Pharmaceutical Activities in Uzbekistan

Pharmaceutical activity is a key element of the public health system, ensuring scientific, manufacturing, and control processes related to medicines and medical devices. With the adoption of Law No. ZRU-399 dated January 4, 2016, Uzbekistan established a renewed legal framework aimed at harmonizing national regulation with international standards and improving access to quality medicines.

According to Article 3 of the Law, pharmaceutical activity includes research and development, production, manufacturing, quality control, and distribution of medicines and medical devices. Its main goal is to ensure the population’s access to safe, effective, and affordable medicines, which is guaranteed by the state under Article 4 of the Law.

System of Regulatory Authorities

The Law defines the system of bodies responsible for implementing state policy:

• Cabinet of Ministers — coordinates overall policy, approves state programs, and determines the procedure for drug registration.
• Ministry of Health — carries out licensing, pharmacovigilance, registration, and quality control of medicines; approves the pharmacopoeia and technical standards.
• Local authorities — implement territorial programs and participate in ensuring the supply of medicines to the population.

Control over the circulation of medicines includes preclinical and clinical trials, ethical review, and state registration, which is a mandatory prerequisite for market access.

Licensing of Pharmaceutical Activities

Pharmaceutical activities in Uzbekistan are subject to licensing, except for research, quality control, and packaging of plant raw materials. A license is issued for five years and may be renewed. The activities of optical stores (retail sale of ophthalmological products) are carried out under a notification procedure.

This differentiation is intended to create a favorable business environment while maintaining strict requirements for the quality and safety of pharmaceutical products.

Main Areas of Pharmaceutical Activity

Article 15 of the Law defines seven areas of activity:

1. Scientific research on drug development;
2. Manufacture of medicines and medical devices;
3. Quality control;
4. Wholesale distribution;
5. Retail distribution;
6. Manufacturing in pharmacies;
7. Packaging and sale of plant raw materials.

Each area requires separate organizational and legal arrangements that meet sanitary, technological, and ethical standards.

Manufacturing and Pharmacy Practice

The manufacture of medicines is allowed only under approved technologies and with quality control departments in place. The production of falsified or unregistered drugs is prohibited.

Pharmacy organizations are responsible for compliance with the rules for storage, dispensing, and quality of medicines. Pharmacy managers must have a pharmaceutical or medical education, and all operations must comply with sanitary regulations.

Ethical and Social Aspects

The Law introduces the institution of ethical review for clinical trials, involving representatives of civil society and non-profit organizations. Special attention is paid to informed consent of research participants, insurance of their life and health, and state pharmacovigilance as a post-registration control system.

Pharmaceutical activity in the Republic of Uzbekistan represents a comprehensive system that combines state regulation, scientific and technical innovation, and social responsibility. Law No. ZRU-399 has become the cornerstone of a transparent pharmaceutical market aligned with international GMP and GCP standards and prioritizing patients’ rights and quality of life.

Algorithm for Licensing and Registration of Pharmaceutical Activities

№	Stage of the Procedure	Description of Actions	Competent Authority
1	Determining the type of activity	The applicant identifies the type of pharmaceutical activity: manufacturing, wholesale or retail trade, pharmacy production, packaging of plant raw materials, etc.	—
2	Preparation of documents for a license	Founding documents, information on staff qualifications, sanitary approval, technical equipment, floor plan, confirmation of the head pharmacist’s education (higher or pharmaceutical).	—
3	Submission of application for a license	Application with supporting documents submitted to the Ministry of Health of the Republic of Uzbekistan or another authorized body.	Ministry of Health
4	Review and issuance of license	Verification of compliance with sanitary and pharmaceutical standards, decision-making, and issuance of license for a term of 5 years (or shorter upon request).	Ministry of Health
5	Registration of medicines	For market circulation — state registration of medicines, medical devices, and equipment (entry into the State Register).	Ministry of Health
6	Publication in the State Register	Registered medicines and devices are included in the State Register and published on the official website of the Ministry of Health.	Ministry of Health
7	Renewal of the license	Upon expiration (5 years), an application for renewal must be submitted no later than three months before expiry.	Ministry of Health
8	Exemption from licensing	Research activities, quality control, packaging, and wholesale of plant raw materials are exempt from licensing.	—
9	Optical activities (ophthalmology)	Retail sale of ophthalmic products is carried out under a notification procedure, without a license.	Authorized body
10	Control and supervision	Licensees must comply with sanitary, pharmaceutical, and ethical standards; supervision is carried out by the Ministry of Health.	Ministry of Health