Regulations on the Control of Narcotic Drugs and Psychotropic Drugs (Revised in 2016)
Regulations on the Control of Narcotic Drugs and Psychotropic Drugs (Revised in 2016)
Regulations on the Control of Narcotic Drugs and Psychotropic Drugs (Revised in 2016)
Order of the State Council of the People's Republic of China No.666
February 6, 2016
(Promulgated by the Order of the State Council No.442 on August 3, 2005; revised for the first time according to Decision of the State Council on Revising Some Administrative Regulations on December 7, 2013; and revised for the second time in accordance with the Decision of the State Council on Revising Certain 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 Drug 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 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 administrative department of drug supervision of the people's government of provinces, autonomous regions or municipalities directly under the Central Government of the place where the enterprise is located. The administrative department of drug supervision responsible for examination and approval shall report the examination and approval status to the administrative department of drug supervision of the people's government of provinces, autonomous regions or municipalities directly under the Central Government of the place where the medical institution is located within five days of approval.
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 administration of the people's government of the province, autonomous region, and municipality directly under the Central Government at its locality.
Article 28 Any national wholesales enterprises or regional wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution, send the drug to the medical institution.
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Order of the State Council of the People's Republic of China No.666
February 6, 2016
(Promulgated by the Order of the State Council No.442 on August 3, 2005; revised for the first time according to Decision of the State Council on Revising Some Administrative Regulations on December 7, 2013; and revised for the second time in accordance with the Decision of the State Council on Revising Certain 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 Drug 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 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 administrative department of drug supervision of the people's government of provinces, autonomous regions or municipalities directly under the Central Government of the place where the enterprise is located. The administrative department of drug supervision responsible for examination and approval shall report the examination and approval status to the administrative department of drug supervision of the people's government of provinces, autonomous regions or municipalities directly under the Central Government of the place where the medical institution is located within five days of approval.
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 administration of the people's government of the province, autonomous region, and municipality directly under the Central Government at its locality.
Article 28 Any national wholesales enterprises or regional wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution, send the drug to the medical institution.
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