RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of March 3, 2025 No. 106

About questions of regulation of the address of veterinary medicines in the territory of the Kyrgyz Republic

For the purpose of harmonization of the veterinary legislation with the regulatory legal base of the Eurasian economic commission, according to article 22 of the Law of the Kyrgyz Republic "About veterinary science", 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:

1) Rules of registration of veterinary medicines according to appendix 1;

2) Regulations of the address of veterinary medicines according to appendix 2.

2. Determine that regulations of the subitem 1 of Item 1 of this resolution will act before final entry into force of the Decision of Council of the Eurasian economic commission "About Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union" of January 21, 2022 with No. 1.

3. Recognize invalid:

1) the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Veterinary Medicines" of August 5, 2013 No. 444;

2) Item 1 of the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About modification of some decisions of the Government of the Kyrgyz Republic in the field of technical regulation" of June 23, 2023 No. 319.

4. To the ministry of water resources, agricultural industry and processing industry of the Kyrgyz Republic in five-months time:

1) to bring the decisions into accord with this resolution;

2) to take the necessary measures following from this resolution.

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

Appendix 1

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of March 3, 2025 No. 106

Rules of registration of veterinary medicines

Chapter 1. General provisions

1. Rules of registration of veterinary medicines (further - Rules) determine procedure for carrying out registration of the veterinary medicines and other procedures connected with registration.

2. Rules extend on the legal entities and physical person which are engaged in the address of veterinary medicines (further - subjects).

3. The address of the veterinary medicines containing drugs, psychotropic and strong substances is regulated by the Law of the Kyrgyz Republic "About drugs, psychotropic substances, their analogs and precursors".

4. In Rules the following concepts are used:

veterinary medicine - the means representing substance or containing the substance or combination of substances coming into contact with organism of animal and intended for treatment, prevention of diseases of animals, rehabilitation, correction or change of physiological functions of organism of animal, preserving, prevention or termination of pregnancy, euthanasia and also for diagnosis of diseases of animals (except for substances or their combinations which are not contacting to animal organism);

veterinary medicine - veterinary medicine in the form of dosage form;

the distributor - the physical person or legal entity which is engaged in sale of veterinary medicines wholesale or at retail;

the applicant - the owner of veterinary medicine or the legal entity authorized by it, the physical person registered in the territory of the Kyrgyz Republic as the individual entrepreneur or the physical person which is acting on the basis of the power of attorney which submits the application for registration of veterinary medicine or for implementation of other procedures in the territory of the Kyrgyz Republic;

the address of veterinary medicines - the activities including development, carrying out preclinical researches (testing), clinical trials (testing), examinations, registration or implementation of other procedures connected with registration, quality control, assessment of safety and efficiency, production, production, storage, transportation, movement, import and export on the territory of the Kyrgyz Republic, advertizing, leave, realization, transfer, application and destruction of veterinary medicines;

registration confirmation of veterinary medicines - the procedure of prolongation of effective period of registration of veterinary medicine;

the owner of veterinary medicine - the legal entity or physical person registered as the individual entrepreneur who has rights to the registered veterinary medicine, the registration file of veterinary medicine (including results of preclinical researches (testing) and clinical trials (testing), the production technology of veterinary medicine) and bears responsibility for quality, safety and efficiency of veterinary medicine;

the registration file of veterinary medicine is set of the documents submitted for registration or registration confirmation of veterinary medicine, and also the documents connected with modification of the registration file of veterinary medicine;

registration number - the specification symbol appropriated to veterinary medicine in case of its registration;

the registration certificate of veterinary medicine - the document confirming the fact of registration of veterinary medicine (further - the registration certificate);

the register of veterinary medicines - the register of the registered veterinary medicines representing the information resource containing data on veterinary medicines concerning which the registration or other procedures connected with registration are performed;

the claim - the claim made by the consumer in connection with discrepancy of quality of the acquired veterinary medicine;

reference veterinary medicine - the veterinary medicine for the first time registered in the territory of the Kyrgyz Republic based on the registration file of the veterinary medicine containing results of all preclinical and clinical trials (testing) confirming its quality, safety and efficiency;

the certificate of proper production practice is the official document issued by regulatory body confirmatory that this production conforms to standards of proper production practice (GMP);

authorized body - authorized state body in the field of the address of veterinary medicines within which competence decision making is during the address of veterinary medicines in the territory of the Kyrgyz Republic;

the regulating document on veterinary medicine - the document on quality control of veterinary medicine containing list of indicators of quality of veterinary medicine with the description of their analytical techniques and researches (testing) or with indication of references to them, and also the corresponding eligibility criterions for these indicators of quality taking into account dosage form;

the expert - the physical person having competence for conducting examination of quality, safety and efficiency of veterinary medicines and confirming them the compliance to the established requirements of these rules performing activities in the field of the address of veterinary medicines.

Other concepts used in these rules are applied in the values determined by the decision of Council of the Eurasian economic commission "About Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union" of January 21, 2022 No. 1.

5. The procedures specified in these rules are held by authorized body.

6. In the territory of the Kyrgyz Republic the address of veterinary medicines is allowed under condition:

1) their obligatory state registration according to these rules or their registration according to the decision of Council of the Eurasian economic commission "About Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union" of January 21, 2022 No. 1;

2) their productions on the production site having the existing certificate of proper production practice for the imported (foreign) veterinary medicines and the license for production;

3) availability for domestic manufacturers of veterinary medicines of the certificate of proper production practice or (and) licenses for production (production) and realization of veterinary medicines;

4) their obligatory quality evaluation according to these rules.

Chapter 2. General principles of registration of veterinary medicines

7. The following veterinary medicines are subject to registration:

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info