Resolution No. 863 of August 15, 2023 approved the Regulation on State Registration of Disinfectants.
The Regulation defines a disinfectant as a substance or mixture of substances of chemical or biological origin used for disinfection measures to destroy vegetative forms of infectious disease agents and their vectors in the human environment. Other terms are used in this Regulation in the meaning given in the Laws of Ukraine "On Public Health System", "On Protection of the Population from Infectious Diseases" and other regulatory legal acts.
At the same time, the state registration and re-registration are subject to the products for which the active substances are subject to medical and sanitary standards and which are intended for:
implementation of disinfection measures in the centers of infectious diseases, health care facilities, preschool education institutions
disinfection of hands of healthcare workers;
Preventive disinfection of residential, industrial, educational, sanitary and other premises, buildings and structures, vehicles, catering and trade facilities, territories of settlements, in places of mass recreation and recreational areas;
industrial disinfection;
washing and cleaning in households and industry with disinfectant properties;
disinfection of indoor air, water (except drinking water), industrial and domestic wastewater;
destruction of vectors of infectious diseases (insecticidal);
destruction of synanthropic insects in the human environment;
repelling insects;
destruction of rodents that are sources and carriers of infectious diseases;
decontamination of the skin of the hands of personnel of food and processing industries, catering, and trade.
It should be noted that the registration of disinfectants will require:
1) an application;
2) a registration dossier for the product containing the information listed in Annex 1;
3) results of evaluation (reports and protocols) of specific activity, safety, quality (efficacy) of the product and results of practical testing conducted by enterprises, institutions, organizations authorized by the Ministry of Health to perform work for the purposes of state registration of disinfectants;
4) a sample label of the product containing the information specified in Annex 2;
5) a sample of instructions for use and destruction of the product containing the information specified in Annex 3;
6) information on the methods of utilization of the product, its stability in the environment, and shelf life;
7) a document confirming the applicant's authority to represent the interests of the manufacturer (if the applicant is not the manufacturer).
The state registration of medicinal products and maintenance of the Register is carried out by the Ministry of Health based on the results of the expert evaluation of registration materials for such products conducted by the expert institution - the State Enterprise "Committee on Hygienic Regulation of the Ministry of Health of Ukraine".
The expert evaluation of registration materials is carried out on a fee basis and the tariff is currently being approved by the Ministry of Health.
The Committee reviews the registration materials for the medicinal product within a period not exceeding 180 calendar days from the date of receipt of all documents from the applicant.
Within 30 business days after receiving the expert opinion, the Ministry of Healthcare of Ukraine makes a decision on state registration of the medicinal product or refusal of state registration.
We recommend that you carefully read the contents of Annex 1 to the Regulation "Requirements for Registration Dossier for Disinfectants", as this annex contains comprehensive information on general and specific information about the products and includes 57 items.
Appendix 2 to the Regulation "Information to be contained on the label of a disinfectant" defines how a sample label should look like.
Annex 3 to the Regulation defines what the Draft Instruction for the use and destruction of a disinfectant should contain.
We can state the fact that the conclusion of the state sanitary and epidemiological examination is no longer required for registration, but there is much more to be provided by manufacturers.
The Resolution will come into force on October 1, 2023.
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