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Kazakhstan is a member of the Eurasian Economic Union (EAEU). Therefore, the state registration of medicinal products in Kazakhstan is regulated by the unified EAEU pharmaceutical legislation, in particular Decision No. 78 of the Council of the Eurasian Economic Commission dated November 3, 2016.
Key registration facts
Working days
Official timeframe for state registration in Kazakhstan according to EAEU Decision No. 78
Months
Average practical duration including expert evaluation by the National Center (NCEM)
Years
Data exclusivity period protecting original drug dossiers from generic competition
Validity
Initial certificate is valid for 5 years, followed by unlimited term after renewal
What is required to register a medicinal product in Kazakhstan
To register a medicinal product in Kazakhstan in accordance with the requirements of the Eurasian Economic Union (EAEU), the applicant must submit the following materials to the National Center for Expertise of Medicines and Medical Devices:
-
eCTD Module 1, including:
- Application for registration;
- Legalized Power of Attorney from the applicant to the representative;
- Copies of Manufacturer’s Authorizations for all manufacturing sites involved in the manufacturing process issued by the competent authorities of the countries-manufacturers;
- Copies of the EAEU 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 (Kazakhstan, Russia, Belarus, Kyrgyzstan or Armenia) or copies of the local GMP Certificates issued by the competent authorities of the countries-manufacturers, as well as Site Master Files, Reports on recent GMP inspections and complaints for the last three years for all manufacturing sites involved in the manufacturing process for conducting the EAEU GMP inspection;
- Copy of Certificate of Pharmaceutical Product or Registration Certificate, or Free Sale Certificate issued by an authorized body of the country of the applicant and/or manufacturer, or justification of its absence;
- 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;
- Copies of Manufacturers’ Declarations for the Active Pharmaceutical Ingredient (API) and medicinal product;
- Country-specific documents: mockups, Instruction for Use (IFU), Report on user testing the draft of IFU, Summary of Product Characteristics (SmPC) for the market of Kazakhstan;
- EAEU-specific documents: draft of Normative document, of the Pharmacovigilance System Master File and Risk Management Plan for a medicinal product;
- eCTD Modules 2-5;
- Samples of the medicinal product and standard samples.
According to the demands of the legislation of the EAEU, it is necessary to conduct clinical studies partially or completely 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 or conduct an unscheduled GCP inspection of one of the clinical centers, located outside the EAEU territory, where the clinical studies were carried out. The decision on which option to follow is made by the Authority.
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) (only Founding and Standing Members such as EU countries, USA, Japan, Canada and Switzerland applies to the mentioned ICH countries) until January 01, 2016, conducting the additional clinical studies in the EAEU territory or GCP inspection of one of the clinical center are not required.
In accordance with EAEU regulatory requirements, a foreign applicant must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) located within the territory of the EAEU with separate Pharmacovigilance system and provide this information in the registration dossier. Our company provides services on acting as a QPPV in the EAEU.
Duration of the registration process
The procedure for state registration of a medicinal product in Kazakhstan in accordance with the requirements of the Eurasian Economic Union (EAEU) is officially conducted within 140 working days. This period does not include the time required for preparing responses to official requests, if any, or the time required for laboratory testing of the medicinal product samples.
In practice, the registration procedure may take approximately 12 to 18 months, depending on the completeness of the submitted documentation, the scope of the materials, the number of requests issued by the National Center for Expertise of Medicines and Medical Devices, and other regulatory factors. The total duration also depends on the time required to prepare responses to the possible authority’s requests.
Simplified registration of medicinal products
EAEU legislation allows a medicinal product that has already been registered in one member state of the Eurasian Economic Union to undergo simplified state registration in other EAEU member states through the procedure of recognition after the issuance of the Eurasian Registration 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. In such cases, the application for registration in the additional member state must be submitted to the competent authority of that state within 14 working days from the date of filing the first registration application.
Data exclusivity in Kazakhstan
According to the Law of the Republic of Kazakhstan “On Public Health and the Healthcare System,” the registration and market entry of generic medicinal products in Kazakhstan are restricted during a specific data exclusivity period that protects confidential information contained in the registration dossier of the original medicinal product.
Conducting own preclinical and clinical trials of a generic medicinal, including bioequivalence studies with the original medicinal product in comparison are permitted. However, using the specific information related to the preclinical and clinical studies of the original medicinal product is prohibited during the six-year exclusivity period, even if such information is available in open sources.
Submitting the dossier for state registration and further market entry of a generic medicinal product are possible only after six-year from the date of approval of the state registration of the original medicinal product. Otherwise, the letter of consent to use confidential data of the original medicinal product must be provided by its marketing authorization holder.
Validity term and renewal
The EAEU Registration Certificate for a medicinal product first registered in Kazakhstan is issued for a period of five years. After this initial period, the registration may be renewed for an unlimited term.
The renewal procedure may be initiated before the expiration of the current registration, but not earlier than 260 working days prior to the expiry date. In practice, the renewal procedure usually takes approximately 80 working days, excluding the time required to prepare responses to official requests, if any.
During the renewal process, the competent authority does not re-evaluate the original quality, preclinical, or clinical data. However, the applicant must submit updated expert reports in Module 2 of the Common Technical Document (eCTD) addressing the quality of the medicinal product and the current benefit–risk balance, based on safety and efficacy data accumulated since the initial registration. These reports should also reference relevant new information available in the public domain.
For more detailed information on the costs associated with registration of medicinal products in Kazakhstan, the list of documents required for submission, etc. please contact our specialists.
