ABOUT US

VitaConsult is a contract consulting organization. We carry out the registration of medicines, dietary supplements, cosmetics, medical devices and specialized nutrition in Uzbekistan and the CIS at all stages.

We begin our work at the stage of developing a registration strategy and analyzing the available project documentation. We create for you a clear understanding of the timing and cost of the project with the milestones you need.

Our work is not limited to the preparation of the necessary documents - we are fully responsible for the successful and timely completion of registration procedures, as well as for conducting clinical and preclinical studies. Thanks to our participation, manufacturers save time and reduce the time to market.

30+

Registration of medicines

50+

Registration of medical devices

200+

Registration of dietary supplements

100+

Registration of specialized food products

Registration procedure for medicines

Step 1

Pre-examination (analysis) of the dossier
  • Dossier preparation and consultation for the client
  • Examination of the importance of conducting preclinical as well as clinical studies in accordance with the law
  • Analysis of the compliance of all submitted documents with the criteria of registration authorities and assessment of the completeness of their content
  • Calculation of the price for registration, making a decision together with the customer

Step 2

Implementation of preclinical studies of the medicinal product, if necessary, identified by the pre-examination
  • Selection of centers for preclinical studies
  • Development of protocols and coordination with the client
  • Conducting preclinical studies
  • Statistical processing of data and the final report on preclinical studies

Step 3

Implementation of clinical trials of the medicinal product, if necessary, identified by the pre-examination
  • Formation and completion of the necessary documents necessary for obtaining permission to conduct clinical trials
  • Choice of clinical sites
  • Obtaining permission for clinical trials
  • Conducting a clinical trial, analyzing the accumulated data, generating a report, notifying the Ministry of Health of the Republic of Uzbekistan about the completion of clinical trials
  • Analysis of the ratio of the expected benefit to the possible risk of using the medicinal product by the competent authority

Step 4

Submission of a drug dossier to the Ministry of Health
  • Compilation and final work on the dossier in accordance with Federal Law-61
  • Registration on the website of the Ministry of Health of the Republic of Uzbekistan, creation and submission of an electronic document (application for a service in electronic form)
  • Submission of a dossier to the Ministry of Health of the Republic of Uzbekistan

Step 5

Analysis of the quality of the medicinal product and the study of the ratio of the expected benefit to the possible risk of using the medicinal product for medical use
  • Carried out by the relevant state authorized body

Step 6

Completion of the registration procedure, entry into the state register
  • Issuance of a registration certificate and its provision to the customer

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NEWS AND STATS

Registration of medicines

The main legislative acts regulating marketing authorization and circulation of medicines are the Law of Uzbekistan "On Medicines and Pharmaceutical Activities", Resolution dated March 23, 2018 No. 213

State Register of Medicines and Medical Devices

Additions to the State Register of medicines and medical devices and medical equipment approved for use in medical practice of the Republic of Uzbekistan No. 26, 2022 2-sq. (07/19/2022).

Uzbekistan recognized the results of registration of medicines from 20 countries

The List of countries and international organizations has been approved, the results of registration of medicines of which will be recognized from November 1, 2018.

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