Obtaining of conclusion on safety, quality and efficacy of medicines and medical devices

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Recipients
Legal entities
Individuals
Terms of the service delivery

According to the date specified in the Rules of SI

Full name of service
Issue of conclusion on safety, quality and efficacy of medicines and medical devices

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. In the service info sheet read the package of documents and click the "Order online service" button on the website of the National center for the examination of medicines and medical devices.

How to get the service in the National center for the examination of medicines, medical devices and medical equipment (necessary documents):

  1. An application for the examination of a medicinal product in accordance with Annex 1 To the rules for the examination of medicinal products, an application for the examination of a medical device on an electronic carrier in accordance with Annex 1 to the Rules for the examination of medical devices.
  2. Registration dossier containing the information and documents on the form according to Appendix 2 to Rules of conducting expert examination of medicines for producers of the Republic of Kazakhstan or in the format of Common technical document in the form of Annex 3 to the Rules of examination of medicinal products, the registration dossier of medical products on electronic media, containing materials and documents under the form according to Appendix 2 to the Rules of examination of medical products.
  3. Samples of medicines, medical devices (except for medical devices that are devices, devices, equipment), standard samples of chemicals, standard samples of biological preparations, test strains of microorganisms, cell cultures, specific reagents, consumables necessary for reproducibility of laboratory testing methods in quantities sufficient for three-time laboratory tests with a residual shelf life of at least six months (except in cases that do not require laboratory testing).
  4. Copy of the document confirming payment by the service recipient of the amount for the examination.

Result of the service delivery

For medicinal products: issuing a conclusion on the safety, quality and effectiveness of medicinal products or a reasoned response on refusal to provide a public service.

For medical devices: issuing an opinion on the safety, quality and effectiveness of medical devices, or a reasoned response to a refusal to provide a public service.