Basic information
Outline of the 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.
Product coverage
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.
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 licensing is intended to protect the consumers.
Questions for products under restriction as to the quantity or value of imports
No quantitative or value restrictions.
The system applies to products originating from which country?
The system applies to products originating in and coming from all countries.
Expected duration of licensing procedure
Legal requirements
Is the licensing statutorily required?
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.
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?
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?
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.
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?
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).
Window of submission of an application
How far in advance of importation must application for a licence be made?
It is up to the applicant to decide when to apply for a licence, knowing that the document will be issued within ten days.
Are there any limitations as to the period of the year during which application for licence can 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.
Issuing the license
Can a licence be granted immediately on request?
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Which administrative body is responsible for approving application of licences?
An importer has to approach only one administrative organ in connection with an application, namely State Medicines Control Agency under the Ministry of Health.
Must the applications be passed on to other organs for visa, note or approval?
An importer has to approach only one administrative organ in connection with an application, namely State Medicines Control Agency under the Ministry of Health.
Are there any other conditions attached to the issue of a licence?
There are no conditions attached to the issuance of a licence.
Fees and other administrative charges
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).
Is there any deposit or advance payment required associated with the issue of licences?
There is no deposit or advance payment requirement associated with the issuance of licences.
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?
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.
Are the reasons for any refusal given to applicants?
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.
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?
There are no limitations as the period of the year during which application for licence and/or importation may be made.
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.
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.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
A licence is valid for two months from the date of issue and validity can be extended.
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.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licences are not transferable between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
Foreign exchange is automatically provided by the banking authorities for products to be imported.