State registration of medicines

in Uzbekistan

Select country for information

State registration of medicines

Service available for:

  • Russia
  • Kazakhstan
  • Kyrgyzstan
  • Uzbekistan

Registered medicines are guaranteed to be efficient and safe

During the registration process in the Republic of Uzbekistan, medicines are checked for compliance with the claimed characteristics and undergo preclinical and clinical trials, as well as pharmaceutical expert examination to identify all types of risks


Items subject to registration

All medicines except those manufactured according to pharmacy prescriptions, radiopharmaceuticals, as well as medicines that are purchased abroad or manufactured in the territory of the Republic of Uzbekistan for non-commercial purposes

  • Medicines

  • New combinations of medicines that have been already registered in Uzbekistan

  • Medicines that have been already registered in Uzbekistan but manufactured in a different pharmaceutical form or dosing or by another manufacturer

Registration of medicines with various medicinal substances under the same trade name, as well as registration of medicines of the same manufacturer having the same composition of medicinal substances under different trade names is not allowed

What problems may arise if you decide to do the registration yourself?

You will have a lot of work, the nuances of which are unknown to you: 

The procedure may take a long time

You may not know the details of the regulatory environment

You may not know the nuances of communication in regulatory bodies or in the country

The benefits of registration with the MedExpert company:

We will undertake all the routine work.

You save time and therefore money

We have a team of professionals in different areas of regulatory affairs

We select individual solutions for each project

We guarantee confidentiality

We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the process

List of services

Consulting

Introducing changes to the registration certificate

Introducing changes to the registration dossier

Preparation and collection of the registration dossier

Development and analysis of normative documentation

Collaboration with testing centers

Support in testing

Interaction with registration bodies

Registration stages

According to the current rules in the Republic of Uzbekistan, the registration of medicines includes the following stages:

  1. Preparation and collection of
    the dossier and submission of the application to the state body

  2. Expert examination of the dossier

  3. Laboratory testing

  4. Preclinical trials

  5. Clinical trials

  6. Expert examination of
    quality and efficacy of the medicine

  7. Obtaining a registration certificate

The final cost and terms will be calculated at your request

By pressing the “Send” button, you confirm that you give the company your consent for processing your personal data

Questions and Answers

1. Is it possible to suspend or revoke the registration certificate of a medicine?

Yes, registration is canceled if the registration certificate expires. In addition, its effects may be revoked in the following cases:
• new causes of harm for health and life of citizens or side effects were found during use;
• the information specified in the certificate changed (information about the manufacturer, dosing, and form);
• the manufacturer submitted a request to cancel the registration

2. What is the period of registration of a medicine?

The application for issuance of a certificate is considered by the State Center in terms not exceeding the following:
50 days for medicines (substances);
120 days for medicines in the form of prepackaged and packaged pharmacopoeia herbal substances
155 days for the other medicines

These terms do not include the preclinical period, the period of clinical trials, the time to eliminate remarks, and inspection of the manufacturing site.

3. When is it not possible to conduct clinical or preclinical trials?

– if there is information about the registration of the medicinal product in the country of manufacture, as well as in another country(ies);
– if documents are confirming the production of the medicine under the requirements of Good Manufacturing Practice (GMP) and conducting clinical trials under the requirements of Good Clinical Practice (GCP), the introduction of a pharmacovigilance system, i.e., Good Pharmacovigilance Practice (GVP), as well as for immunological medicines in case of their prequalification by WHO