State registration of medicines and medical devices

We oversee the state registration of local and foreign medicines and medical devices, from preparing the documents to obtaining the registration certificate.

The main goal of registration is to protect public health and harmonise national procedures with international standards

The main task of the Registration Support Department is to provide practical and methodological support to local and foreign manufacturers and their representatives in state registration, re-registration and amendments to the registration certificate.

Under Resolution No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan dated 26 February 2026, the state registration of medicines, medical devices and medical equipment is a regulatory process that involves the expert review of documents and quality, safety and efficacy data submitted in the established manner, and the authorisation of the product for marketing in the Republic of Uzbekistan.

Types of services

A single digital platform for the expert review of documents for the state registration of domestic and foreign medicines and for maintaining the state register.

  • State registration of domestic and foreign medicines

  • Registration of domestic and foreign medical equipment and medical devices

  • Registration of biologically active supplements

  • Registration in the "Asl Belgisi" marking system

  • Clinical trials of medicines

  • Registration in CIS countries and the European Union

Registration stages

Under the rules in force in the Republic of Uzbekistan, the registration of medicines includes the following stages:

  1. Step 01

    Document submission

    Uploading the registration documents to the electronic system and submitting samples to the Centre

  2. Step 02

    Expert review

    Primary (preliminary) expert review of the registration documents and samples

  3. Step 03

    Laboratory testing

    Laboratory testing of medicine samples where required under the registration procedure

  4. Step 04

    Specialised expert review

    Specialised expert review of the registration documents

  5. Step 05

    Clinical evaluation

    Clinical evaluation or clinical trials (for original and generic products, except where clinical studies are not required)

  6. Step 06

    Final decision

    Deciding on state registration or refusal based on the expert review results

Required documents

Documents submitted for registration must be prepared in line with the established requirements.

  1. 01

    Application and administrative documents

    Registration application, information on the applicant and the manufacturer, and the relevant permits.

  2. 02

    CPP and registration documents

    CPP, registration certificate and other supporting documents (where applicable).

  3. 03

    GMP certificate and manufacturing documents

    The manufacturer's GMP certificate, manufacturing licence, latest GMP inspection report and CAPA plan.

  4. 04

    Registration dossier (CTD)

    Documents on the medicine's quality, composition, manufacture, control methods and stability.

  5. 05

    Safety and efficacy documents

    Clinical, non-clinical and bioequivalence data confirming the medicine's safety and efficacy (where applicable).

  6. 06

    Pharmacovigilance documents

    Pharmacovigilance system, risk management plan and related documents on the medicine's safety.

  7. 07

    Instructions and packaging layouts

    Instructions for medical use, and primary and secondary packaging layouts.

  8. 08

    Samples and reference standards

    Samples of the medicine, reference standards and documents confirming their quality (where applicable).

Frequently asked questions

Answers to the most common questions about registration, state fees and service timelines.

Up to 210 working days under the standard procedure and up to 60 working days under the recognition procedure. The timeframe depends on the completeness of the documents, the expert review results and how promptly the applicant addresses any deficiencies. Time spent addressing deficiencies and conducting clinical studies is not counted towards the registration period.

Need expert help?

If you represent a domestic manufacturer or an international pharmaceutical company and have questions, contact the Agency's advisory centre.

Agency address
BioPharma City
Support phone
1833

Send a request