Medical products
- Document symbol
- G/LIC/N/3/KAZ/8
- Original language
- English
- Published on
- 15/04/2024
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another 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 April 2015, as amended on 13 December 2017, Annex 2.14).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
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
Q3. The system applies to goods originating in and coming from which countries?
The system applies to importers of controlled substances from all countries
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
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.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
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;
- Order of the Ministry of Healthcare of the Republic of Kazakhstan of 8 December 2020 No. KR DSM-237/2020 "On Approval of the Rules for the Importation into the Territory of the Republic of Kazakhstan and Exportation from the Territory of the Republic of Kazakhstan of Medicines and Medical devices and the Provision of Governmental Service" Issuance of Approval and/or Conclusion (Permission) for the Importation (Exportation) of Medicines and Medical Devices Registered and Not Registered in the Republic of Kazakhstan".
This system cannot be cancelled without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
The maximum period for issuing an authorization (authorization document) is three working days.
Q7.b. Can a licence be granted immediately on request?
No.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
The importer must apply to single administrative body - the Ministry of Healthcare of the Republic of Kazakhstan.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
The issue of permission for the import may be declined if the necessary documents are not provided in full.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
Natural and legal persons have the right to apply for the licence (permission).
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
The application form and required documents are available on the website https://adilet.zan.kz/rus/docs/V2000021749#z16.
The importer is required to provide the documents specified in the Governmental Service Standard "Issuance of Approval and/or Conclusion (permit) for the Importation (Exportation) of Medicines and Medical Devices Registered and Not Registered in the Republic of Kazakhstan" through the "Electronic Government" web-portal www.egov.kz or through the web-portal of electronic licensing of the Republic of Kazakhstan "E-license" www.elicense.kz.
Q11. What documents are required upon actual importation?
Upon importation, an importer must present standard customs documentation along with a valid permission (authorization).
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The issuance of the permission (authorization) is carried out for free.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no requirement for a deposit or for an advance payment related to the issuance of a permission (authorization).
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The permission (authorization) is valid for the period of its issuance.
Q15. 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).
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The permission (authorization) cannot be transferred between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
There are no other requirements related to issuing of permission (authorization).
Other Procedural Requirements
Q18. 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.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
Currency exchange is automatic and is carried out by banking authorities for imported goods.