{"id":50800,"date":"2026-03-10T13:01:13","date_gmt":"2026-03-10T10:01:13","guid":{"rendered":"https:\/\/kz.f-chain.com\/?p=50800"},"modified":"2026-03-10T13:01:13","modified_gmt":"2026-03-10T10:01:13","slug":"licensing-pharmaceutical-activities","status":"publish","type":"post","link":"https:\/\/kz.f-chain.com\/en\/feautured-post\/licensing-pharmaceutical-activities\/","title":{"rendered":"Licensing of Pharmaceutical Activities in Kazakhstan: Import and Wholesale Distribution of Medicines"},"content":{"rendered":"

Licensing of Pharmaceutical Activities in Kazakhstan: Import and Wholesale Distribution of Medicines<\/strong><\/h2>\n

For foreign or local pharmaceutical companies, entering the Kazakhstan market is impossible without a clear understanding of licensing requirements. It is important to note that the import of medicines is not licensed as a separate activity, however, it forms part of pharmaceutical activity and can only be carried out with the appropriate pharmaceutical license.<\/p>\n

In this article, we explain which license is required for the import and wholesale distribution of medicines in Kazakhstan, which authority issues the license, what documents must be prepared, and what qualification and infrastructure requirements apply to applicants. We also discuss why obtaining a license alone is not sufficient without the actual implementation of Good Distribution Practice (GDP) standards and compliance with sanitary regulations.<\/strong><\/p>\n

 <\/p>\n

\u00a02. <\/strong>Licensing of Import and Wholesale Distribution of Medicines<\/strong><\/h3>\n

In this section, the questions are combined because the import of medicines is not licensed as a separate type of activity. However, it forms part of pharmaceutical activity (subparagraph 275, paragraph 1, Article 1 of the Code of the Republic of Kazakhstan \u201cOn Public Health and the Healthcare System\u201d<\/em>) and may only be carried out with a valid pharmaceutical activity license.<\/p>\n

 <\/p>\n

1.1. General Information on Obtaining a License<\/strong><\/p>\n

To obtain a license in the healthcare sector in the Republic of Kazakhstan, it is necessary to strictly comply with the provisions of the current regulatory legal acts governing the issuance of permits for conducting certain types of activities (licenses).<\/p>\n

In accordance with paragraph 1 of Article 17 of the Code of the Republic of Kazakhstan \u201cOn Public Health and the Healthcare System\u201d<\/em> dated July 7, 2020 No. 360-VI (hereinafter \u2013 the Code), the following types of activities in the healthcare sector are subject to licensing:<\/p>\n

    \n
  1. medical activities;<\/li>\n
  2. pharmaceutical activities, among others.<\/li>\n<\/ol>\n

    According to subparagraph 275, paragraph 1, Article 1 of the Code, pharmaceutical activity is an activity carried out in the healthcare sector involving the production and (or) manufacture, and (or) wholesale and (or) retail distribution of medicines and medical devices. It also includes procurement (acquisition), storage, import, export, transportation, quality control, documentation, distribution, use and disposal of medicines and medical devices, as well as ensuring their safety, quality, and effectiveness.<\/p>\n

    In accordance with Article 16 of the Law of the Republic of Kazakhstan No. 202-V \u201cOn Permits and Notifications\u201d<\/em> (hereinafter \u2013 the Law), the permitting regime is established depending on the level of risk associated with the activity. Licenses are classified as Category I permits and apply to activities with a high level of risk.<\/p>\n

    Pharmaceutical activities, including the wholesale and retail distribution of medicines, are classified as licensed activities and require obtaining a license as a Category I permit.<\/p>\n

    According to Appendix No. 1 to the Law, the pharmaceutical activity license includes subtypes for the wholesale and retail distribution of medicines.<\/p>\n

    Based on the above, a pharmaceutical activity license is required for the import and distribution of medicines, and under the provisions of the Law, such a license is classified as a Category I permit.<\/p>\n

    According to paragraph 1 of Article 17 of the Law, in order to commence and subsequently carry out certain types of activities or actions (operations), individuals and legal entities must possess a valid permit or submit a notification to the state authorities responsible for receiving notifications in accordance with the procedure established by the Law.<\/p>\n

    In accordance with Article 23 of the Law, a pharmaceutical activity license belongs to Class 1 \u2013 permits issued for activities.<\/p>\n

    According to Article 24 of the Law, the forms of permits and (or) their appendices are approved by the relevant regulatory state authorities. An appendix to a permit constitutes an integral part of the permit. The appendix to the license is issued to indicate the subtypes of the licensed activity or actions (operations), or the facilities for which the license is issued, as well as the actual address where the activity or actions (operations) are carried out.<\/p>\n

    Thus, when submitting an application for a license, it is necessary to ensure that the documents are prepared specifically for obtaining the following required subtypes:
    \n\u2022 wholesale distribution of medicines;
    \n\u2022 retail distribution of medicines
    \n(in accordance with paragraphs 5 and 6 of Appendix No. 1 to the Law).<\/p>\n

    At the same time, only one license (for pharmaceutical activity) will be issued, but it is possible to obtain two separate appendices to the license for retail and wholesale distribution of medicines.<\/p>\n

    It should also be noted that according to paragraph 3 of the Order of the Minister of Health of the Republic of Kazakhstan dated September 17, 2020 No. \u049a\u0420 \u0414\u0421\u041c-104\/2020 \u201cOn Approval of the Rules for Wholesale and Retail Distribution of Medicines and Medical Devices\u201d<\/em>, wholesale distribution of medicines and medical devices is carried out by entities involved in the circulation of medicines and medical devices that have obtained the appropriate license for wholesale distribution through pharmaceutical warehouses.<\/p>\n

     <\/p>\n

    1.2. Determination of the Licensing Authority<\/strong><\/p>\n

    Based on the provisions of the current legislation, in order to obtain a pharmaceutical activity license, the application and notification must be submitted to the authorized state body in the field of healthcare.<\/p>\n

    In accordance with subparagraph 89 of Article 1 of the Code, the authorized body in the field of healthcare is the central executive authority responsible for management and intersectoral coordination in the areas of public health protection in the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological well-being of the population, circulation of medicines and medical devices, and the quality of medical services (care).<\/p>\n

    Therefore, when submitting an application for a pharmaceutical activity license, it is necessary to apply to the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan. In the city of Almaty, applications are submitted to the Department of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan for the city of Almaty.<\/p>\n

     <\/p>\n

    1.3. List of Documents Required to Obtain a License<\/strong><\/p>\n

    In accordance with Article 29 of the Law of the Republic of Kazakhstan \u201cOn Permits and Notifications\u201d<\/em>, a license and (or) an appendix to a license are issued at the location of the licensing authority based on the applicant\u2019s request.<\/p>\n

    To obtain a license, the following documents must be submitted:<\/p>\n

      \n
    • an application;<\/li>\n
    • a document confirming the state registration of the legal entity;<\/li>\n
    • a document confirming payment of the licensing fee;<\/li>\n
    • documents confirming the applicant\u2019s compliance with the established qualification requirements (see section \u201cQualification Requirements\u201d).<\/li>\n<\/ul>\n

       <\/p>\n

      1.4. Timeframes and State Fees<\/strong><\/p>\n

      After the application is registered, the authorized body verifies the completeness of the submitted documents within two working days. If an incomplete package of documents is identified, a reasoned refusal to proceed with the review is issued.<\/p>\n

      If approvals from other state authorities are required, the relevant requests are also sent within two working days, and a response must be provided within ten working days. If no response is received within this period, the approval is considered granted unless otherwise explicitly provided by law.<\/p>\n

      The total period for issuing the license or providing a reasoned refusal is no more than 15 working days from the date the complete set of documents is submitted (Article 30 of the Law). Reissuance of a license is carried out within three working days.<\/p>\n

      A pharmaceutical activity license is indefinite and non-transferable (Appendix No. 1 to the Law).<\/p>\n

      The result of the procedure is an electronic license and\/or its appendix, or a reasoned refusal, which is sent through the electronic licensing portal.<\/p>\n

      In accordance with Article 31 of the Law, a licensing fee must be paid for the issuance (or reissuance) of the license in the amount established by the Tax Code of the Republic of Kazakhstan. According to Article 616 of the Tax Code, the state duty rate is 10 MCI (Monthly Calculation Index), which in 2026 equals 43,250 tenge.<\/p>\n

       <\/p>\n

      1.5. Qualification Requirements (Including Requirements for the Responsible Specialist)<\/strong><\/p>\n

      To obtain a license, the applicant must comply with the established qualification requirements.<\/p>\n

      According to the Order of the Minister of Health of the Republic of Kazakhstan dated October 22, 2020 No. \u049a\u0420 \u0414\u0421\u041c-148\/2020 \u201cOn Approval of Qualification Requirements for Medical and Pharmaceutical Activities\u201d<\/em>, the qualification requirements for legal entities applying for a pharmaceutical activity license include the availability of:<\/p>\n

        \n
      1. premises or a building owned or leased, compliant with sanitary regulations establishing sanitary and epidemiological requirements for facilities involved in the circulation of medicines and medical devices (see paragraph \u201cSanitary and Epidemiological Requirements\u201d);<\/li>\n
      2. equipment, furniture, inventory, instruments and devices necessary to ensure quality control and compliance with the conditions for production, manufacturing, storage and distribution of medicines and medical devices in accordance with regulatory legal acts (see section \u201cSanitary and Epidemiological Requirements\u201d);<\/li>\n
      3. qualified staff, confirmed by information about specialists (the staff must include at least two persons: a manager and an employee);<\/li>\n
      4. appropriate education and professional experience in accordance with the declared subtypes of pharmaceutical activities.<\/li>\n<\/ol>\n

        For a pharmaceutical warehouse, the following requirements apply:<\/p>\n

          \n
        • the head of the pharmaceutical warehouse must have higher pharmaceutical education and at least three years of professional experience;<\/li>\n
        • heads of warehouse departments and employees responsible for receiving, storing and dispensing medicines and medical devices must have higher or secondary pharmaceutical education.<\/li>\n<\/ul>\n

          All of the above qualification requirements must be confirmed when submitting the application by completing Appendix No. 2 to the Order of the Minister of Health of the Republic of Kazakhstan No. \u049a\u0420 \u0414\u0421\u041c-148\/2020.<\/p>\n

           <\/p>\n

          1.6. GDP Requirements<\/strong><\/p>\n

          Good Distribution Practice (GDP) requirements are established by the Order of the Acting Minister of Health of the Republic of Kazakhstan dated February 4, 2021 No. \u049a\u0420 \u0414\u0421\u041c-15 \u201cOn Approval of Good Pharmaceutical Practices\u201d<\/em> (GDP) and apply to organizations engaged in the wholesale distribution of medicines, including their import into the territory of the Republic of Kazakhstan.<\/p>\n

          In accordance with GDP, an organization must implement and maintain a documented quality system covering all processes related to the circulation of medicines. The quality system must include the distribution of responsibilities, risk management, deviation control, change management procedures, and corrective actions. The functioning of the system must be ensured by the organization\u2019s management, and all processes must be carried out on the basis of approved Standard Operating Procedures (SOPs).<\/p>\n

          The organization must ensure the availability of qualified personnel, including the appointment of a responsible person for compliance with GDP requirements. Employees must have relevant education and appropriate professional experience, undergo regular training with documented confirmation, and their responsibilities must be defined in internal documentation.<\/p>\n

          Warehouse infrastructure must ensure proper storage conditions for medicines. This includes zoning of warehouse premises (quarantine area, approved products, returns, defective goods), access control, temperature mapping of storage areas, and regular calibration of measuring equipment.<\/p>\n

          Wholesale distribution activities must be fully documented. Documentation must ensure complete traceability of each batch of medicines from the supplier to the final recipient and must be stored in accordance with established procedures.<\/p>\n

          Medicines may be purchased only from entities authorized to distribute them, and suppliers must undergo prior evaluation. During receipt of goods, accompanying documentation and the integrity of packaging must be verified. Storage and distribution of products must follow the FEFO principle (First Expired \u2013 First Out). The organization must also implement procedures to prevent the circulation of falsified medicines.<\/p>\n

          The supply of medicines must be accompanied by documentation enabling identification of the product batch, its quantity, the supplier, and the recipient. All complaints, returns, and suspected quality defects must be recorded and investigated.<\/p>\n

          Returns of products are permitted only if compliance with storage and transportation conditions, packaging integrity, and full traceability of origin can be confirmed. To ensure the safety of the circulation of medicines, the organization must maintain a functioning product recall system allowing batches to be promptly withdrawn from the market.<\/p>\n

          When certain functions are outsourced, written agreements must be concluded with a clear allocation of responsibilities and prior evaluation of service providers. At the same time, responsibility for compliance with GDP requirements remains with the organization.<\/p>\n

          The organization must also conduct regular self-inspections and ensure proper transportation conditions for medicines. Transport must comply with the requirements for pharmaceutical product transportation, including maintaining required temperature conditions, while transport containers must ensure protection and proper labeling of the products. Special transportation conditions must be applied for thermolabile and other sensitive medicines.<\/p>\n

           <\/p>\n

          Conclusion<\/strong><\/p>\n

          For the wholesale distribution of medicines with import into the territory of the Republic of Kazakhstan, it is not sufficient to formally obtain a pharmaceutical activity license (subtype \u2014 wholesale distribution).<\/p>\n

          Before commencing operations, the organization must:<\/p>\n

            \n
          1. implement a comprehensive quality system in accordance with GDP requirements;<\/li>\n
          2. appoint a responsible person and ensure the availability of qualified personnel;<\/li>\n
          3. ensure that warehouse premises comply with zoning, temperature control, and safety requirements;<\/li>\n
          4. implement a full traceability system for batches of medicines;<\/li>\n
          5. establish procedures for procurement, receipt, storage, return, recall, and transportation strictly in accordance with GDP requirements;<\/li>\n
          6. ensure supplier evaluation and monitoring of transportation providers.<\/li>\n<\/ol>\n

            The absence of a functioning GDP system or its merely formal implementation creates a risk of refusal to grant a license, suspension of activities, administrative liability, and withdrawal of products from circulation.<\/p>\n

             <\/p>\n

            2. Inspections and Regulatory Control<\/strong><\/h3>\n

            2.1. Sanitary and Epidemiological Requirements<\/strong><\/p>\n

            According to subparagraph 6, paragraph 1 of the Order of the Minister of Health of the Republic of Kazakhstan dated July 7, 2021 No. \u049a\u0420 \u0414\u0421\u041c-58 \u201cOn Approval of the Sanitary Rules \u2018Sanitary and Epidemiological Requirements for Facilities Involved in the Circulation of Medicines and Medical Devices\u2019\u201d<\/em> (hereinafter \u2014 the Sanitary Rules), a pharmaceutical warehouse is considered a facility involved in the circulation of medicines and medical devices within the healthcare system and carrying out the wholesale distribution of medicines and medical devices.<\/p>\n

            In accordance with subparagraph 9, paragraph 1 of the Sanitary Rules, facilities involved in the circulation of medicines include, among others:<\/p>\n

              \n
            • pharmacies;<\/li>\n
            • pharmacy points;<\/li>\n
            • mobile pharmacy points;<\/li>\n
            • pharmaceutical (distribution) warehouses;<\/li>\n
            • temporary storage warehouses for medicines and medical devices;<\/li>\n
            • medical device stores;<\/li>\n
            • organizations engaged in the manufacturing of medicines and medical devices.<\/li>\n<\/ul>\n

              According to paragraph 11 of the Sanitary Rules, pharmaceutical warehouses, medical device warehouses, and temporary storage facilities may be located:<\/p>\n

                \n
              1. in standalone buildings;<\/li>\n
              2. in isolated premises within non-residential buildings.<\/li>\n<\/ol>\n

                If the facility is located within a building structure, an isolated block of premises must be provided (paragraphs 12\u201313 of the Sanitary Rules).<\/p>\n

                 <\/p>\n

                2.2. Requirements for Engineering Systems<\/strong><\/p>\n

                In accordance with paragraphs 14\u201321 of the Sanitary Rules, facilities must be equipped with water supply, heating, sewage, ventilation, and lighting systems (para. 14). If centralized utility networks are not available, the use of autonomous systems and water heaters is permitted (para. 15).<\/p>\n

                Requirements for temperature conditions and air exchange in the premises must also be observed (para. 16). Outdoor air intake for ventilation must be taken from a clean area at a height of not less than 2 meters (para. 17). Production areas must be equipped with supply and exhaust ventilation, while natural ventilation is permitted in other premises (para. 18).<\/p>\n

                Premises must comply with established lighting standards (para. 19). At the same time, the installation of sewage pipes under the ceilings of medicine storage areas is not permitted (para. 21).<\/p>\n

                 <\/p>\n

                2.3. Requirements for Premises and Equipment<\/strong><\/p>\n

                According to paragraphs 22\u201325 of the Sanitary Rules, the interior finishing of production and storage premises must allow for wet cleaning and disinfection (para. 22). Equipment and furniture must be resistant to cleaning agents and disinfectants, and the preparation of premises and equipment must be carried out in accordance with Appendix 4 to the Sanitary Rules (para. 23).<\/p>\n

                Before entering production premises, sinks with hot and cold-water supply must be installed. In addition, changing rooms, showers, and sanitary facilities for personnel must be provided (para. 24).<\/p>\n

                Cleaning equipment must be properly labeled and stored separately (para. 25).<\/p>\n

                Brief List of Equipment for Wholesale Distribution (Pharmaceutical Warehouse):<\/strong><\/p>\n

                Shelving units, pallets and pallet racks, at least two refrigerators, one cabinet for storing medicines, one cabinet for sanitary clothing and footwear, loading and unloading equipment, devices for measuring air parameters, disinfectants, cleaning equipment, electricity supply, water supply, sewage system, air conditioning, ventilation, and fire-fighting equipment.<\/p>\n

                 <\/p>\n

                2.4. Personnel Requirements<\/strong><\/p>\n

                In accordance with subparagraphs 79\u201380 of the Sanitary Rules, personnel working with medicines must undergo preliminary and periodic medical examinations and possess personal medical records. Staff changing rooms must be equipped with lockers that ensure separate storage of personal and sanitary clothing.<\/p>\n

                It is also important to consider the requirements set out in the Appendices to the Sanitary Rules.<\/p>\n

                 <\/p>\n

                2.5. Appendix No. 1 \u2013 Requirements for the Composition and Area of Premises<\/strong><\/p>\n

                For a pharmaceutical warehouse (wholesale):<\/p>\n

                The following premises and minimum areas are mandatory:<\/p>\n

                  \n
                1. receiving and dispatch area \u2014 not less than 20 sq. m;<\/li>\n
                2. main storage premises \u2014 not less than 30 sq. m;<\/li>\n
                3. additional storage premises:
                  \n\u2022 for narcotic, psychotropic, poisonous substances and precursors \u2014 not less than 6 sq. m;
                  \n\u2022 for flammable and combustible liquids \u2014 not less than 6 sq. m;
                  \n\u2022 for disinfectants and acids \u2014 not less than 6 sq. m;<\/li>\n
                4. service and utility premises \u2014 not less than 20 sq. m.<\/li>\n<\/ol>\n

                  For a pharmacy (retail, without compounding):<\/p>\n

                    \n
                  1. customer service area \u2014 not less than 15 sq. m;<\/li>\n
                  2. storage premises (including receiving area) \u2014 not less than 9 sq. m;<\/li>\n
                  3. separate storage rooms when selling special categories of medicines;<\/li>\n
                  4. service and utility premises \u2014 not less than 6 sq. m.<\/li>\n<\/ol>\n

                     <\/p>\n

                    2.6. Appendix No. 2 \u2013 Temperature and Air Exchange<\/strong><\/p>\n

                    For retail and wholesale pharmaceutical operations it is necessary to ensure:<\/p>\n

                      \n
                    1. air temperature in storage areas \u2014 18\u201325 \u00b0C (unless otherwise specified by the storage conditions of specific medicines);<\/li>\n
                    2. regulated air exchange rate (supply\/exhaust) depending on the type of premises;<\/li>\n
                    3. enhanced exhaust ventilation for premises storing flammable liquids (FL) and other special categories.<\/li>\n<\/ol>\n

                       <\/p>\n

                      2.7. Appendix No. 3 \u2013 Lighting Standards<\/strong><\/p>\n

                      For pharmacies and pharmaceutical warehouses, it is required to ensure:<\/p>\n

                        \n
                      1. illumination of medicine storage areas \u2014 not less than 150 lux (lx);<\/li>\n
                      2. for premises storing flammable liquids and disinfectants \u2014 75 lx;<\/li>\n
                      3. for packaging storage \u2014 10 lx;<\/li>\n
                      4. use of approved light sources (primarily fluorescent lamps).<\/li>\n<\/ol>\n

                         <\/p>\n

                        2.8. Appendix No. 4 \u2013 Preparation of Premises and Equipment<\/strong><\/p>\n

                        Applicable to both retail and wholesale activities in relation to:<\/p>\n