Basic information
Outline of the system
The permission is issued in order to control the import of certain medicinal products (The unified list of goods to which the Non-Tariff Regulation measures under the EAEU regime are applied in trade with third countries (Decision of the Board of the EEC No. 30 dated 21.04.2015, as amended on 13.12.2017, Annex 2.14).
Product coverage
The permission system allows to control the turnover of certain medical products in order to protect the life and health of people, animals and plants.
Please see Products - Medical products
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The implementation of permission system allows the Government to track the number of controlled imported goods. The permission system is not intended to limit the quantity or cost of import.
Questions for products under restriction as to the quantity or value of imports
Not applicable.
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
Legal requirements
Is the licensing statutorily required?
The control of import of the specified goods in this category is a mandatory requirement under the following legislation:
- The Treaty on the Eurasian Economic Union (EAEU) of 19 May 2014;
- Decision of the Collegium of the Eurasian Economic Commission (EEC) No. 30 "On Measures of Non Tariff Regulation" of 21 April 2015 (Section 2.14);
- Code of the Republic of Kazakhstan No. 360-VI "On Public Health and Healthcare System" of 7 July 2020;
- The Law of the Republic of Kazakhstan No. 202-V "On Permissions and Notifications" dated 16 May 2014;
- 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 January 31, 2020;
- The Order of the Minister of Health and Social Development of the Republic of Kazakhstan No. 668 "On approval of the Rules for the importation into the territory of the Republic of Kazakhstan of medical products and medical devices and the exportation from the territory of the Republic of Kazakhstan of medical products and medical devices and on the government service "On approval and (or) conclusion (permit) for import (export) of registered and unregistered in the Republic of Kazakhstan medical products and medical devices", dated 17 August 2015;
- The Order of the Minister of Health and Social Development of the Republic of Kazakhstan No. 293 "On Approval of Public Services’ Standards in the Field of Pharmaceutical Activity", dated 28 April 2015;
- Order of the Acting Minister of Health of the Republic of Kazakhstan No. KR DSM-65/2020 "On Certain Issues of Providing Public Services in the Field of Pharmaceutical Activity" of 15 June 2020.
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 cancelled 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?
Natural and legal persons have the right to apply for the licence (permission).
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
Application forms are available at: http://adilet.zan.kz/rus/docs/V2000021749
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. The list of documents required for submission can be found at the following link: http://elicense.kz/LicensingContent/ServicesList?scode=%D0%A0%D0%9414&la..., with the selection of appropriate criteria and subspecies of activity.
- The import of unregistered medical products is carried out on the basis of a permit, for which it is necessary to submit the following documents to the authorized body - Ministry of Healthcare:
- electronic copy of the application;
- copy of the agreement (contract).
- The import of registered medical products should be implemented with the information on the inclusion of imported medical products in a single register of the Eurasian Economic Union or the state register of medical products of the Republic of Kazakhstan.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
No.
Issuing the license
Can a licence be granted immediately on request?
No.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The maximum period for issuing an authorization (authorization document) is three working days.
Which administrative body is responsible for approving application of licences?
The importer must apply to single administrative body - the Ministry of Healthcare 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 other requirements related to issuing of permission (authorization).
Fees and other administrative charges
Is there any licensing fee or administrative charge?
The issuance of the permission (authorization) is carried out for free.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
There is no requirement for a deposit or for an advance payment related to the issuance of a permission (authorization).
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?
The issue of permission for the import may be declined if the necessary documents are not provided in full.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Importation
Are there any limitations as to the period of year during which importation may be made?
No.
What documents are required upon actual importation?
Upon importation, an importer must present standard customs documentation along with a valid permission (authorization).
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures other than obtaining a permission (authorization) prior to importation.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The permission (authorization) is valid for the period of its issuance.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for not using the permission (authorization).
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The permission (authorization) cannot be transferred between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Currency exchange is automatic and is carried out by banking authorities for imported goods.