What is a BAA and why does it need to be registered?
Biologically active additives (BAA) are products containing natural or nature-identical biologically active substances, as well as probiotic microorganisms, intended for consumption alongside food or for incorporation into food products. In the Republic of Uzbekistan, the production, import, and sale of BAAs may only be carried out after undergoing state registration in the prescribed manner and obtaining the relevant permits from authorized bodies.
What is required for the legal sale of BAAs?
To officially place BAAs on the Uzbekistan market, the following key requirements must be met:
A registration document or permit issued by the authorized body (based on expert evaluation conclusions);
Laboratory testing protocols — covering safety and quality indicators;
A properly completed label and a full set of product documentation.
Main stages of the registration process
The BAA registration process consists of several sequential stages, each involving specific activities:
Preliminary review of composition and dosage form: ingredients, dosages, restrictions, and the admissibility of label claims are analyzed.
Preparation of the product dossier: all documentation from the manufacturer is compiled — composition, specifications, technological data, certificates, raw material origin, and a label draft.
Testing at an accredited laboratory: samples are submitted for research on safety indicators.
Expert review stage: responses are provided to expert comments, and necessary amendments are made to the dossier and label.
Obtaining test results and expert conclusions: protocols and conclusions required for submission to authorized bodies are formalized.
Submission of documents to the authorized body: registration and permit are formalized in the prescribed manner.
Obtaining the registration document: following this stage, the product may be officially imported, manufactured, and sold.
Why is professional assistance important throughout the process?
The BAA registration process is multi-staged and complex from a regulatory and legal standpoint, and errors at any stage may result in time and financial losses. With the support of experienced specialists, it is possible to properly prepare documents, maintain communication with experts, and efficiently manage the entire process. Pharm Way Group provides comprehensive support services for BAA registration.
