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ORDER OF THE MINISTRY OF HEALTH OF THE KYRGYZ REPUBLIC

of October 18, 2016 No. 764

About approval of the Regulations on forming of the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic

Due to the limited amount of the domestic pharmaceutical market the manufacturing plants of medicines have no interest in their registration in the Kyrgyz Republic. However, the organizations of health care and the population of the Kyrgyz Republic feel the sharp need for number of the unregistered vital medicines. Also in the market there are no test systems, necessary for statement of clinical analyses, reactants and reagents. Domestic manufacturers of medicines and drugstore with the right of production of medicines according to recipes of the doctor lack for pharmaceutical substances and auxiliary materials, packaging materials, container.

According to Art. 35 of the Law of the Kyrgyz Republic "About medicines", medicines can be made, be on sale and be applied in the territory of the Kyrgyz Republic if they are registered or brought in the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic by authorized state body of the Kyrgyz Republic in the field of health care.

For the purpose of uninterrupted providing the population and the organizations of health care of the Kyrgyz Republic with medicines for treatment of widespread and socially important diseases I order:

1. Approve the enclosed "Regulations on forming of the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic" (further the Provision) (appendix 1).

2. Approve the enclosed structure of the commission on forming of the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic (appendix 2).

3. УОМПиЛП (Toymatova S. Sh.) to provide to the chief monitoring of supply of the medicines permitted to import and application according to the List according to this Provision.

Term: quarterly

4. To the director ДЛОиМТ (to Kurmanov R. A.) provide:

4.1. quality control of the imported medicines according to the approved List, in accordance with the established procedure;

Term: constantly

4.2. provision of data on deliveries of HP, according to the approved List.

Term: quarterly

5. Declare invalid the order MZ KR No. 4 of 08.01.2014 "About approval of the Regulations on forming of the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic".

6. To impose control of execution of this order on the deputy minister Murzaliyev A.Dzh.

Minister

T. Batyraliyev

Appendix 1

to the Order of the Ministry of Health of the Kyrgyz Republic of October 18, 2016 No. 764

Regulations on forming of the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic

I. General provisions

1. This Provision is developed in pursuance of Art. 35 of the Law of the Kyrgyz Republic "About medicines", for the purpose of uninterrupted providing the population and the organizations of health care of the Kyrgyz Republic with medicines for treatment of widespread and socially important diseases.

2. This Provision establishes requirements to forming of the List of the medicines permitted to import and application in medical practice not registered in the territory of the Kyrgyz Republic (further - the List).

3. Authorized state body on forming of the List is the Ministry of Health of the Kyrgyz Republic.

4. The list is created on the basis of the criteria approved by this Provision.

5. Medicines are included in the List under the International non-proprietary name.

6. The medicines delivered on the territory of the KR on the basis of the approved List shall have the instruction on medical application, marking and packaging in official language.

7. In reasonable cases of impossibility of supply activity of medicines from the List with marking and packaging in official language use of stickers, and also instructions for application with transfer into official language is allowed.

8. Stated below means are included in the List without specifying of names, based on their belonging to the following groups of medicines:

a) The pharmaceutical substances, auxiliary materials intended for pharmaceutical production;

b) The packaging materials intended for pharmaceutical production and pharmaceutical production;

c) The chemical reactants used for laboratory diagnostics;

d) The consumable materials used for laboratory diagnostics, and also for operation of the medical equipment.

II. Criteria of inclusion of medicines in the List

9. The medicines unregistered in the Kyrgyz Republic but which entered PZhVLS.

10. The medicines unregistered in the Kyrgyz Republic but which entered clinical protocols / clinical managements of the Ministry of Health as medicines of the first row.

11. The medicines applied to treatment of rare diseases ("orphan medicines" / "orphan medicines").

12. In reasonable cases inclusion in the List of the medicines registered in the Kyrgyz Republic which import was not performed from the moment of registration or during the long period is allowed.

13. The diagnostic test systems having the documents confirming availability of quality management system at the producer.

14. Pharmaceutical substances, excipients if they enter in State Pharmacopoeias of the USSR, the Russian Federation, the USA, European, International, British and other Pharmacopoeias.

III. Procedure for forming of the List

15. The Ministry of Health accepts requests for inclusion in the List from the organizations of health care, professional associations, associations of patients, the pharmaceutical organizations, producers of medicines (further the Organizations).

16. In process of receipt the submitted requests are considered by the Commission on forming of the List of the medicines permitted to import and application in medical practice in the territory of the Kyrgyz Republic (further the Commission).

17. The commission considers requests for inclusion of medicines in the List and passes the positive or negative decision on inclusion in the List, and also makes the decision on exception of the List.

18. The list of the medicines permitted to import and application in the territory of the Kyrgyz Republic affirms as medical practice the order MZ KR and as required additions or changes by the order MZ KR are made to it.

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