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ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of April 30, 2020 No. 227

About approval of the Regulations on Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic

For the purpose of reduction of the decision of the Government of the Kyrgyz Republic in compliance with the legislation of the Kyrgyz Republic in the field of drug circulation and medical products, according to articles 10 and 17 of the constitutional Law of the Kyrgyz Republic "About the Government of the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve Regulations on Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic according to appendix.

2. Recognize to be invalid the following:

1) the order of the Government of the Kyrgyz Republic "About formation of Department of provision of medicines and medical equipment under the Ministry of Health of the Kyrgyz Republic" of September 26, 1997 No. 556;

2) Item 3 of the order of the Government of the Kyrgyz Republic "About modification of some decisions of the Government of the Kyrgyz Republic" of November 11, 2002 No. 747;

3) the order of the Government of the Kyrgyz Republic "About modification of some decisions of the Government of the Kyrgyz Republic" of April 20, 2009 No. 237;

4) the order of the Government of the Kyrgyz Republic "About modification and amendments in the order of the Government of the Kyrgyz Republic of September 26, 1997 No. 556 "About formation of Department of provision of medicines and medical equipment under the Ministry of Health of the Kyrgyz Republic" of August 14, 2009 No. 521;

5) item 4 of the order of the Government of the Kyrgyz Republic "About questions of reorganization of the medico-technical center under the Ministry of Health of the Kyrgyz Republic" of April 17, 2014 No. 217;

6) the order of the Government of the Kyrgyz Republic "About modification of the order of the Government of the Kyrgyz Republic "About formation of Department of provision of medicines and medical equipment under the Ministry of Health of the Kyrgyz Republic of September 26, 1997 No. 556" of December 2, 2015 No. 824;

7) the order of the Government of the Kyrgyz Republic "About entering of amendments and changes into some decisions of the Government of the Kyrgyz Republic" of September 16, 2015 No. 644;

8) Item 3 of the order of the Government of the Kyrgyz Republic "About entering of amendments and changes into some decisions of the Government of the Kyrgyz Republic" of June 13, 2017 No. 362.

3. To impose control of execution of this resolution on department of social development of Government office of the Kyrgyz Republic.

4. This resolution becomes effective after ten days from the date of official publication.

Prime Minister of the Kyrgyz Republic

M. Abylgaziyev

Appendix

to the Order of the Government of the Kyrgyz Republic of April 30, 2020 No. 227

Regulations on Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic

Chapter 1. General provisions

1. The department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic (further - Department) is subordinated division of the Ministry of Health of the Kyrgyz Republic (further - the Ministry), acts as body under authorized state body:

- on regulation of the sphere of drug circulation and medical products;

- on control of legal drug trafficking, psychotropic substances and their precursors;

- on regulation of activities in the field of drug circulation and medical products according to the single principles and rules of drug circulation and medical products within the Eurasian Economic Union.

2. The department in the activities is guided by the Constitution of the Kyrgyz Republic, the laws of the Kyrgyz Republic "About drug circulation" and "About the address of medical products", other regulatory legal acts of the Kyrgyz Republic which came in the procedure established by the law into force international treaties which participant is the Kyrgyz Republic, orders and orders of the Ministry, and also this Provision.

3. The department is legal entity, has seal with the image of the State Emblem of the Kyrgyz Republic, stamp, letterheads in the state and official languages, settlement, special and other accounts in bank and treasurer systems.

4. The department has the territorial subdivision acting as branch on the basis of the provision approved by the department director.

5. Official name of Department:

- in state language: "Kyrgyz Respublikasynyn Salamattyk saktoo ministrliginin Dara's aldyndaga of karazhattara of Jean Meditsinalyc buyumdar department" (abbreviated name: "DKzhMBD");

- in official language: "Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic" (abbreviated name: "DLSIMI").

6. Legal address of Department: 720000, city of Bishkek, st. 3 line, 25.

Chapter 2. Purpose of activities of Department

7. The purpose of activities of Department is realization of state policy in the field of drug circulation and medical products, and also in the field of control of legal drug trafficking, psychotropic substances and their precursors.

Chapter 3. Tasks of Department

8. Tasks of Department are:

- regulation of drug circulation and medical products by means of mechanisms, stipulated by the legislation the Kyrgyz Republic in the field of medicines and medical products;

- control of legal drug trafficking, psychotropic substances and their precursors.

Chapter 4. Functions of Department

9. The department for the purpose of realization of tasks performs the following functions:

1) carries out registration, registration confirmation and modification of the registration file of medicines, registration and modification of the registration file of medical products; issues, stops and cancels the registration certificate of medicine and medical product;

2) the practician carries out pharmaceutical inspections of subjects of pharmaceutical activities on compliance to requirements of rules proper pharmaceutical;

3) carries out quality evaluation of medicines and quality evaluation and safety of medical products;

4) carries out certification of authorized persons of producers of medicines according to the right of the Eurasian Economic Union;

5) is performed by pharmakonadzor according to rules of proper practice of pharmakonadzor;

6) is performed by monitoring of safety, quality and efficiency of medical products;

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