2. (amended, SG No. 55/2007) the measures against abuse of and illicit traffic in narcotic substances;

Transcription

1 Narcotic Substances and Precursors Control Act Promulgated, State Gazette No. 30/ , effective , amended, SG No. 63/ , 74/ , 75/ , effective , amended and supplemented, SG No. 120/ , effective , SG No. 56/ , amended 76/ , effective , amended and supplemented, SG No. 79/ , amended, SG No. 103/ , SG No. 30/ , effective , supplemented, SG No. 75/ , effective , amended, SG No. 82/ , SG No. 31/ , effective , amended and supplemented, SG No. 55/ , effective , amended, SG No. 36/ , amended and supplemented, SG No. 43/ , amended, SG No. 69/ , supplemented, SG No. 41/ , effective , amended, SG No. 74/ , effective , SG No. 82/ , effective , SG No. 93/ , effective , amended and supplemented, SG No. 22/ , corrected, SG No. 23/ , amended, SG No. 29/ , effective , SG No. 59/ , effective , SG No. 98/ , effective , SG No. 8/ , effective , amended and supplemented, SG No. 12/ , effective , amended, SG No. 60/ , effective , amended and supplemented, SG No. 61/ , effective Text in Bulgarian: Закон за контрол върху наркотичните вещества и прекурсорите CHAPTER I COMMON PROVISIONS Article 1. This Act lays down provisions establishing: 1. (amended, SG No. 79/2005, SG No. 55/2007) the organisation, powers and assignments of the government authorities exercising control on the production, processing, trading, use, storage, import, export, transit, transfer, transport and reporting of narcotic substances, as well as on the launch on the market, import and export of precursors; 2. (amended, SG No. 55/2007) the measures against abuse of and illicit traffic in narcotic substances; 3. (new, SG No. 55/2007) the measures for the implementation of Regulation (EC) No. 272/2004 of the European Parliament and of the Council on drug precursors, Council Regulation (EC) No. 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors, and Commission Regulation (EC) No. 1277/2005 laying down implementing rules for Regulation (EC) No. 273/2004 and Regulation (EC) No. 111/2005, hereinafter referred to as "Regulation 273/2004", "Regulation 111/2005", and Regulation 1277/2005". 4. (renumbered from item 3, SG No. 55/2007) the scientific research and expert work related to narcotic substances and precursors. Article 2. (Supplemented, SG No. 55/207) The purpose of this Act is to regulate social relations with regard to the control of narcotic substances and precursors in accordance with the requirements of the international treaties to which the Republic of Bulgaria is a Party and the Regulations of the European Union. Article 3. (1) This Act shall apply to: 1. all plants and substances classified as narcotic drugs or psychotropic substances, and preparations thereof; 2. all the substances used to produce narcotic drugs or psychotropic substances classified as precursors. (2) (Amended, SG No. 55/2007, SG No. 61/2011, effective ) The Regulation adopted by the Council of Ministers has set forth the procedures for classifying plants and substances as narcotic plants and substances, and the names of narcotic substances are listed in the Schedules as follows: 1. Schedule I - Plants and substances presenting high risk to public health due to the harmful effect of abuse thereof, which are prohibited for use in human and veterinary medicine;

2 2. Schedule II - Substances presenting high risk, which are in use in human and veterinary medicine; 3. Schedule III -Risk substances. (3) (New, SG No. 61/2011, effective ) The Regulation under paragraph 2 above sets forth the terms and procedures for including and removing of plants and substances as narcotic, as well as for changing their position in the respective Schedules under paragraph 2 above. (4) (New, SG No. 56/2003, amended SG No. 55/2007, renumbered from Paragraph 3, SG No. 61/2011, effective ) The precursors subject to control on market release are listed in the Schedule I of Regulation 273/2004. (5) (New, SG No. 55/2007, renumbered from Paragraph 4, SG No. 61/2011, effective ) Precursors subject to control on import and export are listed in the Schedule to Regulation 111/2005. Article 4. (1) (Amended, SG No. 55/2007, supplemented, SG No. 61/2011, effective ) Plants and narcotic substances shall be included in the Schedules under Paragraph 2 of Article 3 above under their common international non-proprietary name or, failing this, under their code. (2) Preparations and analogues shall be subject to the same control measures as the narcotic substances. (3) Preparations containing two or more narcotic substances, subject to different control measures, shall be subject to the control measures applicable to the most strictly controlled drug. Article 5. (Amended, SG No. 55/2007, SG No. 22/2010, SG No. 61/2011, effective ) Medicinal products containing narcotic substances listed in Schedules under items 2 and 3, para 2 of Article 3 above may be exempted from certain measures of control under the terms and conditions established by regulation of the Minister of Health, provided that: 1. (amended, SG No. 22/2010) Medicinal products are compounded in such a way as to present no or a negligible risk of abuse; 2. the narcotic substance cannot be recovered from the preparation in a quantity that might give rise to abuse. Article 6. (Amended, SG No. 61/2011, effective ) The narcotic substances listed in Schedules under items 2 and 3 of para 2 under Art. 3 above and their preparations and analogues shall be subject to the provisions related to human and veterinary medicine to the extent that such provisions are not contrary to those laid down in this Act. Article 7. (Amended, SG No. 56/2003) (1) (Amended, SG No. 56/2003, previous Article 7, amended, SG No. 79/2005, SG No. 55/2007) The production, processing, transfer and transport, trading, import, export, transit and storage of narcotic substances shall be prohibited to any person without licenses, issued under the terms and procedure of this Act. (2) (New, SG No. 79/2005, repealed, SG No. 55/2007). (3) (New, SG No. 79/2005, repealed, SG No. 55/2007). Article 8. Illegally produced, processed, kept in stock, acquired, used, imported, retained, transferred and transported, imported, intended for export, re- export or transit narcotic substances and precursors, as well as cultivated plants containing narcotic substances shall be seized in favour of the State under the conditions set out in this Act. Article 9. (Amended, SG No. 56/2003) (1) (Amended and supplemented, SG No. 79/2005) Under this Act, fees shall be charged for issuance, modification or renewal of licences, as well as for issuance of permits, authorizations and certificates of registration and change of the certificates of registration, which shall cover the costs for preparation thereof. (2) (Supplemented, SG No. 79/2005) Revenue from fees shall be disbursed for financing the activities under Paragraph 1 and controlling compliance with the licenses, permits, authorizations and certificates of registration issued. Revenue from fees, the administrator of which is the Minister of Economy, Energy and Tourism, shall be allocated also for storage and destruction

3 of precursors, confiscated in favour of the state and transferred for disposal to the Interdepartmental Precursor Control Commission. (3) (Supplemented, SG No. 22/2010) The amounts of the fees and the manner of payment thereof shall be specified in a tariff, adopted by the Council of Ministers at the proposal of the Minister of Health, the Minister of Agriculture and Food and the Minister of Economy, Energy and Tourism. Article 9a. (New, SG No. 56/2003) The Minister of Health shall be the administrator of: 1. (supplemented, SG No. 22/2010, amended, SG No. 61/2011, effective ) revenue from fees charged for issuance, modification or renewal of licences and authorisations, as well as for issuance of permits for activities involving narcotic substances listed in Schedules under items 2 and 3 of para 2 under Art. 3 of this Act; 2. revenue from fines and property sanctions, imposed under the procedure of this Act, by the control bodies with the Minister of Health. Article 9b. (New, SG No. 56/2003) The Minister of Economy, Energy and Tourism shall be the administrator of: 1. (amended and supplemented, SG No. 79/2005) revenue from fees charged for issuance, modification or renewal of licences, as well as for issuance of permits, authorizations and certificates of registration of activities, involving precursors and for change of certificates of registration; 2. revenue from fines and property sanctions, imposed under the procedure of this Act, by the control bodies with the Minister of Economy, Energy and Tourism. Article 9c. (New, SG No. 22/2010) The Minister of Agriculture and Food shall be the administrator of: 1. proceeds from fees collected to issue authorisations and licences for activities under Article 29 and Article 35(1); 2. proceeds from penalties and pecuniary sanctions imposed under the procedure of this Act by control authorities under the Minster of Agriculture and Food. CHAPTER II NATIONAL NARCOTIC SUBSTANCES COUNCIL Article 10. (1) A National Narcotic Substances Council shall be created with the Council of Ministers as a body entitled to enforce the national policy of combating the abuse of narcotic substances as well as against narcotic substances trafficking. (2) The National Narcotic Substances Council shall carry out its activity according to Rules of Procedure to be adopted by the Council of Ministers. (3) (Amended, SG No. 22/2010) The National Narcotic Substances Council shall be a collective body consisting of a President, three Vice-presidents, a Secretary and members. (4) (Amended, SG No. 74/2002, supplemented SG No. 56/2003, amended and supplemented, SG No. 43/2008, amended, SG No. 69/2008, SG No. 93/2009, effective , SG No. 22/2010) President of the Council shall be the Minister of Health, and its Vice-presidents shall be the Secretary General of the Ministry of Interior, a deputy Chairperson of the State Agency for National Security and a Deputy Minister of Justice. Members of the Council shall be representatives of the President of the Republic of Bulgaria, the Supreme Court of Cassation, the Supreme Administrative Court, the Supreme Cassation Prosecutor's Office, the National Investigation Service and the ministries and departments concerned, specified by the Council of Ministers. (5) (Amended, SG No. 22/2010) According to the issues put on their agenda, the meetings of the Council are also attended by representatives of legal persons engaged in a non-profit making activity, medical treatment facilities registered under the Medical Treatment Facilities Act, as well as other organisations.

4 Article 11. The National Narcotic Substances Council shall: 1. (amended, SG No. 56/2003, SG No. 22/2010) define and co-ordinate the national policy in the field of narcotic substances and precursors by drafting and presenting to the Council of Ministers, for the purpose of adoption of a national strategy to combat the narcotic substances abuse and illicit traffic in narcotic substances and precursors for a five-year period; 2. (amended, SG No. 22/2010) present to the Council of Ministers, for the purpose of adoption, national programmes to fight against narcotic substances abuse and illicit traffic in narcotic substances and precursors; 3. submit to the Minister for Finance a draft-budget for the enforcement of national policy in the said area; 4. submit to the Council of Ministers draft legislation relating to narcotic substances and precursors; 5. give its opinion on draft instruments for conclusion of or accession to international treaties; 6. give its statement on the participation of the Republic of Bulgaria in international programmes aimed at combating the distribution, abuse of and illicit traffic in narcotic substances and precursors, and shall control their enforcement; 7. (amended, SG No. 22/2010) nominate and approve the national drug coordinators and national coordinators on international programmes and projects in the field of narcotic substances. 8. (new, SG No. 56/2003, amended, No. 79/2005) collect, store, analyse and disseminate information from ministries and other agencies, from the councils for narcotic substances of the respective municipalities and non-profit legal persons, required for definition, implementation and coordination of the national policy in the area of narcotic substances and precursors. Article 12. (1) The President of the National Narcotic Substances Council shall: 1. represent the Council; 2. chair the meetings and direct the overall work of the Council; 3. submit for discussion to the Council of Ministers proposals and issues which fall within its exclusive competence; 4. sign the minutes of the Council meetings; 5. (amended, SG No. 56/2003) appoint employees of the Ministry of Health to discharge the functions of Secretary and Secretariat of the Council. (2) In the absence of the President, his functions shall be performed by a Vice-president designated by him for that purpose. Article 13. (1) The Secretary of the National Narcotic Substances Council shall: 1. organise the preparation of the Council meetings; 2. co-ordinate the implementation of the decisions taken at the meetings; 3. (amended, SG No. 22/2010) coordinate the work of the expert groups pursuant to Article 14; 4. co-ordinate the work of the councils pursuant to Article 15. (2) The Secretary of the Council shall be assisted by a Secretariat. Article 14. (1) The National Narcotic Substances Council may establish expert groups in the fulfilment of its functions. (2) (Amended, SG No. 61/2011, effective ) An expert council shall be established with the National

5 Narcotic Substances Council to prepare an opinion on each proposal for inclusion of new plants and substances, for their deletion or transfer from one Schedule to another. Article 15. (Amended and supplemented, SG No. 56/2003, amended, SG No. 79/2005, amended, SG No. 22/2010) (1) Municipal Narcotic Substances Councils and prevention information centres thereto shall be set up in municipalities which are administrative centres of regions. The organization and activities of these Councils and information centres shall be set out by the Rules on the Organisation and Activities of the National Narcotic Substances Council. (2) (New, SG No. 56/2003) The councils for narcotic substances under Paragraph 1 shall develop, ensure and coordinate the implementation of the municipal programs for combating narcotic substances abuse; (3) Prevention information centres referred to in Paragraph 1 shall carry out prevention activities and programs, and also collect, maintain and analyse the information needed to implement, coordinate and prepare programs under Paragraph 2. (4) The Narcotic Substances Councils under Paragraph (1) and the prevention information centres shall be financed from the national budget through the municipal budgets as delegated state activities. (5) The Municipal Councils of municipalities which are not administrative centres of regions may set up narcotic substances committees, to be funded by the relevant municipal budget. (6) The Municipal Councils referred to in Paragraph 1 may carry out methodological activities to support the prevention of narcotic substances abuse in municipalities referred to in Paragraph 5 where no narcotic substances committees are operating. Article 15a. (New, SG No. 79/2005, amended, SG No. 22/2010) (1) The National Narcotic Substances Council shall control the activity of Narcotic Substances Councils under Article 15 (1). (2) At the end of each year the Councils under Article 15 (1) shall report their activities to the National Narcotic Substances Council. CHAPTER III CONTROL BODIES AND THEIR INTERACTION Article 16. (1) (Amended, SG No. 56/2003, No. 79/2005, supplemented, SG No. 22/2010, amended, SG No. 61/2011, effective ) The Minister of Health shall exercise control on the production, processing, import, export, transit, trading, storage, reporting, transfer, transport, use and advertisement of the plants and narcotic substances listed in Schedules under items 1, 2, and 3 of para 2 under Art. 3 of this Act and preparations thereof, as well as control over the medical treatment of drug addicts. (2) (Amended, SG No. 56/2003) The Minister of Health shall exercise control on the performance of obligations, deriving from international treaties, to which the Republic of Bulgaria is a Party. (3) (Amended, SG No. 56/2003) The control functions pursuant to Paragraphs 1 and 2 shall be supported by a Narcotic Substances Directorate, which shall be a unit of the specialized administration of the Ministry of Health. Article 16a. (New, SG No. 22/2010) (1) The Minister of Education, Youth and Science and the Minister of Health shall exercise control with respect to the prevention of narcotic substances abuse. (2) The Minister of Health and the Minister of Labour and Social Policy shall exercise control with respect to the psychosocial rehabilitation of drug addicts. (3) When exercising the control under Paragraphs 1 and 2, the Minister of Health shall be assisted by officials of the National Drug Addicts Centre under the Ministry of Health. Article 17. (1) (Previous Article 17, amended, SG No. 56/2003, amended, SG No. 98/2010, effective ) Narcotic substance Inspectors with the regional health inspectorates shall carry out the control within the national territory

6 pursuant to Article 16. The co-ordination and methodological guidance of their activity will be entrusted to the Narcotic Substances Directorate. (2) (New, SG No. 56/2003) Inspectors under Paragraph 1 shall be individuals holding higher education degrees in medicine or pharmaceutics. (3) (New, SG No. 22/2010, amended, SG No. 56/2003, amended, SG No. 98/2010, effective ) The control within the territory of Bulgaria with respect to the medical treatment of drug addicts shall be exercised by officials of the regional health inspectorates who hold academic degrees in medicine. Article 18. (1) (Amended, SG No. 56/2003, supplemented, SG No. 55/2007) An Interdepartmental Precursor Control Commission shall be established with the Minister of Economy, Energy and Tourism, which is the national competent authority within the meaning of Art. 11 of Regulation 273/2004 and Art. 27 of Regulation 111/2005. (2) (Amended, SG No. 56/2003, amended and supplemented, SG No. 43/2008, amended, SG No. 22/2010) Chairman of the Interdepartmental Precursor Control Commission shall be the Minister of Economy, Energy and Tourism, and members shall be representatives of the Ministry of Health, the Ministry of Economy, Energy and Tourism, the Customs Agency under the Minister of Finance, the Ministry of the Interior and the Ministry of Justice. (3) (Amended, SG No. 56/2003, No. 79/2005, SG No. 55/2007) The Interdepartmental Precursor Control Commission with the Minister of Economy, Energy and Tourism shall exercise control over the launch on the market of precursors listed in categories I and II of Schedule I of Regulation 273/2004, as well as the import and export of precursors listed in the Schedule of Regulation 111/2005. (4) (Amended, SG No. 55/2007) This Commission under Paragraph 1 shall: 1. exercise control also on the compliance with the provisions of Article 12 of the United Nations' Convention of 1988 Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (adopted at the conference of 19 December 1988 and ratified by law - SG No. 60/1992 (Promulgated, SG No. 89/1993; Emended, SG No. 58/2001); 2. prepare and submit to the International Narcotics Control Board the annual report under Art. 12(12) of the Convention under Item 1. (5) (New, SG No. 55/2007) The Commission under Paragraph 1 shall collect and submit the information under Art. 13 of Regulation 273/2004 and Art. 32 of Regulation 111/2005. (6) (New, SG No. 79/2005, renumbered from Paragraph 5, amended, SG No. 55/2007) The Commission under Paragraph 1 shall fulfil the obligations under Art. 9, para 3 of Regulation 273/2004 and Art. 10, para 3 of Regulation 111/2005. (7) (New, SG No. 55/2007) The organisation and activities of the Interdepartmental Precursor Control Commission, and the procedure for submission of documents and information related to the implementation of Regulation 273/2004, Regulation 111/2005 and Regulation 1277/2005 shall be defined in an ordinance issued by the Minister of the Economy, Energy and Tourism. (8) (New, SG No. 56/2003, renumbered from Paragraph (5), SG No. 79/2005, renumbered from Paragraph (6), SG No. 55/2007). The Minister of Economy, Energy and Tourism shall appropriate each year the budgetary funds, required for the functioning of the Commission under Paragraph (1). Article 18a. (New, SG No. 55/2007) (1) The Minister of the Economy, Energy and Tourism or a Deputy Minister authorized by the Minister, at the proposal of the Interdepartmental Precursor Control Commission, shall issue or refuse to issue licences and addenda thereof, withdraw and suspend licenses within the meaning of Art. 3, para 2 of Regulation 273/2005, Art. 6 of Regulation 111/2005, Art. 8, Art. 10, paras 2 and 3 and Art. 11 of Regulation 1277/2005. (2) The Minister of the Economy, Energy and Tourism shall carry out the registration within the meaning of Art. 3, para 6 of Regulation 273/2005, Art. 7, para 1 of Regulation 111/2005. The Minister of the Economy, Energy and Tourism or a Deputy Minister authorized by the Minister shall issue registration certificates and addenda thereof for the registration and any

7 changes in the registered details within ten working days. (3) The Minister of the Economy, Energy and Tourism or an official authorized by the Minister, at the proposal of the Interdepartmental Precursor Control Commission, shall issue, refuse to issue, withdraw and suspend import and export permits within the meaning of Arts. 12, 15, 16, 20, 23 and 24 of Regulation 111/2005. (4) The registration application and the documents attached to the applications for the issuance of a license, a registration certificate or an import or export permit, as well as the content and form of the records kept by the operators within the meaning of Art. 5, para 4 of Regulation 273/2004 and the form of submission of information under Art. 8, para 2 of Regulation 273/2004 and Art. 9, para 2 of Regulation 111/2005 shall be defined in the ordinance under Art. 18, para 7. Article 18b. (New, SG No. 55/2007) (1) The Minister of the Economy, Energy and Tourism shall designate the officials from the Ministry of the Economy and Energy to support the work of the Interdepartmental Precursor Control Commission. (2) The officials under Paragraph 1 shall: 1. accept and handle the applications for the issuance of a license, a registration certificate or a precursor import or export permit; 2. inspect the licensed and registered operators and their records and premises; take samples, if needed, from the substances and mixtures located on the working premises; 3. interact with the administration of other ministries and institutions and with the operators in connection with the monitoring and control of chemical substances which could be used for illicit production of narcotic drugs; 4. exchange official information with international organisations and with administrations in other countries in connection with the prior notification in the case of precursor export, as well as in connection with international operations for monitoring of the trade in precursors; 5. interact with the bodies of the executive power and the judiciary in the destruction of seized precursors which the Interdepartmental Precursor Control Commission has decided to destroy. Article 19. (Repealed, SG No. 55/2007). Article 20. (Amended and supplemented, SG No. 43/2008) The Ministry of the Interior, through its specialised services and the State Agency for National Security, will prevent, detect and combat offences relating to illicit trafficking in narcotic substances and precursors. Article 21. (Supplemented, SG No. 22/2010) The Ministry of Finance through the customs administration shall exercise control on the import, export and transit, from and to third countries, of narcotic substances and precursors and carry out the activities for prevention and detection of their illicit trafficking. Article 22. (Supplemented, SG No. 79/2005, amended, SG No. 93/2009, effective , SG No. 22/2010) The Ministry of Agriculture and Food shall exercise control on the compliance with the provisions of Article 29 and 35. Article 23. (Repealed, SG No. 22/2010). Article 24. Natural and legal persons shall be required to provide at any time the free access of the control bodies to the records and premises where narcotic substances and precursors are being produced, processed or stored. Article 25. (Amended, SG No. 55/2007) Natural and legal persons shall be required to exercise internal control on the activities they carry out in order to prevent thefts or depredation and diversion, by whatever means, of narcotic substances for illicit purposes. Article 26. (Amended, SG No. 55/2007) Natural and legal persons shall be required to notify the control bodies of any suspicious transaction and endeavour for diversion of narcotic substances for illicit purposes.

8 Article 26a. (New, SG No. 56/2003) The Council of Ministers shall determine reference prices of narcotic substances for the purposes of criminal procedure. CHAPTER IV PROHIBITION OF THE PLANTS, SUBSTANCES AND PREPARATIONS LISTED IN THE SCHEDULE UNDER ITEM 1 OF PARAGRAPH 2 UNDER ARTICLE 3 OF THIS ACT (Title amended, SG No. 61/2011, effective ) Article 27. (1) (Supplemented, SG No. 56/2003, amended, SG No. 22/2010) The seeding and cultivation within the territory of the Republic of Bulgaria of the opium poppy, the coca bush plants, as well as plants of the genus Cannabis shall be prohibited, excluding the cases referred to in Article 29(1). (2) The owner or user of a plot of land for agricultural or other purposes shall be required to destroy any plants mentioned in Paragraph 1 found growing there. (3) (Supplemented, SG No. 56/2003, amended, SG No. 22/2010) Illegally sowed opium poppy, coca bush plants, as well as plants of the genus Cannabis shall be seized and destroyed under the terms and procedures specified in this Act. Article 28. (Amended, SG No. 56/2003) Production of opium and opium straw from opium poppies, and that of cannabis, hashish and hashish resin, shall be prohibited. Article 29. (Supplemented, SG No. 56/2003, amended, SG No. 93/2009, effective , SG No. 22/2010) (1) Cultivation, production of seeds, import and export of plants and seeds of the genus Cannabis containing less than 0.2 per cent by weight of tetrahydrocannabinol established in leaf mass, flowering and fruiting tips, as well as the import and export of seeds of opium poppy, shall be carried on only upon obtaining an authorisation issued under the terms and procedures laid down by an ordinance of the Minister for Agriculture and Food. (2) An ordinance of the Minister for Agriculture and Food shall lay down the terms and procedures governing the approval with respect to importers of hemp and hemp seeds other than for sowing, as well as the issuance of licences for import of hemp and hemp seeds other than for sowing, as referred to in the third sub-section of Article 5(2) of Council Regulation (EC) No 1673/2000 of 27 July 2000 on the common organisation of the markets in flax and hemp grown for fibre. Article 30. (Amended, SG No. 61/2011, effective ) The production, processing, trading, storage, import, export, re export, transit, transfer, transport, supply, acquisition, use and possession of the plants, narcotic substances and preparations thereof listed in Schedule under item 1 of para 2 under Art. 3 above shall be prohibited. Article 31. (Amended, SG No. 61/2011, effective ) The prohibition under Articles 27, 28 and 30 shall not apply to limited quantities provided in this Act for medical or teaching purposes, or for scientific or laboratory assays. CHAPTER V CONTROL OF NARCOTIC SUBSTANCES AND MEDICINAL PRODUCTS CONTAINING NARCOTIC SUBSTANCES LISTED IN SCHEDULES UNDER ITEMS 2 AND 3 OF PARA 2 UNDER ARTICLE 3 OF THIS ACT AS WELL AS OF NARCOTIC DRUG PRECURSORS (Title amended, SG No. 55/2007, SG No. 22/2010, SG No. 61/2011,

9 effective ) Section I Licences Article 32. (1) (Supplemented, SG No. 41/2009, effective , amended, SG No. 22/2010, SG No. 60/2011, effective , SG No. 61/2011, effective ) The production, processing, storage, trading within the national territory, import, export and transit, transfer and transport of narcotic substances listed in Schedules under items 2 and 3 of para 2 under Art. 3 of this Act shall be carried out under licence for activities, buildings and premises issued by the Minister of Health, or by a Deputy Minister authorized by the Minister, under the terms laid down by regulation of the Minister of Health. (2) (Amended, SG No. 79/2005) The licence pursuant to Paragraph 1 may be issued only if the use of the substances concerned is restricted to medical purposes. (3) (Amended, SG No. 56/2003) Licences for medical purposes may be issued only to natural or legal persons which are licensed for production or wholesale trade of medicinal products under the Medicinal Products in Human Medicine Act. (4) (Repealed, SG No. 56/2003) (5) (Amended, SG No. 61/2011, effective ) Licences are not required for limited quantities of plants and substances, used for medical and teaching purposes, or for research and laboratory assays under Chapter V, Section VII. Article 32a. (New, SG No. 56/2003, amended, SG No. 79/2005, SG No. 93/2009, effective , SG No. 22/2010) (1) Persons applying for a licence under Article 32(1) shall submit to the Ministry of Health an application form, to which the applicant shall enclose: 1. a copy of the authorisation to produce medicinal products or to wholesale medicinal products issued as per the procedure of the Medicinal Products in Human Medicine Act; 2. an extract from the judicial record in respect of the applicant, where the applicant is a sole trader, or the director/executive director, where the applicant is a legal person, as well as in respect of the Master of Pharmacy under Article 34; 3. a document issued by the relevant regional investigation department certifying that neither the applicant, where the applicant is a sole trader, or the applicant's director/executive director, where the applicant is a legal person, nor the responsible Master of Pharmacy under Article 34 is indicted for an intentional offence of general nature; 4. a copy of the court ruling on the registration; a current status certificate, tax registration; BULSTAT registration, or unified identification code in the case of persons having been registered or re-registered under the Commercial Register Act; 5. where the applicant is a trader, a document issued by the Registry Agency, or by the competent court governing the registration of the applicant, certifying that the applicant is not subject to bankruptcy proceedings; 6. where the applicant is a legal person, a document issued by the Registry Agency, or by the competent court governing the registration of the applicant, certifying that the applicant is not subject to bankruptcy proceedings; 7. a statement issued by the relevant tax authority attesting to the existence or lack of public debts to the state; 8. a copy of the document attesting to the right of ownership (title) or right to use the facility where activities pertaining to narcotic substances and medicinal products containing narcotic substances are carried out. 9. an architectural design of the buildings and premises where activities pertaining to narcotic substances are to be carried out, with the design having been approved by the chief architect of the relevant municipality; 10. a copy of the security contract concluded with the bodies of the Ministry of the Interior, or with a natural/legal person who holds a licence to carry out private security activities, as well as a copy of the said licence;

10 11. (repealed, SG No. 61/2011, effective ); 12. an instruction approved by the persons referred to in Item 2 above which regulates the procedure of carrying out activities with narcotic substances and medical products containing narcotic substances; 13. an order by the sole trader or the company's director appointing the persons who will be directly responsible for the execution of the activities involving narcotic substances; 14. a higher education diploma attesting to a pharmacy degree course completed by the Master of Pharmacy under Article 34; 15. a document certifying that the responsible Master of Pharmacy under Article 34 has been entrusted with the function to fulfil the obligations set out in the licence; 16. a document attesting that the relevant fee has been paid as per the tariff under Article 9(3). (2) In addition to the documents under Paragraph 1, manufacturers of medicinal products containing narcotic substances shall also submit: 1. a copy of the authorization to use the medicinal products containing narcotic substances which the relevant manufacturer produces; 2. a description of the technological process (narcotic production process design) and a short description of the facilities and equipment which will be used when producing and processing narcotic substances and medicinal products containing narcotic substances; 3. a copy of the resource consumption norm of the technological production regulation in respect of each medicinal product containing narcotic substances; 4. (new, SG No. 61/2011, effective ) schedule of narcotic substances intended to be used for the activities stated in the application. (3) (Amended, SG No. 98/2010, effective , SG No. 60/2011, effective ) Within 5 days of submission of application for issuance of license for wholesale trade in narcotic substances the Ministry of Health shall require ex officio the narcotic substance inspectors of the relevant regional health inspectorate, on the territory of which the buildings and premises, where wholesale trade activities are to be carried out, to carry out a check. (4) (Amended, SG No. 98/2010, effective , SG No. 60/2011, effective ) The narcotic substance inspectors shall conduct an on-the-spot check in order to ascertain whether the realities on the ground comply with the requirements of the Act and of the regulation under Article 32, Paragraph 1, and draw up a statement of findings in duplicate. (5) The statement of findings under Paragraph 4 shall be submitted, ex officio, to the Ministry of Health within 5 days from the on-the-spot check completion. (6) Experts from the Narcotic Substances Directorate under the Ministry of Health may also be involved in on-the-spot checks under Paragraph 4. (7) The experts referred to in Paragraph 6 shall conduct an on-the-spot check of the buildings and premises where production and storage activities are to be carried out in respect of narcotic substances and medicinal products containing narcotic substances in order to ascertain whether the realities on the ground comply with the legal requirements and the provisions laid down in the regulation under Article 32(1), whereupon the experts shall draw up a statement of findings in two copies. (8) Where, in the course of the checks under Paragraphs 4 and 7, shortcomings have been found in the documents submitted, or where discrepancies between the condition of the buildings/premises and the provisions laid down in the regulation under Article 32(1) have been established, the director of the Narcotic Substances Directorate shall notify the

11 applicant in writing and shall give instructions for these shortcomings/discrepancies to be rectified. (9) In cases under Paragraph 8, the period for issuing the licence shall be suspended until the shortcomings and/or discrepancies have been rectified. (10) The Minister of Health, based on a proposal by the Narcotic Substances Directorate, shall issue a licence to produce, process, store, wholesale (in Bulgaria), import, export, transit, carry and transport narcotic substances and/or medicinal products containing narcotic substances. The Minister of Health may otherwise give a reasoned refusal to issue the licence within two months from the application submission date. Article 32b. (New, SG No. 22/2010) (1) The licence under Article 32(1) shall contain: 1. the grounds and the date of issue/renewal; 2. (supplemented, SG No. 12/2011, effective ) the name, seat and registered office of the licence holder, Unified Identification Code (UIC); 3. the type of activities and the licence period; 4. the address of the buildings and the type of premises where narcotic substances and medicinal products containing narcotic substances are produced, processed, stored or traded, as well as the relevant safety requirements; 5. (repealed, SG No. 61/2011, effective ); 6. the type of reporting; 7. the full name of the Master of Pharmacy who is in charge of the relevant warehouse under Article 197(2) of the Medicinal Products in Human Medicine Act; 8. (amended, SG No. 12/2011, effective ) the full name of the responsible person under Article 34. (2) (New, SG No. 61/2011, effective ) The license under Paragraph 1 above, issued to the manufacturers of medicinal products containing narcotic substances shall include a list of the narcotic substances used for performing the activities. (3) (Renumbered from Paragraph 2, SG No. 61/2011, effective ) The Ministry of Health shall keep a special register of licences issued under Article 32(1). (4) (Supplemented, SG No. 12/2011, effective , renumbered from Paragraph 3, amended, SG No. 61/2011, effective ) Any information collected under Paragraph 1 and information contained in the identity document of the responsible person under Article 34 shall be recorded in the register referred to in Paragraph 3. Article 33. (Amended and supplemented, SG No. 56/2003, amended, SG No. 79/2005, 31/2007, 22/2010) (1) (Amended, SG No. 60/2011, effective , SG No. 61/2011, effective ) Retail trade and storage of medicinal products containing narcotic substances listed in Schedules under items 2 and 3 of para 2 under Art. 3 of this Act shall be carried out based on a licence issued by the Minister of Health, or by a Deputy Minister authorised by the Minister of Health, as per the conditions laid down in the regulation under Article 32(1). (2) The licence under Paragraph 1 shall be issued to a person who has been authorised to open a pharmacy as per the procedure of the Medicinal Products in Human Medicine Act; Article 33a. (New, SG No. 22/2010) (1) Persons applying for a retail trade licence under Article 33(1) shall submit to the Ministry of Health an application form, to which the applicant shall enclose: 1. an extract from the judicial record in respect of the applicant, where the applicant is a sole trader, or the director/executive director, where the applicant is a legal person, as well as in respect of the Master of Pharmacy under Article 34;

12 2. a document issued by the relevant regional investigation department certifying that neither the applicant, where the applicant is a sole trader, or the applicant's director/executive director, where the applicant is a legal person, nor the responsible Master of Pharmacy under Article 34 is indicted for an intentional offence of general nature; 3. a copy of the court ruling on the registration; a current status certificate; tax registration; BULSTAT registration, or unified identification code in the case of persons having been registered or re-registered under the Commercial Register Act; 4. where the applicant is a trader, a document issued by the Registry Agency, or by the competent court governing the registration of the applicant, certifying that the applicant is not subject to bankruptcy proceedings; 5. where the applicant is a legal person, a document issued by the Registry Agency, or by the competent court governing the registration of the applicant, certifying that the applicant is not subject to bankruptcy proceedings; 6. a statement issued by the relevant tax authority attesting to the existence or lack of public debts to the state; 34; 7. a higher education diploma attesting to a pharmacy degree course completed by the Master of Pharmacy under Article 8. a copy of the security contract concluded with the bodies of the Ministry of the Interior, or with a natural/legal person who holds a licence to carry out private security activities, as well as a copy of the said licence; 9. an instruction approved by the persons referred to in Paragraph 1(1) which regulates the procedure of carrying out activities with narcotic substances; 10. an order appointing the person/s who will be directly responsible for the execution of the activities involving narcotic substances; 11. a document certifying that the responsible Master of Pharmacy under Article 34 has been entrusted with the function to fulfil the obligations set out in the licence; 12. a document attesting that the relevant fee has been paid as per the tariff under Article 9(3). (2) (Amended, SG No. 98/2010, effective , SG No. 60/2011, effective ) Within 5 days of submission of application for issuance of license for retail trade in and storage of medicinal products containing narcotic substances the Ministry of Health shall require ex officio the narcotic substance inspectors of the relevant regional health inspectorate, which governs the location of the pharmacy, to carry out a check. (3) (Amended, SG No. 98/2010, effective , SG No. 60/2011, effective ) The narcotic substance inspectors shall conduct an on-the-spot check in order to ascertain whether the realities on the ground comply with the requirements of the Act and of the regulation under Article 32, Paragraph 1 and draw up a statement of findings in duplicate. (4) The statement of findings under Paragraph 3 shall be submitted, ex officio, to the Ministry of Health within 5 days from the on-the-spot check completion. (5) Where, in the course of the checks under Paragraph 3, shortcomings have been found in the documents submitted, or where discrepancies between the condition of the buildings/premises and the provisions laid down in the regulation under Article 32(1) have been established, the Narcotic Substances Directorate shall notify the applicant in writing and shall give instructions for these shortcomings/discrepancies to be rectified. (6) In cases under Paragraph 5, the period for issuing the licence shall be suspended until the shortcomings and/or discrepancies have been rectified (7) (Repealed, SG No. 60/2011, effective ). (8) (Amended, SG No. 60/2011, effective ) The Minister of Health shall issue a licence to retail and store medicinal products containing narcotic substances. The Minister of Health may otherwise give a reasoned refusal to issue the

13 licence within two months from the application submission date. Article 33b. (New, SG No. 22/2010) (1) The licence under Article 33(1) shall contain: 1. the grounds and the date of issue; 2. (supplemented, SG No. 12/2011, effective ) the name, seat and registered office of the licence holder, UIC; 3. the type of activities to be carried out; 4. the location of the pharmacy where medicinal products containing narcotic substances are retailed and stored; 5. the type of reporting; 6. the full name of the Master of Pharmacy who is in charge of the pharmacy; 7. (amended, SG No. 12/2011, effective ) the full name of the Master of Pharmacy under Article 34. (2) The Ministry of Health shall keep a special register of licences issued under Article 33(1). (3) (Supplemented, SG No. 12/2011, effective ) Any information collected under Paragraph 1 and information contained in the identity document of the Master of Pharmacy under Article 34 shall be recorded in the register referred to in Paragraph 2. Article 33c. (New, SG No. 22/2010) (1) No later than 10 days from the occurrence of a change in any circumstances specified in a licence under Article 32(1) or Article 33(1), the licence holder shall submit an application as per the procedure of Article 32a or Article 33a, respectively, enclosing the documents related to the change. (2) The application and related documents under Paragraph 1 shall be reviewed as per the procedure of Article 32a and Article 33a. (3) The Minister of Health shall issue a licence reflecting a given change or shall issue a reasoned refusal within two months from the application submission under Paragraph 1. (4) In the case of substitution of the Master of Pharmacy under Article 34 whose name was noted in the licence under Article 33(1), the licence holder shall suspend its retail operations with medicinal products containing narcotic substances from the time of suspension of obligations under Article 34 by the Master of Pharmacy, as registered in the licence. Article 33d. (New, SG No. 22/2010) (1) In order to have their licence under Article 32(1) renewed, licence holders shall submit an application to the Ministry of Health, within three months prior to the licence expiry date, and shall enclose the documents under Article 32a(1). (2) When proceeding to licence renewal where no changes have occurred, licence holders shall also submit a declaration form, as approved by the Minister of Health, without submitting the documents under Article 32a(1)(8) and (9). (3) Any licence renewal shall be executed within the time limit and procedure laid down in Article 32a. Article 34. (Amended, SG No.120/2002, SG No. 22/2010, SG No. 61/2011, effective ) Licences under Article 32(1) and Article 33(1) shall be issued to a natural or legal person who has been registered as a trader under Bulgarian law or under the law of a EU Member State, provided that the activities involving narcotic substances, as listed under Schedules under items 2 and 3 of para 2 under Art. 3 of this Act, as well as medicinal products containing narcotic substances shall be carried out under the supervision of a Master of Pharmacy, who shall be personally liable for the application of the measures laid down in this Act and in the relevant licence. Article 35. (Amended and supplemented, SG No. 56/2003, amended, SG No. 79/2005, repealed, SG No. 55/2007, new, SG No. 22/2010)

14 (1) (Amended, SG No. 61/2011, effective ) Manufacturing, processing, storing, trading, importing and exporting narcotic substances, as listed under Schedules under items 2 and 3 of para 2 under Art. 3 of this Act, for veterinary medicinal purposes shall be carried out upon the issuance of a licence by the Minister of Agriculture and Food. (2) (Amended, SG No. 61/2011, effective ) Licences under Paragraph 1 shall be issued to a natural or legal person who has been registered as a trader under Bulgarian law or under the law of a EU Member State, provided that the activities involving narcotic substances, as listed under Schedules under items 2 and 3 of para 2 under Art. 3 of this Act, as well as medicinal products containing narcotic substances shall be carried out under the supervision of a Master of Pharmacy, who shall be personally liable for the application of the measures laid down in this Act and in the relevant licence. (3) The requirements and conditions to carry out activities under Paragraph 1 shall be laid down by ordinance of the Minister of Agriculture and Food. Article 36. (Amended, SG No. 56/2003, repealed, SG No. 55/2007, new, SG No. 22/2010) (1) Persons applying for a licence under Article 35(1) shall submit to the executive director of the Bulgarian Food Safety Agency an application form, which shall contain: 1. the name and address, or the name, seat and registered office of the applicant; 2. the location of the buildings and premises where activities which involve narcotic substances and medicinal products containing narcotic substances are to be carried out; 3. the type of activities to be carried out; 4. the name and information contained in an identity document held by the veterinarian under Article 35(2). 5. the unified identification code (UIC); (2) The following documents shall be enclosed with the application under Paragraph 1: 1. a copy of the production licence or wholesale/retail licence in respect of veterinary medicinal products issued as per the procedure of the Veterinary Practices Act; 2. an extract from the judicial record in respect of the applicant, where the applicant is a sole trader, or the director/executive director, where the applicant is a legal person, as well as in respect of the veterinarian under Article 35(2); 3. a copy of the higher education diploma of the veterinarian under Item 2; 4. a document issued by the relevant regional investigation department certifying that neither the applicant, where the applicant is a sole trader, or the applicant's director/executive director, where the applicant is a legal person, nor the veterinarian under Article 35(2) is indicted for an intentional offence of general nature; 5. where the applicant is a trader, a document issued by the Registry Agency, or by the competent court governing the registration of the applicant, certifying that the applicant is not subject to bankruptcy proceedings; 6. where the applicant is a legal person, a document issued by the Registry Agency, or by the competent court governing the registration of the applicant, certifying that the applicant is not subject to bankruptcy proceedings; 7. a statement issued by the relevant tax authority attesting to the existence or lack of public debts to the state; 8. a copy of the court ruling on the registration; a current status certificate, tax registration; BULSTAT registration, or unified identification code in the case of persons having been registered or re-registered under the Commercial Register Act; 9. a copy of the facility commissioning document in respect of the location where activities which involve narcotic substances and medicinal products containing narcotic substances are to be carried out; 10. a copy of the document attesting to the title of ownership or right to use the facility where activities which involve