Article 251. The procedure for the import of medicines and medical devices into the territory of the Republic of Kazakhstan is the Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. The import of medicines and medical products into the territory of the Republic of Kazakhstan is carried out in accordance with the procedure determined by the authorized body, in accordance with the customs legislation of the Republic of Kazakhstan and (or) international treaties and acts in the field of customs regulation of the Eurasian Economic Union.
Russian Russian and Kazakh-language medical products and medical devices registered in the Republic of Kazakhstan may be imported with stickers in the Republic of Kazakhstan, with stickers in the Kazakh and Russian languages, and with instructions for medical use (leaflet) or instructions for medical use or an operational document for medical use. the product in Kazakh and Russian for their sale is below the approved maximum wholesale and retail prices in the Republic of Kazakhstan in the order, determined by the authorized body.
The texts of stickers, instructions for medical use (leaflet), instructions for medical use or an operational document for a medical device must comply with the requirements of the Law of the Republic of Kazakhstan "On Languages in the Republic of Kazakhstan".
2. It is not allowed to import into the territory of the Republic of Kazakhstan medicines and medical devices that have not passed state registration in the Republic of Kazakhstan, except for the cases specified in paragraph 3 of this Article and Article 253 of this Code.
3. It is allowed to import into the territory of the Republic of Kazakhstan medicines and medical devices not registered in the Republic of Kazakhstan on the basis of a conclusion (authorization document) issued by the authorized body, if they are intended for:
1) conducting clinical trials;
2) expertise of medicines and medical devices during state registration, re-registration and amendments to the registration dossier;
3) implementation of state registration of medicines and medical devices;
4) providing medical care for the vital signs of a particular patient or providing medical care to a limited number of patients with rare and (or) particularly severe pathology with the possibility of medical use and purchase;
5) holding exhibitions without the right to further sell them;
6) humanitarian assistance, prevention and (or) elimination of consequences of emergency situations;
7) introduction of innovative medical technologies;
8) purchase by a single distributor of medicines and medical products supplied by international organizations established by the General Assembly of the United Nations and (or) reclassified by the World Health Organization, with the exception of medicines and medical products under long-term contracts for the supply of medicines and medical products;
9) use as a component part or device of a medical device and not intended for independent use outside the composition or device of a medical device;
10) prevention and treatment of the effects of exposure to radioactive, biological and chemical substances (vaccines, antidote).
11) manufacture of medicinal products by importing bulk products, as well as pharmaceutical substances (active pharmaceutical substances), with the exception of their standard samples.
4. It is prohibited to import medicines and medical products that have not passed state registration into the territory of the Republic of Kazakhstan as humanitarian aid, except in certain cases determined by the authorized body.
5. Medicines and medical devices imported into the territory of the Republic of Kazakhstan that do not comply with the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare are subject to confiscation and destruction.
President
Republic of Kazakhstan
© 2012. RSE na PHB "Institute of Legislation and Legal Information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan
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