Licensing

Licensing services:

  • for pharmaceutical activities and paid medical services;
  • for selling, repair and import of X-ray equipment;
  • for importation of medical equipment, medical devices and medicines;

The Law of the Republic of Kazakhstan “”On Licensing” has been amended according to the Law of the Republic of Kazakhstan “”On Amendments to Certain Laws of the Republic of Kazakhstan on Health Care Issues” signed by the President on July 16, 2009. According to this Law the wording of the type of activities “the pharmaceutical activities: production, manufacture, whole and retail sale of medicines” was amended to read as follows: “”pharmaceutical activities” and divided into subtypes of activities.

According to Article 26 of the Law of the Republic of Kazakhstan “On Licensing", the following subtypes of pharmaceutical activities are subject to licensing:

  • whole sale of medicines;
  • whole sale of medical devices;
  • whole sale of medical equipment; retail sale of medicines;
  • retail sale of medical devices;
  • retail sale of medical equipment.

Entities performing pharmaceutical activities are chemist's shops, pharmacies, pharmacy depots, temporary storage warehouses for medicines, optic stores, stores of medical equipment and medical devices, warehouses for medical equipment and medical devices, laboratories for certification and testing of medicines, medicines manufactures.

Licensing services are provided by the Ministry of Health of the Republic of Kazakhstan. In accordance with Order No.47 of the Minister of Health of the Republic of Kazakhstan dated 22.04.2005 “On certain licensing issues” the pharmaceutical activity licensing function was transferred to the Departments of Health Care of regions, in Astana, to the Department of Economics and Budget Planning of the Mayor in Almaty city. Subjects of licensing are individuals and legal entities operating in the field of medicines that meet the qualification requirements to the licensing of pharmaceutical activities. One of the documents required to obtain a license for pharmaceutical activity is an expert opinion issued by the bodies of the Department of Supervision Committee for Sanitation and Epidemiology of the Ministry of Health of the Republic of Kazakhstan and the Fire-Fighting Service on the applicant's compliance with qualification requirements provided for in the course of licensing of such type of pharmaceutical activity. The license for pharmaceutical activities shall be considered to be general without any limitations of the validity term.

Any individuals wishing to perform types of pharmaceutical activities subject to licensing without establishing a legal entity shall have an academic degree in pharmacy.

Import License

Any X-ray equipment including X-ray tubes (irrespective of a country of origin) except for replacement parts and appliances shall be imported to the Republic of Kazakhstan under the import license.

Any import or export license shall be regulated by Law of the Republic of Kazakhstan No.579 “On certain licensing issues of goods export and import” (see clause 1 + subclause 3) where the import license procedure and the list of the required documents are specified.

According to the import licensing procedure an application with a package of documents shall be sent to the Industry Committee of the Ministry of Industry and New Technologies of the Republic of Kazakhstan for further delivery to certain state bodies for approval.

The validity of an import license is one year.

The list of goods the importation of which is approved by the Committee of Nuclear Energy is provided for by Decree No.104 of the Government of the Republic of Kazakhstan dated February 5, 2008 “On Approval of the List of Goods Subject to the Export Control” supplemented by the list of “The Goods Controlled on the Grounds of National Safety and under International obligations” (enacted on 10.01.2013 according to Decree No.1320 of the Government of the Republic of Kazakhstan dated 17.10.2012) that includes X-ray equipment.

The list of goods subject to automatic import licensing is approved by the Government of the Republic of Kazakhstan. The list of goods to be licensed for export and (or) import:

  • Ionizing radiation sources and isotopes, X-ray alpha-, beta-, gamma- or neutron radiation equipment (X-ray equipment, tubes, mammographers and other generators of X-ray radiation);
  • X-ray equipment, devices and equipment with use of radioactive substances and isotopes (radiographic systems).

Commodity Nomenclature.

Any organizations using X-ray equipment or register it shall receive a license for “Operation of plants generating ionizing radiation" (licensed by the Committee of Nuclear Energy).

Suppliers of X-ray equipment do not need a license to sell X-ray equipment, since this kind of activity is excluded from the Law “On Licensing".

One application for licensing may only contain unlimited number of various types of X-ray equipment if it has the same code of foreign economic activity (CN FEA), i.e. for each CN FEA one application form is filled in