Kazakhstan. Registration and re-registration of medicinal products
Who renders the state service?
The state service renders to individual and legal entities Management of pharmaceutical control of Pharmaceutical Control Committee around Almaty city of the Ministry ofHealthcare of the Republic of Kazakhstan (further - Management), by the address:
Almaty, Abylaikhan Avenue, 63Form of completion of the state service - registration certificate on medical products, iatrotechnics and products of medical appointment with term instructions during which medical application is authorized in the territory of the Republic of Kazakhstan.
Ph.: +7(727) 274-15-55, 2 73-63-80
E-mail: farmco@dari.kz
Terms of service rendering
- from the moment of filing of application on the state registration of MP, IT and PMA – 11 months;
- from the moment of filing of application on the state re-registration of MP, IT and PMA – 6 months;
- from the moment of filing of application on modification of the registration file – 5 months.
Fee rate
According to the governmental order of the Republic of Kazakhstan from November, 14th, 2001 №1448 "On approval of fee rates for state registration of medical products" at state registration, re-registration of medical products the admission fee will be charged and transferred to the republican budget in amount of following rates:- Fee Rate for the state registration makes 11 MCI (MCI for 2009 year – 1273 tenge);
- Fee Rate for the state re-registration 5 MCI.
Documents
- List of documents, required for registration, re-registration of pharmaceutical products;
- List of documents, required for registration of Biologically active additive;
- List of documents required for registration and re-registration of medical equipment as per the protection class;
- List of documents required for registration and re-registration of medical purpose products as per the protection class
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