Narcotic drugs and psychotropic substances
- Document symbol
- G/LIC/N/3/UKR/16
- Original language
- English
- Published on
- 04/09/2023
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.
Imports of narcotic drugs and psychotropic substances is subject to a permission on the right to import of narcotic drugs and psychotropic substances. Such permissions are issued by the State Service of Ukraine on Medicines and Drugs Control. The permissions are issued to control the imports of specified narcotic drugs and psychotropic substances (controlled substances).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
This system fulfils part of Ukraine's obligation under UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.
The list of narcotic drugs and psychotropic substances, the circulation of which is restricted, is approved by the Resolution of the Cabinet of Ministers of Ukraine No. 770 on 6 May 2000 "On Approval of the List of narcotic drugs, psychotropic substances and precursors".
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 system is based on the requirements of the international treaty. The permission system aims at monitoring trade and authorization of imports of narcotic drugs and psychotropic substances. The permission system is intended to restrict the quantity of imports to quotas determined by the Ministry of Health of Ukraine on information provided by the State Service of Ukraine on Medicines and Drugs Control and approved by the Cabinet of Ministers of Ukraine. Proposals on the required quota for import of narcotic drugs and psychotropic substances for respective year are submitted by entities to the State Service of Ukraine on Medicines and Drugs Control. Based on information received from entities, the State Service of Ukraine on Medicines and Drugs Control prepares and submits to the Ministry of Health of Ukraine proposals on determining quotas for import of narcotic drugs and psychotropic substances for corresponding year. The quota is approved annually by the Cabinet of Ministers of Ukraine.
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 legislation under which the permission is maintained includes:
- Law of Ukraine "On Narcotic Drugs, Psychotropic Substances and Precursors" No. 60/95-ВР of 15 February 1995;
- Resolution of the Cabinet of Ministers of Ukraine No. 770 of 6 May 2000 "On Approval of the List of narcotic drugs, psychotropic substances and precursors";
- Resolution of the Cabinet of Ministers of Ukraine No. 146 of 03 February 1997 "On approval of the Procedure for issuing permissions for the right to import into the territory of Ukraine, export from the territory of Ukraine of narcotic drugs, psychotropic substances and precursors".
This system cannot be abolished 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?
Volume of quota for imports of narcotic drugs and psychotropic substances for the respective year is approved by the Cabinet of Ministries of Ukraine. Information on quotas and required documents for obtaining a permission can be viewed at the official website of the State Service of Ukraine on Medicines and Drugs Control: https://www.dls.gov.ua. Quotas are set for specific importers, not for the country. The legislation does not provide for any exception or derogation from the permission requirements.
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?
Quota is established on an annual basis. The volume of the import quota is determined based on the demand for narcotic drugs and psychotropic substances. Imports of narcotic drugs and psychotropic substances into Ukraine in an amount exceeding the quota determined by the Cabinet of Ministers of Ukraine is prohibited. Additional quota can be requested from the Ministry of Health, if required, during the year. The permission is issued per consignment. Importers are required to apply for a permission each time they intend to import.
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.)
Unused allocations cannot be extended to the next year.
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?
Applications are demand driven. Applications can be submitted at any time.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
The decision on issuing a permission or on its refusal shall be made within 30 working days from the date of receipt of the application. A permission may be issued in a shorter time frame and depends only on technical capacity of the relevant authority.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
A permission is effective for imports from the date it is granted.
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?
The State Service of Ukraine on Medicines and Drugs Control considers applications for permission to import of narcotic drugs and psychotropic substances into Ukraine. Such permissions are issued under the approvals from the Security Service of Ukraine. The permission is issued per consignment. Importers are required to apply for a permission each time they intend to import.
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?
Applications are examined and processed in order of their receipt. There is maximum volume of quota that can be allocated per applicant.
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?
An import permission is required for all consignments regardless of whether an export permission is also needed.
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)?
Q7.b. Can a licence be granted immediately on request?
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.
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?
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?
A permission may not be granted if the applicant fails to meet ordinary criteria, including not being the holder of the import licence. If the permission is not granted, the applicant shall be informed on the reasons for that in writing. A decision to refuse to issue a permission may be appealed to the district administrative court in accordance with the provisions of the Code of Administrative Proceedings of Ukraine.
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?
Legal entity that has a valid import licence (import activity licence) may apply for a permission. A permission is issued only to the licence holder.
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 requirements for the application and the necessary documents, as well as their list, are set out in the Resolution of the Cabinet of Ministers of Ukraine No. 146 of 3 February 1997 "On approval of the Procedure for issuing permissions for the right to import into the territory of Ukraine, export from the territory of Ukraine of narcotic drugs, psychotropic substances and precursors", available at https://zakon.rada.gov.ua/laws/show/146-97-%D0%BF#Text.
The mentioned Resolution also provides for the Procedure for issuing permissions for imports of narcotic drugs, psychotropic substances and precursors into the territory of Ukraine under the martial law. The Procedure became effective on 11 May 2022 and is valid until the termination or cancellation of martial law in Ukraine.
Information on business entity, which is a seller or a buyer under the contract, can be specified on the reverse side of the permission at the request of the applicant.
Q11. What documents are required upon actual importation?
At the time of actual importation the permission on the right to import of narcotic drugs and psychotropic substances is required along with other necessary customs documents. A certified copy of the permission is attached to and accompanies each consignment of narcotic drugs and psychotropic substances. Imports of narcotic drugs and psychotropic substances into Ukraine is carried out only through customs points, determined by the Cabinet of Ministers of Ukraine.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
A fee for issuing the permission is charged in amount of one percent of the value of the import contract.
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.
No deposit or advance payment requirement associated with the issue of permission.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The permission specifies the period within which narcotic drugs and psychotropic substances shall be imported. The permission validity can be extended once by the State Service of Ukraine on Medicines and Drugs Control up to 31 December of the year in which it was issued, if the declared consignment has not crossed the customs border of Ukraine during the mentioned in the permission period due to justifiable reasons. To extend the term of validity of the permission it is necessary to submit such permission to the State Service of Ukraine on Medicines and Drugs Control not later than the term of its validity expires.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization of a permission or a portion of a permission.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Permissions are not transferable 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?
A permission in case of its loss cannot be restored. The State Service of Ukraine on Medicines and Drugs Control shall be immediately reported on the loss of the permission.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Yes, the importer should have a valid import licence (import activity licence for).