Registration of pharmaceutical products in Uzbekistan

Registration of medicinal products (MP)

Registration of medicinal products in the Republic of Uzbekistan is a mandatory procedure confirming the quality, safety, and efficacy of a product before it is placed on the market.

Ministry of health divisions involved in MP registration

The following structures of the Ministry of Health of the Republic of Uzbekistan are involved in the registration process:

• Ministry of Health of the Republic of Uzbekistan — makes decisions on state registration;

• Authorized expert organization — conducts expert evaluation of the registration dossier, as well as the quality, safety, and efficacy of medicinal products;

• Pharmacological and pharmacovigilance control — assesses risks and post-registration safety, when required.

MP registration procedure

The registration procedure includes several stages:

1. preparation and compilation of the registration dossier;

2. submission of documents to the authorized body;

3. expert evaluation of the submitted materials;

4. adoption of a registration decision;

5. inclusion of the product in the State Register of Medicinal Products.

The timelines and scope of the evaluation depend on the category of the medicinal product and the completeness of the submitted data.

Documents required for MP registration

As a rule, the following set of documents is required for registration:

• an application in the prescribed form;

• a registration dossier (administrative, chemical-pharmaceutical, non-clinical, and clinical sections);

• documents confirming the quality of the active substance and the finished dosage form;

• a draft patient information leaflet and packaging layouts;

• manufacturer certificates (GMP, if available);

• samples of the medicinal product (upon request).

Registration of medical devices (MD)

State registration of medical devices in the Republic of Uzbekistan is a mandatory requirement for their placement on the market and use in medical practice.

Ministry of health divisions involved in MD registration

The following bodies are involved in the medical device registration process:

• Ministry of Health of the Republic of Uzbekistan — carries out state registration and makes the final decision;

• Authorized expert organization — performs technical, toxicological, and clinical evaluation of the device;

• Sanitary and epidemiological control authorities — participate in the assessment of MD safety, when required.

MD registration procedure

The registration procedure for medical devices includes the following stages:

1. preparation of the registration dossier for the device;

2. submission of documents to the authorized body;

3. expert evaluation of safety, quality, and functional characteristics;

4. testing and clinical evaluation, if required;

5. adoption of a registration decision and inclusion of the device in the State Register.

The scope of evaluation and registration timelines depend on the device risk class and its intended use.