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The state registration, re-registration and amendments to the registration dossier of medicinal products and medical devices
Subspecies of
The state registration, re-registration and amendments to the registration dossier in the Republic of Kazakhstan
Legal person
Individual businessman
The value of payment depends on a type of the service: registration - 11 MCI, re-registration - 5 MCI, modification – is free
The amount of payments should not exceed 10% of the amount required for payment (for amounts up to 1000 tenge, the allowable overpayment is 100 tenge)
5 working days
The application for this service is submitted through the elicense.kz and through integration interaction is sent (for processing) to the information system "System of Drug Supply Management, Drug Monitoring" (SDSM) of the Ministry of Health of the Republic of Kazakhstan. If you have any questions about the provision of the service, please contact the authorized state body.
In addition, we inform that after the service is provided by the state body, the result goes to the personal account on elicense.kz portal.
The state registration, re-registration and amendments to the registration dossier of medicinal products and medical devices
An authorization needed to get the public service
For individual entrepreneurs
- An application in the form of an electronic document, certified by the EDS of a service recipient (necessarily )(Data form)
- An electronic copy of statement on the safety, quality and efficiency of pharmaceutical/medical product issued by a state expert organization under the procedure stipulated by Clause4, Article 23 of the Code (necessarily )
- Information confirming payment for the provision of public service through the payment gateway of "e-government" (necessarily )(Data form)
- An application in the form of an electronic document, certified by the EDS of a service recipient (necessarily )(Data form)
- An electronic copy of statement on the safety, quality and efficiency of pharmaceutical/medical product issued by a state expert organization under the procedure stipulated by Clause4, Article 23 of the Code (necessarily )
- Information confirming payment for the provision of public service through the payment gateway of "e-government" (necessarily )(Data form)
