State registration, re-registration and amendments in registration dossier of medicine or medical device

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Recipients
Legal entities
Individuals
Cost of the service

11 MCI valid on the day of payment of the state registration fee

MCI, effective on the day of payment of the fee for state re-registration

Terms of the service delivery

5 working days

Full name of service
State registration, re-registration and amendments in registration dossier of medicine or medical device

How to get online service (on the portal “electronic licensing” www.elicense.kz)

  1. Click the "Request online" button on this page, after that the portal of "electronic licensing" will be opened in a new window.
  2. Log in or register on the "electronic licensing" portal.
  3. In the service info sheet read the package of documents and click the "Order online service" button, or select the necessary subtype of activity and the "Further" button.
  4. After specifying the necessary data, fill out the application and sign with your EDS.
  5. You can track the status of the submitted application in the Personal Account in the section "My applications". You can find out about obtaining the permit in the section "My approved documents", about receiving a notification - in the section "My notifications".

Payment of the license fee can be made by the service recipient in cash and non-cash form through second-tier banks.
To receive a public service, payment can be made through the payment gateway of the "electronic government".

An application for re-registration, including an expert examination for re-registration, is submitted before the expiration of the registration certificate.

When state registration is established, the validity period of the registration certificate for medicines is 5 years, with the exception of medicines produced in the Republic of Kazakhstan.
At the state registration of medicines produced in the Republic of Kazakhstan, as well as for medical devices, an indefinite registration certificate is issued.
Upon re-registration, an indefinite registration certificate for medicines is issued.

 

Result of the service delivery

1) registration certificate valid on the territory of the Republic of Kazakhstan;
2) registered instructions (leaflet) for the medical use of a medicinal product or medical device and general characteristics of the medicinal product in the Kazakh and Russian languages;
3) registered layouts of packages, labels, stickers for medicines, medical devices in Kazakh and Russian languages.
In case of refusal of state registration, re-registration of a medicinal product or medical device, making changes to the registration dossier of a medicinal product or medical device, a reasoned response about the refusal to provide a state service.