Dietary supplements (biologically active food supplements, BAS) are products that contain natural or nature-identical biologically active substances (and, where applicable, probiotic microorganisms) intended to be consumed together with food or incorporated into food products.
In the Republic of Uzbekistan, dietary supplements may be imported, manufactured, and sold only after completing the установленная (required) state registration procedure (or sanitary-epidemiological assessment/permit procedures—depending on the product category) and obtaining the relevant documents confirming safety and compliance with regulatory requirements.
To officially place a dietary supplement on the market and sell it in Uzbekistan, the following is typically required:
a registration certificate/permit issued by the authorized body (based on the results of expert review);
test reports/protocols (safety and quality parameters);
correct labeling and a complete set of product documentation.
Preliminary review of the composition and dosage form
Analysis of ingredients, dosages, restrictions, and the admissibility of claims on the packaging.
Preparation of the product dossier
Collection and preparation of the manufacturer’s documents: composition, specification, technological information, certificates/standards, origin of raw materials, draft label, and instructions for use.
Laboratory testing at an accredited laboratory
Submission of samples for testing against safety indicators (and other requirements applicable to the specific product).
Expert support during the review process
Responding to comments, adjusting the dossier and labeling, and making revisions in line with expert requirements.
Obtaining test results and expert conclusions
Receiving the test reports and conclusions required for submission to the authorized bodies.
Submission of documents to the authorized body of Uzbekistan
Filing the dossier and completing registration/permit documentation in accordance with the established procedure.
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
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).
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.