RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of August 12, 2015 No. 647

About approval of the Regulations on Public service of Ukraine on medicines and control of drugs

Cabinet of Ministers of Ukraine decides:

Approve Regulations on Public service of Ukraine on medicines and control of drugs which are applied.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of August 12, 2015 No. 647

Regulations on Public service of Ukraine on medicines and control of drugs

1. Public service of Ukraine on medicines and control of drugs (Gosleksluzhba) is the central executive body which activities go and coordinated by the Cabinet of Ministers of Ukraine through the Minister of Health who realizes state policy in the sphere of quality control and safety of medicines, including medical immunobiological supplies (further - medicines), of medical equipment and products of medical appointment (further - medical products) and drug trafficking, psychotropic substances and precursors, counteraction to their illicit trafficking, donorship of blood and components of blood, functioning of system of blood.

2. The Gosleksluzhba in the activities is guided by the Constitution and the laws of Ukraine, presidential decrees of Ukraine and resolutions of the Verkhovna Rada of Ukraine adopted according to the Constitution and the laws of Ukraine, acts of the Cabinet of Ministers of Ukraine, other acts of the legislation.

3. The main objectives of Gosleksluzhby are:

realization of state policy in spheres of quality control and safety of medicines, medical products and addresses of drugs, psychotropic substances and precursors, counteractions to their illicit trafficking, and also introduction to the Minister of Health of offers on forming of state policy in the specified spheres;

licensing of economic activity on production of medicines, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade by medicines, drug trafficking, psychotropic substances and precursors;

technical regulation in certain spheres;

implementation of state regulation and control in the sphere of drug trafficking, psychotropic substances and precursors and counteractions to their illicit trafficking;

licensing of economic activity on procurement and testing of donor blood and components of blood, irrespective of their final appointment, on conversion, storage, distribution and realization of donor blood and the components of blood intended for transfusion;

realization of state policy in the sphere of donorship of blood and components of blood, functioning of system of blood, conducting check of compliance of conditions of activities of the subjects of system of blood performing procurement, conversion, testing, storage, distribution and realization of donor blood and components of blood, to requirements of proper production practice.

4. The Gosleksluzhba according to the tasks assigned to it:

1) generalizes practice of application of the legislation on the questions which are within its competence develops suggestions for improvement of legal acts, acts of the President of Ukraine, the Cabinet of Ministers of Ukraine, regulatory legal acts of the ministries and in accordance with the established procedure represents them to the Minister of Health;

2) develops drafts of the state target programs concerning control of quality of medicines and medical products and control in the sphere of drug trafficking, psychotropic substances and precursors, counteractions to their illicit trafficking, participates in ensuring accomplishment of such programs;

3) carries out industry certification of laboratories for control of quality of medicines;

4) carries out certification of pharmacists and druggists;

Creates 5) and keeps the Register of persons responsible for introduction into circulation of medical products, active medical products who implant also medical products for diagnostics of in vitro;

6) grants to subjects of managing licenses for production of medicines, import of such means (except active pharmaceutical ingredients), wholesale and retail trade by medicines;

Creates 7) and keeps the licensed register of types of economic activity on production of medicines, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade of medicines and provides transfer of data in the Unified licensed register;

8) selects in accordance with the established procedure samples of medicines and medical products for check of their quality;

9) exercises the state control of observance of requirements of the legislation for quality assurance and safety of medicines and medical products at all stages of the address, including the rules of implementation ought the practician (production, distributor, storages, pharmaceutical);

10) exercises control of observance by subjects of managing of licensed conditions of implementation of economic activity on production of medicines, import of medicines (except active pharmaceutical ingredients), wholesale and retail trade by medicines;

11) exercises the state market supervision within the sphere of the responsibility;

12) exercises the state control of import to customs area of Ukraine of medicines;

12-1) makes the decision on provision or refusal in provision of permission to parallel import of medicines, and also suspension, cancellation, cancellation of such permission;

12-2) exercises the state supervision (control) concerning medicines which are in parallel imported on the territory of Ukraine;

12-3) enters in the State register introduced into drug circulation, imported on the territory of Ukraine, and the State register of medicines which are in parallel imported on the territory of Ukraine, and places in them on the terms of open access of the data on permissions to parallel import of medicine and the medicines imported on the territory of Ukraine as parallel import;

13) constitutes protocols on administrative offenses and considers cases on administrative offenses in the cases provided by the law;

14) provides instructions, obligatory for execution, about elimination of violations of standards and specifications, pharmakopeyny Articles and production schedules, and also about elimination of violations during production, storage, transportation and realization of medicines;

15) makes in accordance with the established procedure decisions on retirement and you will lock (stop) of production, realization and use of medicines and medical products, not conforming to the requirements determined by regulatory legal acts and also which are imported on the territory of Ukraine and are exported from the territory of Ukraine with violation of the procedure established by the legislation;

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