Registration of disinfectants
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What we offer
- Consult on current legislation regarding the registration of disinfectants.
- Check the composition and active substances to determine whether they are listed in the Register of Hazardous Factors and other relevant lists.
- Support the evaluation process (reports and protocols) of the product’s specific activity, safety, quality (effectiveness), and results of practical testing.
- Prepare documents for submission to the State Enterprise “Committee on Hygienic Regulation under the Ministry of Health of Ukraine.”
- Assist in preparing and submitting the application, registration dossier, sample label, sample instructions for use, information on disposal methods, product stability in the environment, and shelf life.
- Accompany the review process with the Committee and the Ministry of Health until the product is included in the Register
Required documents for disinfectant registration
Disinfectant registration is a complex process that combines legislative requirements, technical regulations, and bureaucratic procedures. That’s why successful registration requires knowledge of the law, expert evaluation, and properly prepared documentation.
Even the smallest mistake, from an incorrectly completed form to an imprecise wording, can result in months of delays or even a complete refusal of registration. For businesses, this means not only lost time but also significant financial risks: inability to enter the market at the right moment, loss of partners, or loss of investors.
Who Needs State Registration of Disinfectants?
State registration of disinfectants is required for all manufacturers or their representatives who aim to:
- Legally sell or use the product in Ukraine.
- Ensure the safety and effectiveness of the product.
- Build consumer trust and protect their brand from unfair competition.
What Qualifies as a Disinfectant?
Disinfectants include substances or mixtures of chemical/biological origin that are used for disinfection measures (eliminating vegetative forms of infectious disease pathogens and their carriers).
The main criteria for determining whether a product qualifies as a disinfectant subject to registration are:
- Availability of established hygienic standards for the product.
- Scope of application:
- disinfection in infection outbreak areas, in medical or educational institutions;
- chemical sterilization of medical devices;
- hand disinfection, including for medical staff and employees of food service, trade, and similar facilities;
- preventive disinfection of various buildings, transport, food service and trade establishments, public areas, etc.;
- industrial disinfection and industrial/household cleaning with disinfectant properties;
- elimination of insects and rodents that are carriers/sources of infectious diseases.
Please note: without state registration, a disinfectant cannot be legally sold or used.
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
What Is Needed to Register a Disinfectant with the Ministry of Health of Ukraine?
To quickly and smoothly prepare the document package for disinfectant registration, our lawyers need the following information from you:
1. Product name (in Ukrainian and, if available, in English).
2. Applicant information:
- For individual entrepreneurs, the identification code, address, e-mail, and phone number.
- For Ukrainian legal entities, the EDRPOU code, address, e-mail, and phone number.
- For foreign legal entities, the company name, registration number, address, e-mail, and phone number.
Timeline and Stages of Disinfectant Registration
The procedure for state registration of a disinfectant includes several stages:
- Research and testing of the product’s specific activity, safety, quality (effectiveness), and practical application. These are carried out by enterprises, institutions, or organizations authorized by the Ministry of Health to perform such work for state registration purposes, in accordance with procedures defined by the Ministry.
- Submission of documents to the Committee on Hygienic Regulation of the Ministry of Health for state registration of the product.
- Decision by the Ministry of Health and issuance of an official order on state registration of the product.
- Entry of information into the Register of Disinfectants.
- The Ministry of Health issues an official certificate of state registration of the disinfectant.
The registration period for a disinfectant is 6 months and more, but it may vary depending on the completeness of the document package and the results of laboratory testing.
We provide full legal support for disinfectant registration, regardless of the country of manufacture or whether you already have a complete document package. Even if you are located outside Ukraine, our lawyers will ensure control of the process, timely completion of all formalities, and minimization of risks.
What Is the Validity Period of Disinfectant Registration and Re-Registration?
The validity period is 5 years. During this time, the applicant is responsible for the quality of the registered disinfectant and must inform the Ministry of Health of any changes. Full information must also be provided regarding the reasons for such changes and their impact on the product’s safety, effectiveness, and quality.
Please note! After the expiration of the certificate for the use of a disinfectant in Ukraine (issued before October 2023) or the product’s registration, further use is permitted only after completing the re-registration procedure.
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Registration or Re-Registration of a Disinfectant: What’s the Difference?
State registration of disinfectants is regulated by the Regulation approved by the Resolution of the Cabinet of Ministers of Ukraine dated August 15, 2023, No. 863. According to this document, there are two procedures:
- Initial registration of a disinfectant. For initial registration, the applicant submits documents to the Committee on Hygienic Regulation of the Ministry of Health, which prepares an expert opinion and forwards it to the Ministry of Health. Based on the Ministry’s order, the disinfectant is entered into the State Register of Disinfectants.
- Re-registration of a disinfectant. This is required if the validity period of the state registration has expired, the product’s composition has changed, the product’s name has changed, production rights have been transferred to another manufacturer, or the intended use of the product has changed. The application for re-registration must be submitted no later than 30 business days before the expiration of the registration period. Re-registration is carried out under the same procedure as the initial state registration.
Answers to frequently asked questions
Is it mandatory to have a registered trademark for a disinfectant?
No, this is not a mandatory requirement for registration. However, having a trademark gives you exclusive rights to use and protect your brand, eliminates the risk of unfair competition, and increases consumer trust.
Can a disinfectant be sold while it is still undergoing registration?
No. The sale and any use of unregistered products is prohibited.
Does the Pravova Dopomoga law firm prepare the registration dossier for a disinfectant?
Yes. Our lawyers can provide full support in preparing all the necessary documents on a turnkey basis.
Can a product manufactured abroad be registered?
Yes. To register an imported product, the UCG FEA code (Ukrainian Classification of Goods for Foreign Economic Activity) and the foreign manufacturer’s registration number are required.
Why It’s Important to Entrust Disinfectant Registration to Professionals
Most manufacturers and importers of disinfectants find the process stressful due to its complexity and bureaucracy, as mistakes can cost both time and money. Preparing the dossier, checking the composition, conducting laboratory tests, creating labels and instructions, and communicating with the Ministry of Health Committee, which requires not only knowledge of the law but also practical experience with regulatory authorities.
That’s why entrusting the process to professionals is a guarantee that your product will be prepared according to all standards, will pass verification without unnecessary delays, and will enter the market without risks to your business or brand.
What you get when working with us:
- Transparency and control – you always know the status of your documents, which tasks are completed, and what still needs to be done.
- Resolution of complex issues without your involvement – we know how the Ministry of Health and the Committee work, and we prevent bureaucracy from stalling the process.
- Time savings – no need to search for laboratories, translate protocols, or check labels on your own.
- Protection from hard-to-fix mistakes – we identify weak points in the dossier and correct them before submission.
Why do clients choose us?
- Over 16 years of experience in the registration and re-registration of disinfectants in Ukraine.
- Dozens of successful registrations where disinfectants quickly entered the market without unnecessary requests or clarifications from the Ministry of Health.
- We know where the process can get stuck and how to prevent it.
Entrust the registration to professionals. Leave an application and we will make sure your product does not remain in line for months.
We are ready to help you!
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