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LAW OF THE KYRGYZ REPUBLIC

of August 2, 2017 No. 165

About drug circulation

Accepted by Jogorku Kenesh of the Kyrgyz Republic on June 21, 2017

Chapter 1. General provisions

Article 1. Subject of regulation of this Law

This Law creates the legal basis of activities of subjects of drug circulation, establishes single requirements to drug circulation in the Kyrgyz Republic, and also governs the relations arising in connection with development, preclinical and clinical trials of medicines, production, production, assessment of their quality, efficiency, safety, realization of medicines and other actions in the sphere of drug circulation.

Article 2. Coverage of this Law

1. This Law is applied to the relations arising in the sphere of drug circulation for medical application in the territory of the Kyrgyz Republic.

2. Operation of this Law extends to the address of narcotic and psychotropic medicines taking into account the features established by the legislation of the Kyrgyz Republic on drugs, psychotropic substances and precursors.

Article 3. The legislation of the Kyrgyz Republic in the sphere of drug circulation

The legislation of the Kyrgyz Republic in the sphere of drug circulation consists of this Law, other regulatory legal acts of the Kyrgyz Republic and come in the procedure established by the law into force of international treaties which participant is the Kyrgyz Republic.

Article 4. The basic concepts used in this Law

For the purposes of this Law the following basic concepts are used:

1) biological medicine - medicine which active ingredient is made or emitted from biological source the description of properties and which quality control requires combination of biological and physical and chemical methods of the analysis to assessment of production process and methods of its control;

2) biosimilar medicine (bioanalogue, biosimilar medicine, biosimilyar) - biological medicine which contains the version of active ingredient of the registered biological original (reference) medicine which day similarity (similarity) on the basis of comparative researches with reference medicine on indicators of quality, biological activity, efficiency and safety is shown;

3) secondary (consumer) package of medicines - packaging in which medicine in primary or intermediate package for realization to the consumer is located;

4) homeopathic medicines - the medicines made of substances of vegetable, animal and mineral origin according to special production technologies of homeopathic medicines;

5) state registration of medicine - process of receipt of permission for medical application of medicine in the territory of the Kyrgyz Republic;

6) preclinical (not clinical) research - chemical, physical, biological, microbiological, pharmacological, toxicological and other types of pilot study or series of researches on studying of substance (medicine) by application of scientific methods of estimates for the purpose of studying of specific action and/or proofs of safety for health of the person;

7) the instruction on medical application of medicine (leaf insert) - the document approved by authorized state body, containing information for the consumer and accompanying medicine in packaging;

8) clinical trial (testing) of medicine - any research with the assistance of the person as object, directed to identification or confirmation of clinical, pharmacological and/or pharmakodinamichesky effects of one or several researched medicines and/or identification of collateral reactions to one or several researched medicines, and/or for studying of absorption, distribution, metabolism and removal of one or several medicines for the purpose of confirmation of its safety and/or efficiency;

9) medicine - medicine in the form of the certain dosage form ready to application;

10) 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;

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

12) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for prevention of diseases of the person, treatment or recovery, correction or change of its physiological function by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and conditions of the person;

13) dosage form - the medicine condition corresponding to methods of its introduction and application and providing achievement of necessary effect;

14) marking of medicines - information placed on primary and/or secondary package of medicine;

15) the international non-proprietary name (INPN) - the name of active ingredient recommended by the World Health Organization;

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