The Republic of Kazakhstan is one of the largest post-Soviet countries with a population of about 18 million people, and it is a member of the Eurasian Economic Union (EAEU) along with Russia, Belarus, Armenia and Kyrgyzstan. Membership of Kazakhstan in the EAEU significantly influences the regulatory policy of the state: there is a choice between the “national” and “centralized” registration procedure for medicinal products and medical devices at present, while special purpose foods (dietary supplements, baby food, sports nutrition, etc.) and cosmetic products undergo the procedure in accordance with the relevant Technical Regulations of the EAEU only.

Kazakhstan is characterized by one of the most transparent market from the point of view of legislation for foreign manufacturers of pharmaceutical products. Medicinal products of foreign manufacturers occupy the dominant position in the rapidly growing medical market of the country: the imported pharmaceutical products share in the market of Kazakhstan is about 88%.

The market of medical devices is also formed mainly by exports, with the share of about 87%. Import and sale of medical devices and medical equipment in Kazakhstan are allowed after state registration. Regulatory legislation is being actively developed through gradual integration into the EAEU.

Import and sale of special purpose food products and cosmetic products are only allowed if marketing authorization is available. Markets are formed mainly by imports; for dietary supplements, its share is about 86%; for cosmetic products, the share of foreign manufacturers is more than 92%. Special food products (dietary supplements, baby food, sports nutrition, etc.) and cosmetic products undergo registration procedure in accordance with the relevant Technical Regulations of the EAEU only.

Competent authorities:

The Ministry of Health and Social Development of the Republic of Kazakhstan.
The central executive authority implementing the state health care policy
Web-site: http://www.mz.gov.kz/ 

National Center for expert evaluation of medicinal products, medical devices and medical equipment
The competent authority, responsible for performing expert activities for the purpose of registration of medicinal products and medical devices, as well as responsible for pharmacovigilance
Web-site: http://www.ndda.kz/ 

State Institution “Committee for quality control and safety of goods and services of the Ministry of Healthcare of the Republic of Kazakhstan”
The authorized body for registration of special food products
Web-site: http://kkkbtu.dsm.gov.kz/ru 

Main legislative acts:

1. Code of the Republic of Kazakhstan 193-IV “On the public health and the healthcare system” dated September 18, 2009.
2. Law of the Republic of Kazakhstan No. 522-II “On medicinal products” dated January 13, 2004.
3. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 735 “On approval of Rules for state registration, re-registration and amendments to the registration dossier of the medicinal product or medical device” dated November 18, 2009.
4. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 421 “On approval of Rules for carrying out pharmacovigilance and monitoring of safety, quality and efficacy of medical devices” dated May 29, 2015.
5. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 414 “On approval of Rules of creation and execution of instructions for medical use and the general characteristics of medicinal products and medical devices” dated May 29, 2015.
6. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 227 “On approval of Rules for labeling of medicinal products and medical devices” dated April 16, 2015.
7. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 743 “On approval of Rules for evaluating the manufacturing conditions and the quality assurance system during state registration of medicinal product or medical device” dated November 19, 2009.
8. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 262 “On approval of the Rules for storage and transportation of medicinal products and medical devices” dated April 24, 2015.
9. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 432 “On approval of the list of orphan drugs” dated May 29, 2015.
10. Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 668 “On approval of the Rules for import to the territory of the Republic of Kazakhstan of medicinal products and medical devices and export from the territory of the Republic of Kazakhstan of medicinal products and medical devices” dated August 17, 2015.

Cratia provides professional services of state registration of medical (healthcare) products in Kazakhstan. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:

• registration of medicinal products in Kazakhstan;
• developing and maintaining of the pharmacovigilance system in Kazakhstan;
• certification of medical devices in Kazakhstan;
• certification of special food products in Kazakhstan;
• certification of cosmetic products in Kazakhstan.

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.