MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

STATE REGISTRATION OF DISINFECTANTS IN UKRAINE

In accordance with the law "On the protection of population from infectious diseases" and Decree of the Cabinet of Ministers of Ukraine dated July 3, 2006 No. 908 "About approval of the Procedure for state registration (re-registration) of disinfectants" the disinfectants are allowed for use in Ukraine after conducting the state registration procedure and entering information about it into the State Register of Disinfectants of the Ministry of Health of Ukraine.

According to the current legislation for the state registration of disinfectants it is necessary to submit the application together with the following documents to the Ministry of Health of Ukraine:

  • legalized Power of Attorney from the applicant to the representative, from manufacturer of the disinfectant to applicant (if they are different);
  • reports and protocols of the specific activity, safety, quality (efficiency) of the disinfectant and the results of the tests conducted in accordance with the requirements of the GLP (including the toxicological studies);
  • original and proposed mockups for the Ukrainian market;
  • original and proposed instruction for use;
  • method of utilization.

Also, in connection with the approval of the Decrees of the Cabinet of Ministers of Ukraine of March 25, 2020 No. 232, registration of disinfectants is possible on the basis of a positive conclusion of the Sanitary-epidemiological examination.

To obtain a Sanitary-epidemiological conclusion, it is necessary to submit the application and samples of the product together with the following documents to the authorized research institution:

  • legalized Power of Attorney from the applicant to the representative, from the manufacturer of the disinfectant to the applicant (if they are different);
  • specification (qualitative and quantitative composition of the product);
  • copies of the document confirming that the product meets the requirements established in Ukraine for its quality and safety for human health;
  • copies of the registration certificates issued by the Authority of the country of a manufacturer and by other countries where disinfectant is registered;
  • original and proposed instruction for use;
  • original and proposed mockups for the Ukrainian market;
  • copies of the documents issued by the competent authorities of country of manufacturer/applicant of disinfectant confirming its safety (legalized by the Ukrainian Embassy);
  • letter from the manufacturer on the provision of samples or the act of sampling for research;
  • certified copies of the documents the disinfectant is manufactured according to (standards, technical conditions, regulations, technological instructions);
  • certificate of inspection of the manufacturer, if any (conclusions of industry examinations or specialists and other materials that characterize its production in terms of quality and safety);
  • reports and protocols of the specific activity, safety, quality (efficiency) of the disinfectant and the results of the tests conducted in accordance with the requirements of the GLP (including the toxicological studies);
  • certificate of stability (shelf-life);
  • methods of quality and safety control of the product.

The procedure of obtaining a Sanitary-epidemiological conclusion may last from about 1 to 4 months after submission of the product samples and necessary documents.

According to the Ukrainian legislation a Registration Certificate for a disinfectant is not issued. A disinfectant is considered as registered after the information about it is entered into the State Register of Disinfectants of the Ministry of Health of Ukraine.

The procedure of the state registration of disinfectant and entering information about registration into the State Register of Disinfectants should be conducted within 30 days. However, in accordance with the usual practice the procedure of the state registration may last from 1 to 2 months.

The period of validity of the state registration of a disinfectant is 5 years and after that it is necessary to renew it each time for the next 5 years.

In order we could provide you with the information on costs associated with registration of disinfectants in Ukraine together with the detailed information and a list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.

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