Regulation on the Administration of Narcotic Drugs and Psychotropic Drugs (2016 Amendment)

Regulation on the Administration of Narcotic Drugs and Psychotropic Drugs (2016 Amendment) Regulation on the Administration of Narcotic Drugs and Psychotropic Drugs (Issued by Order No.442 of the State Council of the People's Republic of China on August 3, 2005, revised for the first time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on December 7, 2013, and revised for the second time in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016) Chapter I General Provisions Article 1 With a view to strengthening control on narcotic drugs and psychotropic drugs, ensuring the lawful, safe and reasonable use of narcotic drugs and psychotropic drugs, and preventing them from flowing into illegal channels, the present Regulation is formulated in accordance with the provisions of the Pharmaceutical Administration Law and other relevant laws. Article 2 The present Regulation shall be applicable to the plant of anesthetic raw herbs and the experiment and research, production, management, use, storage, and transportation of narcotic drugs and psychotropic drugs, and other activities, and the supervision and administration thereof. The import and export of narcotic drugs and psychotropic drugs shall be handled in accordance with the provisions of relevant laws. Article 3 The narcotic drugs and the psychotropic drugs as mentioned in the present Regulation shall refer to the drugs and other substances listed into the Catalog of Narcotic Drugs and the Catalog of Psychotropic Drugs (hereinafter called Catalogs). Psychotropic drugs shall be classified into psychotropic drugs of category I and psychotropic drugs of category II. The Catalogs shall be formulated, adjusted and publicized by the department of drug supervision and administration of the State Council together with the public security department of the State Council and the competent department of health of the State Council. In case there occurs any misuse of any drug or any other substance that is listed for sale but has not been listed in the Catalogs or of the psychotropic drugs of category II, which has resulted in or may result in serious social harmfulness, the department of drug supervision and administration of the State Council shall, together with the public security department of the State Council and the competent department of health of the State Council, list the drug or the substance into the Catalogs or adjust the psychotropic drugs of category II into the psychotropic drugs of category I. Article 4 The state shall make control on anesthetic raw herbs and narcotic drugs and psychotropic drugs. Unless otherwise specified by the present Regulation, no entity or individual may plant any anesthetic raw herbs, or carry out experiment and research, production, management, use, storage, or transportation of narcotic drugs and psychotropic drugs and other activities. Article 5 The department of drug supervision and administration of the State Council shall be responsible for the supervision and administration of narcotic drugs and psychotropic drugs nationwide, and shall, together with the competent department of agriculture of the State Council, conduct supervision and administration on anesthetic raw herbs. The department of public security of the State Council shall be responsible for making investigation into acts which result in the flowing of anesthetic raw herbs and narcotic drugs and psychotropic drugs into illegal channels. Other competent departments of the State Council shall be responsible for the work in relation to the administration of narcotic drugs and psychotropic drugs within their own scope of functions. The departments of drug supervision and administration of the people's governments at provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the supervision and administration of narcotic drugs and psychotropic drugs within their own administrative regions. The local public security organs at or above the county level shall be responsible for making investigation into acts which result in the flowing of narcotic drugs and psychotropic drugs into illegal channels within their own administrative regions. Other relevant competent departments of the local people's governments at or above the county level shall be responsible for the work relating to the administration of narcotic drugs and psychotropic drugs within their own scope of functions. Article 6 Any enterprise undertaking the production and management of narcotic drugs and psychotropic drugs and any entity using these drugs may take part in the industry association according to law. The industry association shall strengthen self-disciplinary management on the industry. Chapter II Planting, Experiment and Research and Production Article 7 The state shall, according to the needs for medical treatment, national reserve and the materials needed for enterprise production, determine the demand of narcotic drugs and psychotropic drugs, and control the total amount of the planting of anesthetic raw herbs and the production of narcotic drugs and psychotropic drugs. The department of drug supervision and administration of the State Council shall formulate annul production plan according to the demand of narcotic drugs and psychotropic drugs. The department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council shall, according to the annual production plan for narcotic drugs, make an annual plan for planting anesthetic raw herbs. Article 8 Any enterprise undertaking the plant of anesthetic raw herbs shall, according to the annual planting plan, plant the anesthetic raw herbs. The enterprises undertaking the plant of anesthetic raw herbs shall report the planting conditions periodically to the department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council. Article 9 The enterprises undertaking the plant of anesthetic raw herbs shall be determined by the department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council together, no other entity or individual shall plant anesthetic raw herbs. Article 10 The following conditions shall be met for carrying out the experiment and research on narcotic drugs and psychotropic drugs, with the approval of the department of drug supervision and administration of the State Council: 1. The purpose is for medical treatment, scientific research or teaching; 2. The entity has measures and management system for ensuring the safety of narcotic drugs and psychotropic drugs needed for the experiment; and 3. The entities or its personnel have no acts in violation of the provisions of any anti-drug law or administrative regulation within 2 years. Article 11 The entities undertaking the experiments and research of narcotic drugs and psychotropic drugs shall, when applying for the certificate documents of approval for the relevant drugs, handle it according to the provisions of the Pharmaceutical Administration Law ; if there is necessity to transfer the research results, they shall be subject to the approval of the department of drug supervision and administration of the State Council. Article 12 In case any drug research entity produces any controlled drugs as prescribed in the present Regulation during the process of making experiment and research on ordinary drugs, it shall stop the activity of experiment and research immediately, and report to the department of drug supervision and administration of the State Council. The department of drug supervision and administration of the State Council shall, according to the reality, make decision on whether to approve it to continue the experiment and research in a timely manner. Article 13 The clinical trials on narcotic drugs and the psychotropic drugs of category I shall not target on healthy people. Article 14 The state shall implement the system of designated production on narcotic drugs and psychotropic drugs. The department of drug supervision and administration of the State Council shall, according to the demand of narcotic drugs and psychotropic drugs, determine the quantity and overall arrangement of the designated production enterprises of narcotic drugs and psychotropic drugs, and make adjustment and publicity on the quantity and layout according to annual demand. Article 15 The designated production enterprises of narcotic drugs and psychotropic drugs shall have the following conditions: 1. Having drug production license; 2. Having documents of approval for the experiment and research of narcotic drugs and psychotropic drugs; 3. Having production facilities, storage conditions and the corresponding safeguard management establishments for narcotic drugs and psychotropic drugs complying with the requirements; 4. Having the ability to conduct work safety management on enterprises through network and to report production information to the department of drug supervision and administration; 5. Having the management system for ensuring the safety production of narcotic drugs and psychotropic drugs; 6. Having the management level and business scale meeting the requirement for safety production of narcotic drugs and psychotropic drugs; 7. The personnel in the departments of production management and quality control over narcotic drugs and psychotropic drugs shall be familiar with the laws and administrative regulations on the control of narcotic drugs and psychotropic drugs and the relevant anti-drug laws and administrative regulations; 8. Having no acts of production and sale of bogus drugs, low quality drugs or in violation of the relevant anti-drug laws and administrative regulations; and 9. Complying with the requirements for the quantity and overall arrangement of the designated production enterprises of narcotic drugs and psychotropic drugs as publicized by the department of drug supervision and administration of the State Council. Article 16 An enterprise that engages in the production of narcotic drugs and psychotropic drugs shall be subject to the approval of the drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. Article 17 Any designated production enterprise shall, when producing narcotic drugs and psychotropic drugs, obtain the number of documents of approval for drugs according to the provisions of the Pharmaceutical Administration Law . The department of drug supervision and administration of the State Council shall organize experts in the aspects of medical science, pharmacy, social science and ethics, as well as anti-drugs, and etc. to form an expert team, which shall make appraisal on the social harmfulness of narcotic drugs and psychotropic drugs coming into the market for the first time and the possibility for their being misused, and propose suggestions on whether to approve it or not. No enterprise that has not obtained the number of documents of approval for drugs may produce narcotic drugs and psychotropic drugs. Article 18 In case of occurrence of any serious critical incident, which results in the incapability of any designated production enterprise to carry out ordinary production or the failure to ensure the supply of narcotic drugs and psychotropic drugs, the department of drug supervision and administration of the State Council shall determine another pharmaceutical production enterprise to produce narcotic drugs and psychotropic drugs. After the end of the serious critical incident, the department of drug supervision and administration of the State Council shall determine in time that the enterprises as prescribed in the preceding paragraph shall stop production of narcotic drugs and psychotropic drugs. Article 19 A designated enterprise shall arrange the production strictly in accordance with the annual production plan for narcotic drugs and psychotropic drugs, and report the production conditions to the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality as prescribed. Article 20 A designated production enterprise shall, according to the provisions of the present Regulation, sell narcotic drugs and psychotropic drugs to the enterprises that have the business qualification of narcotic drugs and psychotropic drugs or to other entities approved by the present Regulation. Article 21 The labels of narcotic drugs and psychotropic drugs shall be printed with the marks as prescribed by the department of drug supervision and administration of the State Council. Chapter III Management Article 22 The state shall apply designated management system to narcotic drugs and psychotropic drugs. The department of drug supervision and administration of the State Council shall, according to the demand of narcotic drugs and the psychotropic drugs of category I, determine the overall arrangement of the designated wholesales enterprises of narcotic drugs and the psychotropic drugs in category I, and make adjustment and publicity on the overall arrangement according to the annual demand. No pharmaceutical management enterprise may deal in anesthetic raw herbs and raw material medicine of psychotropic drugs of category I. But the small package of the said drugs for the use of medical treatment, scientific research and teaching may be dealt in by wholesales pharmaceutical enterprises as prescribed by the department of drug supervision and administration of the State Council. Article 23 The designated wholesales enterprise of narcotic drugs and psychotropic drugs shall not only have the conditions for establishing pharmaceutical management enterprises as prescribed in Article 15 of the Pharmaceutical Administration Law , but also shall have the following conditions: 1. Having the conditions for storage of narcotic drugs and pharmaceutical drugs as prescribed in the present Regulation; 2. Having the ability to implement safety management on enterprises and to report management information to the department of drug supervision and administration through networks; 3. The entity and its staff members have no acts in violation of the relevant anti-drug laws and administrative regulations within 2 years; and 4. Complying with the overall arrangement of the designated wholesales enterprises as promulgated by the department of drug supervision and administration of the State Council. The designated wholesales enterprises of narcotic drugs and the psychotropic drugs of category I shall also have the ability to ensure the supply of narcotic drugs and the psychotropic drugs of category I as needed for the medical institutions within their own responsibility areas, and shall have the management system for ensuring the safety operation of narcotic drugs and the psychotropic drugs of category I. Article 24 Any enterprise that undertakes the wholesales business of narcotic drugs and the psychotropic drugs of category I across any province, autonomous region, or municipality directly under the Central Government (hereinafter referred to as the national wholesales enterprise) shall be subject to the approval of the department of drug supervision and administration of the State Council; any enterprise undertaking the wholesales business of narcotic drugs and the psychotropic drugs of category I within its own province, autonomous region or municipality directly under the Central Government (hereinafter referred to as the regional wholesales enterprise) shall be subject to the approval of the department of drug supervision and administration department of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality. Any enterprise specially undertaking the wholesales business of the psychotropic drugs of category II shall be subject to the approval of the department of drug supervision and administration department of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality. National wholesales enterprises and regional wholesales enterprises may undertake the wholesales business of psychotropic drugs of category II. Article 25 A national wholesales enterprise may sell narcotic drugs and the psychotropic drugs of category I to regional wholesales enterprises or to the medical institutions that have obtained the qualification for using narcotic drugs and the psychotropic drugs of category I or other entities approved according to the provisions of the present Regulation. A national wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution that has obtained the qualification on using narcotic drugs and the psychotropic drugs of category I, be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at the place where the medical institution is located. The department of drug supervision and administration of the State Council shall, when approving national wholesales enterprises, clarify the areas in which they shall undertake liabilities for drug supply. Article 26 A regional wholesales enterprise may sell narcotic drugs and the psychotropic drugs of category I to the medical institutions that have obtained the qualification on using narcotic drugs and the psychotropic drugs of category I within the administrative region of its own province, autonomous region, and municipality directly under the Central Government; where there is necessity to sell the said drugs to the medical institutions that have obtained the qualification on using narcotic drugs and the psychotropic drugs of category I within the administrative region of any neighboring province, autonomous region, and municipality directly under the Central Government due to the reason of special geographical locations, it shall be subject to the approval of the department of drug supervision and administration of the people's government of the province, autonomous region and municipality directly under the Central Government of the place where the enterprise is located. The drug supervision and administration department in charge of approval shall, within five days upon approval, notify the approval conditions to the drug supervision and administration of the people's government of the province, autonomous region, and municipality directly under the Central Government of the place where the medical institution is located. The department of drug supervision and administration of the people's government of any province, autonomous region, and municipality directly under the Central Government shall, when approving any regional wholesales enterprise, clarify the region where it shall undertake liabilities for drug supply. Where there is necessity to adjust narcotic drugs and the psychotropic drugs of category I between regional wholesales enterprises due to emergency medical treatment and difficulties in transportation and other special circumstances, the adjustment information shall be reported to the department of drug supervision and administration of the people's government at the province, autonomous region and municipality directly under the Central Government at the place where the enterprises are located for archival filing within 2 days after the adjustment. Article 27 A national wholesales enterprise shall purchase narcotic drugs and the psychotropic drugs of category I from designated production enterprises. A regional wholesales enterprise may purchase narcotic drugs and the psychotropic drugs of category I from national wholesales enterprises or may purchase narcotic drugs and the psychotropic drugs of category I from designated production enterprises upon the approval of the department of drug supervision and administrati......