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 Kazakhstan.
Procedure
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 Kazakhstan and obtaining expert conclusions from these institutions.
So, the state registration procedure consists of the following main steps:
- submission of the samples of the product and required documents to the authorized institutions for conducting the tests and obtaining expert conclusions;
- submission of the application and required documents together with the abovementioned expert conclusions to the Committee for Quality Control and Safety of Goods and Services of the Ministry of Healthcare of the Republic of Kazakhstan to obtain a registration certificate.
Required documents
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 the following documents:
- legalized Power of Attorney from the applicant to the representative, from the manufacturer to the applicant (if they are different);
- 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);
- specification;
- methods of quality control, including methods of determination of the active substance of the disinfectant;
- 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;
- Material Safety Data Sheets for disinfectant and active substance;
- proposed mockups for the market of Kazakhstan.
Timeframe
The procedure of obtaining the expert conclusions from the authorized institutions may last from about 4 to 6 months after submission of the product samples and necessary documents.
According to the legislation of the Republic of Kazakhstan the procedure of the state registration of a disinfectant should be conducted within 15 days. However, in accordance with the usual practice the procedure of the state registration may last from 1 to 2 months.
Validity term
The Certificate about the state registration of a disinfectant in Kazakhstan is valid on the permanent basis. Also, the registration of a disinfectant in Kazakhstan gives an opportunity to import this product into other member-states of the Eurasian Economic Union (Russia, Belarus, Kyrgyzstan and Armenia).
In order we could provide you with the information on costs associated with registration of disinfectants in Kazakhstan 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.
