Medicinal Products Registration in Kyrgyzstan

Kyrgyzstan is a member of the Eurasian Economic Union (EAEU). Therefore, the state registration of medicinal products in Kyrgyzstan is governed by the unified EAEU pharmaceutical regulations, in particular Decision No. 78 of the Council of the Eurasian Economic Commission dated November 3, 2016.

Key registration facts

140

Working days

Official timeframe for state registration in accordance with EAEU regulations

12-18

Months

Practical duration depending on documentation scope and official requests

5

Years

Validity period of the initial EAEU Registration Certificate

∞

Renewal

Possibility to renew the certificate for an unlimited term after 5 years

Requirements for registration of a medicinal product in Kyrgyzstan

To register a medicinal product in Kyrgyzstan in accordance with the requirements of the Eurasian Economic Union (EAEU), the applicant must submit the following documents to the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic:

1. eCTD Module 1, including:
   • Application for registration;
   • Legalized Power of Attorney from the applicant to the representative;
   • Copies of Manufacturing Licenses 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 CPP or the 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 has been registered/re-registered/cancelled with indication of dates, numbers, and validity of the registration certificates/dates;
   • Copies of QP Declarations for 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 Kyrgyzstan;
   • EAEU-specific documents: draft of Normative document, Master file of the pharmacovigilance system and Risk Management Plan for a medicinal product;
2. eCTD Modules 2-5;
3. Samples of the medicinal product and standard samples.

In accordance with EAEU regulations, clinical studies must be conducted partially or fully within the territory of at least one EAEU member state (Russia, Belarus, Kazakhstan, Kyrgyzstan, or Armenia), and the corresponding reports must be included in the registration dossier. Alternatively, the competent authority may require an unscheduled GCP inspection of a clinical center located outside the EAEU where the studies were conducted. The decision on whether additional studies or a GCP inspection are required is made by the competent authority.

If clinical studies were conducted partially or fully within countries of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) region (such as EU member states, the United States, Japan, Canada, or Switzerland) before January 1, 2016, additional clinical studies in the EAEU or a GCP inspection are generally not required.

In addition, EAEU regulations require a foreign applicant to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) located within the EAEU and separate Pharmacovigilance system. This information must be included in the registration dossier. Our company offers Pharmacovigilance services in the territory of EAEU.

Duration of the registration process

The official timeframe for the state registration procedure of a medicinal product in Kyrgyzstan in accordance with EAEU regulations is 140 working days. This period does not include the time required to prepare responses to official requests, if any, or to conduct laboratory testing of medicinal product samples.

In practice, the registration procedure typically takes approximately 12 to 18 months, depending on the completeness of the submitted documentation, the scope of the dossier, and the number of requests issued by the competent authority.

Simplified registration of medicinal products

EAEU regulations allow a medicinal product that has already been registered in one EAEU member state to undergo simplified state registration in other member states through the recognition procedure following the issuance of a Eurasian Registration Certificate. It is also possible to apply for registration in additional EAEU member states without waiting for approval in the reference country. In such cases, the application must be submitted to the competent authority of the respective member state within 14 working days from the date of filing the initial application for state registration in reference country.

Validity term and renewal

The EAEU Registration Certificate for a medicinal product first registered in Kyrgyzstan 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.

The renewal process does not involve re-evaluation of the quality, preclinical, or clinical data. However, the applicant must submit updated independent expert reports in Module 2 of the Common Technical Document (CTD), including an assessment of the current benefit–risk balance based on safety and efficacy data accumulated since the initial registration, with reference to relevant new information available in the public domain.

For more detailed information on the costs associated with registration of medicinal products in Kyrgyzstan, a list of the required documents, etc. please contact our specialists.