Registration of Medicines in Uzbekistan

The registration of medicines (drugs) is a key instrument of state control ensuring the safety, efficacy, and quality of pharmaceutical products. According to Resolution No. 213 of the Cabinet of Ministers dated March 23, 2018, registration represents a comprehensive procedure aimed at authorizing medicinal products, medical devices, and medical equipment for medical use in the Republic of Uzbekistan.

This system ensures the protection of public health and the harmonization of national procedures with international standards.

Regulatory Framework

The main regulatory instruments include:

• The Law of the Republic of Uzbekistan “On Medicinal Products and Pharmaceutical Activities”;
• Presidential Resolutions Nos. PP-3052 (June 12, 2017), PP-3489 (January 23, 2018), and PP-3532 (February 14, 2018) aimed at developing the pharmaceutical sector;
• Cabinet of Ministers Resolution No. 213 of March 23, 2018, which approved the Regulation on the Procedure for State Registration of Medicinal Products, Medical Devices, and Medical Equipment.

These acts establish the requirements for the composition of registration materials, timelines and procedures for expert examination, as well as the competence of state authorities.

Key Definitions and Participants

The Regulation provides detailed terminology, including definitions of “medicinal products,” “medical devices,” “medical equipment,” and “pharmaceutical substances.”

The central registration authority is the State Institution “Center for Pharmaceutical Product Safety” under the Ministry of Health. Applicants may be legal entities — manufacturers or their authorized representatives.

Stages of State Registration

The registration procedure includes several key stages:

1. Submission of Application and Documents. Electronic submission of an application and registration dossier with the applicant’s electronic digital signature.
2. Expert Examination of Documents and Samples. Conducted by specialized laboratories and expert committees (Pharmacopoeial, Pharmacological, and New Medical Equipment Committees).
3. Laboratory, Toxicological, and Clinical Studies. Performed in accordance with GCP and GMP standards.
4. Review by the Expert Council of the Ministry of Health.
5. Issuance of the Certificate of State Registration. (valid for 5 years for foreign manufacturers; indefinite for domestic manufacturers).

Scientific and Expert Component

The expert examination aims to provide a comprehensive assessment of the product’s quality, safety, and efficacy. It evaluates:

• compliance with pharmacopoeial and normative documentation;
• data from preclinical and clinical trials;
• protection of intellectual property rights (trademarks, patents);
• evidence of GMP compliance at the manufacturing facilities.

Medicinal products pre-qualified or registered by the World Health Organization (WHO) may be accepted without additional clinical trials, ensuring international recognition of results.

Economic and Legal Aspects

Applicants must pay registration fees established as multiples of the Base Calculation Value (BCV).

• The fee for application review — 10 × BCV;
• The fee for issuing the certificate — 2 × BCV. Additionally, foreign manufacturers pay for services according to the price list approved by the Ministry of Health.

Terms and Specifics of Review

The review duration depends on the product category:

• 15 days — for products registered under the recognition principle;
• 50 to 155 days — depending on product type;
• up to 120 days — for pharmacopoeial plant raw materials and polymer-based products.

If clinical trials are conducted, the review period may be extended — up to 1 year for generics or up to 3 years for original medicines.

International Cooperation and Recognition

The Republic of Uzbekistan is gradually implementing the principle of mutual recognition of registrations of medicinal products approved in countries with developed regulatory systems (EU, USA, Japan, etc.) and by international organizations such as the WHO. This fosters integration of the national system into the global pharmaceutical framework and enhances the competitiveness of domestic manufacturers.

The registration of medicinal products in Uzbekistan is a comprehensive, scientifically grounded, and legally structured procedure ensuring a balance between the interests of patients, the state, and the business sector.
The system established by Resolution No. 213 complies with international quality standards and serves as a mechanism for protecting public health, stimulating the development of the national pharmaceutical industry, and promoting integration into the global medical community.

State Registration Procedure of Medicines (Drugs)

№	Stage of Procedure	Sub-stages and Specific Actions	Timeframe	Responsible Authorities
1	Submission of Application	• Electronic submission of an application with the registration dossier and product samples. • Documents certified by EDS. • Includes data on composition, manufacturer, quality-control methods, and storage conditions.	On the day of submission	Applicant, Center for Pharmaceutical Product Safety
2	Registration Dossier	• Electronic set of documents, including: – Administrative section; – Pharmaceutical section (composition, technology, quality control); – Pharmacological-toxicological section; – Clinical section; – Data on GMP, GCP, GVP; – Documents on trademarks and patents.	On the day of submission	Applicant
3	Primary Examination	• Verification of completeness and accuracy of the dossier. • Verification of intellectual property rights (patents, trademarks). • Conclusion on the possibility of further review.	Up to 15 working days	Center for Pharmaceutical Product Safety
4	Expert Evaluation and Testing	• Examinations: – Chemical-pharmaceutical; – Biological; – Toxicological; – Pharmacological. • Inspection of manufacturing conditions (GMP). • Laboratory analyses, bioequivalence, and clinical studies. • Verification of IP rights and compliance with international norms.	15 – 155 days (depending on product category)	Laboratories of the Center, Pharmacopoeial Committee, Pharmacological Committee, New Medical Equipment Committee
5	Expert Committees	• Pharmacopoeial Committee — approves normative documentation. • Pharmacological Committee — assesses efficacy and safety. • Committee on New Medical Equipment — evaluates technical parameters. • Committee on Narcotics Control — analyzes composition. • Pharmaceutical Inspection — verifies manufacturing conditions.	15 – 120 days	Relevant Committees of the Ministry of Health
6	Expert Council of the Ministry of Health	• Review of conclusions from committees and laboratories. • Decision on registration or refusal. • Preparation of final conclusion and registration certificate.	Within 5 working days after receiving all expert opinions	Expert Council of the Ministry of Health
7	Issuance of Certificate	• The certificate confirms registration and authorization for medical use. • Validity: 5 years (for foreign manufacturers) / indefinite (for domestic).	1 working day after decision	Center for Pharmaceutical Product Safety
8	State Fees	• 10 × BCV – for application review. • 2 × BCV – for issuance of certificate. • For foreign manufacturers – payment according to MoH price list.	Before submission and upon receipt of certificate	Applicant, Ministry of Health
9	Special Cases (Exemptions)	• Not subject to registration: – Substances for manufacturing; – Medicines for R&D and clinical trials; – Products for exhibitions and humanitarian aid. • Requires Ministry of Health conclusion.	Ongoing	Ministry of Health