Article 1. Amendments and additions shall be introduced into the Law of the Republic of Uzbekistan No. 415-I of April 25, 1997 “On Medicines and Pharmaceutical Activity” (Bulletin of the Oliy Majlis of the Republic of Uzbekistan, 1997, Nos. 4-5, Article 120; 1999, No. 5, Article 124; Bulletin of the Chambers of the Oliy Majlis of the Republic of Uzbekistan, 2006, No. 10, Article 536; 2009, No. 9, Article 336; 2014, No. 9, Article 244) and its new edition shall be approved (attached).

Article 2. The Cabinet of Ministers of the Republic of Uzbekistan shall:

bring government decisions in line with this Law;

ensure that state management bodies review and repeal their normative legal acts that contradict this Law.

Article 3. This Law shall enter into force from the date of its official publication.

The purpose of this Law is to regulate relations in the field of medicines and pharmaceutical activity.

The legislation on medicines and pharmaceutical activity consists of this Law and other legislative acts.

If an international treaty of the Republic of Uzbekistan establishes rules other than those provided for by the legislation of the Republic of Uzbekistan on medicines and pharmaceutical activity, the provisions of the international treaty shall apply.

The following basic concepts are used in this Law:

medicines — means obtained on the basis of medicinal substances (substances) and excipients, permitted for use in medical practice for the prevention, diagnosis, and treatment of diseases, as well as for changing the condition and functions of the human body; medicinal substances (substances), medicinal preparations;

medicinal substances (substances) — natural or synthetic substances having pharmacological, immunological, or metabolic activity, or used for diagnostic purposes, permitted for use in medical practice;

medicinal preparations — dosed, packaged, ready-to-use medicines;

medicinal plant raw material — plants or parts thereof containing biologically active substances, used for the manufacture and preparation of medicines;

subject of clinical research — a natural person who voluntarily participates in clinical research of a pharmacological agent or medicine on the basis of written consent;

prescription — a written instruction of a doctor to a pharmaceutical specialist to prepare and/or dispense a medicinal preparation and on its method of application;

low-quality medicine and medical product — a medicine or medical product that has become unusable and/or whose shelf life has expired;

medical products — items permitted for use in medical practice for the prevention, diagnosis, and treatment of diseases, as well as for changing the condition and functions of the human body;

medical equipment — apparatus, equipment, devices, instruments, tools, and complexes permitted for use in medical practice for the prevention, diagnosis, and treatment of diseases, as well as for determining and changing the condition and functions of the human body;

pharmacological agents — a substance or mixture of substances with a specific dosage form, pharmacological activity, and safety identified in preclinical studies, which are objects of clinical research;

pharmaceutical activity — activity covering research and development of medicines and medical products, their production, preparation, quality control, and sale;

illegal copies of medicines registered in the Republic of Uzbekistan — medicines put into circulation in violation of intellectual property legislation;

counterfeit medicine and medical product — medicine or medical product with false information attached about its composition or properties, or about its manufacturer.

The State guarantees access to essential medicines, as well as medical products, and their quality.

The Cabinet of Ministers of the Republic of Uzbekistan shall:

ensure the implementation of a unified state policy in the field of medicines and pharmaceutical activity;

approve state programs in the field of medicines and pharmaceutical activity and exercise control over their implementation;

coordinate the activities of state and economic management bodies in the field of medicines and pharmaceutical activity;

establish the procedure for state registration of medicines, medical products, and medical equipment.

The Cabinet of Ministers of the Republic of Uzbekistan may exercise other powers in accordance with legislation.

The Ministry of Health of the Republic of Uzbekistan shall:

participate in the development and implementation of state programs in the field of medicines and pharmaceutical activity;

form a state order for medicines included in the list of essential medicines, as well as for medical products, and ensure control over their availability in state medical institutions;

carry out licensing of pharmaceutical activity (except retail sale of ophthalmological medical products (optics)) in the prescribed manner;

ensure the preferential provision of certain categories of persons with medicines in the manner established by the Cabinet of Ministers of the Republic of Uzbekistan;

approve normative legal acts in the field of medicines and medical products, as well as normative documents in the field of technical regulation;

approve and publish the State Pharmacopoeia;

ensure state registration, quality control, standardization, and certification of medicines, medical products, and medical equipment in the prescribed manner;

establish the procedure for sale, distribution, storage, and accounting of narcotic drugs, psychotropic substances, and precursors permitted for use in medical practice, as well as for sale, storage, and accounting of ethyl alcohol;

maintain and periodically publish the state register of medicines, medical products, and medical equipment permitted for use in medical practice;

suspend the production, preparation, import, and sale of medicines and medical products in cases where facts confirming their harmful effects are available. Suspension of production and preparation of medicines and medical products leading to suspension of business activity (except cases of suspension for not more than ten working days to prevent emergencies, epidemics, and other real threats to life and health of the population) shall be carried out by court procedure;

carry out pharmacological control;

develop and approve the list of orphan medicines intended for the treatment of rare diseases, as well as the list of medical products intended for the diagnosis and treatment of rare (orphan) diseases;

form the order of the Ministry of Health of the Republic of Uzbekistan for the supply of medicines, medical products, and medical equipment used for prevention, diagnosis, and treatment of highly dangerous infections and other epidemiologically significant infections;

approve the procedure for classifying medicines as prescription and non-prescription;

develop and approve the list of essential medicines at least once every two years;

approve the list of medical products.

The Ministry of Health of the Republic of Uzbekistan may exercise other powers in accordance with legislation.

Local state authorities shall:

participate in the implementation of state programs in the field of medicines and pharmaceutical activity;

approve and implement regional programs in the field of medicines and pharmaceutical activity;

participate in providing state healthcare institutions and the population in the relevant territory with medicines and medical products;

participate in organizing and conducting information and explanatory work among the population on issues of circulation of medicines and pharmaceutical activity.

Local state authorities may exercise other powers in accordance with legislation.

The State Pharmacopoeia is an official publication consisting of a set of documents that include requirements for medicines and medical products, general pharmacopeial articles, pharmacopeial articles, and methods for quality control of medicines and medical products.

A general pharmacopeial article establishes general requirements for the quality of medicines and medical products, for medicinal plant raw materials, for methods of their quality control, for standard samples and reagents used in the quality control of medicines, and for packaging materials used in the manufacture of medicines.

A pharmacopeial article establishes requirements for the quality of a specific medicine, medical product, medicinal plant raw material, or excipient.

The development of general pharmacopeial articles and pharmacopeial articles and their inclusion in the State Pharmacopoeia shall be carried out by the Ministry of Health of the Republic of Uzbekistan in the prescribed manner.

The State Pharmacopoeia shall be published by the Ministry of Health of the Republic of Uzbekistan at least once every five years. During the period between reprints of the State Pharmacopoeia, supplements to the State Pharmacopoeia shall be published.

Preclinical studies of pharmacological agents or medicines shall include chemical, physical, biological, microbiological, pharmacological, toxicological, and other studies aimed at examining the safety and efficacy of pharmacological agents or medicines.

Preclinical studies of medical products shall include chemical, physical, technical, biological, microbiological, toxicological, and other studies aimed at examining the safety of medical products.

The organization and conduct of preclinical studies of pharmacological agents, medicines, or medical products shall be carried out by their developers and manufacturers in the prescribed manner and may be conducted in research institutions, organizations engaged in quality control of medicines, higher education institutions, and other organizations that have the necessary material and technical base and qualified specialists in the relevant field of research.

Clinical trials of pharmacological agents or medicines shall be conducted to study their pharmacological properties and to obtain information on adverse effects and interaction with other medicines for the purpose of determining safety and efficacy.

Clinical trials of pharmacological agents or medicines may be conducted in one treatment-and-prophylactic institution or, as a multicenter clinical trial, in more than one treatment-and-prophylactic institution according to a single protocol.

The decision to conduct clinical trials of pharmacological agents or medicines in humans shall be made by the Ministry of Health of the Republic of Uzbekistan.

The grounds for deciding to conduct clinical trials of pharmacological agents or medicines shall be:

results of preclinical studies confirming the safety and efficacy of pharmacological agents or medicines;

information that the potential risk of adverse effects from the use of the pharmacological agent or medicine is significantly lower than the expected beneficial effect.

Clinical trials of pharmacological agents or medicines shall not be permitted without a conclusion of an ethics expertise confirming that the conduct of such trials is ethically justified. Participation of a clinical trial subject in a clinical trial of a pharmacological agent or medicine shall be voluntary on the basis of his or her written consent. The head of the clinical trial must provide the clinical trial subject with a detailed explanation of the significance of the study method, the essence of the study, and the potential risk. A clinical trial subject has the right to refuse to participate at any stage of the study.

If a clinical trial of a pharmacological agent or medicine is conducted with the participation of a minor or a legally incapable clinical trial subject, written consent must be obtained prior to the start of the study from his or her parents or other legal representatives.

Before conducting a clinical trial involving minor clinical trial subjects, as a rule, a clinical trial must have been conducted in adult clinical trial subjects.

Prior to the start of a clinical trial of a pharmacological agent or medicine, the treatment-and-prophylactic institution conducting the trial or the legal entity that provided the pharmacological agent or medicine under study shall conclude with an insurer a civil liability insurance contract for harm caused to the life or health of the clinical trial subject.

If a threat arises to society or to the life or health of the clinical trial subject participating in a clinical trial of a pharmacological agent or medicine, the head of the clinical trial shall stop the clinical trial and notify in writing the Ministry of Health of the Republic of Uzbekistan, which decides on continuation or termination of the study.

Financing of clinical trials of pharmacological agents or medicines shall be carried out at the expense of funds of legal entities that provided the pharmacological agents or medicines under study, or from other sources not prohibited by legislation.

The procedure for conducting clinical trials of pharmacological agents or medicines and the list of treatment-and-prophylactic institutions where clinical trials are conducted shall be approved by the Ministry of Health of the Republic of Uzbekistan.

Ethics expertise shall be carried out for the purpose of issuing a conclusion on the ethical justification of conducting clinical trials of pharmacological agents or medicines.

Ethics expertise shall be conducted by an Ethics Committee operating on a public basis, which shall include representatives of medical and research organizations, higher education institutions, mass media, non-governmental non-profit organizations, and other institutions of civil society.

The regulations on the Ethics Committee and its composition shall be approved by the Ministry of Health of the Republic of Uzbekistan.

As a general rule, the use of medicines, medical products, and medical equipment in medical practice shall be permitted after their state registration.

The following shall be subject to state registration:

medicines (except medicinal substances (substances) used in the manufacture of medicines);

new combinations of medicines registered in the Republic of Uzbekistan;

medicines previously registered in the Republic of Uzbekistan but manufactured in different dosage forms, doses, or by another manufacturer;

medical products;

medical equipment.

State registration of medicines, medical products, and medical equipment shall be carried out by the Ministry of Health of the Republic of Uzbekistan.

Registered medicines, medical products, and medical equipment shall be included in the state register of medicines, medical products, and medical equipment permitted for use in medical practice.

It shall not be permitted to state-register, under the same trade name, medicines with different medicinal substances in their composition. Registration of medicines of the same composition of medicinal substances by one manufacturer under different trade names shall be permitted in the manner established by legislation.

Medicines and medical products prepared in pharmacies shall not be subject to state registration. When a medicine containing new chemical substances is registered, confidential information contained in the registration dossier of the medicine provided shall not be disclosed without the consent of the applicant and shall not be used for commercial purposes for six years from the date of its state registration.

“New chemical substance” means any chemical compound not previously registered within the territory of the Republic of Uzbekistan, regardless of its patentability.

Disclosure and use of the information specified in part seven of this Article without the consent of the applicant shall be permitted on the basis of a court decision if one of the following circumstances exists:

within twelve months from the date of its state registration in the Republic of Uzbekistan, the supply volume of the medicine is insufficient to meet the needs of the population;

violations of the requirements of competition legislation are identified.

Based on the results of state registration of medicines, medical products, and medical equipment, foreign manufacturers shall be issued the corresponding certificate of registration valid for five years, while local manufacturers shall be issued such certificate without a time limit.

The validity period of the certificate of registration may be extended upon application of the holder of the certificate of registration with the necessary documents attached. The application for extension of the validity period of the certificate of registration must be submitted within three months prior to the expiry of the validity period of the certificate. Extension of the validity period of the certificate of registration shall be carried out in the manner provided for issuing the certificate of registration.

After the expiry of the validity period of the certificate of registration, the sale and use in medical practice of medicines, medical products, and medical equipment shall be permitted if they were manufactured during the validity period of the certificate of registration.

The holder of the certificate of registration shall notify the Ministry of Health of the Republic of Uzbekistan of new information relating to the safety, quality, and efficacy of the medicine, medical product, and medical equipment.

Pharmacological control is an activity aimed at detecting, assessing, and preventing adverse reactions — unintended and undesirable effects on the body — that are observed in humans when a medicine is used in accordance with its instructions for use.

Treatment-and-prophylactic institutions, pharmacies, and organizations that manufacture, sell, and use medicines must notify the Ministry of Health of the Republic of Uzbekistan in writing of all cases in which adverse reactions are detected during the use of medicines.

The Ministry of Health of the Republic of Uzbekistan shall evaluate adverse reactions identified during the use of medicines; in the course of evaluation, it shall determine causal links between the clinical manifestations of the adverse reaction and the use of the medicine, as well as the ratio of the expected benefit to the potential risk of using medicines.

If facts are identified that affect the ratio of the expected benefit to the potential risk of using medicines, manufacturers and their representatives must take measures to eliminate adverse consequences, to prevent harm to human life or health, and to protect against the use of such medicines.

If evidence is found of non-compliance of a medicine, when used, with the established requirements for safety and efficacy, the Ministry of Health of the Republic of Uzbekistan shall consider the issue of withdrawing such medicine from circulation or suspending its use.

The following information shall be posted on the official website of the Ministry of Health of the Republic of Uzbekistan:

in the state register of medicines, medical products, and medical equipment permitted for use in medical practice;

in the list of orphan medicines intended for the treatment of rare diseases;

in the list of medical products intended for the diagnosis and treatment of rare (orphan) diseases;

in the list of essential medicines;

in the list of medicines, medical products, and medical equipment imported by order of the Ministry of Health of the Republic of Uzbekistan for use in the prevention, diagnosis, and treatment of highly dangerous infections and infections posing an epidemiological threat;

in the list of medical products.

Information on over-the-counter medicines shall be indicated in the instructions for the use of medicines in medical practice, as well as in the state register of medicines, medical products, and medical equipment permitted for use in medical practice. Information on over-the-counter medicines may also be provided in mass media and in specialized print publications.

Information on prescription medicines and medical products shall be provided only in specialized print publications intended for medical and pharmaceutical workers, in the instructions for the use of medicines and medical products in medical practice, as well as in the state register of medicines, medical products, and medical equipment permitted for use in medical practice.

Advertising of medicines shall be carried out in the manner established by legislation.

The areas of pharmaceutical activity shall consist of:

research and development for the creation of medicines and medical products;

manufacture of medicines and medical products;

quality control of medicines and medical products;

wholesale sale of medicines and medical products;

retail sale of medicines and medical products;

preparation (compounding) of medicines and medical products;

packaging and wholesale sale of medicinal plant raw material.

Pharmaceutical activity shall be carried out on the basis of a license granted in the prescribed manner.

A license for carrying out pharmaceutical activity shall be issued for a period of five years. A license may be issued for a period of less than five years only upon the application of the license applicant. The validity period of the license may be extended upon the application of the licensee.

No license shall be required for the following areas of pharmaceutical activity:

manufacture, preparation, and wholesale sale of medical products;

research and development for the creation of medicines and medical products;

quality control of medicines and medical products;

packaging and wholesale sale of medicinal plant raw material.

Use of medicines, medical products, and medical equipment for medical purposes shall be carried out on the basis of a certificate of state registration granted in the prescribed manner. Retail sale of ophthalmological medical products (optics) shall be carried out upon notifying the competent authority in the prescribed manner.

Research and development for the creation of medicines and medical products shall, as a rule, be carried out by research organizations and by manufacturers of medicines and medical products.

Research and development for the creation of medicines shall include the search for new pharmacological agents, subsequent study of their properties, development of the composition of pharmacological agents or medicines, development of technologies for manufacturing medicinal substances (substances) and medicines, conduct of preclinical studies in the prescribed manner, and preparation of normative documents setting out requirements for the safety and quality of pharmacological agents or medicines and for methods of their quality control.

Research and development for the creation of medical products shall include the search for new types of medical products, subsequent study of their technical characteristics, development of manufacturing technologies, and preparation of normative documents setting out requirements for the safety and quality of medical products and for methods of their quality control.

Manufacture of medicines and medical products shall consist of serial production in accordance with the rules for organizing their manufacture and quality control, and shall include production under a full technological cycle or by separate stages thereof.

It shall be prohibited to manufacture counterfeit medicines and medical products, medicines and medical products not registered in the Republic of Uzbekistan, as well as illegal copies of medicines registered in the Republic of Uzbekistan.

Manufacture of medicines and medical products may be carried out under contract by other manufacturers holding the appropriate license, in accordance with the order of a manufacturer of medicines and medical products. In such case, the certificate of state registration for the medicines and medical products shall be issued to the organization that directly manufactures the medicines and medical products under the order.

Manufacture of medicines and medical products intended for state registration, export, research and development, preclinical studies, and clinical trials may be carried out without their state registration.

Manufacturers of medicines and medical products must have internal departmental services responsible for quality control of medicines and medical products.

The rules for labeling and packaging of medicines and medical products shall be approved by the Ministry of Health of the Republic of Uzbekistan.

Wholesale sale of medicines shall be carried out by manufacturers of medicines and by organizations engaged in wholesale sale of medicines that hold an appropriate license for pharmaceutical activity, in accordance with the rules for wholesale sale and storage of medicines and medical products approved by the Ministry of Health of the Republic of Uzbekistan.

Organizations engaged in wholesale sale of medicines and medical products shall have the right to purchase medicines and medical products from manufacturers of medicines and medical products, from other organizations engaged in wholesale sale of medicines and medical products, as well as from foreign manufacturers and wholesale organizations of medicines and medical products.

Organizations engaged in wholesale sale of medicines and medical products shall have the right to sell medicines and medical products to organizations that hold a license for pharmaceutical activity or operate under a notification regime, to manufacturers and wholesale organizations of medical products, to medical organizations, as well as to organizations that use medicines and medical products for their own needs for medical purposes.

Warehouse premises of organizations engaged in wholesale sale of medicines and medical products must meet the requirements of sanitary rules, norms, and hygiene standards. A warehouse manager of an organization engaged in wholesale sale of medicines and medical products must have pharmaceutical education.

It shall be prohibited to purchase and wholesale medicines and medical products that are of poor quality, counterfeit, or not registered in the Republic of Uzbekistan, as well as illegal copies of medicines registered in the Republic of Uzbekistan.

Wholesale sale of medicines and medical products shall be carried out in the manner established by the Cabinet of Ministers of the Republic of Uzbekistan.

Retail sale of medicines and medical products (except ophthalmological medical products) shall be carried out only by pharmacies and their branches.

Retail sale of medicines shall be carried out on the basis of prescriptions in the form approved by the Ministry of Health of the Republic of Uzbekistan, or without prescription.

Retail sale of medicines and medical products that are registered in the Republic of Uzbekistan or prepared by pharmacies shall be permitted.

It shall be prohibited to purchase, retail, and use medicines and medical products that are of poor quality, counterfeit, or not registered in the Republic of Uzbekistan, as well as illegal copies of medicines registered in the Republic of Uzbekistan.

Retail sale of medicines and medical products shall be carried out in the manner established by the Cabinet of Ministers of the Republic of Uzbekistan.

A pharmacy may be established as a legal entity holding the appropriate license to retail and to prepare medicines and medical products, or as a structural subdivision of a legal entity.

Pharmacy branches and pharmacies of treatment-and-prophylactic institutions shall also be deemed pharmacies.

Pharmacies may sell sanitary and hygiene items, therapeutic nutrition products, mineral waters, as well as therapeutic and cosmetic products and biologically active supplements, provided that the documents required for their use and sale are available.

A pharmacy manager must have higher medical or higher pharmaceutical education.

A manager of a pharmacy branch must have pharmaceutical education.

Pharmacies must comply with the rules for preparation, dispensing, and sale of medicines and medical products and with storage conditions that ensure their quality.

Pharmacies must meet the requirements of sanitary rules, norms, and hygiene standards.

Activity for retail sale of ophthalmological medical products (optics) may be carried out by establishing an optics outlet (a point for the sale of ophthalmological medical products) as a legal entity or as a structural subdivision of a legal entity, upon notifying the competent authority of the commencement of such activity in the prescribed manner. Branches of optics outlets and optics of treatment-and-prophylactic institutions shall also be deemed optics.

Legal entities holding a license for retail sale of medicines and medical products shall not be required to notify the competent authority in order to carry out activity for retail sale of ophthalmological medical products (optics).

Managers of optics outlets and their branches must have higher or secondary specialized pharmaceutical education.

Activity for retail sale of ophthalmological medical products (optics) must be carried out in accordance with the rules for preparation, dispensing, and sale of ophthalmological medical products and with storage conditions that ensure their quality.

Activity for retail sale of ophthalmological medical products (optics) must be carried out in compliance with the requirements of sanitary rules, norms, and hygiene standards.

Medicines shall be prepared in pharmacies from medicinal substances (substances) permitted for use by the Ministry of Health of the Republic of Uzbekistan.

Preparation of medicines not included in the List of Medicines Permitted for Preparation, approved by the Ministry of Health of the Republic of Uzbekistan, shall be prohibited.

Preparation and storage of medicines and medical products, their quality control, and their documentation shall be carried out by pharmacies in the manner established by the Ministry of Health of the Republic of Uzbekistan.

Organizations holding a license for pharmaceutical activity, medical organizations, as well as organizations that use medicines and medical products for their own needs for medical purposes shall be permitted to store medicines and medical products.

Storage and transportation of medicines and medical products must be carried out under conditions that ensure their safety, quality, and integrity.

It shall be prohibited to store and transport for the purpose of sale medicines and medical products that are of poor quality, counterfeit, or not registered in the Republic of Uzbekistan, as well as illegal copies of medicines registered in the Republic of Uzbekistan.

Medicines and medical products that are of poor quality, counterfeit, or not registered in the Republic of Uzbekistan, illegal copies of medicines registered in the Republic of Uzbekistan, as well as medicines and medical products in circulation, if facts confirming their harmful effects on human health are identified, must be withdrawn from circulation and destroyed in the manner established by the Cabinet of Ministers of the Republic of Uzbekistan.

Destruction of medicines and medical products shall be carried out at the expense of their owners.

Export and import of medicines and medical products, including export and import of medicines and medical products intended for research and development, preclinical studies, clinical trials, state registration, and for display at exhibitions, fairs, and international conferences, shall be carried out in the manner established by legislation.

Import of medicines and medical products that are of poor quality, counterfeit, or not registered in the Republic of Uzbekistan, as well as illegal copies of medicines registered in the Republic of Uzbekistan, shall be prohibited.

Import of orphan medicines and of medical products used for the diagnosis and treatment of orphan diseases, as well as import of medicines, medical products, and medical equipment used for the prevention, diagnosis, and treatment of highly dangerous infections and infections posing an epidemiological threat, imported by order of the Ministry of Health of the Republic of Uzbekistan, may be carried out without state registration.

In the following cases, bringing medicines and medical products into and out of the country without state registration and without customs clearance shall be permitted, if they:

are intended for personal use by natural persons during their stay in the country;

are intended for the treatment, within the course of therapy, of a patient residing within or outside the territory of the Republic of Uzbekistan, on the basis of a medical indication confirmed by a treatment-and-prophylactic institution;

are intended for the personal use of diplomatic and administrative-technical staff of diplomatic missions and missions equated thereto, including family members residing with them;

are included in the contents of a first-aid kit intended for providing first aid to passengers of a vehicle entering the territory of the Republic of Uzbekistan or leaving its territory.

Bringing medicines and medical products into and out of the country for the treatment of participants of international scientific, cultural, and sports events, and of participants of international expeditions, shall be carried out in the manner established by the Cabinet of Ministers of the Republic of Uzbekistan.

Disputes in the field of medicines and pharmaceutical activity shall be settled in the manner established by legislation.

Persons guilty of violating legislation on medicines and pharmaceutical activity shall be liable in the manner prescribed.