Medical products

Member: 

Basic information

1

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).

2

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

3

If Automatic, administrative purpose

Non-Automatic

4

If Non-Automatic, description of the notified Non-Automatic Licensing regime

5

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.

6

Questions for products under restriction as to the quantity or value of imports

Not applicable.

7

The system applies to products originating from which country?

The system applies to importers of controlled substances from all countries

8

Expected duration of licensing procedure

Eligibility of applicants

12

Is there a system of registration of persons or firms permitted to engage in importation?

13

What persons or firms are eligible to apply for a licence?

Natural and legal persons have the right to apply for the licence (permission).

14

Is there a registration fee?

15

Is there a published list of authorized importers?

Contact point for information on eligibility

16

Ministry/Authority

17

Address

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Telephone

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Fax

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E-mail address

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Website

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Contact officer

Submission of an application

23

Administrative body(ies) for submission of an application

Documentation requirements

24

What information is required in applications?

Application forms are available at: http://adilet.zan.kz/rus/docs/V2000021749

25

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

26

How far in advance of importation must application for a licence be made?

27

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

28

Can a licence be granted immediately on request?

No.

29

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.

30

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.

31

Must the applications be passed on to other organs for visa, note or approval?

32

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

33

Is there any licensing fee or administrative charge?

The issuance of the permission (authorization) is carried out for free.

34

What is the amount of the fee or charge?

35

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).

36

Amount or rate?

37

Is it refundable?

38

What is the period of retention?

39

What is the purpose of this requirement?

Refusal of an application

40

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.

41

Are the reasons for any refusal given to applicants?

42

Have applicants a right of appeal in the event of refusal to issue a licence?

43

If so, to what bodies and under what procedures?

Importation

44

Are there any limitations as to the period of year during which importation may be made?

No.

45

What documents are required upon actual importation?

Upon importation, an importer must present standard customs documentation along with a valid permission (authorization).

46

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

47

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.

48

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).

49

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

50

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.

51

Is a licence required as a condition to obtaining foreign exchange?

52

Is foreign exchange always available to cover licences issued?

53

What formalities must be fulfilled for obtaining the foreign exchange?