of January 12, 2024 No. 13
About drug circulation
Accepted by Jogorku Kenesh of the Kyrgyz Republic on November 22, 2023
Subject of regulation of this Law are the relations arising in connection with drug circulation, the special control of transportation, storage, production, production, realization, destruction and utilization relating to socially important products and being specific goods owing to possible damnification to health and human life, requiring.
This Law creates the legal basis of activities of subjects of drug circulation, establishes single requirements to drug circulation in the Kyrgyz Republic, including governs the relations arising in connection with development of medicines, preclinical (not clinical) and clinical trials (testing) of medicines, production, production, assessment of their quality, efficiency, safety, realization of medicines and other actions in the field of drug circulation.
1. This Law determines procedure for 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.
The legislation of the Kyrgyz Republic in the field of drug circulation consists of this Law, other regulatory legal acts of the Kyrgyz Republic and international treaties which became effective according to the legislation of the Kyrgyz Republic.
For the purposes of this Law the following basic concepts are used:
1) active pharmaceutical substance (pharmaceutical substance) - the medicine intended for production and production of medicines;
2) drugstore - the complex of specialized rooms (the specialized room) and the equipment intended for pharmaceutical production and/or realization, leave of medicines, medical products and other goods of pharmaceutical assortment;
3) 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);
4) secondary (consumer) package of medicines - packaging in which medicine in primary or intermediate package for realization to the consumer is located;
5) preclinical (not clinical) trial (testing) - chemical, physical, biological, microbiological, pharmacological, toxicological and other pilot study or series of researches on studying of substance (medicine) by use of scientific evaluation methods for the purpose of studying of specific action and/or proofs of safety for health of the person;
6) production of medicines - the type of activity in the field of drug circulation including acquisition of initial materials, medicine production, storage, quality control, registration in pharmaceutical conditions and realization/leave of ready medicines;
7) the instruction on medical application of medicine (leaf insert) - the document approved by authorized state body in the field of health care, containing information for the consumer and accompanying medicine in packaging;
8) the initial materials used in production of medicines - pharmaceutical substances, excipients, primary, intermediate and secondary packages, including materials for their production in production process;
9) quality of medicine - the set of properties and characteristics of pharmaceutical substance or medicine providing their compliance to the regulating document on quality/specification/pharmacopoeia;
10) clinical trial (testing) of medicine - studying of diagnostic, medicinal, preventive, pharmacological properties of medicine in the course of its medical application the subject of research, including processes of absorption, distribution, metabolism and removal, by use of scientific methods of estimates for the purpose of the receipt of proofs of safety and efficiency of medicine this about undesirable reactions of human body to medical application of medicine and about effect of its interaction with other medicines and/or foodstuff;
11) medicine - medicine in the form of certain dosage form, ready to use;
12) 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;
13) 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;
14) dosage form - the medicine condition corresponding to methods of its introduction and use and providing achievement of necessary effect;
15) marking of medicines - information placed on primary and/or secondary package of medicine;
16) proper regulatory practice on regulation of the sphere of drug circulation - the rules regulating activities of authorized state body in the field of health care on ensuring the principles of legality, sequence, independence, impartiality, proportionality, flexibility, clarity, efficiency and transparency of regulation of the sphere of drug circulation;
17) proper pharmaceutical practicians in the field of drug circulation (further - proper pharmaceutical practicians) - the rules extending to all stages of drug circulation: proper laboratory practice (GLP), proper clinical practice (GCP), proper production practice (GMP), proper distributor practice (GDP), proper pharmaceutical practice (GPP), proper practice of pharmakonadzor (GVP) and other practicians;
18) narcotic medicines - the medicines which are drugs or containing the drugs included in lists of the drugs, psychotropic substances and precursors which are subject to control in the Kyrgyz Republic;
19) substandard (substandard) medicines - the medicines not suitable for use owing to discrepancy to the regulating document on quality/specification/pharmacopoeia;
20) undesirable reaction - the inadvertent adverse reaction of organism connected using the medicinal (researched) drug;
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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