REGULATORY LICENSING · KAZAKHSTAN
Pharmaceutical Licensing in Kazakhstan
A company needs two separate things to sell a medicine in Kazakhstan: a pharmaceutical licence for the activity and state registration of the product. The licence covers manufacture, compounding, and wholesale and retail sale of medicines, and is decided within 15 working days. Medical device trade runs on notification, not on a licence. There is no separate import licence, but only licensed or notified businesses may import commercially.
Registration is the longer step. Medicines and devices follow the rules of the Eurasian Economic Union (EAEU), with national procedures continuing for a limited period. Selling or importing an unregistered product is prohibited, apart from narrow exceptions.
Legal Framework
- Code on Public Health and the Healthcare System No. 360-VI of 7 July 2020: Art. 23 (registration), Arts. 230–233 (pharmaceutical activity), Art. 239 (expert evaluation), Art. 244 (inspectorate), Art. 245 (prices), Art. 247 (single distributor), Arts. 251–252 (import).
- Law on Permits and Notifications No. 202-V of 16 May 2014: Annex 1, item 16 lists the licence and its sub-activities. Annex 3 covers device trade notifications.
- Ministry of Healthcare orders: No. 45 of 16 May 2022 (licensing procedure), No. 148/2020 of 22 October 2020 (qualification requirements), No. 16 of 9 February 2021 (national registration) and No. 10 of 27 January 2021 (expert evaluation).
- EAEU: Agreement on Common Principles and Rules for the Circulation of Medicines of 23 December 2014; Eurasian Economic Commission Council Decision No. 78 of 3 November 2016 (medicines); Agreement on medical devices of 23 December 2014 and Council Decision No. 46 of 12 February 2016 (devices).
- Fees: Tax Code No. 214-VIII of 18 July 2025, Art. 616.
What Needs a Licence
| Activity | Authorisation | Where it takes place | Practice standard |
|---|---|---|---|
| Manufacture of medicines | Licence | Production site | GMP of Kazakhstan or the EAEU, mandatory (Art. 231) |
| Manufacture of medical devices | Licence | Production site | Device production rules (Art. 231) |
| Compounding medicines and making devices | Licence | Pharmacy | In-pharmacy quality control (Art. 232) |
| Wholesale of medicines | Licence | Pharmacy warehouse | GDP, mandatory (Art. 233) |
| Retail of medicines | Licence | Pharmacy, pharmacy point, mobile pharmacy point | GPP, voluntary (Art. 233) |
| Wholesale of medical devices | Notification | Medical device warehouse | — |
| Retail of medical devices | Notification | Optics and medical device shop | — |
The licensing body is the territorial department of the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare. The licence cannot be transferred. It has no expiry date, because Annex 1 sets no term for it (Law on Permits, Art. 29(7)).
Who May Apply
Legal entities and individuals may apply, and Order No. 45 has provisions for foreign legal entities. The Law on Permits allows a foreign legal entity to hold a licence directly (Arts. 20, 29), but it must meet the same premises and staffing tests in Kazakhstan. A representative office is not a route to licensed activity. A foreign group can instead work through a local subsidiary or a licensed distributor; see Company Formation.
Licence Requirements
Order No. 148/2020 requires:
- Premises: a building or rooms held by ownership, lease or trust management of state property, meeting sanitary rules.
- Equipment: furniture, instruments and equipment to control quality and maintain production, storage and sale conditions.
- Staff: employees with the education and experience set for each sub-activity.
| Position | Requirement |
|---|---|
| Head of a production unit (medicines and devices) | Higher pharmaceutical, chemical-technological or chemical education and at least three years' experience |
| Head of a pharmacy warehouse | Higher pharmaceutical education and at least three years' experience |
| Head of a pharmacy | Higher, technical and vocational or post-secondary pharmaceutical education and at least three years' experience |
| Staff who sell, receive, store or dispense | Higher, technical and vocational or post-secondary pharmaceutical education |
A manufacturer of medicines must also have at least one authorised person on staff, responsible for GMP duties (Code, Art. 231(9)).
Licence Procedure
- Prepare. Secure the premises, install equipment and hire qualified staff. The licence is assessed against what exists, not against plans.
- File. Submit the electronic application, proof of the fee and the form of information on qualification requirements to the territorial department.
- Completeness check. The department checks the filing within two working days and asks other state bodies for their views. Those bodies reply within ten working days.
- Review. The department reviews compliance within 13 working days. Before a refusal the applicant is notified and heard.
- Decision. The total period is 15 working days for a licence or annex, and three working days for a re-issue (Order No. 45, Annex 1).
The fee is 10 MCI, about KZT 43,250 at the 2026 monthly calculation index of KZT 4,325 (Tax Code, Art. 616).
Product Registration
All medicines and devices made in or imported into Kazakhstan must be registered, by trade name, form, dosage, pack and production site (Code, Art. 23(1)). The Committee registers them after expert evaluation by the state expert organisation, the National Centre for Expertise of Medicines and Medical Devices. That evaluation is a state monopoly, and the applicant pays for it (Arts. 23, 239). A fee also applies under tax law. Article 23(2) lists exclusions, such as compounded medicines and exhibition samples.
| Point | Medicines, EAEU | Medical devices, EAEU | National route |
|---|---|---|---|
| Rules | Decision No. 78 | Decision No. 46 | Code Art. 23; Order No. 16 |
| Structure | Reference state, then mutual recognition in states the applicant selects (para. 66) | Reference state; the certificate may cover one or several member states | Kazakhstan only |
| Time limit | 140 working days in the reference state (para. 46); 40 working days for expert evaluation in a recognition state (para. 69) | Expert conclusion within 45 working days of starting the procedure (para. 29) | See Order No. 10 |
| Applicant's reply to a query | Up to 90 working days (paras. 53, 72) | 60 working days (para. 28) | Set by the Order |
| Certificate | 5 years, then unlimited (para. 18) | Unlimited | Medicines 5 years, unlimited on re-registration; locally made medicines and devices unlimited (Order No. 16, para. 12) |
Medicines registered under national rules had to be brought into line with EAEU requirements by 31 December 2025, and national certificates continue for a limited period where an alignment application was filed by that date. The Council has also extended temporary national registration procedures to 31 December 2027. For medical devices, a protocol signed on 29 December 2025 keeps applications under national rules open until 31 December 2027. An applicant should confirm which route is open for the specific product before building a dossier.
An accelerated expert procedure exists by decision of the authorised body, in the cases listed in Art. 23(10). A device manufacturer must maintain a quality management system meeting EAEU requirements (Decision No. 46, para. 8).
GMP, GDP and Inspections
Manufacture in Kazakhstan requires both a licence and compliance with GMP of Kazakhstan or the EAEU (Art. 231(2)). There is no EAEU manufacturing licence. Active substances in medicines made in or imported into Kazakhstan must also be produced to at least those GMP standards (Art. 231(5)).
The pharmaceutical inspectorate inspects on application, for licensing and registration purposes, and to confirm certificates at least once every two years under an inspection schedule (Art. 244). The state body and its territorial units issue and withdraw certificates of compliance with good practices. A foreign manufacturer should expect site assessment: if it refuses a visit to assess the quality system, or the actual conditions do not match the dossier, the expert conclusion is negative (Art. 239(4)).
Import
Medicines and devices must be registered in Kazakhstan before import (Art. 251(2)). Commercial import is open to licensed manufacturers, licensed wholesalers of medicines, businesses on the register of device wholesalers, and healthcare organisations for their own medical activity (Art. 252). A foreign manufacturer or its representative may import directly only for expert evaluation, clinical research or testing, and exhibitions.
Unregistered products may enter on a conclusion of the authorised body for listed purposes, including clinical trials, registration samples, and treatment of a specific patient on vital grounds (Art. 251(3)). Registered medicines may be imported with stickers in Kazakh and Russian. Non-compliant imports are subject to confiscation and destruction (Art. 251(5)).
Ongoing Obligations
- Licence changes. Apply for re-issue within 30 calendar days of a triggering change (Law on Permits, Art. 33).
- Certificates. Re-register a national medicine before its 5-year certificate ends. Keep dossier changes up to date.
- Pharmacovigilance. A registration holder must meet its pharmacovigilance duties, and failure is a ground for a negative conclusion (Art. 239(4)).
- Prices. The State regulates prices for listed medicines in wholesale and retail sale, and for medicines and devices within guaranteed free care and mandatory social health insurance (Art. 245).
- Public supply. The single distributor, SK-Pharmacy LLP, buys for those programmes (Art. 247).
- Sale restrictions. No sale of unregistered, expired or non-compliant products. Prescription medicines may not be sold without a prescription (Art. 233).
Common Mistakes by Foreign Investors
- Looking for an import licence. None exists. The question is who may import, and a foreign supplier normally needs a licensed local importer.
- Assuming EU or US approval carries over. A product still needs registration here, and GMP means Kazakhstan or EAEU GMP.
- Treating a licence as the end of the process. A licensed distributor cannot sell a product until that product is registered.
- Filing before premises and staff exist. The review tests actual premises, equipment and employees.
- Applying for a licence to sell devices. Device warehouses and shops work on notification, though medicines in the same business need a licence.
- Using the old national timeline. Plan around EAEU rules and the transition dates.
- Registering a single site. Registration is by production site, so a new site affects the certificate.
Frequently Asked Questions
Which authority issues pharmaceutical licences in Kazakhstan?
The territorial departments of the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare.
How long does a pharmaceutical licence take?
The statutory period is 15 working days from registration of the application. The fee is 10 MCI. Premises and staff must be in place first, and that time is not included.
Is there a pharmaceutical import licence?
No. Article 252 of the Code lists who may import, chiefly licensed manufacturers and wholesalers and notified device wholesalers. The product must be registered.
Does a medical device distributor need a licence?
No, wholesale and retail sale of devices through a device warehouse or an optics and medical device shop works on notification. Manufacture of devices needs a licence, and the devices themselves must be registered.
How long does EAEU registration of a medicine take?
The rules set 140 working days in the reference state, and 40 working days for expert evaluation in each recognition state. Time for the applicant's replies and any inspection can extend this.
Does a medicine registered in Russia or another member state circulate in Kazakhstan automatically?
No. A medicine registered in a reference state reaches Kazakhstan only if the applicant selects Kazakhstan and the mutual recognition procedure ends with registration here.
Must a pharmacy follow Good Pharmacy Practice?
The Code makes GPP voluntary for retail sellers, while GDP is mandatory for wholesalers and GMP for manufacturers of medicines.
Experience
Licensing · Kazakhstan · Pharma
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Medical Device Registration
Registering Class II and Class III medical devices with the Committee for Medical and Pharmaceutical Control — technical documentation, clinical evaluation report, labelling compliance, and post-market surveillance plan preparation.
Licensing · Kazakhstan · EAEU
EAEU Market Entry — Registration Strategy
Advising a European pharmaceutical company on EAEU Common Pharmaceutical Market entry strategy — choosing between Kazakhstan national registration and EAEU Common Market registration, and structuring the registration timeline across priority EAEU markets.
Related Pages
Regulatory Licensing in Kazakhstan →
Pharmaceuticals & Healthcare →
Business Licences and Permits →
Company Formation →
Investment in Kazakhstan →
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Primary sources: zakon.uchet.kz — Code No. 360-VI Arts. 23, 230–233, 239, 244, 245, 247, 251, 252; Law No. 202-V Arts. 20, 29, 33, Annexes 1 and 3; Tax Code No. 214-VIII Art. 616; Ministry of Healthcare Orders Nos. 45 (2022), 148/2020, 16 (2021) and 10 (2021); Council Decisions Nos. 78 and 46.