The authorization procedure includes the following steps:
- Sanitary and hygienic study (analysis of the compliance of the ingredient composition, physical and chemical indicators, determination of the content of heavy metals, radionuclides, pesticides, mycotoxins, microbiological study and study of the toxic effect on the body in an acute experiment on laboratory animals).
- Expertise of the Master File presented by the manufacturer, with an expert council based on the Kazakh Academy of Nutrition.
- Assignment of an marketing authorization number, inclusion in the Register of Goods registered in the Republic of Kazakhstan by the Committee of Sanitary and Epidemiological Control of the Ministry of Healthcare of the Republic of Kazakhstan.
To register a Biologically Active Dietary Supplement:
to obtain a marketing authorization for baby food products, nutrient additives and biologically active dietary supplements, genetically modified objects, dyes, disinfectants, pest control and extermination agents, materials and products in contact with water and food, chemicals, certain types of products and substances that have a harmful effect on human health (hereinafter - the Marketing authorisation):
to the service provider:
- document information reference form for obtaining a marketing authorization;
- copies of documents whereby the products are manufactured (standards, requirements specification, regulations, technological instructions, specifications, recipes, information about the composition), certified by the manufacturer (producer);
- a copy of the written notification of the manufacturer (producer) that the products manufactured by him/her (product samples) meet the requirements of the documents whereby they are manufactured;
- copies of the manufacturer's (producer’s) documents for the application (operation, use) of controlled goods (instructions, guidelines, regulations, recommendations) or a copy thereof certified by the service recipient);
- sampling report (specimen);
- manufacturer’s (producer's) declaration on the presence of genetically modified (transgenic) organisms, nanomaterials, hormones, pesticides in food;
- an extract from the Unified State Register of Legal Entities or the Unified State Register of Sole Proprietors.
- copies of labels (packages) or their layouts, certified by the service recipient;
- copies of documents on the specific activity of a biologically active dietary supplement (for preparations containing unknown components, unofficial prescriptions), certified by the service recipient;
- copies of study protocols (tests protocols), (hygienic testing reports), scientific reports, expert opinions.
The validity period of the marketing authorization is determined for the entire period of manufacture of products or supplies of controlled goods to the territory of the Customs Union.
Requirements for biologically active dietary supplements to be authorized:
The prerequisites for biologically active dietary supplements subject to authorization are the presence of a label, instructions for use for the consumer:
- product name, presentation;
- manufacturer’s trademark (if any);
- information on the ingredient composition indicating the exact amount (grams, milligrams, millilitres, percentage) of their constituent components, nutritional value (energy value, content of proteins, fats, carbohydrates, vitamins and microelements, stating the percentage of physiological daily maintenance, amino acid composition, the content of biologically active dietary supplements);
- information on the properties of biologically active dietary supplements, their purpose, recommendations for use;
- the title of the regulatory document to be met by biologically active dietary supplements;
- name (company name), location (legal address) of the manufacturer, organization that filled and packer (if not the same as manufacturer);
- nominal quantity of a packaging unit (mass or volume), number of doses and their nominal quantity (mass or volume);
- lot number, date of manufacture, expiration date, storage conditions;
- the statement that the biologically active dietary supplement is not a medicinal product;
- information on marketing authorization of a biologically active dietary supplement detailing the number and date;
- information on contraindications for use in certain types of diseases.