RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of February 9, 2023 No. 53

About implementation of system of traceability of medicines in the Kyrgyz Republic

For the purpose of implementation of presidential decrees of the Kyrgyz Republic "About urgent measures for development of health sector and improvement of quality of life and health of the population in the Kyrgyz Republic" of February 8, 2021 23, "About the National development program of the Kyrgyz Republic till 2026" of October 12, 2021 No. 435, according to articles 13, of the 17th constitutional Law of the Kyrgyz Republic "About the Cabinet of Ministers of the Kyrgyz Republic" the Cabinet of Ministers of the Kyrgyz Republic decides No.:

1. Start step-by-step implementation of system of traceability of the medicines made, imported and realized in the territory of the Kyrgyz Republic.

2. Approve the Procedure for ensuring traceability of medicines (further - the Procedure) according to appendix.

3. Assign to Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic (further - Department of medicines and medical products) functions on implementation and maintaining system of traceability of medicines.

4. To department of medicines and medical products by the time of entry into force of this resolution:

To approve 1):

- step-by-step plan of implementation of system of traceability of medicines;

- the list of the medicines which are subject to tracing;

- methodical recommendations about use of the Information system "Electronic Database of Medicines and Medical Products" (further - IS EBD) participants of circulation of medicines;

2) to carry out the corresponding information and explanatory work.

5. Determine that:

- from the moment of approach of the terms provided by the step-by-step plan of implementation of system of traceability of medicines wholesale and retail sale of the medicines included in the list of the medicines which are subject to tracing without registration of codes of digital marking in IS EBD is forbidden;

- the medicines imported into the Kyrgyz Republic or made in the Kyrgyz Republic to the terms provided by the step-by-step plan of implementation of system of traceability of medicines are left in the address before the expiration of their validity without registration of codes of digital marking in IS EBD;

- requirements of this resolution do not extend to medicines which selling price in case of production in the territory of the Kyrgyz Republic or delivery price when importing to the territory of the Kyrgyz Republic does not exceed 100 som for packaging (such medicines can be traced on voluntary basis).

6. Ceased to be valid according to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of 19.09.2024 No. 575

7. To impose control of execution of this resolution on management of control of execution of decisions of the President and the Presidential Administration Cabinet of Ministers of the Kyrgyz Republic.

8. This resolution becomes effective after fifteen days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of February 9, 2023 No. 53

Procedure for ensuring traceability of medicines

Chapter 1. General provisions

1. This Procedure for ensuring traceability of medicines (further - the Procedure) determines requirements to process of traceability of the medicines made, imported and realized in the territory of the Kyrgyz Republic to participants of circulation of medicines and their function, order of registration of participants of circulation of medicines in the Information system "Electronic Database of Medicines and Medical Products" and information exchange of participants of circulation of medicines, procedure for provision of codes of digital marking to participants of circulation of medicines in the Information system "Electronic Database of Medicines and Medical Products", requirements to drawing code of digital marking on the medicines which are subject to traceability, procedure for provision of data in the Information system "Electronic Database of Medicines and Medical Products" on input of medicines in turnover being in circulation and conclusion from turnover, and introduction of changes in them.

2. For the purposes of this Procedure the following concepts are used:

1) aggregation - documentary confirmation of the hierarchical relation between the outside packaging having unique identification code, and the made products containing in it which also have unique identification code for the purpose of enhancement of the working processes connected with serialization and providing data exchange and/or fulfillment of requirements of regulating documents;

2) serialization - process and results of determination, assignment and drawing unique codes on packaging of products;

3) input in circulation of medicines - primary registration of code of digital marking of medicines in system of traceability;

4) conclusion from circulation of medicines - cancellation of registration of code of digital marking of medicines in system of traceability concerning specific unit of medicine in case of achievement of the final consumer or destruction;

5) primary (internal) package - the packaging which is directly adjoining to medicine;

6) secondary (outside or consumer) packaging - packaging in which medicine in primary and intermediate package is located;

7) group packaging - the packaging combining sets homogeneous (within one code of packaging of medicine, also called GTIN (Global Trade Item Number) - the global room of products in single international base of goods, is applied on packaging of goods by the standardized rules in barcode type) secondary (and in case of their absence - primary) consumer packagings of the medicines used for storage and transportation for the purpose of protection them from damages when moving, and forming independent transport unit. The aggregation code is applied on group packaging. Group packaging can include shipping packages of the smaller size (amount);

8) individual number of packaging (serialization code) - the sequence of symbols, it is unique identifying secondary package of medicine within one commodity code;

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