Market requirements for food supplements

Food supplements - are products that include dietary supplements, parapharmaceutical products, nutritions, special food products, sport meals and child meals. According to legislation of Ukraine such group of products are defined as "food products of special dietary purpose".

Food supplements can be used only in oral form: tablets, capsules, syrup, solution for oral use, creams or gels for adding to foods etc. All food supplements are objects of VAT tax (20%).

Import and sale of food supplement is allowed only after it's state marketing authorization. Marketing authorization (state regstration) is performed by Ministry of Health of Ukrane by expertise of quality and safety of the product: expertise of submitted documents and laboratory analysis of samples.

Marketing authorization certificate is valid from 3 to 5 years, information on the product is included to state registry of special food products.

Certifcate includes information regarding trade name, product's composition, manufacturer, Applicant (owner of the certificate), sales restrictions, specification of quality of the product, necessity of additional quality control and other data.

Integral Annex to the marketing authorization certificate is text for labeling of the package. Labeling information includes composition, recomendations on use, contradictions, method of administration and dosage, shelf-life and other information for consumer or doctor. Text of the labeling in Ukrainian language is addopted during state expertise.

There are lots of restrictions for labeling information of food supplement: diagnoses or names of diseases, conditions of patient, statements regarding proofed results are not allowed, as well as many other particular wordings. Approved text of labeling can be applied on the package during manufacturing process or can be applied as a sticker on existing package (before sending product to Ukraine or at the licensed warehouse in Ukraine).

Market requirements for food supplements | Cratia 2

Wholesale and retail sale of food supplements is not object of licensing. Retail sale is allowed through pharmacies, special shops or special departments of supermarkets.

Information that is approved in marketing authorization certificate and text for the labeling of the package are objects of very strict expertise during import and custom clearance of the product. Any incompliance between adopted registraton materials and custom documents (Invoice, packaging list, certificates of analysis, package of the product) can lead to serious problems. Thus registration process must be performed by experienced specialist, information must be approved with Applicant and manufacturer.

Cratia offers professional services of organization of marketing authorization of food supplements in Ukraine. We have great experience in registration, excellent knowledge of Ukrainian and international legislation, friendly relations with state authorities and experts, knowledge of customs requirements. We can fill in the dossier, deliver samples, translate documents and perform correct marketing authorization in short terms. We have registered more than 100 products from 2005, and in 2010 our Customers return to us for prolongation of registration for the next period.

Following information can be also useful for you:

It is obvious that all preliminary advices and consulting are free of charge.

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.