Regulation on the SMDC

Regulation on the SMDC

 

CABINET OF MINISTERS OF UKRAINE

RESOLUTION

12.08.2015 № 647

Kyiv

 

On approval of the Regulation of the State Service of Ukraine on Medicines and Drugs Control

 

 

The Cabinet of Ministers of Ukraine decides:

 

Approve the Regulation of the State Service of Ukraine on Medicines and Drugs Control, that is attached.

 

 

Prime-Minister of Ukraine                                                                                                                                                                   A. YATSENYUK

 

1. The State Service of Ukraine on Medicines and Drug Control is the Central Executive Body, directed by the Cabinet of Ministers of Ukraine through the Minister of Health of Ukraine. The State Service of Ukraine on Medicines and Drugs Control was formed to ensure implementation of the state policy in the sphere of quality control and safety of medicines, including medical immunobiological medicines (further – medicines), medical equipment and medical products and circulation of narcotic drugs, psychotropic substances and precursors, counteractions to their illicit trafficking.

 

2. The State Service of Ukraine on Medicines and Drugs Control is guided by the Constitution of Ukraine and Laws of Ukraine, Decrees of the President and resolutions of the Verkhovna Rada, adopted in accordance with the Constitution and laws of Ukraine, legal acts of the Cabinet of Ministers of Ukraine, other legislative acts.

 

3. The main tasks of the State Service are:

 

implementation of the State policy in the sphere of monitoring of the quality and safety of medicines, medical products and circulation of narcotic drugs, psychotropic substances and precursors, counteractions to their illicit trafficking and submitting proposals  to the Minister of Health concerning the state policy development in the abovementioned sphere;

 

licensing of economic activity on production of medicines, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade of medicinal products, narcotic drugs, psychotropic substances and precursors;

 

technical regulation in the identified areas;

 

implementation of the State regulation and control in the sphere of narcotic drugs circulation, psychotropic substances and their precursors, combating their illicit trafficking.

 

licensing of economic activities related to the donor blood and blood components collection and testing, regardless of their final destination, processing, storage, distribution and realization of donor blood and blood components intended for transfusion;

 

implementation of the state policy in the blood and blood components donation, blood system functioning, conducting inspections of the blood system entities’ activity conditions that are engaged in the blood donation, processing, testing, storage, distribution and realization of donated blood and blood components to the good manufacturing practice requirements.

 

4. The State Service of Ukraine on Medicines and Drugs Control in line with its mandates:

 

1)  summarizes the practice of application of the legislation on issues falling within SMDC` competence;  

 

2) develops draft of the State programs on providing of quality control of medicinal products and medical devices, narcotic drugs circulation, psychotropic substances and precursors, counteracts to their illegal circulation;

 

3) provides certification of the laboratories on medicines quality control;

 

4) administers the certification for pharmacists;

 

5) forms a Register of the responsible persons for introduction  into circulation of medical devices, active medical devices that are implanted and medical devices for in vitro diagnostics;

 

6) issues licenses for medicines production, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade of medicines;

 

7) forms and maintains license registry of types  of business  activity on  medicines production, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade of medicinal products and secures data transmission to the Uniform License Registry;

8) selects the samples of medicinal products and medical devices for quality control according to the legislation;

9) administers State control over compliance with the requirements of the legislation regarding quality assurance and safety of medicines and medical devices at all stages of their circulation, including rules of implementation of appropriate practices (production, distribution, storage, pharmacy);

 

10) administers State control over compliance with licensed conditions of economic activity managing by business entity in medicines production, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade of medicines;

 

11) administers State market supervision over compliance with the requirements of technical regulations on medical devices;

 

12) administers State control over import of medicines to the customs territory of Ukraine;

 

13) makes the protocols on administrative offences and consider cases on administrative offences in the cases provided by the legislation;

 

14) gives obligatory for execution orders on elimination of administrative offences concerning the standards and technical conditions, articles of pharmacopoeia  and technological regulations, as well as to eliminate offences  during production, storage, transportation and sale of drugs;

 

15) takes a decision on recall circulation and prohibition (stop) of production, sale and use of medicines and medical products do not comply with the requirements of legislation, as well as those imported to the territory of Ukraine and exported from the territory of Ukraine with violation of established by law order;

 

16) issues a license to the business entities for activities concerning plants cultivation included that in Table 1 of the List of narcotic drugs, psychotropic substances and precursors, and for the development, production, manufacture, storage, transportation, acquisition, sale (release), import to Ukraine, export from Ukraine, use, utilization of narcotic drugs, psychotropic substances and precursors included to the Registry;

 

17) controls compliance by business entities with the license conditions for conducting business activities in the field of circulation of narcotic drugs, psychotropic substances and precursors;

 

18) make a decision in accordance with the established procedure to revoke licenses for conducting economic activities for the cultivation of plants included in Table I of the List of narcotic drugs, psychotropic substances and precursors, and on the development, production, manufacture, storage, transportation, acquisition, sale (release), importation into the territory of Ukraine, exportation from the territory of Ukraine, use and destruction of narcotic drugs, psychotropic substances and precursors included in the mentioned List;

 

19) issues the permission to the business entity for the right to import (export) and on the right to transit through the territory of Ukraine of narcotic drugs, psychotropic substances and precursors;

20) holds the annual calculations and pre-determines the need of Ukraine for narcotic drugs, psychotropic substances;

 

21) submit suggestions for the definition of quotas for circulation of narcotic drugs, psychotropic substances;

 

22) inspects of warehouse, trading and other premises that are in use by legal entities and which are used in the sphere of narcotic drugs circulation, psychotropic substances and precursors;

 

24) interacts with law enforcement authority, citizens, public and international organizations in combating illicit trafficking of narcotic drugs, psychotropic substances and precursors.

 

25) Carries out interaction and exchange of information with relevant international organizations on issues of controlling the circulation of narcotic drugs, psychotropic substances, and precursors in accordance with the Ukraine’s international agreements, namely:

 

informs, in accordance with international agreements ratified by the Verkhovna Rada of Ukraine, the competent authorities of other states about the export from the Ukrainian territory or transit through the territory of Ukraine of narcotic drugs, psychotropic substances and precursors, and also reports to the International Narcotics Control Board of the United Nations about the execution of such operations;

 

26) еnsures public information on issues of controlling the introduction of medical devices into circulation and the circulation of narcotic drugs, psychotropic substances, and precursors;

 

27) organizes the consideration of public appeals on issues related to the activities of the State Service of Ukraine on Medicines and Drugs Control, its territorial authorities, enterprises, institutions and organizations within its management;

 

27¹) provides authorized body functions in the field of blood and blood components donation, blood system functioning, namely:

 

licensing of blood system entities’ economic activities related to procurement and testing of donated blood and blood components regardless of their final destination, processing, storage, distribution and realization of donated blood and blood components intended for transfusion, formation and maintenance of the license register and license files, control over licensees’ compliance with the license conditions for conducting relevant economic activities in the field of blood and blood components donation, and functioning of the blood system;

 

conducts state supervision (control) over the blood system entities activities, as well as entities providing blood component transfusion services, in order to verify compliance by such entities with the requirements for the relevant type of activity, safety and quality of donated blood and blood components, hemovigilance, traceability and documentation of their activities;

 

ensures the collection of samples of donated blood and blood components for testing and research, analyzes any documents and notes related to the purpose of state supervision (control) in the field of blood and blood components donation and the functioning of the blood system;

 

conducts scheduled and unscheduled measures of state supervision (control) over the activities of blood system entities engaged in the procurement, processing, testing, storage, distribution and sale of donated blood and blood components, in terms of its compliance with the requirements of good manufacturing practice;

 

receives information about serious adverse incidents, serious adverse reactions and suspected incidents or reactions;

 

receives information from blood system entities about the appointment of a responsible person who ensures that the blood system entity complies with the requirements for the functioning of the quality control system, as well as notifications about the delegation of the responsible person’s functions to another person or the permanent or temporary replacement of the responsible person;

 

takes measures to ensure international cooperation and exchange of information with authorized authorities in the sphere of blood and blood components donation, blood system functioning in other countries;

 

participates in the exchange of information in the common system for reporting serious adverse incidents, serious adverse reactions related to the collection, processing, testing, storage and distribution of blood and blood components in the EU;

 

28) сarries out other powers determined by law.