For the production and distribution of disinfection, disinsection and deratization agents in the territory of the Russian Federation, these agents should be registered by the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being of the Russian Federation (Rospotrebnadzor).
We will execute the registration, re-registration and introduction of amendments into the Registration Documentation of Russian and foreign agents.
We have over 10 years of experience in state certification of Russian and foreign disinfection, disinsection, deratization agents in the territory of the Russian Federation.
The registration services will be supplied by one of the best experts in this field, possessing the highest degree of competence.
We will carry out the work for a reasonable remuneration, in the optimum time; we will also provide a flexible system of payments
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Our company provides the following services for certification of the disinfection, disinsection and deratization agents:
Assistance in preparing a registration papers at all stages of the product registration process;
Organization and support during the testing of products;
Organization and support in obtaining an expert opinion;
Organization and support in obtaining the Rospotrebnadzor certificate;
Receipt of the Declaration of Conformity
In the process of obtaining an expert opinion, our professionals will organize and accompany the research of disinfectants (physico-chemical, toxicological, microbiological, clinical research, as well as tests to confirm the effectiveness of the product) on the basis of specialized accredited institutes.
The disinfectant registration process includes the following steps:
Preparation of the papers and product samples for testing
Laboratory examination of the product samples
Registration of the test reports and expert opinion
Submission of the papers and expert opinion to Rospotrebnadzor
Obtaining the certificate
Сertificate Acquisition Time
The acquisition time of the disinfection, disinsection and deratization agent certificate is at least 4 months.
This period includes the testing, in the case when the testing laboratory does not have any additional questions to the product.
Actually the terms are the following:
Testing – 2-3 months;
Expert opinion – 1 month;
Obtaining the certificate – 15 working days.
Benefits of Working With Us:
During testing: reduction of costs, the advance payment system, the minimum time for testing;
Accompanying at all stages of the registration process;
Providing services in this area for more than 10 years.
Individual approach to each customer, flexible interaction system.
General Information
The certificate of state registration (CSR) of disinfectants is issued by the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being of the Russian Federation (Rospotrebnadzor).
The validity of the registration certificate is set for the entire period of manufacturing of Russian products or supply of foreign agents (until the cessation of production and distribution of disinfectant in the territory of the Russian Federation).
The state duty for the CSR is 5,000 rubles ($79). The re-registration duty is 300 rubles ($4.74).
The certificate is issued for the following groups of products:
1
Disinfection agents for skin in operational and injection areas, hands of medical personnel, personnel of trade organizations and public catering, cleaning and disinfection of skin in everyday life
2
Drinking water disinfection agents.
3
Desinfection agents for indoor air, appliances, sanitary and technological equipment, vehicles, patient care goods, dishes, linens, clothes, shoes, toys, washing water, human and animal secretions, and other objects during focal and preventive disinfection.
4
Disinfection agents for preventing the development of microorganisms in food products, as well as intended to prevent the microbial decomposition of human and animal secretions.
5
Disinfection agents with detergents, cleaning, deodorizing properties and intended for the treatment of dishes, equipment, washing of clothes and linen, cleaning of premises.
6
Disinfection agents of presterilizing cleaning and sterilization of medical and special-purpose items.
7
Arthropod control:
Agents intended for the treatment of rooms, bedding, underwear, clothing and footwear, as well as the scalp of human skin (pediculocides).
Agents intended for the arthropod control of sanitary-hygienic and epidemiological significance (bugs, fleas, mosquitoes, ticks, flies, cockroaches, moths and others) in residential, public and other buildings, in populated areas, and also in natural stations (insecticides, acaricides, insectoacaricides).
Agents for processing premises, clothing, protective nets, bed curtains, tents, as well as human skin in order to scare away bloodsucking arthropods (insect- and acaro-repellents)
8
Rodent control:
Agents for the rodent control of sanitary, hygienic and epidemiological significance, besides those used in agriculture and veterinary medicine (rodenticides, ratids, rodent-repellents).
The disinfecting chemicals, antimicrobial agents, as well as agents used to destroy the causative agents of infectious human, animals and plant diseases in the external environment should be registered according to Federal Law No. 52-Fz dated March 30, 1999 on Sanitary and Epidemiological Welfare of the Population, as well as Section II of the Unified List of Products (Goods) Subject to State Sanitary and Epidemiological Supervision (Control) at the Customs Border and Customs territory of the Eurasian Economic Union.
Re-registration of Disinfectants. Registration Documentation Amendments
Re-registration and amending is carried out in connection with the following circumstances:
changing the dosage form of disinfectant, changing the scope and recommendations for its use;
changing the name of the manufacturer, changing the brand of products;
changing the restrictions on the use of disinfectants;
amendments to the regulatory and technical documentation.
In case of changes in the composition or the manufacturer, the disinfectant is registered as a new one.
The documents required for the Disinfectant Registration
A notice;
An application;
A power of attorney to represent the interests of the Manufacturer (if necessary);
A formulation of domestic Solution;
A formulation of imported Solution in Russian;
A certificate of stability (expiration date);
for domestic solutions: GOST, TU, other regulatory documents, for imported solutions: specifications.
Methods of control of active substances and other values;
for chemicals: Safety Data Sheet of the Active Substance (Solution); for domestic products — according to GOST 30333-2007 “Safety Data Sheet of Chemical Products”; for imported products: Safety Data Sheet (SDS);
Samples and the Sampling Report, standard samples of active substances (if necessary);
Chemical and Analytical Research Records to study the effectiveness and safety of the Solution;
The Disinfectant Instruction draft containing the necessary information;
A label (container) layout;
A label layout (for households).
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