Biologically active food supplements (or BAFS) are products used as special additives to the diet. They include dietary supplements, parapharmaceutical preparations, nutrition supplements, special food products, sports nutrition supplements and baby meal. In accordance with Ukrainian legislation that group of products belongs to the «foods for special dietary use». Since the dietary supplements are food products, they can be administered only in oral form: tablets, capsules, syrup, oral solution (beverage), creams and gels to be added to food, etc. All food supplements are object of value added tax (VAT 20%).

Import and sale of food supplements requires state registration. Registration is performed by Ministry of Health of Ukraine on the basis of expert evaluation of product quality and safety: expertise of submitted documentation and laboratory testing (analysis) of the product samples. After the registration, a certificate (marketing authorization) is issued for a period from 3 to 5 years, and the product’s information is added to State register of foods for special use. The certificate contains information about the trade name of the product, its composition, manufacturer, the Applicant (marketing authorization holder), method of sale, requirements to product’s quality, necessity and frequency of quality control.

Mandatory Annex to the certificate is the text of the package label (mock-up labeling). Label contains detailed information about product composition, recommendations for use, warnings, method of administration, dosage, expiry date, and other information for consumer or physician. Text of the label is adopted in Ukrainian language and being approved during state expertise. There are some limitations applied to the package label to food supplements: it is prohibited to use any diagnosis or name of disease, any wordings implying a guaranteed result, etc. Subsequently, the label text can be applied to the package layout during manufacture of the product batch, or can be rendered on (or sticked to) an existing package (before shipment to Ukraine, or at the customs-bonded warehouse before clearance).

Wholesale and retail sale of dietary supplements are not licensed activities. At retail, products are sold through the pharmacies and special shops (or specialized departments of stores and supermarkets).

The information provided in the marketing authorization certificate and at the package label is subject to serious and detailed inspection during import (customs clearance) of the product. Any incompliance between adopted registration documents and customs documents (Proforma Invoice, packing list, quality certificates, product’s package) can result a serious problems. That is why the registration process should be conducted on a professional level; the information should be adopted with manufacturer and Applicant.

Cratia provides services of organization of marketing authorization of food supplements in Ukraine. We have great experience in registration and superior knowledge of Ukrainian and international legislation; our Company has established excellent relations with state authorities and expert organizations, we are well familiar with the customs requirements and can complete the registration of a special dietary food supplement correctly, quickly and with the best service. Since 2005, we have registered more than 100 products, and in 2010 our customers return to us for renewal of registration.

The process of cooperation with a new Customer is as follows:

You contact us by phone +38 044 332-42-94, e-mail info@cratia.com.ua or agree the time of visit to our office. We review the initial information about the product (composition, recommendations for use) and confirm that the product is a food for special dietary purpose (BAFS). Next, you should submit us the documents as per list either in paper or electronic form. In order to accelerate the process of preparation and localization of documents, we usually offer to send us the copies of documents by e-mail, and after verification and approval you submit us the hard copy of the original documentation. As documents are received, we will prepare a draft of Application and package labeling, send them to you for approval. Samples of the finished product will be needed for the laboratory analysis. Cratia Ltd. is authorized by the Customs Service of Ukraine, and the samples will be imported on the name of our company. The registration materials on food supplement obtained from you will be filled to the dossier in accordance with the Ukrainian legislation, translated if necessary, and submitted to the Ministry of Health of Ukraine. We will need a Power of Attorney to represent your interests in the Ministry of Health and at expert organizations. After the initial evaluation, a specialized expertise and laboratory testing will be appointed. During the specialized expertise some amendments to the draft of package labeling can be made at the request of an expert organization. All changes and proposals will be agreed with the Customer. After positive conclusion of expert evaluation of documentation and laboratory testing of the product samples, a draft Conclusion is issued, which is also agreed with the Customer. Thereafter, we obtain the original Certificate and package labeling. We also provide post-approval assistance on the product labeling: we will check the package mock-ups for compliance with the approved documents and provide all necessary consultations on issues related to the product registration.	Initial request
	Documentation receipt, check and approval
	Execution of contract for services for BAFS registration
	Samples import; translation and preparation of dossier; elaboration of the Application and package label
	Submission of the dossier to the Ministry of Health; the primary analysis
	Specialized expertise of documentation and laboratory testing of  product samples
	Agreement of changes to package label
	Drafts proofreading
	Receipt of the original Certificate and package labels
	Post-registration assistance with the product label

Cost of our service fee for marketing authorization of food supplement depends on several factors:

Thus, our service fees amount from $ 1300 to $ 2500 (without discount). Our service fees include all necessary costs for registration, including state fees and duties.

The period of registration is approximately 1 month from the date of submission of registration materials to the Ministry of Health.

Cooperation implies the execution of Agreement on the organization of state registration, in which we specify all the obligations in terms of scope of works, cost and deadlines. Procedure of payment for our services is as follows:

If necessary, other payment procedure can be discussed.
Payment is accepted in UAH, EUR, USD or Russian rubles.

Advantages of cooperation with Cratia Ltd.: