On May 16, 2019, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” (hereinafter – “the Law”) was published. The Law will enter into force on July 16, 2019, and transitional periods of 6 months have been set for a significant part of the provisions.

The Law has a significant impact on user information (product labeling, instructions, interface), marketing and promotional materials, websites, public events (seminars, conferences) etc. We have prepared an analysis of the most important changes affecting the circulation of medical products, food products, disinfectants and cosmetics (open in PDF file).

Please note that when drafting user information, specialists of Cratia take into account the requirements of sectoral and related legislation, and also advise to apply the most important norms of the new Law in advance. We have reason to believe that for the majority of our partners’ products, new requirements have been already taken into account for labeling and instructions which may not require changes. However, we recommend that manufacturers and their representatives review the compliance of products with the requirements of the new Law, in particular:
– regarding the completeness and conformity of labeling;
– regarding the localization of the user interface (UI / GUI);
– regarding the use of the Ukrainian language in marketing and promotional materials, on the website;
– national producers according to the OBL-OEM model.

Within two weeks, we will update the internal labeling guidelines that will be available to company’s customers upon request.

We invite you to participate in the seminar on labeling of health care products (medical devices, food products, disinfectants and cosmetics), which will be held on June 21, 2019 (Friday). Detailed information is available on request at education@cratia.ua