Kazakhstan is a member of the Eurasian Economic Union and thus, issues associated with the state registration of medicinal products in Kazakhstan are regulated by the Decision of the Council of the Eurasian Economic Commission No. 78 of November 3, 2016.
WHAT IS REQUIRED TO REGISTER A MEDICINAL PRODUCT IN KAZAKHSTAN
In order to register a medicinal product according to the demands of the Eurasian Economic Union (the EAEU), it is necessary to provide to the National Center for Expertise of Medicines and Medical Devices the following:
1) Application with the following documents attached::
- legalized Power of Attorney from the applicant to the representative;
- legalized copies of Manufacturer's Authorizations for all manufacturing sites involved in the manufacturing process issued by the competent authorities of countries-manufacturers;
- legalized copies of GMP Certificates for all manufacturing sites involved in the manufacturing process issued by the competent authorities of countries-manufacturers;
- certified copies of Conclusions of Compliance to the GMP requirements for all manufacturing sites involved in the manufacturing process issued by one of the competent authorities of the member-state of the EAEU: Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia (if available) or certified copies of the Eurasian GMP Certificates for all manufacturing sites involved in the manufacturing process issued by one of the competent authorities of the member-state of the EAEU: Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia (the procedure of issuance of this document may be conducted in parallel to the procedure of registration after submitting the Application for registration);
- legalized copy of a Registration Certificate issued by an authorized body of the country of the applicant and/or manufacturer, or justification of its absence;
- certified list of countries, where the medicinal product is registered/re-registered/cancelled with indication of dates, numbers and validity of the registration certificates/dates and reasons of cancelling;
- proposed mockups for the market of Kazakhstan;
- legalized copy of Certificate of Pharmaceutical Product or Free Sale Certificate (if available), etc.
2) Registration dossier in the format of the common technical document (CTD);
3) Samples of the medicinal product and standard samples.
Besides, the "National Center for medicines, medical devices and medical equipment expertise" may request additional information and/or documents. This is individual for each instance.
According to the demands of the legislation of the EAEU, it is necessary to conduct clinical studies partially or completely (depending on the type of the medicinal product) in the territory of one of the member-states of the EAEU (Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia) and provide reports for the same in the registration dossier. In the presence of reports on clinical studies conducted partially or completely in the territories of the countries of the region of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), conducting the studies in the territory of one of the member-states of the EAEU can be replaced with an unscheduled inspection of one of the clinical centers, where the clinical studies were conducted during the first registration procedure.
Also, according to the demands of the EAEU, a foreign applicant must have a contact person responsible for pharmacovigilance (CPPV) with location in the EAEU and provide this information in the registration dossier. Our company provides services on acting as a CPPV in the EAEU.
Duration of registration process
The procedure of state registration of a medicinal product according to the demands of the EAEU should be conducted within 140 working days without consideration of the time required for preparation of responses to requests. However, in accordance with the usual practice, depending on the completion of provided materials and scope of documentation, number of requests forwarded by the National Center for Expertise of Medicines and Medical Devices and other factors, the procedure of registration may last from 12 to 18 months without consideration of the time required for preparation of responses to requests.
Simplified registration of medicinal products
The procedure of state registration of a medicinal product according to the EAEU legislation allows conducting a simplified state registration of said medicinal product in other member-states of the EAEU by the centralized procedure of recognition of the state registration in another member-state of the EAEU after issuance of the Eurasian Certificate. It is also possible to apply for a simplified state registration of the medicinal product in another member-state of the EAEU without waiting for approval of registration in the first reference country, however, in this case the application for state registration in another member-state has to be filed in the competent Authority of that member-state of the EAEU within 14 working days from the date of filing the first application for state registration.
Validity term and renewal
The Eurasian Certificate about state registration of medicinal product in Kazakhstan issued in accordance with the EAEU legislation is valid on the permanent basis. However, it is necessary to renew the registration of medicinal products that are first registered in Kazakhstan within 5 years. The procedure of renewal of the registration may be initiated before expiration date of previous registration, but not earlier than 140 working days. The usual renewal procedure lasts for about 6 months without consideration of the time for preparation of responses to remarks. The renewal procedure does not require checking the quality, pre-clinical and clinical data, however, it will be necessary to provide reports made by independent experts in the form of Module 2 of the common technical document (CTD) on quality and current benefit/risk balance for the product on the basis of safety/efficacy data accumulated since the first registration, making reference to relevant new information in the public domain.
For all medicinal products that were registered in Kazakhstan according to the national legislation, till December 31, 2025 it is necessary to conduct the procedure of bringing the registration dossier into compliance with the demands of the EAEU legislation, and conduct an obligatory GMP inspection of all manufacturing sites involved in the manufacturing process of the medicinal product according to the demands of the EAEU. Otherwise, registration of said medicinal products will be cancelled from January 01, 2026.
For more detailed information, including on the costs associated with registration of medicinal products in Kazakhstan, list of documents required for submission, sample of the Power of Attorney for execution, etc. contact our specialists.