ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of February 19, 2019 No. 64

About some questions of creation of the special list of medicines and forming of the list of medical products

For the purpose of implementation of article 10 of the Law of the Kyrgyz Republic "About drug circulation", article 10 of the Law of the Kyrgyz Republic "About the address of 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:

- Procedure for creation and criteria of inclusion of medicines in the special list of the medicines which are temporarily permitted to import and medical application without registration according to appendix 1;

- Procedure for forming of the list and inclusion in it of medical products which import and application in the territory of the Kyrgyz Republic are resolved without registration, according to appendix 2.

2. To the Ministry of Health of the Kyrgyz Republic:

- bring the decisions into accord with this resolution;

- take the adequate measures following from this resolution.

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 seven days from the date of official publication.

Appendix 1

to the Order of the Government of the Kyrgyz Republic of February 19, 2019 No. 64

Procedure for creation and criteria of inclusion of medicines in the special list of the medicines which are temporarily permitted to import and medical application without registration

1. This Procedure determines procedure for creation and criteria of inclusion of medicines in the special list of the medicines which are temporarily permitted to import and medical application without registration.

2. Creation of the special list of the medicines which are temporarily permitted to import and medical application without registration (further - the special list), is performed by the Commission on creation and inclusion of medicines in the special list of the medicines which are temporarily permitted to import and medical application without registration (further - the commission), based on the applications submitted by the organizations of health care.

The commitment form and the special list affirm the order of authorized state body of the Kyrgyz Republic in the field of health care (further - authorized body).

3. The staff of the commission affirms the order of authorized body. The staff of authorized body and the organizations of health care having the higher medical (pharmaceutical) education and work experience in at least five years, and also the representatives of the civil sector specializing in the field of health care are part of the commission.

The total quantity of members of the commission constitutes 11 people from whom three are representatives of the civil sector.

4. Members of the commission participate in its meetings personally. Commission session is competent if at it there is at least a half of list of members of the commission.

5. Commission chairman is the representative of authorized body. In the absence of the commission chairman, its powers are performed by one of members of the commission elected on commission session by a majority vote of members of the commission as the chairman on commission session.

6. Commission session is competent with the assistance of at least a half of members of its structure. Vote for the absent members of the commission is not allowed. Decisions of the commission are drawn up by the protocol which is signed by the chairman and members of the commission.

7. Decisions of the commission are made by open voting and by a simple majority vote her members participating in meeting. In case of separation of voices the decision for which the chairman voted is equally deemed accepted.

8. Inclusion of medicines in the special list is performed by the commission on their international non-proprietary name, and in case of lack of the international non-proprietary name - according to the grouping name.

9. The medicines specified regarding the 2nd article 10 of the Law of the Kyrgyz Republic "About drug circulation" are included in the special list by the decision of the commission on condition of compliance to the following criteria:

1) the medicines which do not have state registration are intended for:

- treatments of rare and socially important diseases;

- delivery of health care according to vital testimonies of the specific patient;

- delivery of health care according to programs of compassionate use of experimental medicines;

- ensuring need for orphan medicines;

2) the medicines which do not have state registration, but included in the National list of the vital medicines or in the clinical protocols approved by orders of authorized body are intended for:

- prevention of vaktsinoupravlyaemy infections and according to epidemiological indications;

- holding preventive actions in case of flash and complications of epidemiological situation for infectious diseases;

- ensuring need for medicines through the humanitarian assistance within programs in the field of health care.

10. The medicines intended for delivery of health care to patients according to the vital indications, included in the National list of the vital medicines, but which do not have state registration are included in the special list based on the decision of the commission approved by the order of authorized body.

11. The authorized body in case of receipt of three and more requests from the organizations of health care initiates carrying out commission session.

12. The commission shall no later than two working days from the date of initiation of commission session consider the health cares of the request which arrived from the organizations, and within two working days to make the decision on inclusion or non-inclusion of medicines in the special list.

13. Decisions of the commission on inclusion in the special list or on exception of it of one and more medicines affirm the order of authorized body within two working days from the date of adoption by the commission of the decision on inclusion in the special list or about exception of medicines of it.

14. The authorized body, for the purpose of updating of the special list performs accounting of the medicines included in the special list by means of assessment of data on import, movement, registration of the medicines included in the special list which is carried out by authorized body each six months.

15. The special list and the order of authorized body on its approval are subject to placement on the official site of authorized body within three working days after its signing.

Appendix 2

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