Volodymyr Misyurak
Lawyer

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Registration of disinfectants

Registration of disinfectants

What we do

  • we submit a package of documents for the registration of disinfectant to the Ministry of Healthcare, as well as perform the functions of representation and protection of the Client in the event of any comments;
  • we assist with the identification of a specific agent as such, which comes or doesn’t come within the scope of definition of disinfectant;
  • we advise on all matters related to the registration (procedure, drafts of instruction, labels and other documents);
  • we organize the assessment and testing of the agent by the authorized institutions;
  • we obtain an extract from the relevant register of the Ministry of Healthcare in the paper form.

OUR FEES

To register disinfectant
from 12 000 грн.

Registration term is up to 2 months.

 

The registration procedure call for the examination of a disinfectant, which lasts up to 3 weeks.

 

After a positive evaluation result, the lawyers of our company check, put together and submit a package of documents to the Ministry of Health, which takes up to 30 days.

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.

WHY CHOOSE US

  • plus

    Long-term practice of cooperation with the Ministry of Health

    We have been cooperating with the Ministry of Health for some years now. Therefore, we know how a registration agency functions not just in theory but also in practice. Thanks to our many years of experience in the field of medicine, you won’t face any unexpected surprises, which is helpful in terms of significantly saving time and money.
  • plus

    An on-going monitoring of legislation and reliable partnership

    Registration of disinfectants is a new and non-standard procedure. However, thanks to reliable relations with a number of state and municipal agencies in the field of clinical research, we know how to go through this process with minimum time and optimum results.

ANY QUESTIONS LEFT?

Our lawyers will advise you!

Ask a lawyer

Required documents

  • Information about the manufacturer and applicant
  • Disinfectant Information
  • The positive conclusion of the State Sanitary and Epidemiological Examination

To prepare a package of documents for registration with the Ministry of Health, the Client provides our lawyers with:


1. Information on the name of the product (in Ukrainian and, if available, in English);

2. Applicant Information:
  • if the applicant is a sole trader - a tax number, address and telephone number;
  • if the applicant is a Ukrainian legal entity - EDRPOU code, address and  telephone number;
  • if the applicant is a foreign legal entity - name, company registration number, address, email address and telephone number;

3. Information about the manufacturer, similar to information about the applicant;


4. The results of the evaluation and testing of the product (protocols, reports);


5. Sticker of the agent (draft);


6. Instructions for use (draft);


7. Information about:

  • stability of the agent in the environment;
  • disposal methods;
  • storage period.

8. Power of attorney for the applicant, if the applicant is a person other than the manufacturer.

REFERENCES FROM OUR CLIENTS

President Tedeev E.S., Ukrainian wrestling association

Ukrainian wrestling association would like to express its sincere appreciation to the team of Law firm "Pravova Dopomoga" for mutually beneficial cooperation... More information

Partner, Denis Y. Lysenko, Vasil Kisil & Partners

... we would like to express our respect and gratitude for the fruitful cooperation.
... our work on joint projects assured us of your high level of professionalism
... More information

General Manager Stashkevych I.Y., LLC “Trading company” Rud”

We would like to indicate that law firm "Pravova Dopomoga" has become a reliable partner for legal services provision and we can recommend it as a team of qualified professionals who are easy and pleasant to deal with... More information

Chief ophthalmologist of Ukraine, Oksana Vitovska, All-Ukrainian alliance of ophthalmologists

We would like to express sincere gratitute to the team of Law firm "Pravova dopomoga" and personally to Volodymyr Gurlov for professionalism and purposefulness in your work.... More information

General director I.Logvinenko , Bravo Airways

Bravo Airways company expresses its gratitude to law firm "Pravova Dopomoga" for high quality and timely provision of legal services.
... More information

General director Skibinskiy V., Yokogawa Electric Ukraine Ltd.

Yokogawa Electric Ukraine Ltd. recommends Vladimir Gurlov and his team of lawyers as a reliable legal partner and advisor for foreign businesses in Ukraine...... More information

L. Chervonyuk, LLC "Vitalux"

Vitalux company highly appreciates results of cooperation with Law firm “Pravova dopomoga”, can characterize it as a reliable partner and based on personal experience is ready to recommend it to interested persons...... More information

Important to know

Disinfectant Registration Procedure

The current legislation provides for two procedures for registration / re-registration of disinfectants:

  1. Based on the positive conclusion of the SSEE (the State Sanitary and Epidemiological Expertise) issued before the entry into force of the Procedure governing registration / re-registration;
  2. By submitting the documents listed in the Documents section on the page of this service.

At the same time, even registration/re-registration based on the conclusion of the SSEE is problematic, due to the lack of a full procedure, as well as the absence of the same regulatory framework.


ANSWERS TO FAQs

Is there a procedure for registering disinfectants today?

In May 2019, the Ministry of Health's website published a register of disinfectants, which means that from that point on there is a possibility to register such disinfectants.

Can wet wipes, antiseptics, etc., be considered as disinfectants?

Yes, they can. Such products have antiseptic properties, and, therefore, are disinfectants.

Is clinical research necessary to successfully register a disinfectant?

One of the stages of registration is a laboratory research. The specialists of our company will help to collect the package of necessary documents and submit it without any problems.

Is it possible to get paper confirmation of disinfectant registration?

Yes, it is. Our lawyers can help you get an extract from the register within 5 days.

SWIFT OBTAINMENT
AND BEST QUALITY PROVEN BY YEARS OF PRACTICE!

Volodymyr Gurlov, Managing partner

Volodymyr Gurlov, Managing partner

RELEVANT INFORMATION

What can be considered a disinfectant

The main criteria that a disinfectant has to meet are as follows:

 

1. the presence of established hygienic standards for agents;

2. 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 agents

The 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 orderof 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.



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