RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of October 7, 2024 No. 604

About approval of the Procedure for ensuring traceability of medicines and medical products

For the purpose of realization of Item 10 of Article 5, of article 7 of the Law of the Kyrgyz Republic "About the address of medical products", Item 10 of Article 5, of Article 7, speak rapidly 2 Articles 29, of part 3 of article 39 of the Law of the Kyrgyz Republic "About drug circulation", 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:

1. Approve the Procedure for ensuring traceability of medicines and medical products according to appendix.

2. Bring in the order of the Government of the Kyrgyz Republic "About approval of the Regulations on Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic" of April 30, 2020 No. 227 the following changes:

in Regulations on Department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic approved by the above-stated resolution:

- add Item 9 with subitems 33, 34 following of content:

"Implements 33) and conducts system of traceability of medicines and medical products;

34) is national operator on marking of medicines and medical products.".

3. Determine that from the date of entry into force of this resolution wholesale and retail sale without registration of codes of digital marking in the information system "Electronic Database of Medicines and Medical Products" only for medicines and the medical products which are not subject to tracing is allowed.

4. To department of medicines and medical products under the Ministry of Health of the Kyrgyz Republic by the time of entry into force of this resolution to approve criteria of the medicines and medical products which are not subject to tracing.

5. Declare invalid the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About implementation of system of traceability of medicines in the Kyrgyz Republic" of February 9, 2023 No. 53.

6. 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.

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

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of October 7, 2024 No. 604

Procedure for ensuring traceability of medicines and medical products

Chapter 1. General provisions

1. This Procedure determines requirements to process of traceability of the medicines and medical products made, imported and realized in the territory of the Kyrgyz Republic to participants of circulation of medicines and medical products, order of registration of participants of turnover in the information system "Electronic Database of Medicines and Medical Products" and information exchange of participants of turnover, procedure for provision of codes of digital marking to participants of turnover in the information system "Electronic Database of Medicines and Medical Products", requirements to drawing code of digital marking on the medicines and medical products which are subject to traceability, procedure for provision of data in the information system "Electronic Database of Medicines and Medical Products" on input of the medicines and medical products in turnover which are 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 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 and medical products - primary registration of code of digital marking of medicines and medical products in system of traceability;

4) conclusion from circulation of medicines and medical products - cancellation of registration of code of digital marking of medicines and medical products in system of traceability concerning specific unit of medicine and medical product 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 and packaging of medical product within one commodity code;

9) code of packaging of medicine and medical product (GTIN) - the code assigned by GS1 association (GS1 - the leading international organization which manages diversified system of commodity numbering. GS1 develops the standards of bar coding and the decision directed to increase in efficiency and transparency of supply chains around the world) to medicine and medical product according to the rules established by GS1, the providing accounting of medicine and medical product in the state register of medicines and medical products and the global GS1 catalog;

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