Kirghizia (Kyrgyzstan, the Kyrgyz Republic) is one of the post-Soviet countries with a population of about 6 million people, and it is a member of the Eurasian Economic Union (EAEU) along with Russia, Belarus, Armenia and Kazakhstan. Membership of Kyrgyzstan in the EAEU significantly influences the regulatory policy of the state: for medicinal products, medical devices, special purpose food products and cosmetic products there is currently the choice between the “national” and “centralized” registration procedure.
Kyrgyzstan is a country with the rapidly developing pharmaceutical market. Import products occupy the dominant position in the pharmaceutical market of the country: about 97% of medicinal products and medical devices are imported, and only 3% of the produced by national manufacturers.
Import and sale of medicines, medical devices, special food products and cosmetic products are allowed only after state registration.
The country’s regulations are at the stage of active changes: the regulatory framework is gradually harmonized with the legislation of the EAEU.
The Ministry of Health of the Republic of the Kyrgyz Republic.
The central executive authority implementing the state health care policy
Department of pharmaceutical supply and medical equipment of the Ministry of Health of the Kyrgyz Republic
Expert evaluation of the materials for medicinal products, medical equipment and medical devices, special purpose food products and cosmetic products
Main legislative acts:
- Resolution of the Government No. 311 “About some questions related to registration of medical devices” dated July 5, 2018;
- Resolution of the Government No. 312 “On approval of the Procedure for evaluating quality of medicinal products” dated July 5, 2018;
- Resolution No. 564 “On approval of the Procedure for implementation of the pharmacovigilance system” dated December 6, 2018;
- The Law No. 165 “On drug circulation” dated August 2, 2017;
- Resolution No. 405 “About some questions related to state registration in the field of drug circulation” dated August 28, 2018.
Cratia provides professional services of state registration of medical (healthcare) products in Kazakhstan. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:
- registration of medicinal products in Kyrgyzstan;
- establishment and maintenance of the pharmacovigilance system in Kyrgyzstan;
- certification of medical devices in Kyrgyzstan;
- certification of special food products in Kyrgyzstan;
- certification of cosmetic products in Kyrgyzstan.