Assessment of the quality of medicinal products and medical devices in Kazakhstan

The assessment of the quality of medicinal products and medical devices is the determination of the compliance of the quality of medicinal products and medical devices with the data of the registration dossier and the regulatory documents with regard to quality, on the basis of which they were registered in the Republic of Kazakhstan. The assessment of the quality of medicinal products and medical devices is carried out by the expert organisation, which is the Republican Enterprise on the Right of Economic Use National Centre for Expertise of Medicines and Medical Devices of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan (hereinafter referred to as the “NC”).

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Laws and regulations governing the process of carrying out the assessment of the quality of medicinal products and medical devices

The quality assessment procedure is carried out in accordance with Order of the Minister of Health of the Republic of Kazakhstan No. KR DSM-282/2020 (ҚР ДСМ-282/2020) dated 20 December 2020 “On Approval of the Rules for Assessing the Quality of Medicines and Medical Devices Registered in the Republic of Kazakhstan”.

Goals of the assessment of the quality of medicinal products and medical devices:

  • Determination of the quality of registered products
  • Determination of the quality of products taken (selected) from the market, taking into account the risk-based approach
  • Prevention of the circulation of counterfeit products in the market of the Republic of Kazakhstan
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Steps to obtain an import licence:

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Collection of documents according to the list
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Registration of the applicant on the NC electronic portal
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Conclusion of an agreement with the NC
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Approval of the documents and receipt of an invoice for payment
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Payment of the state fee according to the invoice for payment
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Submission of the documents through the electronic portal
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Expert examination of the documents
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Issuance of a certificate of conformity
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