This service is provided in cases where the Client needs to make a one-time import of an unregistered medical product to the Republic of Kazakhstan. In the course of solving this problem, Blitz Medica LLP selects the optimal import option in accordance with the Code of the Republic of Kazakhstan «ON PEOPLE’S HEALTH AND THE HEALTHCARE SYSTEM» and Order No. ҚР ДСМ-237/2020. The service is completed by issuing an import permit document from the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan.
- Kazakhstan prohibits the import of medical products, medicines and medical equipment that have not received a registration certificate
Before importing a batch of medical products, medicines and medical equipment, it is necessary to carry out state registration of the medicines/medical equipment.
But what to do in emergency cases, when certain circumstances do not allow obtaining a registration certificate or the time frame is very limited?
For emergency and exceptional circumstances, it is necessary to obtain a permit for a one-time import of medical products or a permit for the import of a medicine.
According to the Code of the Republic of Kazakhstan «On the Health of the People and the Healthcare System», the import of medical products, medicines and medical equipment that have not been registered is permitted in cases of import for the purpose of:
Stages and terms of registration of medical devices according to the national procedure
- clinical trials
- examination of medicines
- for the purpose of state registration of medical products, medicines and medical equipment
- providing medical assistance to a specific patient or group of patients with a rare or particularly severe pathology; in the form of an exhibition display (without the right of subsequent use or sale)
- prevention/elimination of consequences of emergency situations
- integration of innovative technologies in the field of Healthcare
- procurement by a single distributor of medical products, medicines and medical equipment supplied by international organizations established by the UN General Assembly
- use as a component included in the composition or device of a medical device
- prevention and treatment of the effects of exposure to radioactive, biological and chemical substances (vaccines, antidotes)
- It is worth noting that medical products, medicines and medical equipment imported into the country for the above purposes are not allowed for sale and subsequent use without state registration.
How can I obtain a one-time import permit?
The term of service provision by the state body is 3 working days and the permit document is issued free of charge. In case of emergency, for example, the current coronavirus pandemic, there is a confirmed list of medical products that fall under this category: thermometers, personal protective equipment, medicines and other medical products.
When there is a need for a one-time import of a medicine or device to a specific patient, if Kazakhstan cannot provide treatment and only the device/drug can save the patient, then a letter of request from the medical institution is required, which indicates the full name of the patient, information about his diagnosis.
If the permit for a one-time import is issued for medical equipment or a device for the purpose of exhibiting at exhibitions, then it is necessary to provide a letter of confirmation from the exhibition organizer about participation and an agreement/invoice. And also after the end of the exhibition, the equipment must be returned back to the country of manufacture.
When registering a one-time import of a medicine or medical product not registered in Kazakhstan, the application must include quality certificates, a certificate of analysis. An important point is the availability of a notarized translation of documents into the state or Russian language.
