Medicinal Products Registration in Uzbekistan

The state registration of medicinal products in Uzbekistan is regulated by the Ministry of Health of the Republic of Uzbekistan. In accordance with the Law of the Republic of Uzbekistan “On Medicinal Products and Pharmaceutical Activity,” medicinal products may be placed on the market in Uzbekistan only after state registration.

Key registration facts

Procedures for registration of medicinal products in Uzbekistan

Uzbek legislation provides two procedures for the state registration of medicinal products:

• Full national state registration procedure according to Decree No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan dated November 24, 2025;
• Recognition of the state registration by conducting the simplified procedure according to Decree No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan dated November 24, 2025 (applicable only for medicinal products that have been registered in the country, wherein regulatory authorities apply high quality standards: EU Member States
  1. Austria
  2. Belgium
  3. Bulgaria
  4. Croatia
  5. Cyprus
  6. Czechia
  7. Denmark
  8. Estonia
  9. Finland
  10. France
  11. Germany
  12. Greece
  13. Hungary
  14. Ireland
  15. Italy
  16. Latvia
  17. Lithuania
  18. Luxembourg
  19. Malta
  20. Netherlands
  21. Poland
  22. Portugal
  23. Romania
  24. Slovakia
  25. Slovenia
  26. Spain
  27. Sweden
  , Switzerland, UK, USA, Canada, Norway, Liechtenstein, Iceland, Japan, Singapore, Republic of Korea and/or have been registered by one of the following regulatory authorities: US FDA (USA); EMA, European Commission (DG SANTE), National Regulatory Authorities (EU); PMDA (Japan); MFDS (Republic of Korea); MHRA (UK); SFDA (Saudi Arabia); HSA (Singapore).

Requirements for national state registration

To register a medicinal product under the national procedure in Uzbekistan, according to Decree No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan dated November 24, 2025, the applicant must submit a registration dossier in eCTD format to the State Centre for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment under the Ministry of Health, including the following documents:

1. eCTD Module 1, including:
   • Application form;
   • Legalized Power of Attorney from the applicant to the representative;
   • Legalized copies of GMP Certificates for all manufacturing sites involved in the manufacturing process issued by competent authorities of countries-manufacturers with the Report on the results of the last inspection;
   • Legalized copy of a certificate of a pharmaceutical product (CPP) or a Registration Certificate, or a Free Sale Certificate issued by the competent authority of the manufacturer’s country or Registration certificates issued by competent authorities of countries, where said medicinal product is registered (if the product is not registered in the manufacturer’s country);
   • General information on the medicinal product;
   • Summary of product characteristics (SmPC), mock-ups and Instruction for Use (IFU) in the Uzbek language;
   • Normative document for the medicinal product for the Uzbek market;
   • Pharmacovigilance System Master File, Risk Management Plan for a medicinal product and a document certifying the appointment of a local contact person qualified for pharmacovigilance (CPPV) located in the Republic of Uzbekistan.
   • IP protection Certificate related to the medicinal product, if applicable.
2. eCTD Modules 2-5.
3. Samples of the medicinal product and standard samples of one batch in all packaging types with appropriate Certificates of Analysis in an amount required for the triple test as well as special reagents and chromatographic columns (this is not applicable to medicinal products prequalified by WHO).

Clinical Studies and GMP Inspection

Please note that, depending on the type of medicinal product, Uzbek legislation may require the conduct of local clinical studies within the territory of Uzbekistan prior to submission of the registration dossier, as well as a GMP inspection of manufacturing sites by the Uzbek competent authority (either before or during the registration procedure).

This does not apply for the following cases:

1. Medicinal products prequalified by WHO;
2. Medicinal products that have a positive conclusion on clinical studies conducted in the territory of the countries mentioned above as well as a GMP Certificate issued by one of the regulatory authorities of countries applicable for recognition of the state registration by conducting the simplified procedure.

Additionally, the clinical studies are not required for biotechnological medicinal products produced on the basis of cell technology obtained by processing human cells without significant changes.

Requirements for recognition of foreign registration in Uzbekistan

Under the simplified recognition procedure, according to Decree No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan dated November 24, 2025, the applicant must submit a registration dossier to the State Centre, including the following documents:

1. eCTD Module 1, including:
   • Application form;
   • Legalized Power of Attorney from the applicant to the representative;
   • Legalized copies of GMP Certificates for all manufacturing sites involved in the manufacturing process issued by competent authorities of countries-manufacturers with the Report on the results of the last inspection;
   • Legalized copy of a certificate of a pharmaceutical product (CPP) or a Registration Certificate, or a Free Sale Certificate issued by the competent authority of the manufacturer’s country or Registration Certificates issued by competent authorities of countries, where said medicinal product is registered (if the product is not registered in the manufacturer’s country);
   • General information on the medicinal product, mock-ups;
   • Summary of product characteristics (SmPC) and Instruction for Use (IFU) in the Uzbek language;
   • Normative document for the medicinal product for the Uzbek market;
   • Pharmacovigilance System Master File, Risk Management Plan for a medicinal product and a document certifying the appointment of a local contact person qualified for pharmacovigilance (CPPV) located in the Republic of Uzbekistan.
2. eCTD Modules 2-5.
3. Samples of the medicinal product in all packaging types with appropriate Certificates of Analysis.

Uzbek legislation requires a foreign applicant to appoint a local contact person responsible for pharmacovigilance (CPPV) located in Uzbekistan and to include this information in the registration dossier. Our company provides services for acting as a local pharmacovigilance representative (CPPV) in Uzbekistan.

Duration of the registration process

According to Uzbek legislation, the national state registration of a medicinal product is conducted within 210 calendar days, excluding the time required to prepare responses to official requests. In practice, the procedure typically takes approximately 7 to 9 months, depending on the completeness of the submitted documentation and the number of requests issued by the competent authority.

The procedure for recognition of the state registration of a medicinal product should be conducted within 60 days after receipt of payment of the state fees by the Centre. However, in accordance with usual practice, depending on the completeness of the provided materials, the scope of documentation, the number of requests from the competent authority, and other factors, the procedure for recognition of the state registration of a medicinal product in Uzbekistan takes about 4-5 months, not including a time for preparation of responses to official requests (if any).

Validity term and renewal

The Certificate of State Registration of a medicinal product in Uzbekistan is valid for five years and must be renewed every five years thereafter.

The renewal procedure must be initiated no later than nine months before the expiration of the current registration. In practice, the renewal process takes approximately 5 to 7 months and does not require re-evaluation of preclinical and clinical data.

The Registration Certificate on recognition of the state registration of a medicinal product in Uzbekistan is valid for 5 years. The procedure for renewal of the registration recognition must be initiated before expiration of the previous registration.

For more detailed information, including on the costs associated with registration of medicinal products in Uzbekistan, the list of documents required for submission, etc., please contact our specialists.