REPUBLIC OF LITHUANIA Official Translation REPUBLIC OF LITHUANIA LAW ON THE CONTROL OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES 8 January 1998, No VIII-602 (As last amended on 16 November 2006 - X-9

Article 1before 1 March 2007: Article 1.

Scope of the Law This Law shall establish the principles of the classification of narcotic drugs and psychotropic substances, legitimate circulation of these drugs and substances when they are used for health care, veterinary and scientific purposes and the control of their circulation in accordance with the requirements of international treaties.

Article 1after 1 March 2007: Article 1.

Scope of the Law

1. This Law shall establish the principles of the classification of narcotic drugs and psychotropic substances, legitimate circulation of these drugs and substances when they are used for health care, veterinary and scientific purposes and the control of their circulation in accordance with the requirements of international treaties.
2. The provisions of this Law have been harmonised with the legal acts of the European Union referred to in the Annex to this Law. Article
3. Definitions
4. Narcotic drugs and psychotropic substances shall mean biological and synthetic substances included in the schedules of controlled substances approved by the Ministry of Health, the harmful effects or abuse whereof give rise to serious deterioration of human health resulting in mental and physical dependence on them, or pose threat to human health.

paragraph 2 before 1 March 2007: 2. Preparation shall mean a medicinal product of any physical form, which has been accorded a certain drug form and containing, one or several narcotic drugs or psychotropic drug substances in therapeutic doses.

paragraph 2 after 1 March 2007:

1. Preparation shall mean a measured or not measured solution or mixture of any physical form containing narcotic drugs or psychotropic substances or one or several narcotic drugs or psychotropic substances in therapeutic doses.
2. Legitimate circulation shall mean the production, processing, acquisition, wholesale or retail trade, keeping, internal transportation, import or export of narcotic drugs or psychotropic substances seeking to use them for health care, veterinary, law enforcement, scientific and educational purposes without violating any requirements stipulated in laws and other legal acts.
3. License (authorisation) shall mean a document issued in accordance with the procedure established by the Government of the Republic of Lithuania and granting the right to acquire, keep, transport within the state, produce, process, import and export narcotic drugs and psychotropic substances, and also use them in wholesale or retail trade.
4. Import shall mean bringing of narcotic drugs and psychotropic substances into the customs territory of the Republic of Lithuania.
5. Export shall mean bringing of narcotic drugs and psychotropic substances out of the customs territory of the Republic of Lithuania.
6. Transit shall mean carriage of narcotic drugs and psychotropic substances through the customs territory of the Republic of Lithuania under customs supervision. Article
7. The Names of Narcotic Drugs and Psychotropic Substances Narcotic drugs and psychotropic substances shall be included in the schedules of controlled substances, approved by the Ministry of Health, under their international names, and in the absence thereof, under their chemical names. Another common use name, which is more familiar to users, may also be indicated. Article
8. The Principles of Classification of Narcotic Drugs and Psychotropic Substances
9. Narcotic drugs and psychotropic substances shall be classified according to their harmful effect upon human health, when they are being abused, and according to whether they can be used for health care purposes. Pursuant to international treaties of the Republic of Lithuania, the Ministry of Health shall classify and include narcotic drugs and psychotropic substances in the schedules according to the control regime applied to them.
10. Three schedules of narcotic drugs and psychotropic substances shall be compiled: 1) the first schedule shall be comprised of plants, narcotic drugs and psychotropic substances the use whereof is prohibited in health care due to harmful effects to human health when they are being abused (hereinafter – Schedule I); 2) the second schedule shall be comprised of plants, narcotic drugs and psychotropic substances used for health care purposes, which are very dangerous to human health due to harmful effects when these substances are being abused (hereinafter – Schedule II); 3) the third schedule shall be comprised of plants and psychotropic substances used for health care purposes, which are dangerous to human health due to harmful effects when these substances are being abused (hereinafter – Schedule III). Article
11. The Classification of Preparations Preparations shall be classified according to narcotic drugs and psychotropic substances contained in them. The control regime of substances contained in them shall be applied in respect of preparations. If different control regimes are applied to substances contained in the preparation, the control regime, which corresponds to the strictest control regime applied in respect of a substance within its composition, shall be applied in respect of the preparation. Article
12. Advertising of Narcotic Drugs and Psychotropic Substances
13. Advertisement of narcotic drugs and psychotropic substances shall be prohibited.
14. Information regarding medicines that are narcotic drugs and psychotropic substances shall be provided to health care, pharmaceutical and veterinary specialists and consumers in accordance with the procedure established by the Ministry of Health. CHAPTER TWO THE REQUIREMENTS OF ACTIVITY INVOLVING THE SUBSTANCES INCLUDED IN SCHEDULE I Article
15. Prohibited Plants It shall be prohibited to grow opium poppies, cannabis plants and coca bushes in the territory of the Republic of Lithuania. Article
16. Legitimate Circulation of the Substances Included in Schedule I
17. It shall be prohibited to use for health care purposes the substances included in Schedule I.
18. It shall be prohibited to acquire, keep, transport within the territory of the state, produce, process, import, export or use for scientific research the substances included in Schedule I without a license (authorisation) issued in accordance with the procedure established by the Government of the Republic of Lithuania.
19. The Ministry of Health shall issue licenses according to the procedure established by the Government for acquisition, keeping, transportation within the territory of the state, producing, processing, importing, exporting and using for scientific research or required for law enforcement institutions the minimum amounts of the substances included in Schedule I.
20. The Ministry of Health shall establish the procedure for legitimate circulation of the substances included in Schedule I for scientific purposes. As of 1 March 2007, Article 8 shall be supplemented with paragraph 5:
21. The authorised institutions shall have a right to exchange of samples of the substances included in Schedule I between the competent institutions of the Member States of the European Union in accordance with the procedure established by the Government or an institution authorised by it where it is required seeking to detect and investigate criminal acts, pursue criminal prosecution and perform examination and analysis of objects. As of 1 March 2007, the Law shall be supplemented with Article 8

paragraph 1 before 1 March 2007: 1. The substances included in Schedules II and III may only be produced, imported into the Republic of Lithuania, exported from the Republic of Lithuania, engaged in wholesale or retail trade thereof in the Republic of Lithuania only by legal persons prepared for that activity and individual enterprises having a licence for such activity, and only in the objects and premises for the use of which a special authorisation has been issued.

paragraph 1 after 1 March 2007:

1. The substances included in Schedules II and III may only be produced, imported into the Republic of Lithuania, exported from the Republic of Lithuania and engaged in wholesale or retail trade thereof in the Republic of Lithuania in accordance with the procedure established by the Government of the Republic of Lithuania only by legal persons and branches of foreign legal persons prepared for that activity and having a licence for such activity, and only in the objects and premises for the use of which a special authorisation has been issued.
2. Issuance of licenses for producing, importing into the Republic of Lithuania and exporting from the Republic of Lithuania of the substances included in Schedules II and III and engaging in wholesale and retail trade thereof, suspension and revocation of licences and the procedure and conditions of re-registration, and the procedure of issuing authorisations for the use of objects or premises shall be established by the licensing rules. The Government of the Republic of Lithuania shall approve and establish the conditions of the licensed activity.

paragraph 3 before 1 March 2007: 3. Legal persons and individual enterprises may acquire and keep the narcotic drugs and psychotropic substances included in Schedules II and III, if they possess a licence for engaging in pharmaceutical activity and a license for this activity issued in accordance with the procedure established by the Government of the Republic of Lithuania.

paragraph 3 after 1 March 2007:

1. Licences for producing, importing into the Republic of Lithuania and exporting from the Republic of Lithuania of the substances included in Schedules II and III and engaging in wholesale and retail trade thereof, shall be issued only to legal persons and branches of foreign legal persons having a licence for pharmaceutical activity issued pursuant to the Law on Pharmacy and in accordance with the procedure established by the Government of the Republic of Lithuania. Only legal persons and branches of foreign legal persons having a licence to produce the substances included in the Schedules I and II may import from the third countries the medicines containing the substances included in Schedules II and III.
2. The Ministry of Health or an institution authorised by it, shall issue the licenses for producing, importing into the Republic of Lithuania and exporting from the Republic of Lithuania the substances included in Schedules II and III and engaging in wholesale and retail trade thereof, suspend and revoke these licenses, and control the licensed activity.

paragraph 5 before 1 March 2007: 5. A legal person or an individual enterprise may appeal to the Ministry of Health against the decision regarding a refusal to issue a license, its suspension or revocation within 30 calendar days. The Ministry shall consider the appeal within 30 days. In case a legal person or an individual enterprise is dissatisfied with the decision of the Ministry of Health, or if the Ministry of Health has failed to consider the appeal within the set period of time, it shall have the right to appeal to court.

paragraph 5 after 1 March 2007: 5. A legal person or a branch of a foreign legal person may appeal to the Ministry of Health against the decision regarding a refusal to issue a license, its suspension or revocation within 30 calendar days. The Ministry shall consider the appeal within 30 days. In case a legal person or a branch of a foreign legal person is dissatisfied with the decision of the Ministry of Health, or if the Ministry of Health has failed to consider the appeal within the set period of time, it shall have the right to appeal to court.

paragraph 6 before 1 March 2007: 6. Having revoked a license, the residue of the substances included in Schedules II and III, held by a legal person or an individual enterprise, shall be sold, in accordance with the procedure established by the Ministry of Health, to persons holding a license to engage in activity related to narcotic drugs and psychotropic substances.

paragraph 6 after 1 March 2007:

1. Having revoked a license, the residue of the substances included in Schedules II and III, held by a legal person or a branch of a foreign legal person, shall be sold, in accordance with the procedure established by the Ministry of Health, to persons holding a license to engage in activity related to narcotic drugs and psychotropic substances. Article
2. Production of the Substances Included in Schedules II and III Licenses for the production of the substances included in Schedules I and II shall be issued only upon presentation of all the documents regarding the technological processes of production and extraction, the projected amounts of production of intermediate substances and the composition thereof. The producer must ensure that the production amounts indicated in the licence will not be exceeded. Article
3. Trade in the Substances Included in Schedules II and III
4. Trade in the substances included in Schedules II and III shall be allowed provided they are properly packed and marked.
5. The Ministry of Health shall determine the specific requirements of the packaging and marking of the substances included in Schedules II and III.
6. It shall be prohibited to trade in the substances included in Schedules II and III, packed in packaging that does not have the written names of substances, or if the markings appearing on the packaging are inaccurate.
7. The names of substances, their amount, the manner of use and warning concerning the required safety measures, must be indicated on the label of the substances included in Schedules II and III.
8. It shall be prohibited to sell the substances included in Schedules II and III, if, due to improper marking or improper label (illegible inscription, damaged label etc.), the absence of the accompanying documents or in case these are incomplete, it is possible to misunderstand the threat posed to health or their purpose (the manner of use).
9. Persons engaged in wholesale trade in the substances included in Schedules II and III must register all the sales records in a special journal of a form approved by the Ministry of Health.

paragraph 7 before 1 March 2007: 7. Persons engaged in wholesale trade in the substances included in Schedules II and III must register, in accordance with the procedure established by the Ministry of Health, those who acquire these substances (full name of a natural person, the name, code and address of a legal person or an individual enterprise), while the persons acquiring these, must submit the set registration data.

paragraph 7 after 1 March 2007:

1. Persons engaged in wholesale trade in the substances included in Schedules II and III must register, in accordance with the procedure established by the Ministry of Health, those who acquire these substances (full name of a natural person, the name, code and address of a legal person or a branch of a foreign legal person), while the persons acquiring these, must submit the set registration data.
2. The persons engaged in wholesale trade in the substances included in Schedules II and III must keep the documents under which they have sold these substances in accordance with the procedure and terms stipulated by the Ministry of Health.
3. Persons engaged in wholesale trade in the substances included in Schedules II and III shall submit the data of registration of the sales records to an institution authorised by the Ministry of Health. The Ministry of Health or an institution authorised by it and law enforcement institutions shall have the right at any time to request that persons engaged in wholesale trade in the substances included in Schedules II and III submit the data regarding the sale of these substances.
4. It shall be prohibited to sell the substances included in Schedules II and III to persons not having a license for the activity related to narcotic drugs and psychotropic substances. Article
5. The Register
6. An institution authorised by the Ministry of Health shall administer the register of licenses which have been issued for the production, import into the Republic of Lithuania, export from the Republic of Lithuania, engaging in wholesale and retail trade in the substances included in Schedules II and III and record the data on suspension and revocation of licences.
7. An institution authorised by the Ministry of Health shall annually establish the need for the substances included in Schedules II and III in the Republic of Lithuania, keep the accounts of the production, import, export, and wholesale and retail trade, and submit, in accordance with the established procedure, the data about the need and legitimate circulation of narcotic drugs and psychotropic substances to the International Narcotics Control Board of the United Nations.

the title of Article 14 before 1 March 2007: Article 14. Conditions of Import, Export, and Transit of the Substances Included in Schedules II and III

the title of Article 14 after 1 March 2007: Article

1. Legitimate Circulation of the Substances Included in Schedules II and III
2. The Government of the Republic of Lithuania shall establish the conditions of and the procedure for implementing import into the Republic of Lithuania, export from the Republic of Lithuania and transit through the territory of Lithuania of the substances included in Schedules II and III on the basis of international treaties of the Republic of Lithuania.
3. It shall be prohibited to store the substances included in Schedules II and III in customs warehouses as well as temporarily keep them in import or export terminals. The customs procedures applied to temporary import, temporary import for processing, and processing under customs supervision may not be applied in respect of these substances.
4. Special authorisation of the Ministry of Health or an institution authorised by it shall be required in every individual case of import or export of the substances included in Schedules II and III.
5. Where the requirements of this Law or other legal acts are violated in the course of importing, exporting or while in transit the substances included in Schedules II and III, the customs shall apply all the statutory measures including the seizure and confiscation of these substances. As of 1 March 2007, Article 14 shall be supplemented with paragraph 5:
6. The authorised institutions shall have the right to exchange of samples of the substances included in the Schedules II and III between the competent institutions of the Member States of the European Union in accordance with the procedure established by the Government or an institution authorised by it where it is required seeking to detect and investigate criminal acts, pursue criminal prosecution and perform examination and analysis of objects. Article
7. Transportation within the Territory of the Republic of Lithuania of the Substances Included in Schedules II and III Persons transporting the substances included in Schedules II and III within the territory of the Republic of Lithuania must have the accompanying freight documents and ensure the safety of these substances. Where a suspicion regarding a possible unlawful use of the substances included in Schedules II and III arises, the person transporting the freight must immediately notify the law enforcement institutions thereof.

Article 16before 1 March 2007: Article 16.

Sending of the Substances Included in Schedules II and III It shall be prohibited to send by post the substances included in Lists II and III.

Article 16after 1 March 2007: Article 16.

Sending of the Substances Included in Schedules II and III It shall be prohibited to send by post the substances included in the Schedules II and III, except for samples of these substances send by diplomatic or registered (express) post to the competent institutions of the Member States of the European Union or received from them in accordance with the procedure established by the Government or an institution authorised by it seeking to detect and investigate criminal acts, pursue criminal prosecution and perform examination and analysis of objects. SECTION FOUR ACQUISITION AND KEEPING OF SUBSTANCES INCLUDED IN SCHEDULES II AND III Article

1. Procedure of Ordering, Acquisition and Distribution of Substances Included in Schedules II and III in Pharmacies and Health Care Institutions
2. The substances included in Schedules II and III may be ordered for health care and veterinary purposes only. The Ministry of Health shall establish the procedure of ordering (prescribing) such medicines.
3. A person who has submitted a valid prescription for health care or veterinary purposes shall have the right to acquire at pharmacies the prepared substances included in Schedules II and III.
4. The Ministry of Health together with the State Food and Veterinary Service shall establish the procedure of acquisition and distribution at pharmacies of the substances included in Schedules II and III for health care or veterinary purposes.
5. The Ministry of Health shall establish the procedure of acquisition, prescription, issuance and keeping of accounts of the substances included in Schedules II and III at health care institutions.
6. The substances included in Schedules II and III shall be distributed for medicinal and veterinary purposes by those who have the right to this activity: 1) pharmaceutical specialists employed in retail trade enterprises (pharmacies); 2) pharmaceutical specialists employed in wholesale trade and production enterprises; 3) specialists employed in health care institutions; 4) veterinary and pharmaceutical specialists employed in veterinary service institutions.
7. The Ministry of Health together with the State Food and Veterinary Service shall set the requirements for health care and veterinary specialists who have the right to acquire and distribute the substances included in Schedules II and III to perform their professional duties. Article
8. Prescription of the Substances Included in Schedules II and III
9. The substances included in Schedule II shall be prescribed on special prescription blanks. The Ministry of Health shall establish the form of special prescription blanks, as well as the procedure of their filling in, keeping of accounts and storing.
10. The substances included in Schedule III shall be prescribed in accordance with the procedure established by the Ministry of Health.
11. It shall be prohibited to sell the substances included in Schedules II and III under an improperly completed prescription. Article
12. Medical First Aid Kits on the Means of Transport Going on International Routes The substances included in Schedules II and III which are in medical kits on the means of transport going on international routes required for rendering the necessary medical first aid shall be stored according to the procedure established by the Ministry of Health.

Article 20before 1 March 2007: Article 20.

The Rights of Passengers Passengers travelling across the Lithuanian state border may carry with them a supply of the substances included in Schedule II for personal consumption for health care purpose accompanied by copies of the prescriptions of medicines prescribed for them to cover a course of treatment of 7 days at the most, and of the substances included in Schedule III - to cover a course of treatment of 30 days at the most.

Article 20after 1 March 2007: Article 20.

The Rights of Travellers

1. Persons travelling to the Schengen state or incoming from it, may carry with them a supply of the substances included in Schedules II and III for personal consumption for health care purpose for a period of 30 days at the most, if they have a certificate of a set form issued by a competent institution of the state in which they reside.
2. Persons travelling to any other state than that referred to in paragraph 1 of this Article or incoming from it, may carry with them a supply of the substances included in Schedule II for personal consumption for health care purpose for a period of 15 days at the most, and of the substances included in Schedule III – for a period of 30 days at the most, if they have copies of the prescriptions to buy these medicines. Article
3. Storage of the Substances Included in Schedules II and III
4. The Ministries of the Internal Affairs and Health shall establish the requirements for the premises where the substances included in Schedules II and III are produced, stored and engaged in their wholesale and retail trade.
5. The Ministry of Health shall establish the reserve quantities of the substances included in Schedules II and III, the procedure for keeping them in the enterprises (pharmacies) engaged in retail trade in medicines, the enterprises engaged in wholesale trade in medicines, the enterprises engaged in the production of medicines, the institutions of health care and veterinary service, laboratories of medicine control and scientific institutions.
6. A person who has been prescribed by the doctor any of the substances included in Schedules II and III for health care purpose may keep the amount of these substances not exceeding the amount than was possible to acquire at the pharmacy under the prescription.
7. Persons keeping any of the substances included in Schedules II and III must protect them from any influence, which may alter their characteristics. The safety of these substances must be ensured and their packaging may not be damaged. CHAPTER FIVE KEEPING OF ACCOUNTS AND CONTROL OF THE CIRCULATION OF NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES Article
8. Entities Keeping the Accounts of Narcotic Drugs and Psychotropic Substances and Controlling it An institution authorised by the Ministry of Health and other institutions authorised by the Government shall keep the accounts of the circulation of narcotic drugs and psychotropic substances and implement its control. Article
9. Keeping of Accounts of the Circulation of Narcotic Drugs and Psychotropic Substances
10. Pursuant to international treaties of the Republic of Lithuania, the Ministry of Health shall establish the procedure of keeping the accounts of the circulation of narcotic drugs and psychotropic substances.

paragraph 2 before 1 March 2007: 2. The procedure for inventory of narcotic drugs and psychotropic substances and accounting of material values and the procedure for drawing up the balance sheet of retail and wholesale trade enterprises and production enterprises shall be established by the Ministry of Health pursuant to the provisions of the Law on the Principles of Accounting.

paragraph 2 after 1 March 2007:

1. The procedure for inventory of narcotic drugs and psychotropic substances and accounting of material values and the procedure for drawing up the balance sheet of retail and wholesale trade enterprises and production enterprises shall be established by the Ministry of Health pursuant to the provisions of the Law on Accounting. Article
2. Reports on the Circulation of Narcotic Drugs and Psychotropic Substances An institution authorised by the Ministry of Health shall keep the accounts of the circulation of narcotic drugs and psychotropic substances in the Republic of Lithuania and submit the reports to the International Narcotics Control Board. CHAPTER SIX FINAL PROVISIONS Article
3. Liability A person in breach of the requirements of this Law shall be held liable according to the procedure established by laws of the Republic of Lithuania. Article
4. Proposal to the Government The Ministry of Health shall, within three months of the coming into force of the Law on the Control of Narcotic Drugs and Psychotropic Substances, prepare legislation in relation to this Law. I promulgate this Law passed by the Seimas of the Republic of Lithuania. PRESIDENT OF THE REPUBLIC ALGIRDAS BRAZAUSKAS As of 1 March 2007, the Law shall be supplemented with Annex: Annex to the Law On the Control of Narcotic Drugs and Psychotropic Substances LEGAL ACTS OF THE EUROPEAN UNION IMPLEMENTED BY THIS LAW
5. Decision of the Executive Committee of 22 December 1994 on the certificate provided for in Article 75 to carry narcotic drugs and psychotropic substances (SCH/Com-ex