Licensing of Pharmaceutical Activities in Kazakhstan: Import and Wholesale Distribution of Medicines - FCHAIN

Licensing of Pharmaceutical Activities in Kazakhstan: Import and Wholesale Distribution of Medicines

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.

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.

 

 2. Licensing of Import and Wholesale Distribution of Medicines

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 “On Public Health and the Healthcare System”) and may only be carried out with a valid pharmaceutical activity license.

 

1.1. General Information on Obtaining a License

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).

In accordance with paragraph 1 of Article 17 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System” dated July 7, 2020 No. 360-VI (hereinafter – the Code), the following types of activities in the healthcare sector are subject to licensing:

1. medical activities;
2. pharmaceutical activities, among others.

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.

In accordance with Article 16 of the Law of the Republic of Kazakhstan No. 202-V “On Permits and Notifications” (hereinafter – 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.

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.

According to Appendix No. 1 to the Law, the pharmaceutical activity license includes subtypes for the wholesale and retail distribution of medicines.

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.

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.

In accordance with Article 23 of the Law, a pharmaceutical activity license belongs to Class 1 – permits issued for activities.

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.

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:
• wholesale distribution of medicines;
• retail distribution of medicines
(in accordance with paragraphs 5 and 6 of Appendix No. 1 to the Law).

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.

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. ҚР ДСМ-104/2020 “On Approval of the Rules for Wholesale and Retail Distribution of Medicines and Medical Devices”, 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.

 

1.2. Determination of the Licensing Authority

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.

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).

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.

 

1.3. List of Documents Required to Obtain a License

In accordance with Article 29 of the Law of the Republic of Kazakhstan “On Permits and Notifications”, a license and (or) an appendix to a license are issued at the location of the licensing authority based on the applicant’s request.

To obtain a license, the following documents must be submitted:

• an application;
• a document confirming the state registration of the legal entity;
• a document confirming payment of the licensing fee;
• documents confirming the applicant’s compliance with the established qualification requirements (see section “Qualification Requirements”).

 

1.4. Timeframes and State Fees

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.

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.

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.

A pharmaceutical activity license is indefinite and non-transferable (Appendix No. 1 to the Law).

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.

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.

 

1.5. Qualification Requirements (Including Requirements for the Responsible Specialist)

To obtain a license, the applicant must comply with the established qualification requirements.

According to the Order of the Minister of Health of the Republic of Kazakhstan dated October 22, 2020 No. ҚР ДСМ-148/2020 “On Approval of Qualification Requirements for Medical and Pharmaceutical Activities”, the qualification requirements for legal entities applying for a pharmaceutical activity license include the availability of:

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 “Sanitary and Epidemiological Requirements”);
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 “Sanitary and Epidemiological Requirements”);
3. qualified staff, confirmed by information about specialists (the staff must include at least two persons: a manager and an employee);
4. appropriate education and professional experience in accordance with the declared subtypes of pharmaceutical activities.

For a pharmaceutical warehouse, the following requirements apply:

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

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. ҚР ДСМ-148/2020.

 

1.6. GDP Requirements

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. ҚР ДСМ-15 “On Approval of Good Pharmaceutical Practices” (GDP) and apply to organizations engaged in the wholesale distribution of medicines, including their import into the territory of the Republic of Kazakhstan.

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’s management, and all processes must be carried out on the basis of approved Standard Operating Procedures (SOPs).

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.

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.

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.

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 – First Out). The organization must also implement procedures to prevent the circulation of falsified medicines.

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.

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.

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.

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.

 

Conclusion

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 — wholesale distribution).

Before commencing operations, the organization must:

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

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.

 

2. Inspections and Regulatory Control

2.1. Sanitary and Epidemiological Requirements

According to subparagraph 6, paragraph 1 of the Order of the Minister of Health of the Republic of Kazakhstan dated July 7, 2021 No. ҚР ДСМ-58 “On Approval of the Sanitary Rules ‘Sanitary and Epidemiological Requirements for Facilities Involved in the Circulation of Medicines and Medical Devices’” (hereinafter — 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.

In accordance with subparagraph 9, paragraph 1 of the Sanitary Rules, facilities involved in the circulation of medicines include, among others:

• pharmacies;
• pharmacy points;
• mobile pharmacy points;
• pharmaceutical (distribution) warehouses;
• temporary storage warehouses for medicines and medical devices;
• medical device stores;
• organizations engaged in the manufacturing of medicines and medical devices.

According to paragraph 11 of the Sanitary Rules, pharmaceutical warehouses, medical device warehouses, and temporary storage facilities may be located:

1. in standalone buildings;
2. in isolated premises within non-residential buildings.

If the facility is located within a building structure, an isolated block of premises must be provided (paragraphs 12–13 of the Sanitary Rules).

 

2.2. Requirements for Engineering Systems

In accordance with paragraphs 14–21 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).

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).

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).

 

2.3. Requirements for Premises and Equipment

According to paragraphs 22–25 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).

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).

Cleaning equipment must be properly labeled and stored separately (para. 25).

Brief List of Equipment for Wholesale Distribution (Pharmaceutical Warehouse):

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.

 

2.4. Personnel Requirements

In accordance with subparagraphs 79–80 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.

It is also important to consider the requirements set out in the Appendices to the Sanitary Rules.

 

2.5. Appendix No. 1 – Requirements for the Composition and Area of Premises

For a pharmaceutical warehouse (wholesale):

The following premises and minimum areas are mandatory:

1. receiving and dispatch area — not less than 20 sq. m;
2. main storage premises — not less than 30 sq. m;
3. additional storage premises:
   • for narcotic, psychotropic, poisonous substances and precursors — not less than 6 sq. m;
   • for flammable and combustible liquids — not less than 6 sq. m;
   • for disinfectants and acids — not less than 6 sq. m;
4. service and utility premises — not less than 20 sq. m.

For a pharmacy (retail, without compounding):

1. customer service area — not less than 15 sq. m;
2. storage premises (including receiving area) — not less than 9 sq. m;
3. separate storage rooms when selling special categories of medicines;
4. service and utility premises — not less than 6 sq. m.

 

2.6. Appendix No. 2 – Temperature and Air Exchange

For retail and wholesale pharmaceutical operations it is necessary to ensure:

1. air temperature in storage areas — 18–25 °C (unless otherwise specified by the storage conditions of specific medicines);
2. regulated air exchange rate (supply/exhaust) depending on the type of premises;
3. enhanced exhaust ventilation for premises storing flammable liquids (FL) and other special categories.

 

2.7. Appendix No. 3 – Lighting Standards

For pharmacies and pharmaceutical warehouses, it is required to ensure:

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

 

2.8. Appendix No. 4 – Preparation of Premises and Equipment

Applicable to both retail and wholesale activities in relation to:

• the requirement for daily wet cleaning of premises;
  • requirements for general cleaning procedures;
  • conditions for processing equipment and surfaces;
  • use of registered disinfectants;
  • compliance with established temperature regimes for equipment sanitation.

Conclusion

Sanitary and epidemiological rules establish mandatory requirements for the placement, equipment, and operation of pharmaceutical warehouses, as well as for the storage conditions of medicines and personnel. Compliance with these requirements is a necessary condition for obtaining and maintaining a pharmaceutical activity license and is subject to verification by authorized authorities during licensing procedures and subsequent inspections.

 

2.9. Rules for Storage and Transportation of Medicines

When conducting pharmaceutical activities, it is necessary to comply with the requirements for the storage of medicines established by the Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-19 “On Approval of the Rules for Storage and Transportation of Medicines and Medical Devices” (hereinafter – the Rules). These rules also apply to entities engaged in wholesale pharmaceutical activities (pharmaceutical warehouses, distributors), and compliance with them is a mandatory condition for obtaining and maintaining a license.

According to the Rules, medicines must be stored in specially designated warehouse zones with restricted access for authorized personnel (para. 26). Products with an unconfirmed quality status (returns, defective products, suspicious or recalled products) must be strictly isolated from products approved for sale (para. 27). The warehouse must provide functional zoning, including receiving areas, quarantine storage, main storage, and dispatch areas (paras. 28–30).

Medicines must be stored under conditions specified by the manufacturer, including requirements for temperature, humidity, and light exposure. In particular, light-sensitive medicines must be stored in light-protective packaging (para. 31), and medicines requiring protection from moisture or containing volatile substances must be stored in hermetically sealed containers (paras. 33, 35). The temperature regime must correspond to the ranges specified in the instructions for medical use (paras. 37–38).

Special storage conditions apply to certain categories of medicines. Flammable and combustible products must be stored separately in compliance with fire safety requirements (paras. 52–55), explosive substances must be stored in separate premises (paras. 65–66), and incompatible substances must not be stored together (para. 69). Gas cylinders must be stored separately and protected from heat sources (paras. 72–73).

Medical devices and related products must be stored in dry heated premises with controlled environmental parameters and separated by product type in accordance with the manufacturer’s requirements (paras. 79–81).

 

Conclusion

Failure to comply with these requirements is considered a violation of the rules for storing medicines and the qualification requirements for pharmaceutical activities. Such violations may result in refusal to issue a license, suspension or termination of the license, issuance of orders to eliminate violations, and administrative liability.

 

Regulatory Framework

1. Order of the Minister of Health of the Republic of Kazakhstan dated 22 October 2020 No. ҚР ДСМ-148/2020 “On Approval of Qualification Requirements for Medical and Pharmaceutical Activities”;
2. Order of the Minister of Health of the Republic of Kazakhstan dated 16 May 2022 No. ҚР ДСМ-45 “On Certain Issues of Public Services in the Field of Pharmaceutical Activities”;
3. Order of the Minister of Health of the Republic of Kazakhstan dated 16 May 2022 No. ҚР ДСМ-45 “On Certain Issues of Public Services in the Field of Pharmaceutical Activities”;
4. Order of the Acting Minister of Health of the Republic of Kazakhstan dated 4 February 2021 No. ҚР ДСМ-15 “On Approval of Good Pharmaceutical Practices”;
5. Order of the Minister of Health of the Republic of Kazakhstan dated 17 September 2020 No. ҚР ДСМ-104/2020 “On Approval of the Rules for Wholesale and Retail Distribution of Medicines and Medical Devices”.

 

How FChain Supports the Pharmaceutical Business

FChain Kazakhstan supports pharmaceutical companies at the stage of market entry and during their ongoing operations.

We assist with:

• structuring the business presence model in Kazakhstan;
  • supporting pharmaceutical activity licensing;
  • analyzing regulatory and tax risks;
  • developing contractual and corporate structures;
  • facilitating interaction with government authorities;
  • providing accounting, tax, and legal support for business operations.

We take into account the specifics of pharmaceutical regulation and help companies build a sustainable, compliant, and legally secure operating model.

 

Entering the Kazakhstan Market for a Foreign Pharmaceutical Company: Registration, Taxes and Customs

 

Prepared by:
Senior Accountant Nurgul Zhailaubayeva
Senior Lawyer Sergey Gaydarov

10 March 2026

📩 almaty@f-chain.com
📱 WhatsApp: +7 771 214 1820