Narcotic drugs and psychotropic substances
- Document symbol
- G/LIC/N/3/LTU/1
- Original language
- English
- Published on
- 03/04/2003
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 licensing of imports of narcotic drugs and psychotropic substances is regulated by the Law on the Control of Narcotic and Psychotropic Substances of 8 January 1998, the Government Resolution No. 1630 “On the Approval of the Regulations of Issuing Licences to Produce, Import into the Republic of Lithuania and Export from the Republic of Lithuania Narcotic and Psychotropic Substances, to Engage in their Wholesale and Retail Trade in the Republic of Lithuania” of 28 December 1995, the Government Resolution No. 509 “Regarding the Implementation of the Republic of Lithuania on the Control of Precursors of Narcotic Drugs and Psychotropic Substances” of 8 May 2000, and is administered by the State Medicines Control Agency under the Ministry of Health.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Imports of narcotic drugs and psychotropic substances are subject to non-automatic licensing.
In accordance with the Government Resolution No. 509 “Regarding the Implementation of the Republic of Lithuania on the Control of Precursors of Narcotic Drugs and Psychotropic Substances” of 8 May 2000 import licencing covers: Please see Product Coverage.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to products originating in and coming 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 licensing is intended to protect the consumers.
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 licencing of narcotic drugs and psychotropic substances is based on Law on the Control of Narcotic and Psychotropic Substances of 8 January 1998 and published in Official Gazette “Valstybes zinios” No. 8-161, 1998, Government Resolution No. 1630 “On the Approval of the Regulations of Issuing Licences to Produce, Import into the Republic of Lithuania and Export from the Republic of Lithuania Narcotic and Psychotropic Substances, to Engage in their Wholesale and Retail Trade in the Republic of Lithuania” of 28 December 1995 and published in Official Gazette “Valstybes zinios” No. 1-26, 1996 and Government Resolution No. 509 “Regarding the Implementation of the Republic of Lithuania on the Control of Precursors of Narcotic Drugs and Psychotropic Substances” of 8 May 2000, published in Official Gazette “Valstybes zinios” No. 38-1068, 2000.
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)?
It is up to the applicant to decide when to apply for a licence, knowing that the document will be issued within ten days.
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.
There are no limitations as the period of the year during which application for licence and/or importation may be made.
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?
An importer has to approach only one administrative organ in connection with an application, namely State Medicines Control Agency under the Ministry of Health.
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?
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
Licence shall not be issued if:
• not all necessary documents are presented;
• the presented documents do not conform to the requirements and are officially incorrectly registered;
• the presented data are misleading;
• the holder of the previously issued licence had violated the conditions of the activities under licencing and did not eliminate the causes that predetermined the violation.
Have applicants a right of appeal in the event of refusal to issue a licence?
The applicant has a right of appeal pursuant to the procedure provided by the law.
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?
Only those companies which have a permit granted by the Ministry of Health to engage in pharmaceutical activities, are eligible to apply for licensing of importation of narcotic drugs and psychotropic substances.
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?
What information is required in applications?
An application form to obtain a licence contains the code of enterprises, its name and address, the list, quantities and HS codes of the products to be imported.
What documents is the importer required to supply with the application?
An application and the following supplementary documents shall be presented to the State Medicines Control Agency:
• a copy of the enterprise registration certificate (enterprises under incorporation submit appropriate incorporation documents or their drafts according to the types of enterprises or other legal acts: the incorporation agreement, the act of foundation, joint activities agreement, the draft of articles of association);
• a copy of the permit granted by the Ministry of Health to the enterprise to engage in pharmaceutical activities;
• a copy of the licence issued by the Ministry of Health to the executive pharmaceutical chemist to engage in pharmaceutical activities;
• a copy of the decree of the enterprise authority concerning the appointment of the executive pharmaceutical chemist;
• description of the premises and facilities assigned for the licenced activities (indicating their address, plan, equipment, safety measures);
• certificate granted by the Ministry of Interior concerning the suitability of the equipment of the premises assigned for the storage of narcotic drugs and medicinal substances as well as the safety measures;
• certificate on the suitability of the equipment of the premises assigned for the storage of psychotropic drugs and medicinal substances as well as the safety measures, granted by the control institutions of the State Medicines Control Agency;
• nomenclature of narcotic or psychotropic drugs and medicinal substances and the data on their projected annual turnover (if engaged in wholesale trade), the nature of the import and export operations, the countries that will be traded with (if export or import is performed).
Q11. What documents are required upon actual importation?
Upon actual importation, an importer is required to submit the approved import licence along with the general document while conducting customs procedure.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
Is there any licensing fee or administrative charge?
The state fee shall be collected for licence issuance in accordance with the Government Resolution No. 1458 “On Approval of the List of Entities Subject to Imposition of the State Fee, the Fee Rate and the Procedure for its Payment and Repayment” (Official Gazette “Valstybes zinios” No. 108-3463, 2000).
What is the amount of the fee or charge?
The fee rate for the wholesale is 300 LTL (87 EUR) and for retail trade 100 LTL (29 EUR).
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 deposit or advance payment requirement associated with the issuance of licences.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
A licence is valid for two months from the date of issue and validity can be extended.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilization of a licence or a portion of it.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences 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?
There are no conditions attached to the issuance of a licence.
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, apart from import licensing required prior to importation for narcotic drugs and psychotropic substances.
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?
Foreign exchange is automatically provided by the banking authorities for products to be imported.