SiteHeart
faq-image

Licensing of Pharmaceutical Activities

The Republic of Kazakhstan has taken a number of measures to provide the people in the Republic of Kazakhstan with quality medicines and medical products. One of the most important measures in this area is pharmaceutical licensing.

In accordance with the Code of the Republic of Kazakhstan "On People's Health and Healthcare System", pharmaceutical activity refers to activities carried out in the field of healthcare in production, manufacture (with the exception of medical equipment), wholesale and retail sale of medical products, medical accessories and medical equipment, associated with the purchase (acquisition), storage, import, export, quality control, design, distribution, use and disposal of medical products, medical accessories and medical equipment, as well as ensuring safety, efficacy and quality thereof.

At the present time, in accordance with the law of the Republic of Kazakhstan "On Licensing" as of 11.01.2007, the following sub-types of pharmaceutical activities are subject to licensing:
  1. production of medicines;
  2. production of medical accessories;
  3. production of medical equipment;
  4. manufacture of medicines;
  5. manufacture of medical accessories;
  6. wholesale trade of medicines;
  7. wholesale trade of medical accessories;
  8. wholesale trade of medical equipment;
  9. retail trade of medicines;
  10. retail trade of medical accessories;
  11. retail trade of medical equipment.

Qualification requirements for entities carrying out activities in the field of healthcare have been approved by Government Regulation No. 2301 as of 30.12.2009.

In order to collect documents and determine sub-activities in the field of circulation of medicines, medical equipment and medical accessories, one must first familiarize themselves with the sales guidelines for the above products.

Sale of medicines, medical equipment and medical accessories

The Code "On People's Health and Healthcare System" specifies that wholesale and retail trade of medicines, medical equipment and medical accessories is carried out in accordance with the procedure established by the Government of the Republic of Kazakhstan.

According to the current legislation of the Republic of Kazakhstan in the field of pharmaceutical activities, wholesale trade of medicines, medical equipment and medical accessories is performed in pharmacy depots and warehouses for medical accessories and medical equipment. Retail trade of medicines, medical equipment and medical accessories is carried out by entities operating in the field of circulation of medicines, medical accessories and medical equipment in drugstores, pharmacies, movable pharmacies, optical stores, and medical equipment and medical accessories stores.

Changes in Pharmaceutical Activities Licensing 

On July 15, 2011, the Act of the Republic of Kazakhstan “On amendments and alterations to certain legislative acts of the Republic of Kazakhstan on improvement of regulatory approval system” (hereinafter referred to as the “Act”) was adopted, which entered into force on 30.01.2012. Changes have also been applied to pharmaceutical industry. In particular qualification requirements had been made more specific for persons wishing to operate in sale of medicines through a mobile pharmacy for remote rural areas where there are no drugstores.

Executed by Senior Associate
of ZAN Legal Firm, Astambaeva Gulzifa

Поделиться в соц сетях