Mikhailyuk, Sorokolat & Partners

Patent and Trademark Attorneys

Amendments to the state registration procedure of disinfectants in Ukraine

Amendments to the state registration procedure of disinfectants in Ukraine August 22, 2023

Amendments to the state registration procedure of disinfectants in Ukraine

On August 15, 2023, the Cabinet of Ministers adopted Resolution No. 863, which has approved new regulations on the state registration of disinfectants in Ukraine.

Said regulations defines the procedure of the state registration and re-registration of disinfectants, as well as requirements to the following:

• application for the state registration of a disinfectant;

• registration dossier and other related documents to be submitted for the state registration of a disinfectant;

• studies required for the state registration of disinfectants;

• SPC (Summary of Product Characteristic);

• package insert (instructions for use and disposal);

• labeling (label, mock-up, sticker);

• the expert conclusion.

It is important to note, that the new Resolution enters into force on October 1, 2023, accordingly the previous Resolution of the Cabinet of Ministers of Ukraine No. 908 dated July 03, 2006 "On Approval of the Procedure for State Registration (Re-registration) of Disinfectants" becomes no longer valid.

In case you would like to receive more detailed information on registration of disinfectants in Ukraine, please contact our specialists from Regulatory Affairs Department.