18.01.2018

Medicine and Pharmaceutical

Medical devices

From 15 February the Law of the Kyrgyz Republic “On the use of medical devices” dated 2 August 2017 No.166 shall take its effect. This law regulates issues on use, safety of production, manufacture, storage, sale, disposal of medical devices. Medical devices can be used, manufactured and sold if they are included in the State Register. Therefore, this law regulates procedure of state registration of medical devices and content of Register. Besides there were specified 10 types of medical devices that are not subject to the registration. The law establishes four classes of medical devices depending on the potential risk of their use (1, 2a, 2b, 3). The rights and duties of citizens and persons in the sphere of medical devices were duly set.

Finally, this law regulates the advertising of medical devices. So, advertisement should not represent a medical product as unique, most effective, most accurate, most safe, exclusive in the absence of side effects, should not be misled about the composition of origin, the novelty of the medical product. It is prohibited to use the image of a doctor, the image of people in medical uniforms, to attract medical and pharmaceutical workers for advertising, to refer to the opinion of famous people, scientists, specialists, cured patients and their relatives in order to avoid uncontrolled use of medical products. In case of violation of these prohibitions, the state body may suspend or cancel the state registration of a medical device.

Medical products

From 15 February the Law of the Kyrgyz Republic “On the use of medicinal products” dated on 2 August 2017 No.165 comes in to force. This law establishes unified requirements for the circulation of medicines in the Kyrgyz Republic, and also regulates the relations arising in connection with the development, preclinical and clinical research of medicines, production, manufacture, evaluation of their quality, effectiveness, safety, sale of medicines and other activities in the sphere circulation of medicines. The law formed the State Pharmacopoeia of the Kyrgyz Republic is harmonized with the leading pharmacopoeias of the world and is periodically updated in connection with a change in their standards.

Medicinal products can be imported, manufactured, sold and used on the territory of the Kyrgyz Republic if they are included in the State Register. Therefore, this law regulates procedure of state registration of medicinal products and content of Register. Besides there were specified 14 types of medicinal products that are not subject to the registration.

The rights and duties of citizens and subjects of pharmaceutical activity are duly set. The law establishes the rule and conditions of compensation for harm caused to human health by the use of medicinal products. It also covers issues of wholesale and retail sales, provision of information and advertising of medicinal products.