Registration of cosmetics in Ukraine

Cosmetic is a type of goods separated from drugs and biological additives in a special group, because their main purpose – caring for appearance and improve the appearance of people. The modern cosmetic industry offers a wide range for skin, hair, nails and mouth care. Much attention is paid to the development of deodorants and antiperspirants, as well as skin protection from environmental hazards. For example, a sunscreen protects against sunburn.

Medicinal cosmetics, which, together with cosmetic raw materials contain some active ingredients or their mixtures, used for the prevention and / or treatment of diseases of human skin and its appendages, mucous coat of the nasal and oral cavities, and genital organs of the patient and are in the form of cream, milk, oils, masks, lotion, gel, powder, losyona, shampoo, lipstick, bath extracts, antiprespiranta, dental office, elixir – are recorded and classified as a cosmetic medicine in Ukraine.

Any cosmetic product supplied to the Ukrainian market must be certified and get a conclusion, issued by Sanitary and Epidemiology Service (SES) of the Ukrainian Ministry of Health.

New registration of cosmetic products

1. The general information

2. The list of “Alenpharm” services

3. Cost and terms of carrying out of procedure

1. The general information

For import and circulatuion of cosmetic products it is necessary to pass its certification – that is, to receive the sanitary-hygienic decision. The Sanitary-hygienic conclusion stands out Sanitary-epidemiologic service (SES) MOH Ukraine, and also – authorised SES institutes.

Important point at decision-making on the beginning of registration of cosmetic product, is the fact of correct classification of a product. In the world there are terms which are not applicable in Ukraine: the medicinal cosmetics, a parapharmaceutical product etc. In other words, a number of products which are classified in the country of the manufacturer as cosmetic means – in Ukraine can be recognised as medical products.

According to acting the Ukrainian legislation, namely order MOH of Ukraine №443 from 11/1/2004: Medicinal cosmetic means which together with cosmetic raw contain separate acting substances or their mixes which are used for preventive maintenance and-or treatment of dermal disorders of the person and its appendages, a mucous membrane of nasal and oral cavities, genitals of the patient and are produced in the form of a cream, milk, oil, mask, balm, gel, powder, lotion, shampoo, lipstick, extract for baths, antiperspirant, toothpaste, elixir – are registered and classified as medical products in Ukraine.

Thus, even prior to the beginning of registration it is necessary to estimate, from the professional point of view as the given product will be classified.

Examination which is conducted for issue of the sanitary-hygienic conclusion, includes:

• examination of the documentation;
• approbation in laboratory.

Usually both tests are conducted by one expert organisation.

For cosmetic products there are no accurate legislative requirements to a packaging marking, except general consumer standards: the text in the Ukrainian language, indication of composition, brief information on a method and warnings in the use, the name and the address of the manufacturer, number of a series and expiration date.

Cosmetic products are object of the 20% VAT.

Company “Alenpharm” will render you the fast and professional help on registration of cosmetic products – we can correctly classify a product, we will prepare the application and documentation, and we will accompany a product throughout period examination, up to the moment of reception of the original sanitary-hygienic conclusion.

2. The list of “Alenpharm” services:

• submission applications and the dossier in state structures MOH of Ukraine (in the chosen base);
• optimum choice of base carrying out of examinations;
• support of dossier while examination carrying out;
• completion of dossier according to legislation requirements;
• rendering of consultations, correspondence conducting;
• translation of necessary parts of the dossier, including – notarial translation;
• preparation and coordination of the applications;
• creation and development of a marking of package, the instruction (if necessary);
• reception of conclusion by code UKT ZED in Commercial and industrial chamber (if necessary);
• customs clearance and import of samples;
• reception of the authentic conclusion;
• all other costs necessary for carrying out of procedure.

The most part of our consultations – is free, and we will be always glad to answer your questions.

3. Cost and terms of carrying out of procedure

Cost of services of our company and volume of the state payments is determined in a current of 3-5 days after file reception: specialists of our company will estimate volume of necessary work and will conduct preliminary dialogue with expected bases of testing. Term of carrying out of registration as in many respects depends on the documentation and the product, and at the average constitutes from 2 weeks from the moment of application till 2,5 months.