Kyrgyzstan

Kyrgyzstan (Kyrgyz Republic) is one of the Central Asian countries with a population of about 6 million people, and it is a member of the Eurasian Economic Union (EAEU). Membership of Kyrgyzstan in the EAEU significantly influences the regulatory policy of the state.

Kyrgyzstan is a country with a fast-developing pharmaceutical market. Products of foreign manufacturers occupy the dominant position in the pharmaceutical market of the country.

Import and sale of medicinal products, and medical devices are only allowed after state registration.

Registration of medicinal products and medical devices is carried out by the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic.

   
Medicinal products
According to the Law of the Kyrgyz Republic “On Medicinal Products”, import and sales of medicinal products in Kyrgyzstan are only allowed after state registration (renewal).

Starting from January 1, 2024, new marketing authorization procedures for medicinal products in the EAEU member states are only possible under the Union’s regulations. By December 31, 2025, medicinal products previously authorized through national procedures must be brought into compliance with the Union’s unified rules.

Kyrgyzstan is a country with high standards of regulation of marketed medicinal products. Inconsistencies between approved and actual packaging artworks, instructions for medical use (package leaflets), and certificates of analysis may cause the withdrawal of the medicinal product and temporary or permanent prohibition of sales.

Marketing authorization holders may be both residents and non-residents of the Republic of Kyrgyzstan. The marketing authorization holder is not obliged to establish a representative office or a legal entity in the territory of Kazakhstan. At the same time Applicant (a person performing the submission of documentation and negotiations with competent authorities) must be a resident.

Registration dossier must be submitted in EAEU e-CTD format. However, for submission of the dossier specific national documents should be developed, namely:

• Application form for registration of a medicinal product.
• A normative document that includes the composition of the finished product, specification for release and shelf life, quality control methods, information on storage conditions, information about manufacturers etc.
• Instruction for medical use.
• Artworks of primary and secondary packaging.

Part of the documents should be translated into Russian or Kyrgyz language. Package labeling and instructions for medical use are submitted and approved in Russian and Kyrgyz languages.

During registration, the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic has the right to request the Applicant to provide additional documents related to the quality, safety, and efficacy of the medicinal product. The Applicant has 90 days to respond to the Department queries or to justify the timelines necessary to provide replies. In the event the Applicant does not provide the requested data or provides them incomplete the registration materials are withdrawn from examination and payments are not returned.

Registration Certificate (Marketing Authorization) consists of several documents:

• Registration Certificate itself.
• Approved text of instructions for medical use.
• Approved color artworks of primary and secondary packaging.
• Agreed normative document (that includes composition of the product, specification for release and shelf-life, quality control methods, etc.).

   
Renewal
Application form for renewal should be submitted before the expiry date of the Registration certificate but not later than 6 months after the Registration Certificate expiration.

During renewal examination, the Department may assign laboratory control of registration samples in case changes in specifications and/or methods of quality control of the finished product take place. The Department may assign an inspection of the manufacturing site during the renewal procedure as well.

The set duration of the expert examination is not more than 120 calendar days excluding timelines for Applicant to reply to deficiency letters and observations obtained during the expert examination; for organization of inspection of manufacturing facilities and quality assurance system; conducting preclinical and clinical studies, pharmacovigilance system, reconciliation of final documents.

Based on the results of renewal Registration Certificate is issued for a period of validity of five years (or unlimited).

   
Variations
Application for variations should be submitted within two months from the date of their approval by the authorized body of the country of manufacturing site (if the relevant variations pass the approval procedure).

   
Pharmacovigilance
The basic principles of the pharmacovigilance system in the Kyrgyz Republic are established by Article 11 of Law of the Kyrgyz Republic No. 91 “On Medicinal Products” dated 30 April 2003 and EAEU GVP.

Marketing Authorization Holders (MAHs) as well as healthcare and pharmaceutical professionals are obliged to submit information on identified adverse reactions in the manner determined by the Ministry of Health of the Kyrgyz Republic.

Marketing Authorization Holders of medicinal products are obliged to implement, ensure, and guarantee the implementation and functioning of the pharmacovigilance system in accordance with the requirements of Resolution on the approval of Technical Regulation “On the Safety of Medicinal Products for Medical Use” No. 137 dated 6 April 2011.

The competent state authority for the pharmacovigilance system in Kyrgyzstan is the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic.

To ensure the performance of the pharmacovigilance system manufacturer/MAH of medicinal products should appoint an authorized person responsible for pharmacovigilance in Kyrgyzstan. The pharmacovigilance system of the manufacturer/MAH is subject to control by the competent authority.

MAHs should submit the following information to the competent authority:

• All cases of serious adverse drug reactions have been recorded during its medical use in the Kyrgyz Republic.
• All cases of lack of efficacy of medicinal products have been recorded during its medical use in the Kyrgyz Republic and emerged during treatment.
• All cases of suspected serious unexpected adverse drug reactions that were fatal or life-threatening.
• All cases of adverse reactions that may cause changes in the risk/benefit ratio.

MAHs are required to submit Periodic Safety Update Reports (PSURs) to the competent state body of the Kyrgyz Republic for all medicinal products registered in the Kyrgyz Republic at the following intervals:
Every 6 months during the first 2 years after obtaining the Registration Certificate.
Once a year during the next 3 years.
Every 5 years in case if medicinal product is marketed in the Kyrgyz Republic.
Immediately upon request of the competent state body of the Kyrgyz Republic responsible for the health care and medicinal products circulation.

   
Medical devices
Medical devices of foreign production may be imported and sold in the territory of the Kyrgyz Republic after their state registration. Currently, the application for registration may be submitted both according to the “national” Kyrgyz and “unified” procedure of the EAEU.

Foreign manufacturers must designate an Authorized representative in Kyrgyzstan.

Registration dossier may be submitted in English with translation into Russian. Languages of labeling and instructions for use (user manual) are Russian and/or Kyrgyz.

The registration procedure is performed by the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic.

The stages of the registration procedure are as follows:

1. Preparation of registration dossier.
2. Submission of application form, registration dossier, and samples of the medical device to the competent authority.
3. Obtaining of invoice from the authority for the registration procedure and providing payment.
4. Expert examination of the registration dossier for the medical device.
5. If required – technical studies;
6. If required – inspection of the site;
7. Consideration of the results, issue of the protocol on a recommendation for use of the medical device in medical practice.
8. Issue of the Registration Certificate and adding the medical device data to the state register.

Renewal of medical devices and medical equipment is performed in the event that the validity of the Registration Certificate expires. The renewal procedure is performed in the manner provided for the registration procedure, without conducting clinical trials.

During the validity of the Registration Certificate variations to registration materials are provided.

Cratia supports in state registration of medicinal products, establishment and maintenance of the pharmacovigilance system, and registration of medical devices in Kyrgyzstan.