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LAW OF THE REPUBLIC OF TAJIKISTAN

of August 6, 2001 No. 39

About medicines and pharmaceutical activities

(The last edition from 17-05-2018)

Chapter 1. General provisions

Article 1. Purpose of this Law

This Law determines the legal basis of state policy of the Republic of Tajikistan in the sphere of drug circulation of medical goods and pharmaceutical activities, governs the relations arising in connection with development, production, preclinical and clinical testing, quality control, efficiency and safety, trade in medicines and other relations arising in this sphere.

Article 2. Legislation of the Republic of Tajikistan on medicines and pharmaceutical activities

The legislation of the Republic of Tajikistan on medicines and pharmaceutical activities is based on the Constitution of the Republic of Tajikistan and consists of this Law, other regulatory legal acts of the Republic of Tajikistan and the international legal acts recognized by Tajikistan.

Article 3. The concepts used in this Law

Basic concepts:

The main medicines - the medicines satisfying priority needs of the population for health care;

Medicines - the substances applied to prevention, diagnostics, treatments of diseases, prevention of pregnancy received from blood, blood plasma and also bodies and tissues of the person or animal, plants, minerals, by methods of synthesis or using biological technologies. The substances of vegetable, animal or synthetic origin having pharmacological activity and intended for production and production of medicines and also the dietary supplements and perfumery having lechebnoprofilaktichesky properties belong to medicines.

Medicinal raw materials - the substance of vegetable, animal, mineral, chemical and other origin subjected to partial development and the substrata received from its structure by ad hoc methods having medicinal properties and used for creation and production of medicines.

The registered medicines - the medicines which passed kontrolnoklinichesky tests and the normative and technical examination of authorized state body in health sector and entered in the State Register of medicines.

The reproduced (generic) medicines - the medicines which arrived in the address after expiration of exclusive patent laws on original medicines.

Medical goods - the products and materials applied in medical practice to diagnostics, treatment and prevention of diseases. Materials (dressing, sutural, account) and products concern to them (medical, medical equipment, objects of patient care).

Immunobiological medicines - the medicines intended for immunobiological prevention and immunobiological therapy (vaccine and serum).

Narcotic medicines - the medicines included in the list of drugs constituted and updated according to the Single Convention of the United Nations on drugs of 1961 and the legislation of the Republic of Tajikistan.

Psychotropic medicines - the medicines included in the list of psychotropic drugs constituted and updated according to the Convention of the United Nations on psychotropic substances of 1971 and the legislation of the Republic of Tajikistan.

Poisonous medicines - the medicines carried to the list of poisonous medicines, approved by authorized state body in health sector.

Radioactive medicines - the medicines applied in medical practice and having properties of ionizing radiation.

Counterfeited medicine - the medicine which is not corresponding on structure, properties and other characteristics to the original or the reproduced medicine (generic) of the manufacturer, illegally and purposely supplied with the counterfeit label or false information about structure, date of production and term of use or about producer of medicine.

Herbs - the plants permitted in accordance with the established procedure by authorized state body in health sector for use in prevention and treatment of diseases.

Homeopathic remedies - the drugs applied by homeopathic rules and included in the special Section of the State Register.

Quality of medicines - compliance of medicines to State standard of quality of medicines.

Safety of medicines - the characteristic of medicines based on the comparative analysis of their efficiency and risk degree.

Efficiency of medicines - the characteristic of extent of positive influence of medicines on course of disease.

The quality certificate of medicine - the document confirming compliance of quality of medicine to State standard of quality of medicines.

Pharmakopeyny Article - the standard establishing requirements to medicine, its packaging, conditions and storage durations, methods of the analysis of quality of medicine.

The state pharmacopeia - the code of regulations regulating quality of medicines and methods of their determination.

The state Register of medicines - the regulating document containing data on the medicines permitted to production and application in medical practice.

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