1. What is the difference between food supplement and medicinal product?
The main difference between dietary food supplements and a medicine is that the efficacy of supplement is either not confirmed or the proven level of efficacy does not allow prescribing the product for the treatment or prophylaxis.
Some products of the same composition but different brand names may be registered both as medicinal product and as food supplements. A good example is herbal products (e.g., ginkgo biloba, artichoke), vitamins and mineral complexes. The registration of the product as a medicine requires a large amount of documentation not only on the product use but also on the manufacturing process, quality control and other chemical-pharmaceutical and production documentation. In addition, registration of a medicinal product is by an order more expensive and takes much more time than registration of biological active dietary supplements.
If the medicinal products are made on the base of vitamins, minerals, amino acids or components of amino or fatty acids, the rate of one of these substances in the recommended daily intake should be much higher that the recommended average daily intake in order to maintain overall health and well-being (quote from the Customs Tariff of Ukraine, notes to the item 3004).
From the viewpoint of import and marketing, there are several key differences between food supplements and medicinal products:
- Taxation. All medicinal products are exempt from value added tax (20%), while all supplements are subject to VAT.
- Quality control. Medicinal products are subject of laboratory testing of each batch quality, which may cost several thousand dollars for a single batch. Supplements are tested for compliance with the sanitary and epidemiological standards, and the cost of such analysis is relatively low.
- Sale. When selling the food supplement through the pharmacy network, the product should be placed under the statement «Dietary supplements. Not medicinal products», thus placing the product in a conspicuous place is limited.
- Advertisement. Advetisement of Rx products in mass media is prohibited. Advertisement of OTC drugs is allowed in the media and public places, provided that certain requirements are met. Advertisement of food supplements follow the same regulations as any other food products.
- Package labeling. Package of a medicinal product can contain information of diagnoses, therapeutic indications and other information for therapeutic and prophylactic properties of the product. For the text of food supplement label, serious restrictions are set and it is not allowed to mention any disease names, diagnoses, etc.
- Registration procedure. Registration of a medicinal product implies submission of a large amount of documentation, ten times larger than for a dietary supplement. Medicinal product registration is also approximately 3 to 5 times more expensive than the registration of supplement and takes almost a year.
2. It is possible to register food supplement in the form of cream for topical application, injection, shampoo?
In accordance with the Ukrainian legislation, all food supplement are defined as «food products for special dietary use». «food products» mean that products are for oral use only. If your product is not intended for oral use, it is most likely a medicinal product, medical device or cosmetic.
3. What are the taxes for import of food supplements?
Foods for special dietary use are subject to the value added tax (VAT 20%) and customs duty.
4. Is there a need to register the company in Ukraine in order to register a food supplement?
No, the registration of the company or representative office is not needed for registration of dietary supplement.
5. Who can be an Applicant for food supplement registration (MAH - Marketig Authorization Holder)? What are the requirements of theMAH?
Any company - a legal person, resident or non-resident of Ukraine - may be an Applicant (MAH). The Applicant is responsible for the quality and safety of the product in Ukraine.
6. Does any trade license is required for sale of food supplements?
Wholesale and retail trade of foods for special use is not licensed activities.