Sanitary-epidemiological conclusion (so-called “SES conclusion”) is required prior to placing cosmetic products on the market of Ukraine. Conclusion confirms the quality and safety of the products, defines specific marketing requirements etc. 

Conclusions are issued by authorized expert organizations of the Sanitary and Epidemiological Service of the Ministry of Health of Ukraine. The procedure consists of two main stages: expert evaluation of the dossier for a cosmetic product and laboratory tests of samples of the finished product. As a result of passing through these stages, an opinion is issued for up to 5 years.

The conclusion can cover an extensive list of products of the same form (for example, cream) and characteristics. Products with different forms / customs codes should be registered by separate Applications. 

The Applicant (Holder) of marketing authorization may be any legal entity, resident or non-resident of Ukraine. The Applicant is not required to create a company in Ukraine.

Adverse events supervision (cosmetovigilance) has not yet been introduced in Ukraine.

Labeling

According to the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as a State Language”, labeling of cosmetics is made in Ukrainian.

Placement of information is allowed with sticker label.

Starting January 1, 2021, medical devices must be labeled with measurement units of the International System of Units (SI) (kilograms, centimeters, liters, etc.), in the Latin letters.

Cratia provides professional services on registration of cosmetic products in Ukraine. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.