The registration of dietary supplements in the Republic of Uzbekistan is regulated by the Resolution of the Cabinet of Ministers No. 131 dated April 30, 2016 “On approval of the provisions on the procedure for licensing procedures in the system of sanitary and epidemiological service of the Republic of Uzbekistan”.
The control of circulation and production of dietary supplements is carried out by state sanitary supervision – this is the activity of the sanitary and epidemiological service to prevent, detect and suppress violations of sanitary legislation. According to the definition adopted by the legislation of the Republic of Uzbekistan, “Dietary supplements are concentrates obtained by processing food raw materials or by artificial means and intended for direct ingestion or incorporation into food products. Supplements are used as an additional source of nutrients and biologically active substances, to optimize carbohydrate, fat, protein, vitamin and other types of metabolism under various functional conditions, to normalize and/or improve the functional state of organs and systems of the human body.”
According to the legislation, the import and production of dietary supplements is subject to an authorization issued by the competent authority – the General Directorate of Sanitary and Epidemiological Surveillance of the Ministry of Health of the Republic of Uzbekistan (GUSEN). Such authorization is placed in the register of issued authorization on the website of the Ministry of Health of the Republic of Uzbekistan.
Both legal entities and individuals can act as an Applicant for registration, however, the manufacturer is the de-facto Holder of the Marketing Authorization.
The manufacturer or it’s representative submits a statement and documents, in accordance with the requirements for special food products. The dossier is filed in 2 copies in paper form in the state and (or) Russian language. Product samples in the quantity necessary for conducting a toxicological and hygienic expert evaluation are attached to the dossier.
A summary of the procedure for registering dietary supplements in the Republic of Uzbekistan can be divided into the following stages:
- Initial expert evaluation of documents conducted by an expert of GUSEN regarding the classification of a product as a dietary supplement, and also the need for clinical trials or other evidence of efficacy is established.
- The appointment and arranging of toxicological studies of the product by specialized scientific institutions following by the transfer of the results to the GUSEN.
- The expert of the GUSEN appoints a place for conducting studies to evaluate the efficacy of the product or clinical trials (if necessary).
- Obtaining a hygienic certificate and issuing an authorization letter from GUSEN on the inclusion to the dietary supplements register.
The validity of the Marketing Authorization (state registration certificate) is 5 years.
Cratia provides professional services of state registration of food supplements in Uzbekistan. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.