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In accordance with Decision No. 299 of the Customs Union dated May 28, 2010, 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 the authorized research institutions of Kazakhstan and obtaining the Expert Conclusions from these institutions.
The state registration procedure consists of the following main steps:
- Submission of the product samples and required documents to the authorized institutions for conducting the tests and obtaining an expert conclusion;
- Submission of the application and required documents along with the above-mentioned Expert Conclusions to the Committee of Sanitary and Epidemiological Control of the Ministry of Healthcare 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, as well as reference standard of the active substance along 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 that the disinfectant is manufactured according to (standards, technical conditions, regulations, technological instructions);
- 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 the country of manufacturer/applicant of said product confirming its safety for human;
- Proposed instruction for use;
- Material Safety Data Sheets, Certificate of Analysis;
- Original and proposed mockups for the market of Kazakhstan.
Timeframe
The procedure of obtaining the expert conclusions from the authorized institutions may last about 2 to 6 months after submission of the product samples and necessary documents.
According to the legislation of Kazakhstan, the procedure of the state registration of a disinfectant should be conducted within 15 days. However, in accordance with usual practice, the procedure of the state registration may last from 1 to 2 months.
Validity term
The State Registration Certificate for a disinfectant in Kazakhstan is valid on the permanent basis. The registration of a disinfectant in Kazakhstan also 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 the costs associated with registration of disinfectants in Kazakhstan, along with the detailed information and a list of documents required from your side, as well as a sample Power of Attorney for execution, etc. please contact our specialists.
