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Registration of disinfection products

Anti-infective agent is a chemical substance, biological factor and agent for medi-cal use applied for disinfection measures (the Law of Ukraine “On Protection of the Population  Against Infectious Diseases”).

Therefore, the disinfection means (disinfection, disinfestation, and deratization) are actions to destroy the agent of infectious diseases (disinfection) as well as their carriers - insects (disinsection) and rodents (deratization) in the environment of vital activity for human.

Based on the above mentioned definitions, agents are subject to registration that are intended for:

  • implementation of disinfectant measures in the foci of infectious diseases, health care institutions, preschool educational institutions;
  • “cold” sterilization of medical devices;
  • disinfection of hands of medical workers;
  • preventive disinfection of residential, industrial, educational, sanitary com-mon and other premises, buildings and structures, transports, public catering and trade objects, territories of settlements, in the place of public entertainment and recreational zones;
  • industrial disinfection;
  • washing and cleaning in household and industry, with disinfecting properties;
  • disinfection of indoor air, water (except drinking water), industrial and domestic wastewater;
  • antisepsis of carriers of infectious diseases (insecticidal agents);
  • antisepsis of synanthropic insects in the environment of vital activity for human;
  • repelling of the insects;
  • antisepsis of rodents, which are sources and carriers of infectious agents;
  • decontamination of the skin of the hands of personnel in the food and processing industry, catering, and trade;
  • pre-sterilization cleaning of medical devices;
  • quality control of sterilization and pre-sterilization cleaning of medical devices.

According to the Resolution of the Cabinet of Ministers of Ukraine No. 908 dated 07/03/2006, the Resolution of the Cabinet of Ministers of Ukraine No. 178 dated 03/14/2018 and the Order of the Ministry of Health of Ukraine No. 739 dated 11/06/2006, these agents should be duly tested and recorded to the official state register.

The function of keeping the register is currently assigned to the Ministry of Health of Ukraine. The disinfection agent is registered after it is published in the “State Register of Disinfectants” of the Ministry of Health of Ukraine.

Issue of certificate of state registration is not performed, but at the request of the manufacturer or his representative, you can get an extract from the register. The record in the state register is performed based on the results of the state sanitary and epidemiological conclusion regarding specific activity, safety, quality and laboratory analysis of the anti-infective agent.

The period of validity of the state registration of a anti-infective agent is 5 years. At the end of this period, it is possible to conduct the re-registration in order to extend the validity of the certificate for the following 5 years.

In order to start the process of registration or re-registration of a anti-infective agent, it is necessary:

  1. To prepare the Application for registration, which contains all the necessary data about the manufacturer and the properties of the agent, to prepare a registration dossier in accordance with the requirements of Ukrainian legislation, to import samples of the anti-infective agent.
  2. To submit the Application, dossier and product samples to an accredited research institute for analysis and testing, according to which the disinfection products will be recommended for registration;
  3. To obtain a sanitary and epidemiological report;
  4. To submit a dossier and a copy of the sanitary and epidemiological conclusion to the Ministry of Health of Ukraine, which will include the product to the register of anti-infective agents.

Company “Cratia” is ready to organize a full procedure for registration of disinfection agents from the moment of receipt of the first inquiry and up to inclusion of all necessary information into the state register. In fact, we will do all the work ourselves, but coordinating with you the key points. We are fluent in English and have knowledge of professional terminology, as well as a database of forms and templates of required documents, which will greatly facilitate the receipt of all necessary permits, both from the domestic manufacturer and from abroad manufacturer. With our help, the procedure of state registration of your anti-infective agent in Ukraine will be performed professionally, quickly and easily.

As a result of our cooperation you will receive the following documents:

  • Conclusion of sanitary-epidemiological expertise for anti-infective agent;
  • Conclusion of sanitary-epidemiological expertise for technical conditions of Ukraine for domestic anti-infective agents;
  • An extract from the state register of anti-infective agents (at Your request).

All preliminary consulting and advices are free of charge, do not hesitate to contact us by e-mail info@cratia.ua, tel. +38 (044) 332-42-94 or visit our office.