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In accordance with Decree No. 863 of the Cabinet of Ministers of Ukraine dated August 15, 2023 “On the Approval of the Regulation on the State Registration of Disinfectants,” disinfectants are allowed for use in Ukraine after their state registration.
Required documents and registration procedure
According to the current requirements, the state registration of disinfectants is possible only after examination of the documents on the product in one of the authorized research institutions of Ukraine.
For this purpose, the applicant must submit an application to the Institute with the set of the following documents:
- Legalized Power of Attorney from the applicant to the representative, from the manufacturer of the disinfectant to the applicant (if they are different);
- Registration dossier for the product according to the established structure;
- Proposed mockups for the Ukrainian market according to the established structure;
- Instructions for use and disposal of the product according to the established structure;
- Information on the methods of utilization of the product, its stability in the environment, and shelf life.
The institute prepares 4 reports based on the materials in the applicant’s dossier:
- Physical, chemical and technical properties of the product;
- Toxicological profile;
- Specific activity against the target organisms;
- Data on the verification in practice.
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 mockups for the Ukrainian market;copies of the documents issued by the competent authorities of country of manufacturer/applicant of disinfectant confirming its safety 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 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.
In case the information in the dossier is incomplete and the applicant cannot provide it as requested by the Institute, then samples of the product must be provided to carry out the required trials.
Once the Institutes finalize the necessary reports, the applicant submits an application for registration with a complete package of the documents to the Hygienic Regulation Committee of the Ministry of Health of Ukraine (the Committee).
In case of receipt of a positive expert conclusion of the Committee, the Ministry of Health of Ukraine makes a decision on the state registration.
Timeframe
Time frames of issuing reports by the Institutes are determined after examination of the submitted dossier by concluding the Contract with the Institute.
Examination of the registration documents should be conducted by the Committee within 180 calendar days after receipt of all the required documents and payment for said service.
The Ministry of Health of Ukraine makes a decision on the state registration within 30 working days.
Validity term and renewal
The period of validity of the state registration of a disinfectant is 5 years and after that it is necessary to renew it every 5 years.
In order we could provide you with the information on the costs associated with registration of disinfectants in Ukraine, along with the detailed information and a list of documents required from your side, as well as a sample Power of Attorney for execution, etc. please contact our specialists.
