New registration of food supplement:

Starting from 01.09.2006 all products for special dietary purpose, functional food products, and dietary supplements were merged into one group of products “special food products”.

For import, sale and use of the special food products (hereinafter an abbreviate SFP or “supplement” can be used) it is necessary to receive positive conclusion of the state sanitary-hygienical expertise. Conclusion of sanitary-hygienical expertise is issued by Sanitary-epidemiological agency of MOH of Ukraine and by authorized institutions.

Upon results of the performed expertise the sanitary-hygienical conclusion (decision) is issued, end of the validity if the conclusion is not specified in legislation.

Important point before start of the registration of cosmetic products is correct classification of the product. There are many different definitions that are not applicable in Ukraine : parapharmaceutical product, vitamin and/or mineral product, herbal product and so on. In other words – some products that are classified in manufacturer's country as dietary products – can be declared as medicinal products in Ukraine .

Hence, it is very important before start of the registration procedure, to professionally classify the product.

Expertise that is performed for issue of the sanitary-hygienical conclusions includes: 1) expertise of documentation and 2) quality assurance in laboratory (laboratory tests), and in some cases – 3) clinical study of the effectiveness of the new type of SFP.

In the annex to the sanitary-hygienical conclusions should be attached an adopted package design. Text of the package must be in Ukrainian language, other international languages are also allowed.

Cratia Ltd. will provide you with efficient and professional assistance in registration of dietary supplements (special food products) – we will help you to correctly classify the product, we will prepare the Application and package of documents, accompany the product during expertise till the moment of issue of original sanitary-hygienical conclusion.

consulting service, correspondence;
translation of required parts of dossier, including notary translation;
preparation of the dossier in accordance with requirements of legislation;
preparation of Application;
assistance in preparation of the package design;
receipt of the conclusion regarding EAN code in State Chamber of Commerce;
optimal choice of the expertise institution;
submission of the Application and dossier to the state authorities of Ukraine (to the chosen institution);
accompanying of the dossier during expertise;
import and custom clearance of the samples;
all other expenses; service fee defrays all charges required for registration including State fees;

Service fee of our company and amount of the state fees can be calculated during 3-5 days after receipt of the dossier: specialists of our company will realize amount of work that should be done and will make a preliminary contact with expected expert institutions.

Total sum of the registration procedure of special food product can vary from 800 to 3000 EURO , depending on the composition of the product and particularities of it's use. Please note that sanitary-hygienical conclusion is issued on the product list of one manufacturer and every additional product (modification) will increase the base sum only for 5-15%.

Term to perform the registration procedure also depend on the documentation and on product itself, a will take from 3 weeks from moment of submission of Application.

If you are interested in services of Cratia Ltd. in the field of state registration of cosmetic products – you can find the following information at our website: