the State Service for prohibition (stopping) the production, sale (trade), storage and use of medicines that do not correspond the requirements specified by regulations and regulatory documents, including those for which notifications of unforeseen side effects have been received. reactions and / or death of a person as a result of the use of a set or series of medicines for investigation their causes.

Provides monitoring of the activities of territorial bodies of the State Service within the competence of the Department in respect of compliance with the requirements of the Ukrainian legislation on the quality assurance of medicinal products, including legislation on administrative violations.

Develops and improves the mechanism of interaction with the territorial bodies of the State Service on matters concerning the competence of the Department.

It ensures the state control over the quality of medicines for ensuring the quality and safety of medicines, including those procured for state and local budgets, at all stages of treatment.

Together with other structural divisions, the State Service prepares materials and participates in the organization of ongoing training seminars for inspectors, laboratory staff, wholesale suppliers of medicines, distributors, pharmacists, on issues falling within the competence of the Department.

Ensures the implementation of state control of medicinal products upon their importation into the customs territory of Ukraine.

Within the competence of the Department, the Department develops and makes suggestions for improving the mechanism of interaction with manufacturers (representations of foreign manufacturers) of medicines for the prompt detection of low-quality, counterfeit and unregistered medicines.

Summarizes and prepares materials for meetings of the college, meetings, seminars, on the state of quality control of medicines in circulation.

Carries out an analysis of indicators of the work of territorial bodies of the State Service on matters that fall within the competence of the Department.

Controls the activities of territorial bodies of the State Service and its subordinate laboratories within the competence of the Department, concerning the quality assurance of medicinal products, including legislation on administrative offenses.

 

Develops forms of work accounting and reporting of territorial bodies of the State Medical Service, as well as laboratories for the quality control of medicinal products, on issues falling within the competence of the Department.

Organizes and conducts work on the recognition in accordance with the established procedure of laboratories authorized by the State Service for the performance of work on the quality control of medicinal products.

Provides analysis and generalization of documents on urgent communications from territorial bodies of the State Service on detected inadequate, counterfeit and unregistered medicinal products, as well as medicines that do not meet the requirements set by the regulatory documents, and prepares newsletters to the territorial bodies of the State Service on the detection of inferior drugs found on the territory of Ukraine. .

Carries out monitoring of the use by the territorial bodies of the State Service to take measures to withdraw from the circulation of inadequate, counterfeit, unregistered medicinal products, as well as medicines which do not meet the requirements established by the normative documents, within the competence of the department.

Ensures the implementation of state control over compliance with the requirements of ensuring the quality and safety of medicines during their treatment.

Organizes and ensures, in accordance with established procedure, the selection of medical products for the purpose of carrying out state control over their quality.

It systematizes and generalizes the information database on issues of low-quality, falsified, unregistered medical products, as well as medicines that do not meet the requirements set by the regulatory documents, which were prohibited by the decisions (orders) of the State Service.

He considers complaints, requests for public information, appeals of citizens, business entities, producers, representations of foreign companies in Ukraine on issues falling within the competence of the Department.

Provides information on complaints related to the quality of medicines.

Interacts in accordance with the established procedure with the regulatory authorities in the sphere of circulation of medicines of foreign states and international organizations (regulators in the field of treatment of medicines of the CIS, EMA, PIC / S, WHO, etc.) on issues falling within the competence of the Department.

Participates in the coordination and fulfillment of obligations stipulated by international treaties, conventions, agreements, memorandums and other international documents on matters that fall within the competence of the Department.

Prepares newsletters to the territorial bodies of the State Service regarding the detected by the regulatory authorities in the sphere of circulation of medicines of foreign countries and international organizations inappropriate and counterfeit medicines.

Provides information exchange with law enforcement agencies on detected and forbidden decisions (orders) counterfeit medicines, as well as on other issues, issues containing signs of a crime.

Prepares letters on cancellation of decisions (orders) of the State Service on the basis of positive results of additional studies to control their quality.

Interacts in accordance with the established procedure with other executive authorities, subsidiary bodies and services established by the President of Ukraine, local self-government bodies, relevant bodies of foreign states and international organizations, trade unions and employers’ organizations, as well as enterprises, institutions, organizations, on issues related to competence of the Department.

 

Within its competence, it participates in preparing reports on the results of the state quality control of medicinal products to the Cabinet of Ministers of Ukraine, the Ministry of Health of Ukraine and other executive authorities (upon request).

Prepares proposals for the formulation of state policy in the field of attestation of laboratories for quality control and safety of medicines, improvement of the quality control system for medicinal products, participates in the implementation of the specified state policy.

Conducts a survey of laboratories of various forms of ownership with the aim of their possible further industry certification.

Within the competence of the Department, it verifies compliance with the requirements of the legislation on the quality of medicinal products by the business entities during their storage, sale and medical use.

 

Provides control over the timely receipt of documents from the territorial bodies of the State Service  concerning confirming plans of inspections of business entities regarding the quality control of medicinal products.

Works in accordance with the Law of Ukraine “On the Basic Principles of State Supervision (Control) in the Sphere of Economic Activity”, with approval by the territorial bodies of the State Service for conducting unscheduled inspections of quality, business entities engaged in production (in pharmacy conditions), wholesale, retail trade in medicinal products and use of medicines.

Analyzes the conclusions of expert institutions regarding the criticality of detected mismatches concerning medicines in order to solve the issue of their further circulation. .

In the case of the establishment of signs of administrative offenses, during inspections of business entities, draw up protocols and impose administrative penalties.

Formation of plans of inspections of business entities in accordance with the Law of Ukraine “On the Basic Principles of State Supervision (Control) in the Sphere of Economic Activity”

 Works on copies of registration medicines certificates, quality control methods (including the text of the marking to the registration certificate), instructions on the use of medicinal products (instructions for medical use) provided in accordance with the established procedure State Enterprise “State Expert Center of the Ministry of Health of Ukraine “And / or the holders of registration certificates, their representatives, to the State Service, and makes their placement in the EAIS.

Practicing treatment of business entities regarding the original package of packaging of medicinal products and places them in the   (ЄАІС) EAIS.

Performs other functions in accordance with the tasks assigned to the Department.

 

Legislation of Ukraine on the above mentioned issues:

 

1. Constitution of Ukraine

https://zakon.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80?lang=en

 

2. Code of Ukraine on Administrative Offenses

https://zakon.rada.gov.ua/laws/show/80731-10?lang=en

 

3. Law of Ukraine “On Medicines”

https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80?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 Main Principles of State Supervision (Oversight) in the Area of Commercial Activity”

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

 

6. Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine to Increase Liability for the Falsification or Circulation of Falsified Medicinal Products”

https://zakon.rada.gov.ua/laws/show/5065-17?lang=en

 

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

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

 

8. Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Regarding Preventing Falsification of Medicines”

https://zakon.rada.gov.ua/laws/show/3718-17?lang=en

 

9. Law of Ukraine «On Citizens’ Appeals»

https://zakon2.rada.gov.ua/laws/show/393/96-%D0%B2%D1%80?lang=en

 

10. Law of Ukraine “On Access to Public Information”

https://zakon.rada.gov.ua/laws/show/2939-17?lang=en

 

11. Law of Ukraine «On Ratification of the Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health»

https://zakon.rada.gov.ua/laws/show/4908-17?lang=en

 

12. Resolution of the Cabinet of Ministers of Ukraine of August 12, 2015 No. 647 “On Approval of the Regulation on the State Service of Ukraine for Drugs and Drug Control”

https://zakon.rada.gov.ua/laws/show/647-2015-%D0%BF?lang=en

 

13. Resolution of the Cabinet of Ministers of Ukraine of May 6, 2000 No. 770 “On Approval of the List of Narcotic Drugs, Psychotropic Substances and Precursors”

https://zakon3.rada.gov.ua/laws/show/770-2000-%D0%BF?lang=en

 

14. Resolution of the Cabinet of Ministers of Ukraine of April 28, 2000, No. 728 “On Approval of the Procedure for the Exit to Ukraine or Destruction of Non-Qualitative and Unusable Goods (Objects) of Humanitarian Aid” (as amended)

https://zakon3.rada.gov.ua/laws/show/728-2000-%D0%BF?lang=en

 

15. Resolution of the Cabinet of Ministers of Ukraine of September 14, 2005 No. 902 “On Approval of the Procedure of State Quality Control of Medicinal Products, imported into Ukraine ”

https://zakon.rada.gov.ua/laws/show/902-2005-%D0%BF?lang=en

 

16. Resolution of the Cabinet of Ministers of Ukraine of October 31, 2007 No. 1279 “On Approval of the Procedure for Compensation by the Subject of Expenses Related to the Examination (Testing) of Samples of Products” (as amended)

https://zakon3.rada.gov.ua/laws/show/1279-2007-%D0%BF?lang=en

 

17. 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

 

18. Resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376 “On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and Amounts of Dues for their State Registration (Re-registration)” (as amended)

https://zakon.rada.gov.ua/laws/show/376-2005-%D0%BF?lang=en

 

19. Resolution of the Cabinet of Ministers of Ukraine of February 3, 2010 No. 260 “Some Issues of State Quality Control of Medicinal Products” (as amended)

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

 

20. Resolution of the Cabinet of Ministers of Ukraine of 08.12.2010 No. 1114 “On Approval of the Agreement on Cooperation in Combating the Circulation of Falsified Medicinal Products”

https://zakon.rada.gov.ua/laws/show/1114-2010-%D0%BF?lang=en

 

21. Resolution of the Cabinet of Ministers of Ukraine of January 15, 1996 No. 73 “On Approval of the Regulation on the Control of the Compliance of Immunobiological Preparations Applied in Medical Practice with the Requirements of State and International Standards”

https://zakon3.rada.gov.ua/laws/show/73-96-%D0%BF?lang=en

 

22. 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

 

23. 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://zakon3.rada.gov.ua/laws/show/z1515-14?lang=en

 

24. 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

 

25. Order of the Ministry of Health of Ukraine of June 17, 2005, No. 287 “On Approval of the Procedure for Interaction between the State Inspection for Drug Quality Control of the Ministry of Health of Ukraine and the State Pharmacological Center of the Ministry of Health of Ukraine in the Sphere of Medicinal Products”

 

26. 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

 

27. Order of the Ministry of Health of Ukraine of January 14, 2004 No. 10 “On approval of the procedure for conducting sector certification of laboratories for quality control and safety of medicinal products” (as amended), registered by the Ministry of Justice of Ukraine on January 30, 2004 No. 130/8729

https://zakon.rada.gov.ua/laws/show/z0130-04?lang=en

 

28. Order of the Ministry of Health of Ukraine of January 15, 2003 No. 8 “On approval of lists of auxiliary substances and dyes authorized for use in the manufacture of medicinal products that (medicines) are registered in Ukraine and are made in pharmacy conditions on prescriptions of doctors and orders of medical and preventive establishments “(with changes), registered by the Ministry of Justice of Ukraine on January 29, 2003 No. 69/7390

https://zakon.rada.gov.ua/laws/show/z0069-03?lang=en

 

29. Order of the Ministry of Health of Ukraine of October 26, 2001 No.428 “On Approval of the Instruction on Registration of Administrative Violations of the Ukrainian Laws regarding the Quality Assurance of Medicinal Products”, registered by the Ministry of Justice of Ukraine of January 18, 2002 No. 47/6335

https://zakon.rada.gov.ua/laws/show/z0047-02?lang=en

 

30. Order of the Ministry of Health of Ukraine of August 25, 2010, No. 722 “On Approval of the Procedure for Marking Drugs in Braille”, registered by the Ministry of Justice of Ukraine on November 5, 2010 No. 1044/18339

https://zakon.rada.gov.ua/laws/show/z1044-10?lang=en

 

31. 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

 

32. Order of the Ministry of Health of Ukraine of April 26, 2011, No. 237 “On Approval of the Procedure for Importation of Unregistered Medicinal Products, Standard Samples, Reagents into the Territory of Ukraine” (with changes), registered by the Ministry of Justice of Ukraine on August 11, 2011, No. 965/19703

https://zakon.rada.gov.ua/laws/show/z0965-11?lang=en

 

33. Order of the Ministry of Health of Ukraine of June 06, 2012, No. 422 “On Certain Issues of the Prohibition of the Advertising of Medicinal Products”, registered by the Ministry of Justice of Ukraine on July 16, 2012, No. 1189/21501

https://zakon.rada.gov.ua/laws/show/z1189-12?lang=en

 

34. Order of the Ministry of Health of Ukraine of December 27, 2006, No. 898 “On Approval of the Procedure for Pharmacovigilance” (as amended), registered by the Ministry of Justice of Ukraine on January 29, 2007 No. 73/13340

https://zakon.rada.gov.ua/laws/show/z0073-07?lang=en

 

35. 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

 

36. Order of the Ministry of Health of Ukraine of January 21, 2013, No. 39 “On Approval of Forms of Documents Applicable to the State Control of the Quality of Medicinal Products Imported into Ukraine”, registered by the Ministry of Justice of Ukraine on February 08, 2013 under No. 234/22766

https://zakon.rada.gov.ua/laws/show/z0234-13?lang=en

 

37. Order of the Ministry of Health of Ukraine of December 8, 2015, No. 830 “On Approval and Entry into Effect of the State Pharmacopoeia of Ukraine (II Edition)”

 

38. Order of the Ministry of Health of Ukraine of December 05, 2016, No. 1308 “On Approval and Entry into Force of the Supplement No. 1 to the State Pharmacopoeia of Ukraine (II Edition)”

 

39. Order of the Ministry of Health of Ukraine of March 14, 2018, No. 476 “On Approval and Entry into Force of the Supplement No. 2 to the State Pharmacopoeia of Ukraine (II Edition)”

 

40. Order of the Ministry of Health of Ukraine of June 20, 2018, No. 1178 “On Approval and Entry into Force of the Supplement No. 3 to the State Pharmacopoeia of Ukraine (II Edition)”

 

41. Order of the Ministry of Health of Ukraine of April 22, 2013, No. 321 “On Definition of concepts of” large “and” extra Large “quantities of Falsified Medicinal Products”, registered by the Ministry of Justice of Ukraine on May 15, 2013 No. 743/23275 

https://zakon.rada.gov.ua/laws/show/z0743-13?lang=en