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CABINET OF MINISTERS OF UKRAINE |
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12.08.2015 № 647 |
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.
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Prime-Minister of Ukraine |
A. YATSENYUK |
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.
The main tasks of the State Service of Ukraine on Medicines and Drugs control 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.
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;
– provides certification of the laboratories on medicines quality control;
– administers the certification for pharmacists;
– 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;
– issues licenses for medicines production, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade of medicines;
– 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;
– selects the samples of medicinal products and medical devices for quality control according to the legislation;
– 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);
– 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;
– administers State market supervision over compliance with the requirements of technical regulations on medical devices;
– administers State control over import of medicines to the customs territory of Ukraine;
– makes the protocols on administrative offences and consider cases on administrative offences in the cases provided by the legislation;
– 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;
– 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;
– 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;
– 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;
– holds the annual calculations and pre-determines the need of Ukraine for narcotic drugs, psychotropic substances;
– submit suggestions for the definition of quotas for circulation of narcotic drugs, psychotropic substances;
– 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;
– interacts with law enforcement authority, citizens, public and international organizations in combating illicit trafficking of narcotic drugs, psychotropic substances and precursors.