On November 5, the Ministry of Health of Ukraine published for public discussion a draft resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Procedure for State Registration (Re-registration) of Disinfectants” (hereinafter – the draft resolution).
The accompanying documentation to the project states that the current procedure of state registration of disinfectants provides that the registration of such means is based on a positive conclusion of the state sanitary-epidemiological examination, which is a document of the established form certifying compliance (non-compliance) with safety requirements. human health and life. But in the process of state registration, the specific activity (effectiveness) of disinfectants is not studied.
That is, in fact, the current procedure of state registration can not guarantee the effectiveness of disinfectants, so it needs to be improved, especially in the context of the spread of COVID-19 in Ukraine
Therefore, the draft resolution proposes to amend the Procedure for state registration (re-registration) of disinfectants (hereinafter – the Procedure), approved by the Cabinet of Ministers of 03.07.2006 № 908.
The amendments to the Procedure provide that the state registration (re-registration) of a product will be carried out by the Ministry of Health on the basis of an application and the results of examination of registration materials for such a tool by the state enterprise “Committee for Hygienic Regulation of the Ministry of Health of Ukraine” order.
The application for state registration (re-registration) of the product, which will be submitted to the Ministry of Health by a legal or natural person responsible for the quality, safety and effectiveness of the product (hereinafter – the applicant), will indicate: name and location of the applicant, name, location and address manufacturer of the product, name of the product, name of the active substance, full composition of the product, purpose of the product, mode of use, shelf life and conditions, packaging information.
In turn, for the examination of registration materials, the applicant will submit to the Committee:
- materials of the registration dossier, the requirements for the content and scope of which are approved by the Ministry of Health;
- results of assessment (reports and protocols) of specific activity, safety, quality of the tool and test results in practice according to the form established by the Ministry of Health;
- packaging labeling text, draft product label;
- draft instructions for use of the tool;
- information on the methods of disposal of the tool, its stability in the environment, shelf life;
- a document confirming the applicant’s authority to represent the interests of the manufacturer (if the applicant is not a manufacturer).
The term of examination of registration materials submitted for state registration (re-registration) of the product should not exceed 30 calendar days after their receipt by the Committee, and the examination of registration materials will be carried out after receiving a letter from the Ministry of Health and payment of the cost established by the applicant and the Committee.
For its part, the Committee will prepare reasoned conclusions on the specific activity, safety and quality of the tool based on the results of the examination of registration materials and will recommend state registration (re-registration) of the tool or refuse it. Based on the results of consideration of the reasoned conclusions, the Ministry of Health makes a decision on state registration (re-registration) of the means or refusal in it.
The decision of the Ministry of Health on state registration (re-registration) of the product will assign a registration number, which is entered into the State Register of Disinfectants (hereinafter – the Register), as well as approve the instructions for its use. The tool will be considered registered from the moment of entering information about it in the Register. It should be noted that in the draft resolution there is no clause that the entry of information about the tool in the Register will be free of charge.
The changes also stipulate that the decision of the Ministry of Health to refuse state registration (re-registration) of a product will be made if the examination of registration materials did not confirm the information on the effectiveness, safety and quality of such a tool.
The Ministry of Health within a period not exceeding 10 working days after the decision, sends the applicant a written reasoned response to the refusal of state registration (re-registration) of the tool.
In addition, the Ministry of Health will decide to terminate the state registration of the tool in case of detection of previously unknown dangerous properties, in particular:
- the composition of the tool does not correspond to that specified in the registration documents;
- the registration documents or information on amendments to them provided by the applicant are unreliable;
- the applicant did not ensure compliance with the requirements specified in the first and second paragraphs of paragraph 10 of this Procedure;
- other dangerous properties of the product, etc. are revealed.