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LAW OF THE REPUBLIC OF UZBEKISTAN

of April 25, 1997 No. 415-I

About medicines and pharmaceutical activities

(as amended on 21-07-2020)

Chapter 1. General provisions

Article 1. Purpose of this Law

The purpose of this Law is regulation of the relations in the field of medicines and pharmaceutical activities.

Article 2. Legislation on medicines and pharmaceutical activities

The legislation on medicines and pharmaceutical activities consists of this Law and other acts of the legislation.

If the international treaty of the Republic of Uzbekistan establishes other rules, than those which are stipulated by the legislation the Republic of Uzbekistan about medicines and pharmaceutical activities then are applied rules of the international treaty.

Article 3. Basic concepts

In this Law the following basic concepts are applied:

medicines - the means received on the basis of medicinal substances (substances) and excipients, medicinal substances (substances), medicines allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for change of condition and functions of human body;

medicinal substances (substances) - the substances of natural or synthetic origin having pharmacological, immunological or metabolic activity or used for the diagnostic purposes, allowed for use in medical practice;

the medicines - dosed, the packed medicines ready to application;

medicinal vegetable raw materials - the plants or their parts containing biologically active agents used for production and production of medicines;

the recipe - written specifying of the doctor to the specialist with pharmaceutical education about production and (or) leave of medicine and method of its application;

substandard medicine and product of medical appointment - the medicine and product of medical appointment which became useless and (or) expired;

products of medical appointment - the products allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for change of condition and functions of human body;

medical equipment - devices, the equipment, devices, tools, devices and complexes allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for identification and change of condition and functions of human body;

pharmacological means - the substances or mix of substances having certain dosage form, with the pharmacological activity established in preclinical researches and safety, being objects of clinical trial;

pharmaceutical activities - the activities covering research work on creation of medicines and products of medical appointment, and also their production, production, control of quality and realization;

illegal copies of the medicines registered in the Republic of Uzbekistan - the medicines which arrived in the address with violations of the law about intellectual property;

counterfeited medicine and product of medical appointment - the medicine and product of medical appointment accompanied with false information about structure or the characteristic or about the producer.

Article 4. The state guarantees in the field of providing the population with the main medicines and products of medical appointment

The state guarantees availability of the main medicines, and also products of medical appointment and their quality.

Chapter 2. Powers of state bodies in the field of medicines and pharmaceutical activities

Article 5. Powers of the Cabinet of Ministers of the Republic of Uzbekistan in the field of medicines and pharmaceutical activities

Cabinet of Ministers of the Republic of Uzbekistan:

provides realization of single state policy in the field of medicines and pharmaceutical activities;

approves state programs in the field of medicines and pharmaceutical activities and exercises control of their realization;

coordinates activities of bodies of the public and economic board in the field of medicines and pharmaceutical activities;

determines procedure for state registration of medicines, products of medical appointment and medical equipment.

The Cabinet of Ministers of the Republic of Uzbekistan can perform also other powers according to the legislation.

Article 6. Powers of the Ministry of Health of the Republic of Uzbekistan in the field of medicines and pharmaceutical activities

Ministry of Health of the Republic of Uzbekistan:

participates in development and implementation of state programs in the field of medicines and pharmaceutical activities;

creates the state order and provides control of availability in the public medical institutions of medicines from the List of the main medicines, and also products of medical appointment;

performs in accordance with the established procedure licensing of pharmaceutical activities (except for licensing of the direction of pharmaceutical activities - retail sale of medicines and products of medical appointment);

provides preferential leave of medicines to separate categories of persons according to the procedure, established by the Cabinet of Ministers of the Republic of Uzbekistan;

approves regulatory legal acts in the field of medicines and products of medical appointment, regulating documents in the field of technical regulation;

claims and publishes the State pharmacopeia;

exercises in accordance with the established procedure state registration, quality control, standardization and certification of medicines, products of medical appointment and medical equipment;

establishes procedure for realization, leave, distribution, storage and accounting of the drugs, psychotropic substances and precursors allowed for use in medical practice and also procedure for realization, leave, storage and accounting of ethyl alcohol;

conducts and periodically publishes the State register of the medicines, products of medical appointment and medical equipment allowed for use in medical practice;

stops production, production, import, realization of medicines and products of medical appointment in the presence of the facts certifying their harmful effects. The suspension of production and production of medicines, products of medical appointment (except as specified suspensions of production and production of medicines and products of medical appointment to term no more than ten working days in connection with prevention of emergence of emergency situations, epidemics and other real threat of life and to health of the population) involving suspension of operations of subjects of entrepreneurship is performed judicially;

performs pharmakonadzor;

develops and approves the List of the orphan medicines intended for treatment of rare diseases, the List of the products of medical appointment intended for diagnostics and treatment of rare (orphan) diseases;

creates the order of the Ministry of Health of the Republic of Uzbekistan on supply of medicines, products of medical appointment and the medical equipment used in case of prevention, diagnostics and treatment of especially dangerous infections, and also the infections posing epidemiological threat;

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