The pharmacovigilance system in the Kyrgyz Republic is established according to Article 11 of Law of the Kyrgyz Republic No. 91 “On medicinal products” dated April 30, 2003. The main legislative act regulating the pharmacovigilance system in Kyrgyzstan is Resolution No. 564 “On approval of the Procedure for implementation of the pharmacovigilance system” dated December 6, 2018.

Marketing Authorization Holders and healthcare professionals are obliged to submit information on identified undesirable effects, including adverse drug reactions, to the Ministry of Health of the Kyrgyz Republic. 

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 (website: http://www.pharm.kg/). 

The holders of the Registration Certificates for medicinal products are obliged to establish and maintain the pharmacovigilance system in accordance with the requirements of Resolution No. 137 dated April 6, 2011 “On the approval of Technical Regulation “On the safety of medicinal products for medical use”. 

Marketing Authorization Holder must designate Local Contact Person, responsible for pharmacovigilance in Kyrgyzstan. The pharmacovigilance system of the manufacturer is subject to control by the competent authority.

MAH must submit the following information to the competent authority:

• All cases of serious adverse drug reactions, which were recorded during its medical use in the Kyrgyz Republic; 
• All cases of lack of effectiveness of the medicinal product, which were 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.

Holders of the Registration Certificates are obliged to submit the Periodic Safety Update Reports (PSURs) to the authorized state body of the Kyrgyz Republic for all medicinal products authorized for medical use and registered in the Kyrgyz Republic within the following timelines: 

• every 6 months during the first 2 years after obtaining the Registration Certificate; 
• once a year during the next 3 years; 
• every 5 years, provided that the medicinal product is on the pharmaceutical market of the Kyrgyz Republic.
• immediately upon request of the competent authority. 

Cratia provides professional services of establishment and maintenance of pharmacovigilance system in Kyrgyzstan. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.