Outline of the system
Licences are issued to control the import of human organs and tissues, blood and its components (the Common List of Goods that are Subject to Non-Tariff Measures in Trade with Third Countries, approved by Decision of the Collegium of the Eurasian Economic Commission No. 30 "On Measures of Non-Tariff Regulation" of 21 April 2015, Annex 2.21).
The licensing system permits to control the turnover of human organs and tissues, blood and its components for protection of human life or health.
Please see Products - Human organs and tissues, blood and its components, samples of human biological materials
Nature of licensing
If Automatic, administrative purpose
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The use of import licences enables the Government to monitor the quantities of controlled substances imported. The system is not intended to restrict the quantity or volume of imports.
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
The system applies to importers of controlled substances from all countries
Expected duration of licensing procedure
Is the licensing statutorily required?
The controls on the importation of goods specified in this category are statutory requirements under the legislation detailed below:
- Treaty on the Eurasian Economic Union (EAEU) of 29 May 2014;
- Annex No. 7 “Protocol on Non-Tariff Measures Concerning Third Countries” to the Treaty on the EAEU;
- Decision of the Collegium of the Eurasian Economic Commission No. 30 “On Measures of Non Tariff Regulation” of 21 April 2015 (Section 2.21);
- Code of the Republic of Kazakhstan No. 360-VI "On Public Health and Healthcare System" of 7 July 2020;
- Law of the Republic of Kazakhstan No. 544-II “On Regulation of Trade Activity” of 12 April 2004;
- Law of the Republic of Kazakhstan No. 202-V “On Permissions and Notifications” of 16 May 2014;
- Resolution of the Government of the Republic of Kazakhstan No. 287 “On Approval of List of Goods Subjects to Import/Export Licensing, Licencers and State Bodies, Coordinating the Issuance of Licences” of 24 April 2015;
- Resolution of the Government of the Republic of Kazakhstan No. 287 "On Approval of the List of Goods, the Export and (or) Import of which is Carried out on the Basis of Permits in accordance with International Treaties and Permits Issued by State Bodies" of 24 April 2015;
- Order of the Acting Minister of Digital Development, Innovation and Aerospace Industry of the Republic of Kazakhstan No. 39/NK "On Approval of the Register of Public Services" of 31 January 2020;
- Order of the Minister of the National Economy of the Republic of Kazakhstan No. 67 “On Approval of the Qualification Requirements Maintained for Activities on Export and Import Licensing of Goods, List of Documents Confirming Compliance with them, Application Forms for Obtaining a Licence and (or) Annex to the Licence, the Form of a Licence and (or) Annexes to the Licence” of 30 January 2015.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Is it possible for the government to abolish the system without legislative approval?
This system cannot be abolished without legislative approval.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
Only legal persons.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
What information is required in applications?
Application forms are available at: http://adilet.zan.kz/rus/docs/V1500011074#z7
What documents is the importer required to supply with the application?
An importer is required to submit the following documents to the authorized body via the web portal of electronic licensing of the Republic of Kazakhstan “E-license” (http://elicense.kz/?lang=en) or via the web portal of "Electronic government" of the Republic of Kazakhstan "e-gov"(https://egov.kz/cms/en)with the application for licence:
- An electronic copy of application;
- A copy of a foreign trade contract;
- An electronic copy of the document confirming payment of the license fee for carrying out certain types of activities, except for payment through the payment gateway "electronic government"
- A copy of document on registration with tax authority or a copy of document on the state registration;
- A copy of licence for medical activity;
- Permission of authorities of third countries responsible for taking decision on possibility of import/export of human organs and tissues, blood and its components.
Window of submission of an application
How far in advance of importation must application for a licence be made?
There is no minimum advance notice required for a licence.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Issuing the license
Can a licence be granted immediately on request?
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The maximum processing time for licence for human organs is one working day; for licence for human tissues and its components – three working days, for licence for blood and its components - three working days.
Which administrative body is responsible for approving application of licences?
Yes, an application is considered by only authorized body- the Control Committee of Medical and Pharmaceutical Activity of the Ministry of Public Health and Social Development of the Republic of Kazakhstan.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
There are no conditions attached to the issuance of a licence.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
Licence application fee is ten Monthly Calculated Indices.
What is the amount of the fee or charge?
Monthly Calculation Index (MCI) is an index used in Kazakhstan for the purpose of calculation of pensions and other social allowances as well as for the application of penalties, calculation of taxes and other payments to the budget, annually approved by Law "On Republican Budget". In 2021 MCI is 2 917 tenge).
Is there any deposit or advance payment required associated with the issue of licences?
There is no deposit or advance payment requirement associated with the issue of licences
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Part II of the Appendix to Annex No. 7 "Rules of the Issuance of Licences and Permits to Export and (or) Import Goods" to the EAEU Treaty establishes the grounds for refusing licences: (i) incomplete or inaccurate information in the documents submitted by the applicant to obtain a licence; (ii) non compliance with the requirements stipulated in the Appendix to Annex No. 7 to the EAEU Treaty; (iii) termination or suspension of one or more documents that served as the basis for issuance of a licence; (iv) violation of international obligations of an EAEU member State, which may occur as a result of performance of the contract which requires a licence; (v) exhaustion of quota (in the case of registration of a licence for goods subject to quotas).
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
The decision to refuse a licence has to be justified and presented by the authorized body to the applicant in writing.
If so, to what bodies and under what procedures?
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
Upon importation, an importer must present standard customs documentation along with a valid licence
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures, apart from import licensing required prior to importation.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
Licences are valid for the licence period and cannot be extended.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of a licence or a portion of a licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Foreign exchange is automatically provided by the banking authorities for goods to be imported.