RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of March 7, 2023 No. 136

About registration, registration confirmation and modification of the registration file of medicines for medical application

For the purpose of implementation of Articles 17, of 18, 20 Laws of the Kyrgyz Republic "About drug circulation", Decisions of Council of the Eurasian economic commission "About Rules of registration and examination of medicines for medical application" of November 3, 2016 No. 78, of the Decision of Council of the Eurasian economic commission "About temporary measures for establishment of drug circulation for medical application" of June 10, 2022 No. 96 and orders of Council of the Eurasian economic commission "About implementation of measures for increase in stability of economies of state members of the Eurasian Economic Union, including ensuring macroeconomic stability" of March 17, 2022 12, 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. Approve the Procedure for state registration of medicines for medical application (further - the Procedure) according to appendix.

2. Determine that:

1) registration, registration confirmation and modification of the registration file of medicine in the Kyrgyz Republic are performed according to the Procedure approved by Item 1 of this resolution or according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78;

2) Procedure provisions are applied to the medicines registered according to Procedure in case of the subsequent confirmation of their registration and modification of their registration file;

3) registration of medicines according to Procedure is performed till December 31, 2024;

4) effective period of registration certificates of the medicines issued according to Procedure is established no later than December 31, 2025;

5) registration confirmation and modification of the registration file of medicine according to Procedure is performed till December 31, 2025;

6) in case of registration, registration confirmation and modification of the registration file of medicine according to Procedure for the requirement of the European pharmacopeia are recognized quality of the main pharmacopeia of the first level, the requirement of the British Pharmacopoeia and United States Pharmacopoeia - as pharmacopeias of the second level. In case of lack of relevant article(s) (monographs) in pharmacopeias of the first and second levels Articles (monograph) of the conventional foreign pharmacopeias, pharmacopeias of the State Parties of intergovernmental agreements in the field of standardization, metrology and certification, national pharmacopeias and standards of manufacturing developers of medicines are used;

7) in case of registration, registration confirmation and modification of the registration file of medicine according to Procedure provisions of Requirements to marking of medicines are applied to the medical application and veterinary medicines approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 76, except as specified, provided by Procedure.

3. In case of consideration of the applications on registration, registration confirmation and modification of the registration file of medicine, arrived before entry into force of this resolution, provisions of this resolution are applied in the part which is not strengthening responsibility of applicants or not worsening their situation.

4. Declare invalid the order of the Government of the Kyrgyz Republic "About some questions connected with state registration in the field of drug circulation" of August 28, 2018 No. 405.

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

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

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

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 fifteen days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of March 7, 2023 No. 136

Procedure for state registration of medicines for medical application

Chapter 1. General provisions

1. The procedure for state registration of medicines for medical application (further - the Procedure) determines procedures of state registration, registration confirmation of medicines, modification of the registration file of medicine, determination of criteria of confidentiality of information containing in the registration file of medicine, carrying out expedited procedure of registration of medicines, forming and maintaining the State register of medicines of the Kyrgyz Republic, issue of the registration certificate about state registration of medicine, suspension of action and cancellation of the registration certificate.

2. The following concepts are according to the procedure used:

1) safety of medicine (ratio "advantage - risk") - assessment of positive therapeutic effects of medicine in relation to the risks connected with its use (the concept of risk includes any risk connected with quality, safety or efficiency of medicine in relation to 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 in 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 and 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 drug there were changes of active ingredient (substances), indications to use, dosages, dosage form or way of introduction in comparison with original drug;

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 - the legal entity, competent to submit the application for state registration, registration confirmation, modification of the registration file of medicines, other procedures connected with registration;

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 drug - the medicine containing in quality of active components exclusively medicinal vegetable raw materials and/or drugs on its basis;

11) proper practice of examination (GRevP) - documentary proper practicians for any aspects connected with process, format, content and the organization of examination of medicines;

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