1. What is the difference between BAFS and medicinal product?
The main difference between a BAFS and a medicine is that the efficacy of BAFS is either not confirmed or the proven level of efficacy does not allow to prescribe 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 BAFS. 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 BAFS.
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 BAFS and medicinal products:
- Taxation. All medicinal products are exempt from value added tax (20%), while all BAFS 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. BAFS are tested for compliance with the sanitary and epidemiological standards, and the cost of such analysis is relatively low.
- Sale. When selling the BAFS 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. Advertisement of OTC drugs is allowed in the media and public places, provided that certain requirements are met. Advertisement of BAFS is restricted.
- Package labelling. 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 BAFS 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 BAFS. Medicinal product registration is also approximately 3 to 5 times more expensive than the registration of a BAFS and takes almost a year.
2. Can a BAFS be in the form of cream for topical application, injection, shampoo?
In accordance with the Ukrainian legislation, all BAFS are «Foods for special dietary use». «Foods» mean that the products for oral use.
If your product is not intended for internal use, it is most likely a medicinal product, medical device or cosmetic.
3. What are the taxes levied on the import of BAFS?
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 BAFS?
No, the registration of the company or representative office is not needed for registration of BAFS.
5. Who can be an Applicant for BAFS registration (Marketig Authorization holder)? What are the requirements of the Marketig Authorization holder?
Any company - a legal person, resident or non-resident of Ukraine - may be an Applicant, ie, Marketing Authorization holder. The Applicant is responsible for the quality and safety of this product in Ukraine.
6. Does the trade license need require to sale BAFS ?
Wholesale and retail trade of foods for special dietary use are not licensed activities.
Did not find the answer to your question at our site? Write up your question as fully as possible, e-mail it to info@cratia.com.ua, and we will do our best to help you.
If you are interested in cooperation with our company for the purpose of registration of Foods for special dietary use, contact us by phone: +38 044 332-42-94, e-mail: info@cratia.com.ua or visit our office.
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