1. General information .

2. List of services of Cratia Ltd.

3. Prices, terms of expertise.

1. General information .

Import and sale of cosmetic products require it's certification – procedure of sanitary-hygienical expertise. Conclusion of sanitary-hygienical expertise is issued by Sanitary-epidemiological agency of MOH of Ukraine and by authorized institutions.

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 : cosmetic with healing effect, parapharmaceutical product and so on. In other words – some products that are classified in manufacturer's country as cosmetic product – can be declared as medicinal products or medical devices in Ukraine .

In accordance with actual Ukrainian legislation – Order of Ministry of Health of Ukraine №443 dated 01.11.2004: cosmetic products with healing effect, that include particles of active substance in cosmetic materials that are used for prophylactic and/or treatment of skin diseases, mucous tunic of nose and mouth, genitals of the patient and has a form of cream, milk, oil, balsam, gel, powder, lotion, shampoo, lipstick, extract for shower, antiperspirant, teeth paste, elixir – should be classified and registered 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). Usually both expertise are performed by one expert institution.

There are no exact requirements to the package design, except general consumer standards: text should be presented in Ukrainian language, composition should be mentioned, brief information about way of administration and safety warnings, name of the product and name and address of the manufacturer, batch number and shelf-life term.

All cosmetic products are the object of VAT tax (20%).

Cratia Ltd. will provide you with efficient and professional assistance in registration of cosmetic 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.

State registration of cosmetic and cosmetological products in Ukraine. Certification and marketing authorization of cosmetics. Sanitary expertise of cosmetic products. Ukraine, Kiev, Cratia Ltd.

Services of Cratia Ltd. includes:

• 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;

3. Prices and terms.

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 cosmetic product can vary from 800 to 2000 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 2 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:

• structure of the dossier (list of required documents) for certification of cosmetic products;

• our contacts;