Registration of dietary supplements

Registration of Dietary Supplements – This is the process of legalizing a dietary supplement when it is introduced into circulation. Unlike medical devices, dietary supplements are not subject to mandatory registration. In Ukraine, dietary supplements are regulated as food products under the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality.” In addition to the law, there is the Ministry of Health Order No. 1114 of December 19, 2013, “On Approval of Hygienic Requirements for Dietary Supplements,” and the Law of Ukraine “On Consumer Information about Food Products” dated August 6, 2019.

According to the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality,” the manufacturer of dietary supplements must produce them according to technical conditions (TC) and implement sanitary measures to ensure the quality of the final product.

All market operators (manufacturers, importers, distributors), including pharmacies, involved in the circulation of food products must be listed in the State Register of Market Operators, which is administered by the State Service for Food Safety and Consumer Protection. If a dietary supplement contains animal-derived components, the manufacturer must obtain an operational permit following a facility audit.

An important aspect of the production and circulation of dietary supplements is their labeling. Hygienic requirements mandate that market operators pay attention to the labeling (packaging) of dietary supplements. Labeling of dietary supplements must include:

• Name of the food product – “dietary supplement.”
• Names of the categories of individual nutrients or other substances that characterize the product or indicate the origin of such individual nutrients or other substances.
• Quantity (serving) of the dietary supplement recommended for daily consumption.
• Warning not to exceed the recommended quantity (serving) for daily consumption.
• Indication that dietary supplements should not be used as a replacement for a balanced diet.
• Warning that the product should be kept out of reach of children.

Hygienic requirements also include information on the form of release, maximum concentrations of each vitamin and/or mineral substance in the recommended daily amount, as well as the maximum content of individual nutrients or other substances that characterize the product.