Foods for Special Medical Purposes

ood for Special Medical Purposes (FSMP) – a food product specifically developed and manufactured for feeding patients (including infants and young children) that must be consumed under medical supervision, either in a healthcare facility or outside of it. Such a product is intended to partially or fully replace the normal diet of patients (including infants and young children) who have a limited, weakened, or impaired ability to ingest, digest, absorb, metabolize, and/or eliminate normal food products and/or certain nutrients contained therein and/or their metabolites. It may also be prescribed for full or partial feeding of patients (including infants and young children) with other physician-defined needs that cannot be met through modification of the normal diet.

Food for special medical purposes is designed to support full or partial nutrition in patients whose dietary needs cannot be met by modifying a normal diet alone. This category of products assists patients with diseases, disorders, or medical conditions that temporarily or permanently affect their ability to obtain adequate nutrition from regular food. FSMPs either complement or fully replace the diet of such patients.

FSMPs include, but are not limited to:

• Oral nutritional products (for patients with intolerance to certain nutrients, low electrolyte levels in renal disease, or elevated fatty acids and antioxidants in cancer patients);
• Enteral tube feeding formulas (for patients who have lost the ability to swallow or have impaired gastrointestinal function);
• FSMPs for infants and young children (needed to support growth and development in children with conditions such as cow’s milk allergy, food protein intolerance, digestive or metabolic disorders, epilepsy, heart disease, or galactosemia).

A weight-control food product is a specially formulated and manufactured food product intended for consumption during a low-calorie diet to support weight reduction. When consumed according to the instructions provided by the market operator, such a product replaces the daily food intake.

This category of products is intended for healthy individuals seeking to lose weight. Weight-control food products provide the necessary daily nutritional intake when used as instructed and are generally consumed over a relatively short period.

The main legislative acts regulating food products – including those manufactured, placed on the market, or imported (shipped) into the customs territory of Ukraine – are:

• the Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality”;
• the Law of Ukraine “On State Control of Compliance with Legislation on Food Products, Feed, By-products of Animal Origin, Animal Health and Welfare”;
• the Law of Ukraine “On Information for Consumers Regarding Food Products”;
• and the Law of Ukraine “On Materials and Articles Intended to Come into Contact with Food Products” (entering into force on November 19, 2025).

Market Authorization Documents

When imported into the customs territory of Ukraine, food for special medical purposes and weight-control food products must be accompanied by an international certificate or other document issued by the competent authority of the country of origin or the exporting country.

An international certificate includes:

• a health certificate,
• an international veterinary certificate,
• or another document issued by the competent authority of the country of origin or exporter confirming the animal’s health and/or the safety of the food product, feed, hay, straw, or by-product of animal origin (as per the Law of Ukraine “On State Control…”).

These products are not subject to mandatory registration. However, they must be subject to notification if they have not previously been placed on the Ukrainian market.

• Before placing a food for special medical purposes or a weight-control product on the market, the operator must ensure that its composition and intended use comply with national legislation. Requirements include:
• the use of food additives and their maximum concentrations;
• restrictions on or prohibition of certain substances in food products;
• the presence of novel foods in the composition;
• the composition of FSMPs must be based on sound medical and nutritional principles, and their use according to the manufacturer’s instructions must be safe, beneficial, and effective for partially or fully meeting the specific nutritional needs of the target population, as supported by generally accepted scientific data.

Composition and Labeling

Currently, no specific national requirements are established for the composition of FSMPs or weight-control food products. The central executive authority responsible for healthcare policy is expected to approve such requirements in accordance with the Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality.”

National legislation contains strict requirements for the labeling of food products, which include:

• the list of mandatory information;
• language of labeling (Ukrainian);
• minimum font size for the information;
• rules for placing information on the packaging;
• the use of units of measurement, rounding rules, and presentation of values;
• specification of information about special dietary needs, functional conditions, or diseases for FSMPs used as baby food;
• and other requirements.

Although Ukrainian legislation is rapidly evolving toward alignment with European standards, no regulatory acts have yet been adopted that establish additional labeling requirements specifically for FSMPs or weight-control food products.

The use of stickers to provide product information to consumers is not prohibited under Ukrainian law.

Responsibility for compliance with food safety legislation and specific quality indicators, including product labeling, lies with market operators within the scope of their activities.

Our Services

We professionally provide regulatory and legalization services for dietary supplements, baby food, food for special medical purposes, and weight control products. Our team possesses the required knowledge, experience, and skills, and our specialists are fluent in English.

We offer:

• Evaluation of product composition with in-depth analysis of its formulation and assessment of compliance with legislation and relevant category;
• Review or development of labeling and instructions for use (leaflet);
• Arrangement of laboratory testing to verify compliance with safety requirements and obtain a product safety report;
• Preparation and submission of notification for placing on the market dietary supplements, baby food, food for special medical purposes, and weight-control products;
• Development and implementation of HACCP / ISO 22000 systems;
• Legal and consulting support for manufacturers and importers.