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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 30-05-2024)

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 subject of clinical trial - the physical person participating in clinical trial pharmacological or medicine on voluntary basis from its written consent;

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.

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