Registration of medicinal products Uzbekistan

During state registration (re-registration) and making changes to the registration dossier in the Republic of Uzbekistan, medicinal products undergo procedures for confirming their quality, safety, and efficacy.

- Russia
- Kyrgyzstan
- Georgia
- Kazakhstan
- Belarus
- Turkmenistan
- Tajikistan
- EAEU

Laws and regulations governing the process of registration of medicinal products:

Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 213 “On Approval of the Regulations on the Procedure for State Registration of Medicines, Medical Devices, and Medical Equipment and the Issuance of a Registration Certificate” dated 23 March 2019.

State bodies (hereinafter referred to as “SB”) participating in the process of registration of medicinal products:

State Unitary Enterprise State Centre for Expert Examination and Standardisation of Medicines, Medical Devices, and Medical Equipment of the State Unitary Enterprise of the Agency on Development of Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan (hereinafter referred to as the “SCEEaS”).

Expert examination period (in the state body): 155 days.
Registration certificate (hereinafter referred to as the “RC”) validity period: 5 years.

The following products are subject to state registration:

Medicinal products

New combinations of medicinal products registered in the Republic of Uzbekistan

Medicinal products previously registered in the Republic of Uzbekistan, but produced in other dosage forms, dosages or by another manufacturer

Medical products

Medical equipment

Registration stages:

Preparation of the registration dossier, collection of all necessary documents

Preliminary analysis of the registration dossier, evaluation of the collected package of documents and making adjustments, if necessary

Submission of an application for the procedure, submission of an application to the state body for preparation of an agreement and carrying out the primary expert examination of the documents

Primary expert examination of the documents, analysis of the documents of the registration dossier with the issuance of an opinion based on the results of the primary expert examination

Inspection of production (if necessary), for medicinal products undergoing the registration procedure at the first declared production site

Sanitary and hygiene and technical tests, testing with the provision of samples for testing and the issuance of the results of acts of hygiene expert examination

Clinical trials or clinical evaluation, evaluation or trials of medicinal products in clinics

Specialised expert examination of the registration dossier and the test results with the execution of the order of the Ministry of Health of the Republic of Uzbekistan with regard to the decision to register medicinal products

Issuance of the registration certificate, with the placement of registration information in the State Register of the Ministry of Health of the Republic of Uzbekistan

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