In accordance with 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 Belarus.
According to the current requirements the state registration of a disinfectant is possible only after conducting complex studies of samples of said product in authorized research institutions of Belarus and obtaining expert conclusions from these institutions. The complex studies include the following types of tests:
- chemical-analytical tests;
- toxicological safety tests;
- antimicrobial effectiveness tests (these tests must be conducted in at least two different institutions);
- virological effectiveness tests.
So, the state registration procedure consists of following main steps:
- submission of the required documents to the authorized institution for conducting chemical-analytical tests of an active substance and obtaining an expert conclusion;
- submission of the required documents to the authorized institutions for conducting the rest of the tests and obtaining the expert conclusions;
- submission of the application and required documents together with the abovementioned expert conclusions to the Republican Research and Practical Center for Epidemiology and Microbiology to obtain a conclusion on the possibility of the state registration;
- submission of the application and the conclusion on the possibility of the state registration to the Republican Center for Hygiene, Epidemiology and Public Health 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 the active substance together with following documents:
- legalized Power of Attorney from the applicant to the representative, from the manufacturer to the applicant (if they are different);
- legalized letter from the official body of the country of the disinfectant manufacturer confirming the official (exclusive) status of the distributor (applicant) (if applicable);
- legalized copy of the Business license of the applicant;
- qualitative and quantitative composition of the 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;
- proposed instruction for use;
- Material Safety Data Sheets for the disinfectant and active substance;
- proposed mockups for the market of Belarus.
The procedure of obtaining the expert conclusions from the authorized institutions may last from about 2 to 4 months after submission of the product samples and necessary documents.
According to the legislation of Belarus the procedure of the state registration of a disinfectant should be conducted within 30 days, and issuance of the registration certificate - within 8 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 Belarus is valid on the permanent basis. Also, the registration of a disinfectant in Belarus gives an opportunity to import this product into other states of the Eurasian Economic Union (Russia, Kazakhstan, Kyrgyzstan and Armenia).
In order we could provide you with the information on costs associated with registration of disinfectants in Belarus 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.