RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of August 12, 2026 No. 541

About approval of the Procedure for state registration of medicines for medical application

For the purpose of implementation of Articles 17, of 18, 20 Laws of the Kyrgyz Republic "About drug circulation", 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 Agreements on the single principles and rules of the drug circulation within the Eurasian Economic Union signed on December 23, 2014 in the city of Moscow according to articles:

1. Approve the Procedure for state registration of medicines for medical application (further - the Procedure) according to appendix.

2. Determine that state registration of medicines and modification of the registration file of medicine according to the Procedure specified in Item 1 of this resolution are performed till December 31, 2027.

3. Recognize invalid:

1) the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About registration, registration confirmation and modification of the registration file of medicines for medical application" of March 7, 2023 No. 136;

2) the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About introduction of amendments to the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About registration, registration confirmation and modification of the registration file of medicines for medical application" of March 7, 2023 No. 136" of July 19, 2024 No. 398;

3) the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About introduction of amendments to the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About registration, registration confirmation and modification of the registration file of medicines for medical application" of March 7, 2023 No. 136" of October 3, 2024 No. 598;

4) the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About introduction of amendments to the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About registration, registration confirmation and modification of the registration file of medicines for medical application" of March 7, 2023 No. 136" of August 1, 2025 No. 463.

4. To the Ministry of Health of the Kyrgyz Republic to take the necessary measures following from this resolution.

5. 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.

6. 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 August 12, 2026 No. 541

Procedure for state registration of medicines for medical application

Chapter 1. General provisions

1. This Procedure for state registration of medicines for medical application (further - the Procedure) determines procedures of state registration, modification of the registration file of medicine, determination of criteria of confidentiality of information containing in the registration file of medicine, carrying out automatic and the accelerated procedures of registration of medicines, forming and maintaining the State register of medicines of the Kyrgyz Republic (further - the State register), issues of the registration certificate about state registration of medicine, and also suspension of action or cancellation of the registration certificate.

2. In this Procedure the following concepts are used:

1) safety of medicine (ratio "advantage - risk") - assessment of positive therapeutic effects of medicine in relation to the risks connected with its application (the concept of risk includes any risk connected with quality, safety or efficiency of medicine and also with its influence on health of the patient or the population);

2) biological availability (bioavailability) - the speed and degree with which active ingredient or its active part of molecule from the dosed dosage form are soaked up and become available in the scene of action;

3) biological equivalence (bioequivalence) - lack of significant distinctions in the speed and degree with which active ingredient or active part of molecule of active ingredient of pharmaceutical equivalents or pharmaceutical alternatives become available in the place of the action in case of introduction in identical molar dose in similar conditions of research with proper design;

4) the reproduced medicine (generic) - the medicine having the same quantitative and high-quality composition of active ingredients and the same dosage form, as original medicine which bioequivalence to original medicine is confirmed by the corresponding researches of bioavailability. Different salts, ethers, isomers, mixes of isomers, complexes or derivatives of active ingredient are recognized the same active ingredient if their safety and efficiency significantly do not differ. Different dosage forms for intake with immediate release are recognized within the bioavailability researches the same dosage form;

5) hybrid medicine - the medicine which is not falling under determination of the reproduced medicine in case of impossibility of confirmation of its bioequivalence by means of bioavailability researches and also if in this medicine there were changes of active ingredient (substances), indications to application, dosages, dosage form or way of introduction in comparison with original medicine;

6) the holder of the registration certificate - the legal entity addressed to whom the registration certificate about state registration of medicine is issued;

7) the applicant - legal entity or physical person, authorized to submit the application for state registration, modification of the registration file of medicine and implementation of other procedures connected with state registration of medicines;

8) quality of medicine - the set of properties and characteristics of pharmaceutical substance or medicine providing their compliance to purpose according to requirements of the specification or the regulating document for quality;

9) medicinal vegetable raw materials - the fresh or dried-up plants, seaweed, mushrooms or lichens or their parts, integral or crushed, used for production and production of medicines;

10) medicinal vegetable medicine - the medicine containing in quality of active components exclusively medicinal vegetable raw materials and (or) medicines on its basis;

11) proper practice of examination (GRevP) - the documentary rules of conducting examination establishing requirements to content and the organization of examination of medicines;

12) general characteristic of medicine - the document containing information for health workers on safe and effective use of medicine;

13) the general technical document - set of the documents and materials presented in the form of five modules consisting of Sections: documentation of administrative nature, chemical, pharmaceutical and biological documentation, pharmacological, toxicological documentation, clinical documentation, represented along with the statement for state registration of medicine for medical application;

14) original medicine - medicine with new active ingredient which was for the first time registered and placed in the world pharmaceutical market based on the registration file containing results of the complete preclinical (not clinical) and clinical trials confirming its quality, safety and efficiency;

15) the representative of the holder of the registration certificate - the legal entity located in the territory of the Kyrgyz Republic and authorized by the holder of the registration certificate on accomplishment of the actions connected with drug circulation in the territory of the Kyrgyz Republic;

16) producer of medicines - the organization performing activities for production of medicines based on the license for implementation of pharmaceutical activities;

17) the production site - territorially isolated complex of the producer of medicines intended for accomplishment of all production process of medicines or its certain stage;

18) the registration file of medicine - set of the documents submitted for holding procedure of state registration of medicine;

19) reference medicine - the medicine used as medicine of comparison and which is standard by which are determined properties of medicine (are normalized);

20) the risks connected using medicine - any risks connected with quality, safety or efficiency of medicine, influencing health of patients or the population, or the risks leading to undesirable impact on the environment;

21) standard sample - the identified homogeneous substance or mix of substances, held for use in chemical, physical and biological researches which properties are compared to properties of the researched medicine and which have degree of the purity sufficient for their corresponding application;

22) the trade name of medicine - the name under which medicine is registered;

23) examination - the complex, comprehensive, cross-disciplinary assessment of the registration file of medicine directed to confirmation of conformity to its scientific and evidential standards of safety, efficiency (pharmacological examination) and qualities (pharmaceutical examination and laboratory researches).

3. The procedures specified in Item of 1 this Procedure are performed by authorized state body in the field of drug circulation and medical products (further - authorized body).

4. The authorized body guarantees protection of the confidential information containing in the registration file.

Criteria of confidentiality of information containing in the registration file are reference of information to data on production process, the personal data of physical persons or data protected by producer of medicine as trade secret namely: data on personal data of persons participating in clinical trials, production technologies, test methods of medicine and the master file on production of active pharmaceutical substance, being private property of the producer or developer.

5. Storage and destruction of the registration file and the documents submitted for state registration of medicines and modification of the registration file are performed by authorized body according to the Law of the Kyrgyz Republic "About National Archive Fund of the Kyrgyz Republic".

The registration file is stored with observance of requirements of confidentiality irrespective of results of examination.

6. The documents and data included in the registration file and represented by the applicant for state registration of medicine or modification of the registration file shall contain reliable, complete and up-to-date information. The applicant bears responsibility for reliability and completeness of the submitted documents and data.

7. The expenses connected with state registration of medicines, modification of the registration file, and also conducting inspections on compliance to rules proper pharmaceutical the practician within the specified procedures are performed at the expense of means of the applicant.

The authorized body makes out the invoice for payment for holding procedures of state registration, modification of the registration file and laboratory researches within 5 working days from the moment of reception of an application. The applicant makes payment within 45 calendar days from the date of presentation of the invoice for payment.

Time necessary for payment does not enter holding procedures of state registration, modification of the registration file and laboratory researches in time. In case of not introduction by the applicant of payment at the scheduled time the statement and documents attached to it are left without consideration.

8. To the applicant the expenses specified in Item 7 of this Procedure do not return.

Chapter 2. Procedure of state registration of medicines

9. For the purpose of passing of state registration of medicine the applicant submits the following documents to authorized body:

1) the statement on conducting examination of medicine in the form approved by authorized body;

2) the registration file of medicine according to appendix 1 to this Procedure in electronic format by means of the information system "Electronic Database of Medicines and Medical Products", at the same time the module of 1 registration file in addition is represented in duplicate on paper. The instruction on medical application of medicine (leaf insert) and the regulating document on quality are represented by the applicant according to requirements of appendices 2 and 3 to this Procedure.

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