In accordance with the article 43 of the Federal Law of the Russian Federation "On sanitary and epidemiological wellbeing of the population" dated March 30, 1999 and the Decision of the Customs Union dated May 28, 2010 No. 299 disinfectants imported into the territory of the Customs Union for the first time are subject to the state registration before their entry into the territory of the Russian Federation.
According to the Order of the Ministry of Health of the Russian Federation dated November 10, 2002 No. 344 the state registration of disinfectants is possible only after conducting the complex studies of samples of said product in research institutions authorized by the Federal Service for Surveillance on Consumer Right Protection and Human Wellbeing of the Russian Federation and obtaining expert conclusion from these institutions. The complex studies include the following types of tests:
- chemical-analytical tests;
- toxicological safety tests;
- antimicrobial and virological effectiveness tests.
So, the state registration procedure consists of the following main steps:
- submission of the samples of the product and required documents to the authorized institution for conducting the complex studies to obtain an expert conclusion;
- submission of the application and required documents along with the abovementioned expert conclusion to the Federal Service for Surveillance on Consumer Right Protection and Human Wellbeing of the Russian Federation to obtain a registration certificate.
For conducting the complex studies and the further procedure of state registration it is necessary to submit the application and samples of the product and reference standard of active substance together with the following documents:
- legalized Power of Attorney from the applicant to the representative, from the manufacturer of the disinfectant to the applicant (if they are different);
- legalized copy of the Business license of the applicant;
- qualitative and quantitative composition of said product;
- certified copies of the documents the disinfectant is manufactured according to (standards, technical conditions, regulations, technological instructions);
- certificate of stability (shelf-life);
- methods of quality control, including methods of determination of the active substance of the disinfectant;
- Material Safety Data Sheet for disinfectant and active substance;
- copies of the documents issued by the competent authorities of country of manufacturer/applicant of said product confirming its safety for human;
- proposed instruction for use;
- proposed mockups for the Russian market.
The procedure of obtaining the expert conclusion from the authorized institution may last from about 2 to 6 months after submission of the product samples and necessary documents.
According to the Russian legislation the procedure of the state registration of a disinfectant should be conducted within 40 days with further issuance of registration certificate within next 5 days. However, in accordance with the usual practice the procedure of the state registration may last from 2 to 3 months.
The Certificate about the state registration of a disinfectant in the Russian Federation is valid on the permanent basis. Also, the registration of a disinfectant in the Russian Federation gives an opportunity to import this product into other member-states of the Eurasian Economic Union (Belarus, Kazakhstan, Kyrgyzstan and Armenia).
In order we could provide you with the information on costs associated with registration of disinfectants in Russia together with the detailed information and a list of documents required from your side, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.