ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of August 28, 2018 No. 405

About some questions connected with state registration in the field of drug circulation

For the purpose of implementation of Articles 9, of 11, 12 Laws of the Kyrgyz Republic "About drug circulation", according to articles 10 and 17 of the constitutional Law of the Kyrgyz Republic "About the Government of the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

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

2. Determine that:

- state registration of medicine till July 1, 2021 is 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;

- confirmation of state registration and modification of the registration file of medicine till December 31, 2025 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;

- requirements established in appendices 1 and 4 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 are imposed to the documents and data of the registration file of medicine used in that order, except for requirements to the regulating document on quality and to the instruction on medical application of medicine;

- effective period of registration certificates about state registration of the medicines issued according to the Procedure approved by Item 1 of this resolution remains before the termination of term of their action, but no later than December 31, 2025;

- requirements of the European pharmacopeia are recognized quality of the main pharmacopeia of the first level, the requirement of the British Pharmacopoeia, United States Pharmacopoeia - as pharmacopeias of the second level according to Item 2 of the Section VII of the Concept of the harmonization of pharmacopeias of state members of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of September 22, 2015 No. 119. 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 are used;

- marking of medicines for medical application is performed according to the Requirements to marking of medicines for medical application and veterinary medicines approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 76;

- conduct of clinical trials of medicines is performed according to the Rules of proper clinical practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 79;

- carrying out preclinical (not clinical) trials (testing) of medicines is performed according to the Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 81.

3. Bring in the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Medicines for Medical Application" of April 6, 2011 No. 137 the following changes:

in the Technical regulation "About Safety of Medicines for Medical Application" approved by the above-named resolution:

- Chapters 3, of 4, 11 to recognize invalid;

- to recognize Items 280-390 of Chapter 14 invalid;

- appendices 7, of 8, 19 to the above-stated Technical regulation to recognize invalid.

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

- bring the decisions into accord with this resolution;

- take the necessary measures following from this resolution;

- make offers in accordance with the established procedure on modification of the Unified register (list) of the state services rendered by state bodies, their structural divisions and subordinated organizations, No. 85 approved by the order of the Government of the Kyrgyz Republic of February 10, 2012.

5. To impose control of execution of this resolution on department of social development of Government office of the Kyrgyz Republic.

6. This resolution becomes effective after six months from the date of official publication.

Appendix

Approved by the Order of the Government of the Kyrgyz Republic of August 28, 2018, No. 405

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:

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);

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;

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;

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;

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;

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