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Doing Business: Pharmaceutics in Kazakstan

29 April 2016

Pharmaceutics in Kazakhstan

The healthcare system suffers many ongoing reforms in light of governmental policies and priorities in social aspirations. These reforms also impact the pharmaceutical industry. The Ministry of Healthcare and Social Development is the regulatory body governing the health care system and pharmaceutical market. The Healthcare Code 2009 is the primary legislative act regulating the pharmaceutical industry in Kazakhstan.

The pharmaceutical market in Kazakhstan is divided into three main sectors:

  • Import and sales of pharmaceutical goods and drugs;
  • Production and sales of pharmaceutical goods and drugs;
  • Import and sales of medical equipment.

Generally, the import of pharmaceutical goods constitutes a large proportion of pharmaceutical market share. Companies which operate with the import & export of drugs must apply for special permission issued by the authorized body (the Committee for Health and Control of Pharmaceutical Activity under the Ministry of Healthcare and Social Development of Kazakhstan). Other requirements are stipulated in the Healthcare Code related to the import or production of pharmaceutical goods:

  • Drugs should comply with safety and quality standards that are set up by the authorized body;
  • Drugs should not contain any colors and substances prohibited by the authorized body.

Act on Advertising 2003 restricts advertising of:

  • medical appliances;
  • medical equipment; and
  • pharmaceuticals.

With a prior governmental approval, the advisement is permitted in special medical journals.
Biological active additives (BAA) are regulated at almost same as drugs. BBA sales are prohibited without state registration of BAA. BAAs will be confiscated and destroyed in case of non-compliance of rules.
 

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