Registration of disinfectants
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What we offer
- Advise on the current legislation, on the procedure for registration of disinfectants (due to the lack of a developed legal framework of the Ministry of Health)
- Submit a package of documents to the State Service of Ukraine for Food Safety and Consumer Protection ( temporarily replacing the Ministry of Health) for the disinfectant registration, as well as represent and protect the Client’s interests, in case of any objections;
- Help to identify a particular disinfectant as such, which falls or does not fall under the definition of a disinfectant;
- Advise on all matters related to the registration (procedure, draft instructions, labels, technical specifications and other documents);
- Obtain paper confirmation of the registration from the relevant register of the State Service of Ukraine for Food Safety and Consumer Protection (temporarily replacing the Ministry of Health).
To prepare the package of documents for the registration of disinfectant with the Ministry of Health, our lawyers need the following information from the Client:
1. Information on the name of the disinfectant (in Ukrainian and, if available, in English);
2. Information on the applicant:
- If the applicant is an individual entrepreneur - the identification code, address and telephone number;
- If the applicant is a Ukrainian legal entity - the EDRPOU code, address and telephone number;
- If the applicant is a foreign legal entity - the name, registration number of the enterprise, address, e-mail address and telephone number;
3. A power of attorney for our lawyers.
Service packages offers
- Providing an introductory oral consultation on the process of obtaining a sanitary and epidemiological certificate (SES)
- Providing oral advice on the timing of obtaining SES
- Provision of a possible algorithm of actions for obtaining a Certificate of registration of a disinfectant
- Consulting on the registration process for disinfectants
- Preparation and submission of documents for obtaining SES
- Full preparation of technical specifications and obtaining an opinion on them
- Preparation of documents and registration of SES technical conditions for further self-submission of documents by the Client
- Advising on the registration procedure for disinfectants
- Obtaining a certificate of registration of SES
- Obtaining a certificate of registration with the Ministry of Health
- Guaranteed result
Period of the disinfectant registration starts - from 2 weeks.
The registration procedure consists of two stages, which must be completed:
- Obtaining technical specifications. The period and price may vary depending on the composition and manufacturer of the disinfectant.
- Passing expert examination of the State Service of Ukraine for Food Safety and Consumer Protection, which lasts about 2 weeks. Based on the results of the examination, the State Service of Ukraine for Food Safety and Consumer Protection issues the conclusion.
We can help you with the registration of a disinfectant, regardless of the country of origin and whether you have a full package of documents.
We can help at any stage, regardless of your location.
We are ready to help you!Contact us by mail [email protected] or by filling out the form:
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The current legislation provides for two procedures for registration/re-registration of disinfectants:
- Based on the positive conclusion of the SSEE (the State Sanitary and Epidemiological Expertise) issued before the legal effectiveness of Registration/Re-registration Procedure;
- By submitting the documents listed in the Documents section on this service page.
However, even the registration/re-registration based on the SSEE conclusion is problematic due to the lack of a complete procedure and established regulatory framework.
Answers to frequently asked questions
For this purpose, it is necessary to get Technical Specifications and a positive conclusion of the State Service of Ukraine for Food Safety and Consumer Protection. This procedure exists de facto due to the lack of a regulatory framework of the Ministry of Health.
Yes, they can. Such products have antiseptic properties, and, therefore, are disinfectants.
One of the registration stages is the laboratory research, but unfortunately this procedure is still not prescribed by the Ministry of Health of Ukraine, so there is a slightly different procedure.
Yes. As a result of our services, you will get the technical specifications and the positive conclusion of the State Service of Ukraine for Food Safety and Consumer Protection.
What can be considered a disinfectantThe main criteria that a disinfectant has to meet are as follows:
- the presence of established hygienic standards for agents;
- scope of application:
- disinfection in foci of diseases of an infectious nature, in medical or educational institutions;
- chemical sterilization of medical devices;
- hand disinfection;
- preventive disinfection of various buildings, vehicles, territories and the like;
- industrial disinfection;
- industrial and domestic cleaning with disinfectants;
- extermination of insects, rodents, which are carriers / sources of infectious diseases;
- other applications.
Problems pertaining to registering agentsThe authority to register disinfectants in 2018 was transferred from the State Sanitary and Epidemiological Service to the Ministry of Health.
According to the current legislation, an agent is considered registered from the moment it is entered in the register, and therefore, this procedure was not in force work prior to the development of appropriate orders and procedures.
The order of the Cabinet of Ministers of Ukraine regulating the issues of registration / re-registration contains an exhaustive list of documents that must be collected for registration. Therefore, manufacturers and applicants can collect documents and take assessments and tests, and our lawyers will do all the other necessary work and help you add an agent to the reister.
It is important that previously issued certificates of state registration are considered valid for the duration specified in such certificates. After the end of their term, it is necessary to carry out the re-registration procedure.
If you want to register a disinfectant simply and reliably - call us!