Article 23. Issuance of a registration certificate for a medicinal product or medical device Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan
1. Medicines and medical devices produced in the Republic of Kazakhstan, as well as those imported into its territory, are subject to state registration, including:
1) medicines under trade names, indicating the dosage form, dosage, and packaging from each production site;
2) medical devices under trade names from each production site;
3) consumables for medical devices, except for those specifically intended by the manufacturer of the medical device for use with medical devices that can only function with these consumables.
4) medical devices included in the composition of a specialized medical transport vehicle;
5) repealed by the Law of the Republic of Kazakhstan dated 04.07.2022 No. 134-VII (entered into force sixty calendar days after the date of its first official publication).
6) advanced therapy medicinal products produced under industrial conditions;
7) medical devices for diagnostics outside a living organism (in vitro).
8) Medical gases.
1-1. State registration of strategically important medicinal products and medical devices is carried out in accordance with the procedure determined by the authorized body.
2. The following are not subject to state registration:
1) medicinal products manufactured in pharmacies;2) pharmaceutical substances (active pharmaceutical substances) produced under good manufacturing practice conditions;3) pharmacopoeial medicinal plant raw materials, including those included in herbal mixtures and consumer packaging.
4) medical devices made according to individual orders of patients exclusively for personal use, which are subject to special requirements in accordance with the appointment issued by a medical professional;
5) medicines and medical products manufactured in the Republic of Kazakhstan for export only;
6) exhibition samples of medicines and medical products for exhibitions without the right of their further sale;
7) samples of medicines and medical devices received for preclinical (non-clinical) and clinical studies and (or) trials;
8) laboratory instruments not used for diagnosing diseases;9) components that are part of medical devices and are not used as a standalone product or device;10) radiopharmaceutical medicinal products manufactured directly in healthcare organizations at the site of their use;11) samples of medicinal products and medical devices for examination during state registration.
12) advanced therapy medicinal products produced for individual use using autologous biological materials of the patient or their donor, selected specifically for them;
13) bulk products of medicinal products or medical devices.
3. State registration, re‑registration of a medicinal product or medical device, and amendments to the registration dossier of a medicinal product or medical device are carried out by the state body responsible for the circulation of medicinal products and medical devices in accordance with the legislation of the Republic of Kazakhstan.
4. A mandatory condition for state registration, re‑registration of medicines or medical devices, and внесения changes to the registration dossier of a medicine or medical device is the conduct of an examination of the medicine or medical device in accordance with the legislation of the Republic of Kazakhstan.
5. The expert organization is provided with a registration dossier containing documents, the list of which is established in accordance with the legislation of the Republic of Kazakhstan, as well as samples of the medicinal product or medical device, standard samples of pharmaceutical substances (active pharmaceutical substances) and their impurities in quantities sufficient for three‑fold analysis, specific reagents and consumables, in exceptional cases and subject to return.
6. The applicants bear the costs associated with conducting an examination of the medicinal product or medical device during their state registration, re‑registration and внесения changes to the registration dossier.
7. State registration, re‑registration, and amendments to the registration dossier of a medicinal product or medical device are carried out on the basis of an application and a positive conclusion of an expert organization regarding the safety, quality, and efficacy of the medicinal product or medical device, issued based on the results of the conducted examination.
8. An application for an examination, state registration, re‑registration of medicinal products or medical devices, amendments to the registration dossier of a medicinal product or medical device, and registration, as well as amendments to the manufacturer’s price, is submitted by the applicant or the manufacturer of the medicinal product or medical device, or their authorized representatives, as part of the provision of a composite service.
A composite service refers to a set of public services related to conducting an examination, state registration, re‑registration of medicines or medical devices, making changes to the registration dossier of a medicine or medical device, and registration, making changes to the manufacturer’s price, as well as the formation of the Kazakhstan National Medicines Formulary, provided either in combination or separately in accordance with the legislation of the Republic of Kazakhstan.
A fee is charged for state registration, re‑registration and the issuance of a duplicate of the registration certificate for a medicine or medical device in accordance with the tax legislation of the Republic of Kazakhstan.
9. Excluded by Law No. 185-VIII dated April 25, 2025 (entered into force ten calendar days after the date of its first official publication).
10. By decision of the authorized body, a medicinal product or medical device may be registered under an expedited examination procedure.
The procedure for an accelerated examination of a medicinal product or medical device is established in accordance with the legislation of the Republic of Kazakhstan.
An accelerated examination of a medicinal product is carried out in the following cases:
a joint procedure for the registration of a medicinal product with the World Health Organization;
a procedure for the prequalification of a medicinal product by the World Health Organization;
the registration of a medicinal product by regulatory authorities with a strict regulatory system, as determined by the World Health Organization;
other cases provided for by the legislation of the Republic of Kazakhstan.
The accelerated examination procedure for medical devices is carried out for medical devices that have certificates from the regulatory authorities of the European Commission in the European Union (CE marking) or from regulatory authorities that are members of the governing committee of the International Medical Device Regulators Forum (IMDRF), or that have been pre‑qualified by the World Health Organization, as well as in other cases provided for by the legislation of the Republic of Kazakhstan.
During the accelerated examination of medicinal products and medical devices, the requirements for their safety, quality, and efficacy are not reduced.
11. The applicant is denied state registration and re‑registration of medicinal products or medical devices, or amendments to the registration dossier of a medicinal product or medical device, if a negative conclusion is issued based on the examination of medicinal products and medical devices and a complete package of documents is not submitted.
12. Based on the results of state registration and re‑registration of a medicinal product or medical device, a registration certificate is issued in the form established by the authorized body.
During the validity period of the registration certificate, the holder of the registration certificate for a medicinal product or the manufacturer of a medical device is responsible for the safety, quality and efficacy of the registered medicinal products or medical devices, which must comply with the registration dossier submitted for the examination of medicinal products or medical devices for the purposes of state registration, re‑registration, or внесения changes to the registration dossier of a medicinal product or medical device.
13. The decision on the state registration of a medicinal product or medical device may be revoked in accordance with the legislation of the Republic of Kazakhstan.
14. Medicinal products and medical devices intended for circulation within the customs territory of the Eurasian Economic Union are subject to registration under uniform rules in accordance with the regulatory legal acts of the Eurasian Economic Union.
To register domestic medicinal products abroad, the authorized body issues a certificate for a pharmaceutical product (SRP) in accordance with the procedure established by the authorized body.
15. The state expert organization in the field of circulation of medicines and medical devices and the state body in the field of circulation of medicines and medical devices are not allowed, without the applicant’s consent, to disclose and use for commercial purposes confidential information provided for the state registration of a medicinal product — information contained in the application for state registration, the materials of the examination of the medicinal product, as well as the registration dossier of a medicinal product containing new chemical substances — within six years from the date of state registration of the medicinal product.
16. The provisions stipulated in paragraph 15 of this article, which prohibit the disclosure and commercial use of confidential information, do not apply to:
1) individuals or legal entities to which a compulsory license for the use of a medicinal product has been issued in accordance with...
Code of the Republic of Kazakhstan "on Public Health and the healthcare system" dated July 7, 2020
The article was amended and supplemented by the Law of the Republic of Kazakhstan dated July 7, 2026, No. 334-VIII SAM.
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