{"id":51161,"date":"2026-04-13T07:07:38","date_gmt":"2026-04-13T04:07:38","guid":{"rendered":"https:\/\/kz.f-chain.com\/?p=51161"},"modified":"2026-04-13T07:09:41","modified_gmt":"2026-04-13T04:09:41","slug":"medicine-one-window-registration-2026","status":"publish","type":"post","link":"https:\/\/kz.f-chain.com\/en\/feautured-post\/medicine-one-window-registration-2026\/","title":{"rendered":"Registration of Medicines and Medical Devices: \u201cOne Window\u201d Pilot Project Extended"},"content":{"rendered":"

Registration of Medicines and Medical Devices: \u201cOne Window\u201d Pilot Project Extended<\/strong><\/h2>\n

In Kazakhstan, the pilot project for implementing a composite public service for the registration of medicines and medical devices under the \u201cone window\u201d principle has been extended. The corresponding decision is \u0437\u0430\u043a\u0440\u0435\u043f\u043b\u0435\u043d\u043e by a joint order of the Minister of Health of the Republic of Kazakhstan dated March 11, 2026 No. 30 and the Deputy Prime Minister \u2013 Minister of Digital Development and Artificial Intelligence dated March 12, 2026 No. 140.<\/p>\n

The document entered into force on April 6, 2026, and applies to legal relations arising from January 1, 2026, and will remain in effect until December 31, 2026.<\/p>\n

 <\/p>\n

What has changed: \u201cOne Window\u201d principle<\/strong><\/h3>\n

The key element of the pilot project is the implementation of the \u201cone window\u201d principle. This means that:<\/p>\n

    \n
  1. all documents are submitted electronically through a single digital interface;<\/li>\n
  2. there is no need to interact with multiple government agencies;<\/li>\n
  3. information systems of authorized bodies are integrated;<\/li>\n
  4. application review processes become faster and more transparent.<\/li>\n<\/ol>\n

    \u00a0<\/strong><\/p>\n

    Objectives of the pilot project<\/strong><\/h3>\n

    The project aims to reduce registration timelines for medicines and medical devices, simplify administrative procedures for businesses, increase transparency of regulatory processes, reduce administrative burden on applicants, and develop digital services and electronic interaction between the state and business.<\/p>\n

     <\/p>\n

    Services provided<\/strong><\/h3>\n

    Through the e-government portal, the Ministry of Health provides a comprehensive service including:<\/p>\n

      \n
    1. expert evaluation;<\/li>\n
    2. registration and re-registration;<\/li>\n
    3. amendments to the registration dossier;<\/li>\n
    4. registration and adjustment of manufacturer prices;<\/li>\n
    5. formation of the Kazakhstan National Drug Formulary.<\/li>\n<\/ol>\n

       <\/p>\n

      Service timelines<\/strong><\/h3>\n

      The total service delivery period does not exceed 100 working days.<\/p>\n

      This period does not include:<\/p>\n

        \n
      1. time for correcting incomplete dossiers;<\/li>\n
      2. time for submission of additional documents by the applicant;<\/li>\n
      3. organization and conduct of inspections;<\/li>\n
      4. expert council procedures;<\/li>\n
      5. approval of final documents.<\/li>\n<\/ol>\n

        Additionally:<\/p>\n

          \n
        1. the applicant must confirm consent for inspection within 30 working days;<\/li>\n
        2. inspections may take up to 90 working days.<\/li>\n<\/ol>\n

          \u00a0<\/strong><\/p>\n

          Cost of services<\/strong><\/h3>\n

          The registration fee is established by the Tax Code of the Republic of Kazakhstan:<\/p>\n