Chapter I General Provision
Article 1 These regulations are formulated according to the provision of Law on Pharmaceutical Administration and related laws for the purpose of enhancing the control of anesthetic and psychoactive drugs, ensure their legal, safe and rational use and prevent them from flowing to illegal channels.
Article 2 These regulations will apply to the cultivation of medical original plans of anesthetic drugs, experimental research, production, distribution, use, storage and transport operations and supervision and management of anesthetic and psychoactive drugs.
The import and export of anesthetic and psychoactive drugs shall be conducted according to relative laws and regulations.
Article 3 “Anesthetic and psychoactive drugs” used in these regulations refer to the drugs and other substances listed in the catalogues of anesthetic and psychoactive drugs (hereinafter referred to as catalogue(s)). The psychoactive drugs are divided into the first class psychoactive drugs and th
e second class psychoactive drugs.
The catalogues shall be formulated, adjusted and publicized jointly by the drug regulatory department, public security department and health department under the State Council.
If abuse of any drug and other substance not listed into the catalogues but sold in the market or any psychoactive drug occurs, already caused of has the potential to cause serious harm to the society, the drug regulatory department under the State Council shall cooperate with the public securit
y department and health department under the State Council to list this drug or substance into the catalogue or adjust the second class psychoactive drug as the first class psychoactive drug.
Article 4 The state enforces control over the original medical plants used as anesthetic drugs as well as anesthetic and psychoactive drugs. Unless otherwise stipulated in these regulations, any institution and individual should not cultivate original medical plants used as anesthetic drugs or condu
ct experimental research, production, business, use, storage and transport of anesthetic and psychoactive drugs.
Article 5 The regulatory department under the State Council shall be responsible for the supervision and management of the anesthetic and psychoactive drugs of the whole country and cooperate with the competent agricultural department under the State Council to conduct supervision and management ove
r the original medical plants used as anesthetic drugs. The public security department under the State Council takes charge of finding out and dealing with the behavior causing original medical plants used as anesthetic drugs and anesthetic and psychoactive drugs to flow into illegal channels. Other
competent departments under the State Council shall be responsible for the administration works with relation to anesthetic and psychoactive drugs in their respective terms of reference.
The drug regulatory department of provinces, autonomous regions and municipalities shall be responsible for the supervision and management of anesthetic and psychoactive drugs in their administrative areas. Local public security department above county level shall be responsible for finding out and
dealing with the behavior causing original medical plants used as anesthetic drugs and anesthetic and psychoactive drugs to flow into illegal channels in their respective district. Other competent administrative departments under local governments above county level shall be responsible for the admi
nistration works with relation to anesthetic and psychoactive drugs in their respective terms of reference.
Article 6 The producing and distribution enterprises and users of anesthetic and psychoactive drugs can take part in trade associations. The trade associations shall enhance self-discipline and management.
Chapter II Cultivation, Experimental Research and Production
Article 7 The state will determine the total amount in need according to the demand of raw materials of anesthetic and psychoactive drugs for medical treatment, state reserve and enterprise production and impose total amount control over the cultivation of the original medical plants used as anesthe
tic drugs and production of anesthetic and psychoactive drugs.
The drug regulatory department of the State Council shall formulate annual production plan according the total demand for the anesthetic and psychoactive drugs.
The drug regulatory department and the competent agricultural department under the State Council shall formulate annual cultivation plan of the original medical plants used as anesthetic drugs according the to annual production plan of anesthetic drugs.
Article 8 Enterprises cultivating original medical plants used as anesthetic drugs should cultivate the original medical plants used as anesthetic drugs according to the annual cultivation plan.
Enterprises cultivating original medical plants used as anesthetic drugs should submit reports on the cultivation regularly to the drug regulatory department and the competent agricultural department under the State Council.
Article 9 Enterprises cultivating original medical plants used as anesthetic drugs shall be determined by the regulatory department and the competent agricultural department under the State Council, and other organizations and individuals should not cultivate any original medical plant used as anest
hetic drug.
Article 10 Experimental research of anesthetic and psychoactive drugs should be conducted subject to the following conditions and approval of the regulatory department under the State Council.
(I) for the purpose of medical treatment, scientific research or education;
(II) with measures and management system ensuring the safety of the anesthetic and psychoactive drugs in experiment;
(III) the institution or its staff involved in the research has no behavior violating laws or administrative regulations on drug prohibition within 2 years.
Article 11 Institutions engaged in experimental research of anesthetic and psychoactive drugs shall apply for approval and certification documents according to the provisions of the Law on Pharmaceutical Administration; and assignment of the research achievements shall be approved by the drug regula
tory department under the State Council.
Article 12 Drug research institutions engaged in experimental research of common drugs should stop their research activities immediately once finding drug varieties controlled by these regulations are generated in the process of their research and report to the drug regulatory department under the S
tate Council. The drug regulatory department under the State Council shall make decision on whether they could continue the experimental research timely according to the actual situation.
Article 13 Clinic tests of anesthetic drugs and the first class psychoactive drugs should not be made on healthy people.
Article 14 The state shall appointed special manufacturers to produce anesthetic and psychoactive drugs.
The drug regulatory department under the State Council shall decide the quantity and distribution of the appointed manufacturers producing anesthetic and psychoactive drugs according to the total demand of anesthetic and psychoactive drugs, and adjust and publicize the quantity and distribution base
d on annual total demand.
Article 15 The appointed manufacturers producing anesthetic and psychoactive drugs shall meet the following conditions:
(I) holding drug production license;
(II) holding approval documents on experimental research of anesthetic and psychoactive drugs;
(III) having qualified production equipment, storage condition and corresponding safety management facilities meeting the provisions for production of anesthetic and psychoactive drugs;
(IV) having the ability to carry out safety management of production and report production information to drug regulatory department through network;
(V) having safety management system on production of anesthetic and psychoactive drugs;
(VI) having management competency and business scale meeting the requirements to safety production of anesthetic and psychoactive drugs;
(VII) with staff responsible for production management and quality management of anesthetic and psychoactive drugs knowing well the management of anesthetic and psychoactive drugs and laws and administrative rules and regulations on drug prohibition;
(VIII) without behaviors with relation to producing and selling counterfeit drugs or violating laws and administrative rule and regulations on drug prohibition;
(IX) according with the requirement on the number and distribution of the appointed enterprises to producing anesthetic and psychoactive drugs publicized by the drug regulatory department under the State Council.
Article 16 The enterprises producing anesthetic drugs and the first class psychoactive drugs and enterprises producing raw materials of the second class psychoactive drug shall be primarily examined by local drug regulatory departments under the governments of provinces, autonomous regions or munici
palities, and approved by the drug regulatory department under the State Council; the enterprises producing the second class psychoactive drugs shall be approved by the drug regulatory department under the governments of local provinces, autonomous regions and municipalities.
Article 17 Appointed enterprises to produce anesthetic and psychoactive drugs should get registered number of approval according to the provisions of the Law on Pharmaceutical Administration.
The drug regulatory department under the State Council shall organize expert group composed of experts on medicine, drugs, sociology, ethnics and drug prohibition etc. to make assessment on the social harm and the abuse possibility of the anesthetic and psychoactive drugs initially applied for enter
ing into market, and provide recommendations on approval or not.
Without the registered number of approval, no enterprise would be permitted to produce anesthetic and psychoactive drugs.
Article 18 In case serious emergency incident stopped an enterprise’s normal production or made the manufacturer unable to ensure supply of anesthetic and psychoactive drugs, the drug regulatory department under the State Council can assign another drug producing enterprise to produce anesthetic an
d psychoactive drugs,
Once the serious emergency incident passed, the drug regulatory department under the State Council shall immediately decide the enterprises assigned according to above item to stop producing anesthetic and psychoactive drugs.
Article 19 The appointed drug producing enterprises shall arrange production strictly according to the annual production plan of anesthetic and psychoactive drugs and provide reports according to the provisions on the situation of production to the drug regulatory departments under the peoples gover
nments of local provinces, autonomous regions and municipalities.
Article 20 According to the provision of these regulations, the appointed producing enterprises shall sell anesthetic and psychoactive drugs to the enterprises with competency to distribute anesthetic and psychoactive drugs or other entities approved according to the provision of these regulations.
Article 21 The labels of anesthetic and psychoactive drugs shall be printed with the marks prescribed by the drug regulatory department under the State Council.
Chapter III Distribution
Article 22 The state implements appointed distribution system on anesthetic and psychoactive drugs.
The drug regulatory department under the State Council shall confirm the overall arrangement of the appointed enterprises involved in wholesale of anesthetic drugs and the first class psychoactive drugs based on the total demand for anesthetic drugs and the first class psychoactive drugs and readjus
t and publicize the arrangement based on annual total demand.
Drug distributors should not distribute the raw materials of anesthetic drugs and the raw materials of the first class psychoactive drugs. But above mentioned drugs in small package used in medical treatment, scientific research and teaching can be distributed by the drug wholesale enterprises appoi
nted the drug regulatory department under the State Council.
Article 23 In addition to the conditions for drug distribution requirements stipulated in article 15 of the Drug Administration Law, the appointed wholesalers of anesthetic and psychoactive drugs also should meet the following requirements:
(I) having the condition for storing anesthetic and psychoactive drugs meeting the provisions of these regulations;
(II) having the ability to carry out safety management of the enterprise and report production information to drug regulatory department through network;
(III) without behavior of the enterprise and its staff violating the laws and administrative rules and regulations with relation to drug prohibition within 2 years;
(IV) according with the overall arrangement of the appointed wholesale enterprises publicized by the regulatory department under the State Council.
The appointed wholesale enterprises of anesthetic drugs and the first class psychoactive drugs also should have the ability to ensure the supply of anesthetic and the first class psychoactive drugs to the medical institutions in their responsible areas and having the management system to ensure safe
distribution of anesthetic and the firs class psychoactive drugs.
Article 24 Enterprises involved in inter-province, autonomous region and municipality wholesale of anesthetic drugs and the first class psychoactive drugs (hereinafter referred to as national wholesalers) shall get approval of the drug regulatory department under the State Council; enterprises invol
ved in wholesale of anesthetic drugs and the first class psychoactive drugs in the administrative areas of local provinces, autonomous regions and municipalities (hereinafter referred to as regional wholesalers) shall get approval of the drug regulatory departments under the people’s government of
the local provinces, autonomous regions and municipalities.
Enterprises specialized in the wholesale of the second class psychoactive drugs shall get approval of the drug regulatory departments under the people’s governments of local provinces, autonomous regions and municipalities.
The national wholesalers and regional wholesalers can be involved in wholesale of the second class psychoactive drugs.
Article 25 The national wholesalers can distribute anesthetic drugs and the first class psychoactive drugs to the regional wholesalers, or as approved to those medical institutions with qualification to use anesthetic drugs and the first class psychoactive drugs and other institutions as approved ac
cording to these regulations.
To distribute anesthetic drugs and the first class psychoactive drugs to the medical institutions with qualification to use anesthetic drugs and the first class psychoactive drugs, the national wholesalers shall get approval of the drug regulatory departments under the people’s governments of the p
rovinces, autonomous regions and municipalities where the medical institutions are located.
When approving the national wholesalers, the drug regulatory department under the State Council shall define the areas where they bear the responsibilities to supply the drugs.
Article 26 The national wholesalers can distribute anesthetic drugs and the first class psychoactive drugs to those medical institutions which have got qualification to use anesthetic drugs and the first class psychoactive drugs within the administrative areas of local provinces, autonomous regions
and municipalities; Distribution of anesthetic drugs and the first class psychoactive drugs to those medical institutions which have got qualification to use these drugs in the nearby administrative areas of other provinces, autonomous regions and municipalities in consideration of the special geogr
aphical locations should be approved by the drug regulatory department under the State Council.
When approving the regional drug wholesalers, the drug regulatory departments under the people’s governments of provinces, autonomous regions and municipalities shall define the areas where they bear the responsibilities to supply the drugs.
In case it is necessary to for regional wholesalers to distribute each other anesthetic drugs and the first class psychoactive drugs because of emergency need in medical treatment or difficulty in transportation and other special circumstances, such distribution should be reported respectively to th
e drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities they are located for record.
Article 27 The national wholesalers shall purchase anesthetic drugs and the first class psychoactive drugs from the local appointed producers.
The regional wholesalers can purchase anesthetic drugs and the first class psychoactive drugs from the national wholesalers; as approved by the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities they are located, the regional wholesale
rs also can purchase anesthetic drugs and the first class psychoactive drugs from the local appointed producers.
Article 28 The national wholesalers and regional wholesalers who distribute anesthetic drugs and the first class psychoactive drugs to medical institutions should send the drugs to the medical institutions. The medical institutions should not pick up the goods by themselves.
Article 29 The appointed wholesalers of the second class psychoactive drugs can distribute the second class psychoactive drugs to medical institutions, appointed wholesalers and drug retailers meeting the provisions prescribed by Article 31 of these regulations and other institutions as approved bas
ed on the provisions of these regulations.
Article 30 Anesthetic drugs and the first class psychoactive drugs cannot be retailed.
It should be prohibited to trade anesthetic drugs and psychoactive drugs with cash except individuals buy anesthetic drugs and psychoactive drugs.
Article 31 As approved by local drug regulatory departments at city level, the chained retailers with unified purchase, unified distribution and unified management can retail the second class psychoactive drugs.
Article 32 The retailers of the second class psychoactive drugs should sell the second class psychoactive drugs according to the descriptions of certified physicians and based on the defined dosage and keep the descriptions for 2 year for check; over dosage or non-description sales of the second cla
ss psychoactive drugs are prohibited; the second class psychoactive drugs should not be sold to juveniles.
Article 33 Anesthetic drugs and psychoactive drugs shall be priced by the government. On the basis of defined ex-factory prices and wholesale prices, the retailing prices shall be gradually unified in the whole country. The specific measures with be stipulated by the competent pricing department und
er the State Council.
Chapter IV Use
Article 34 The drug producing enterprises that need to produce common drugs with anesthetic drugs and psychoactive drugs as raw materials should submit plans of annual demand to the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities wh
ere they are located. The drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities shall collect the plans and report them to the drug regulatory department under the State Council for approval before permitting the producer to purchase from
the appointed producing enterprises.
The drug producing enterprises that need to produce common drugs with the second class psychoactive drugs as raw materials should submit plans of annual demand to the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities where they are lo
cated before purchasing from appointed wholesalers or appointed producing enterprises.
Article 35 The enterprises producing non-drug products like foodstuffs, food additives, cosmetics and paints etc with caffeine as raw materials shall get approval of the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities where they are
located before purchasing from appointed wholesalers or appointed producing enterprises.
The scientific research and teaching institutions that need to use anesthetic drugs and psychoactive drugs for experiments and teaching activities shall get approval of the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities where they
are located before purchasing from appointed wholesalers or appointed producing enterprises.
The institutions that need to use anesthetic drugs and psychoactive drugs for standard and comparison shall get approval of the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities where they are located and then purchase them from the i
nstitutions approved by the drug regulatory departments under the State Council.
Article 36 The medical institutions that need to use anesthetic drugs and the first class psychoactive drugs shall get approval of the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities where they are located and obtain the signature c
ard for purchase and use of anesthetic drugs and the first class psychoactive drugs (hereinafter referred to as signature card). Medical institutions should show the signatures cards for buy anesthetic drugs and the first class psychoactive drugs from the appointed wholesale enterprises in the provi
nces, autonomous regions and municipalities they are located.
When issuing signature card to an medical institution, the competent department under the people’s government of a city with districts should send the information about the medical institution to the drug regulatory department under the people’s government of the city with district where the medic
al institution is located, and report it to the drug regulatory department under the people’s government of the province, autonomous region or municipality for record. The drug regulatory department under the people’s government of the province, autonomous region or municipality for record shall n
otice the list of medical institutions with signature cards to the ass appointed wholesalers of drugs within their administrative areas.
Article 37 To get signature card, a medical institutions should meet following requirements:
(I) having full time persons to manage anesthetic drugs and the first class psychoactive drugs;
(II) having certified physicians with competency to prescribe anesthetic drugs and the first class of psychoactive drugs;
(III) having facility and management system to ensure safety storage of anesthetic drugs and the first class psychoactive drugs.
Article 38 Medical institutions shall provide training and examination to the certified physicians of their units on use of anesthetic drugs and psychoactive drugs. The certified physicians passing the examinations shall be invested with the competency to prescribe anesthetic drugs and the first cla
ss psychoactive drugs. Only getting the competency to prescribe anesthetic drugs and the first class psychoactive drugs can a certified physician prescribe anesthetic drugs and the first class psychoactive drugs in his medical institution, but cannot prescribe such drugs for himself.
Medical institutions shall keep the lists of certified physicians with competency to prescribe anesthetic drugs and the first class psychoactive drugs and the information about their change and report them regularly to the competent health department under local people’s government at city level an
d copy them to the drug regulatory department at the same level.
Medical staff shall use anesthetic drugs and psychoactive drugs according to the guideline for clinic use stipulated by the competent health department under the State Council.
Article 39 The certified physicians with competency to prescribe anesthetic drugs and the first class psychoactive drugs should meet the rational dosage demands of the patients who need to use anesthetic drugs or the first class psychoactive drugs according the guideline of clinic use. In case the p
atients in pain of cancer or serious case in the medical institutions cannot get necessary anesthetic drugs or the first class psychoactive drugs, the patients or their families can apply to the certified physicians. If the certified physicians with competency to prescribe anesthetic drugs and the f
irst class psychoactive drugs think it is reasonable to use, he should provide the patients anesthetic drugs or the first class psychoactive drugs they need.
Article 40 Certified physicians should prescribe anesthetic drugs and psychoactive drugs with specialized prescription papers; the maximum dosage of a single prescription should accord with the provision of the competent health department under the State Council.
The preparing and checking staff should carefully check, sign and register the prescriptions of anesthetic and the first class psychoactive drugs; if there is any inconsistence with these regulations, the preparing and checking staff should refuse to deliver the drugs.
The format of the specialized prescription of anesthetic drugs and psychoactive drugs shall be formulated by the competent health department of the State Council.
Article 41 Medical institutions shall register the prescriptions of anesthetic drugs and psychoactive drugs respectively and enhance their management. The prescriptions of anesthetic drugs shall be kept for at least 3 years, and the prescriptions of psychoactive drugs shall be kept for at least 2 ye
ars.
Article 42 In case a medical institution is in urgent need to use anesthetic drugs and the first class psychoactive drugs to give emergency treatment to a patient but could not provide, such drugs can be borrowed from other medical institutions or appointed wholesalers. After the emergency treatment
completed, the information about the borrowing should be reported to the drug regulatory department and the competent health department of the city with districts for record.
Article 43 If the medical institutions with drug preparation licenses and signature cards need to prepare anesthetic drugs and psychoactive drugs in urgent need because there are no such drugs in the market, they should get approval of the drug regulatory departments under the people’s governments
of provinces, autonomous regions and municipalities they are located. The anesthetic and psychoactive drugs prepared by medical institutions can be used only in their own institutions but cannot be sold out.
Article 44 For the need to treat diseases, individuals can take anesthetic and the firs class psychoactive drugs of the maximum dosage of a single prescription along with medical diagnosis certificates opened by medical institutions and individual IDs. The customs shall give clearance to the entry a
nd exit of the anesthetic drugs and the first class psychoactive drugs taken by individuals according to the principles of self-use and rationality.
To bring in or out small amount of anesthetic drugs and psychoactive drugs for medical treatment, medical personnel should exhibit the certificates of bringing anesthetic drugs and psychoactive drugs issued by the drug regulatory departments under the people’s governments above provincial level. Th
e customs shall give clearance to the entry and exit of them according to the certificates.
Article 45 For the purpose of drug-relief, the medical institutions and drug-relief institutions can use Methadone or other anesthetic and psychoactive drug used for drug-relief determined by the state. The specific management measures shall be stipulated by the drug regulatory department, the publi
c security department and the competent health department under the State Council.
Chapter V Storage
Article 46 Original medical plants cultivation enterprises, appointed production enterprises, national wholesale enterprises, regional wholesale enterprises and the state established storage units of anesthetic drugs shall arrange specialized warehouses to store anesthetic drugs and the first class
psychoactive drugs. The specialized warehouses should meet the following requirements:
(I) equipped with specialized burglarproof doors locked with two locks and managed by two persons;
(II) equipped with proper fire-proof facilities;
(III) equipped with monitoring and warning devices connected on line with the warning system of local public security departments.
The drug storage points established by the national wholesale enterprises as approved by the drug regulatory department under the State Council shall comply with the provision of above item.
The appointed production enterprises of anesthetic drugs shall store the raw materials and the products respectively.
Article 47 The units using anesthetic drugs and the first class of psychoactive drugs shall arranged specialized warehouses or cabinets to store anesthetic drugs and the first class of psychoactive drugs. The specialized warehouses should be equipped with antitheft and warning devices; the specializ
ed cabinets should have strong boxes. The specialized warehouses and cabinets should be locked with two locks and managed by two persons.
Article 48 Original medical plants cultivation enterprises, appointed production enterprises, national wholesale enterprises, regional wholesale enterprises, the state established storage units of anesthetic drugs and the units using anesthetic drugs and the first class psychoactive drugs shall staf
fed with specialized management persons and establish specialized account books for the inventory of anesthetic drugs and the first class psychoactive drugs. The warehousing drugs should be inspected by two persons and the discharge of the warehouses should be checked by two persons too to ensure go
ods to accord with the account. The account books should be kept for at least 5 years after expiration of the validity of the drugs.
Article 49 The distribution enterprises of the second class psychoactive drugs shall arranged specialized warehouses or cabinets to store the second class psychoactive drugs and registered in specialized account books under the management of specialized persons. The specialized account books should
be kept for at least 5 years after expiration of the validity of the drugs.
Chapter VI Transportation
Article 50 Consignment, carriage and self-transport of anesthetic drugs and psychoactive drugs should adopt safety and insurance measure to prevent anesthetic drugs and psychoactive drugs from being theft, robbed or lost in the process of transportation.
Article 51 Transportation of anesthetic drugs and the first class psychoactive drugs through railway should use containers or the luggage vans. The specific measures shall be stipulated by the drug regulatory department under the State Council with the competent railway department under the State Co
uncil.
Transportation of anesthetic drugs and the first class of psychoactive drugs through highway or waterway because there is no railway should be escorted by specialized persons.
Article 52 The units planning to consign the transportation of anesthetic drugs and the first class psychoactive drugs or transport them by themselves shall apply to the drug regulatory departments under the people’s governments of provinces, autonomous regions and municipalities they are located f
or certificates of the transportation. The validity period of the certificate is 1 year.
The transportation certificate should be kept by specialized persons; alteration, transference or subtenancy are prohibited.
Article 53 To go through the formalities for the transportation of anesthetic drugs and the firs class psychoactive drugs, the consignors should submit the copies of the transportation certificate to the carriers. The carriers shall check, accept and keep the copies of transportation certificates an
d inspect the package of goods. If transportation certificates are not provided or the package does not meet the requirements, the carrier should refuse to transport.
In the process of transportation, the carriers should bring about the copies of transportation certificates for check.
Article 54 To mail anesthetic drugs and psychoactive drugs through postal service, the consignors should exhibit the mail-permitting certificates opened by the drug regulatory departments under the people’s governments of the provinces, autonomous regions and municipalities they are located. The po
stal services agencies shall check, accept and keep the mail-permitting certificates. If there is no mail-permitting certificate, the postal service agencies shall refuse to accept and mail the drugs.
The drug regulatory departments of provinces, autonomous regions and municipalities shall appoint postal service agencies meeting the requirements on safety and insurance to accept and mail anesthetic drugs and psychoactive drugs. The postal service agencies shall check and inspect the anesthetic dr
ugs and psychoactive drugs they accepted for mailing.
The specific methods for the management of mailing anesthetic drugs and psychoactive drugs shall be formulated by the drug regulatory department under the State Council with the competent postal department under the State Council.
Article 55 For the transportation of anesthetic drugs and the first class psychoactive drugs among the appointed production enterprises, national wholesale enterprises and regional wholesale enterprises, the consigners report relative information before consignment to the drug regulatory departments
under the people’s governments of the provinces, autonomous regions and municipalities they are located. For the cross-province, cross-autonomous regions and cross-municipality transportation, the drug regulatory departments shall report the information they received to the drug regulatory departm
ent at the equivalent level in the administrative areas where the consignees are located. For the transportation within the administrative areas of the province, autonomous region or municipality, the drug regulatory department shall report the information received to the drug regulatory departments
at the city level where the consignees are located.
Chapter VII Application Procedures and Administration
Article 56 To apply for examination and approval of matters stipulated in these regulations, the applicants shall submit relative materials and data that can certify their application according with the provisions of these regulations. The examining and approving departments shall make out decision
on approval within 40 days after receiving the application; if approved, issuing approval certificates or mark the approval certificate with notice; if not approved, giving reasons in written form.
The appointed production enterprises and appointed wholesale enterprises shall be primarily confirmed and publicized by the examining and approving departments based on the requirements of distribution through fair competition among the enterprises meeting the conditions in the review. Other qualifi
ed enterprises can make objection to the examining and approving departments within 10 days after the date of publication. The examining and approving departments should make review and make decision on adjustment or not within 20 days after receiving the objection.
Article 57 The drug regulatory departments shall conduct supervision and inspection over the cultivation of original medical plants used for anesthetic drugs and the operations of experimental research, production, distribution, use, storage and transportation of anesthetic drugs and psychoactive dr
ugs with the limit of their duties.
Article 58 The drug regulatory departments under the people’s governments above provincial level shall establish networks of supervision information to conduct real-time supervision over the production, purchase, sales, storage, consumption and flow direction of the anesthetic drugs and psychoactiv
e drugs of the appointed production enterprises, appointed wholesale enterprises and the using units, and share the information with the public security organs at the same level.
Article 59 The appointed production enterprises, appointed wholesale enterprises and the using units of anesthetic drugs and psychoactive drugs having not connected with the supervision information networks shall report the information about the production, purchase, sales, storage, consumption and
flow direction of the anesthetic drugs and psychoactive drugs to the drug regulatory departments and public security departments of the cities subordinating district where they are located every month in e-mail, fax or written forms. The medical institution also should report the information to the
competent health departments under the people’s governments of cities subordinating districts where they are located.
The drug regulatory departments of the cities subordinating districts shall report the relative information about anesthetic drugs and psychoactive drugs in local areas to the higher level drug regulatory departments every 3 months.
Article 60 For those varieties of anesthetic drugs and psychoactive drugs that have been abused or caused serious harm to the society, the drug regulatory department under the State Council shall adopt measures to stop their production, distribution and use with a certain period or limit the scope o
f use. For the anesthetic drugs and psychoactive drugs that have already not be used as medicines, the drug regulatory department under the State Council shall withdraw their pharmaceutical approval registration numbers and standards and make announcement.
Once finding any hidden trouble of safety in management of the anesthetic drugs and psychoactive drugs in the production and distribution enterprises or consuming units, the drug regulatory departments should order them to eliminate such trouble immediately or within limited time period; If there we
re evidence to prove that anesthetic drugs and psychoactive drugs might flow into illegal channels, the drug regulatory departments should adopt administrative coercive measures of sealing up and distraint timely and make decision of administrative handling and notice the security departments at the
equivalent level within 7 days.
Once finding any medical institution holding signature card buying anesthetic drugs and the first class psychoactive drugs not according to the provisions, the drug regulatory department should immediately give notice to the competent health department at the same level. Once received the notice, th
e competent health department should start investigation and treatment. If necessary, the drug regulatory department can order the appointed wholesale enterprises to stop selling anesthetic drugs and the first class psychoactive drugs to this medical institution.
Article 61 The producers, distributors and users of anesthetic drugs and psychoactive drugs should register the expired and damages anesthetic drugs and psychoactive drugs in special records and apply to the local drug regulatory departments at county level for destroying them. The drug regulatory d
epartment shall go to the field to supervise the destruction within 5 days starting from the date of receiving the application. For the expired and damaged anesthetic drugs and psychoactive drugs stored in their institutions, the medical institutions shall apply to the competent health departments f
or destruction according to the procedure prescribed in this article, and the competent health departments will supervise the destruction.
The anesthetic drugs and psychoactive drugs taken over according to law shall be destroyed according related rules and regulations of the state except those used in scientific research as approved by the drug regulatory department or public security department under the State Council.
Article 62 The competent health departments under the people’s government above county level shall supervise and inspect the prescriptions of anesthetic drugs and psychoactive drugs opened by certified physicians.
Article 63 Drug regulatory departments, competent health departments and public security departments shall communicate with each other the list and other management information of the producer, distributors and users of anesthetic drugs and psychoactive drugs.
The drug regulatory departments at different levels shall give notice to the public security departments at the equivalent level about the affairs of examination, approval and withdrawal in different links of management of cultivation of the original medical plants used for anesthetic drugs and the
experimental research, production, distribution, use, storage and transportation of anesthetic drugs and psychoactive drugs.
The proceedings reported by distributors and users of anesthetic drugs and psychoactive drugs to drug regulatory departments at different levels for record also should be reported to the public security department at the same level.
Article 64 Once finding anesthetic drugs and psychoactive drugs are theft, robbed, lost or flow into illegal channels, related units should take countermeasures immediate and report local public security departments at county level and drug regulatory departments. If above cases occur in medical ins
titution, the situation also should be reported to their administrative departments in charge.
Once received the report or evidence on the possibility of anesthetic drugs and psychoactive drugs flowing into illegal channels, the public security departments shall immediately start investigation and adopt necessary control means over related units.
The drug regulatory department, competent health department and other departments related shall cooperate with the public security departments in works.
Chapter VIII Legal Liabilities
Any drug regulatory department and competent health department that violates the provisions of these regulations and commits one of the following acts shall be instructed by the competent authority at the next higher level or the supervisory body to rectify within a time. When the circumstances are
serious, administrative sanctions shall be given to the persons directly in charge and the other persons directly responsible in accordance with law. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.
(I) issuing administrative licenses to the applicants that do no comply with the statutory requirements and making decision to issue administrative licenses beyond its statutory terms of reference;
(II) failing to go to the site to supervise the destruction of expired and damaged anesthetic drugs and psychoactive drugs;
(3) failing to perform its duties on supervision and inspection, failing to find illegal acts that should be found, finding illegal acts but failing to start investigation and treatment timely, or failing to conduct supervision and inspection according to the procedures prescribed in these regulatio
ns;
(4) other delinquency and malfeasance against the provisions of these regulations.
Article 66 Any enterprise cultivating original medical plants used for anesthetic drugs that that violates the provisions of these regulations and commits one of the following acts shall be instructed by drug regulatory department to rectify within a time limit and given warning. If it fails to do s
o, it shall be fined not less than RMB50,000 yuan but not more than RMB100,000 yuan. If the circumstances are serious, the qualifications of the enterprise for cultivation shall be annulled.
(I) failing to cultivate the original medical plants used for anesthetic drugs according to the annual cultivation plan;
(II) failing to report the situation of cultivation according to the provisions;
(III) failing to store anesthetic drugs according to the provisions.
Article 67 Any appointed production enterprise that violates the provisions of these regulations and commits one of the following acts shall be instructed by drug regulatory department to rectify within a time limit and given warning, and the illegal income and drugs illegally sold shall be confisca
ted. If it fails to do so, it shall be instructed to stop production and be fined not less than RMB50,000 yuan but not more than RMB100,000 yuan. If the circumstances are serious, the qualifications of the enterprise for appointed production shall be annulled.
(I) failing to the anesthetic drugs and psychoactive drugs according to the annual production plan;
(II) failing to report to the drug regulatory department the situation of production according to the provisions;
(III) failing to store anesthetic drugs and psychoactive drugs according to the provisions or failing to establish or keep the specialized account books;
(IV) failing to distribute anesthetic drugs and psychoactive drugs according to the provisions;
(V) failing to destroy anesthetic drugs and psychoactive drugs according to the provisions.
Article 68 Any appointed distributor that violates the provisions of these regulations in distributing anesthetic drugs and psychoactive drugs or distributing drugs used as raw materials of anesthetic drugs or the first class psychoactive drugs shall be instructed by drug regulatory department to re
ctify within a time limit and given warning, and the illegal income and drugs illegally sold shall be confiscated. If it fails to do so, it shall be instructed to stop operation and be fined not less than 2 times of the amount of money it get through illegal sales of the drugs but not more than 5 ti
mes of that amount. If the circumstances are serious, the qualifications for appointed distributor shall be annulled.
Article 69 Any appointed distributor that violates the provisions of these regulations and commits one of the following acts shall be instructed by drug regulatory department to rectify within a time limit and given warning. If it fails to do so, it shall be instructed to stop operation and be fined
not less than RMB20,000 yuan but not more than RMB50,000 yuan. If the circumstances are serious, the qualifications for appointed wholesale shall be annulled.
(I) failing to purchase anesthetic drugs and first class psychoactive drugs according to the provisions;
(II) failing to ensure the supply of anesthetic drugs and first class psychoactive drugs to its responsibility area;
(III) failing to perform its obligation to deliver goods to the medical institutions;
(IV) failing to report the purchase, distribution, inventory and flow direction of the anesthetic drugs and psychoactive drugs according to the provisions;
(V) failing to store anesthetic drugs and psychoactive drugs according to the provisions or failing to establish or keep the specialized account books;
(VI) failing to destroy anesthetic drugs and psychoactive drugs according to the provisions;
(VII) violating the provisions of these regulations to coordinating anesthetic drugs and the first class psychoactive drugs among regional distributors or failing to put on record after such coordination under special circumstances.
Article 70 Any retailer of the second class psychoactive drugs that violates the provisions of these regulations in storing, selling or destroying the second class psychoactive drugs shall be instructed by drug regulatory department to rectify within a time limit and given warning, and the illegal i
ncome and drugs illegally sold shall be confiscated. If it fails to do so, it shall be instructed to stop operation and be fined not less than RMB5,000 yuan but not more than RMB20,000 yuan. If the circumstances are serious, the qualifications for retailing the second class psychoactive drugs shall
be annulled.
Article 71 Any unit that violates the provision of article 34 and article 34 of these regulations in buying anesthetic drugs and psychoactive drugs shall be instructed by drug regulatory department to rectify within a time limit and given warning, and the anesthetic drugs and psychoactive drugs it b
ought illegally shall be confiscated. If it fails to do so, it shall be instructed to stop operation and related activities and be fined not less than RMB20,000 yuan but not more than RMB50,000 yuan.
Article 72 Any medical institution with signature card that violates the provisions of these regulations and commits one of the following acts shall be instructed by competent health department under the people’s government of city subordinating districts to rectify within a time limit and given wa
rning. If it fails to do so, it shall be fined not less than RMB5,000 yuan but not more than RMB10,000 yuan. If the circumstances are serious, the signature card shall be revoked. Administrative sanctions including degradation, dismissal and discharge shall be given to the persons directly in charge
and the other persons directly responsible.
(I) failing to buy and store anesthetic and the first class psychoactive drugs according to the regulations;
(II) failing to keep the prescriptions of anesthetic drugs and psychoactive drugs or register the prescriptions according to the regulations;
(III) failing to report the purchase, storage and consumption of anesthetic drugs and psychoactive drugs according to the regulations;
(IV) failing to put on record the emergency borrow and use of anesthetic drugs and the first class psychoactive drugs;
(V) failing to destroy anesthetic drugs and psychoactive drugs according to the regulations.
Article 73 Any certified physician with qualification to open prescription of anesthetic drugs and the first class psychoactive drugs that violates the provisions of these regulations in opening prescription of anesthetic drugs and the first class psychoactive drugs or uses anesthetic drugs and the
first class psychoactive drugs not according with the guideline of clinic use shall be devoted of his qualification to open prescription of anesthetic drugs and the first class psychoactive drugs by the medical institution. If it causes serious consequence, his/her certificate shall be revoked by th
e issuing department. If any certified physician failed to use the second class psychoactive drugs according to the guidelines of clinic use or failed to use the special form to prescribe the second class psychoactive drugs and causes serious consequence, his/her certificate shall be revoked by the
issuing department.
Any certified physician without qualification to open prescription of anesthetic drugs and the first class psychoactive drugs that opens prescription of anesthetic drugs and the first class psychoactive drugs without authorization shall be warned by the competent department under the people’s gover
nment above county level and be instructed to stop operation. If serious consequence occurs, his/her certificate shall be revoked. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.
If any prescription preparer or checker violates the provisions of these regulations and fails to check the prescription of anesthetic drugs and the first class psychoactive drugs and causes serious consequence, his/her certificate shall be revoked by the issuing department.
Article 74 Any transportation unit that violates the provisions of these regulations to transport anesthetic and psychoactive drugs shall be instructed by drug regulatory department and transport regulatory department in their terms of reference to rectify and given warning, and also shall be fined
not less than RMB20,000 yuan but not more than RMB50,000 yuan.
Any postal unit accepting and posting anesthetic drugs and psychoactive drugs that fails to go through the formalities according to the provisions of these regulations shall be instructed to rectify and given warning by the competent postal department. If it causes loss of anesthetic drugs and psych
oactive drugs, it shall be treated according toe postal law and administrative laws and regulations.
Article 75 Any qualification for experimental research, production, distribution and use of anesthetic drugs and psychoactive drugs got through deceiving means such as providing false data, disguising relative information or others shall be withdrawn by the original approving department and related
individual or unit should not submit any application with relation to anesthetic drugs and psychoactive drugs. If the circumstances are serious, related individual shall be fined not less than RMB10,000 yuan but not more than RMB30,000 yuan, and the drug production license, drug distribution license
and medical institution practicing license if any shall be revoked according to law.
Article 76 Any drug research institution engaged in experimental research of common drugs that finds drug varieties controlled by these regulations are generated in the process of the research but does not report according to the provisions of these regulations shall be instructed to rectify and war
ned by the drug regulatory department. The illegal drugs shall be confiscated. If it fails to do so, it shall be instructed to stop operation of experiment and research.
Article 77 Any drug clinic test institution that tests anesthetic drugs and the first class psychoactive drugs on healthy people shall be instructed by the drug regulatory department to stop its illegal conduct and given warning. If the circumstances are serious, its qualification for clinic test of
drugs shall be revoked. If a crime is constituted, criminal liabilities shall be investigated in accordance with law. If the test objectives are harmed, the test institution shall bear the liability for compensation in accordance to law.
Article 78 Any appointed producer, wholesaler or the second class psychoactive drugs retailer that produces or distributes counterfeit or substandard anesthetic and psychoactive drugs shall be revoked its qualification for appointed production, appointed wholesale or retail of the second class psych
oactive drugs by the drug regulatory department and be punished according with relative provisions of the Drug Administration Law.
Article 79 Any appointed producer, appointed wholesaler or any other unit that trade anesthetic drugs and psychoactive drugs with cash shall be instructed by the drug regulatory department to rectify and given warning. The traded drugs shall be confiscated and be fined not less than RMB10,000 yuan b
ut not more than RMB30,000 yuan
Article 80 Any unit that finds anesthetic drugs and psychoactive drugs being theft, robbed or lost but fails to take necessary countermeasures or to report according to the provisions of these regulations shall be instructed the drug regulatory department and the competent health department within t
heir terms of reference to rectify and given warning. If the circumstances are serious, the unit shall be fined not less than RMB5,000 yuan but not more than RMB10,000 yuan. and the drug production license, drug distribution license and medical institution practicing license if any shall be revoked
according to law. If there is competent authority at the next higher level, the authority shall give administrative sanctions including degradation and dismissal to the persons directly in charge and the other persons directly responsible.
Article 81 Any unit getting qualification for cultivating original medical plants used for anesthetic drugs or qualification for research, production, distribution, use and transport of anesthetic drugs and psychoactive drugs according to law that scalps, transfers, leases, lends or alters the licen
se certificate of anesthetic drugs and psychoactive drugs shall be revoked of its certificate and the illegal income shall be confiscated. If the circumstances are serious, the unit shall be fined not less than RMB20,000 yuan but not more than RMB50,000 yuan. If a crime is constituted, criminal liab
ilities shall be investigated in accordance with law.
Article 82 Any unit that violates the provisions of these regulation, making anesthetic drugs and psychoactive drugs flow into illegal channels and exerting harms shall be fined not less than RMB20,000 yuan but not more than RMB50,000 yuan. If a crime is constituted, criminal liabilities shall be in
vestigated in accordance with law. The illegal income shall be confiscated. If the circumstances are serious, it shall be fined not less than 2 times of the illegal income but not more than 5 times of the illegal income. The license certificate for drug production, distribution or use shall be revok
ed by the original issuing department.
Once find any above mentioned cases in their works of supervision and management, the drug regulatory department and competent health regulatory department shall immediately give notice to the local public security department at the equivalent level and shall deliver the cases and related data or ma
terials to the public security department according to relative rules of the state.
Article 83 The administrative punishment given by the drug regulatory department as prescribed in these regulations shall be implemented by the drug regulatory departments above county level in accordance with the terms of reference stipulated by the drug regulatory department under the State Counci
l.
Chapter IX Supplementary Provisions
Article 84 The “experimental research” used in these regulations refers to medical and scientific research and the medicine research before clinic test.
If any family planning service institution that provides clinic medical services with relation to family planning as approved need to use anesthetic drugs and psychoactive drugs, it can do so according to the provisions of these regulations for medical institutions to use anesthetic drugs and psycho
active drugs.
Article 85 The poppy shell listed into the category of anesthetic drugs only can be used in the production of prepared slices of Chinese crude drugs and traditional Chinese medicine preparations and drug preparation for medical treatment. The specific measures shall be stipulated respectively by the
drug regulatory department under the State Council.
Article 86 For the production of compound preparations containing anesthetic drugs, the raw materials of anesthetic drugs shall be purchased, stored and used in accordance with the provisions on the management of anesthetic drugs of these regulations.
Article 87 The specific management measures for the supply and use of anesthetic drugs and psychoactive drugs in the army medical institutions shall be stipulated by the drug regulatory department under the State Council with the General Logistics Department of the PLA according to the provisions of
these regulations.
Article 88 The specific management measures for anesthetic drugs and psychoactive drugs used on animals shall be stipulated by the competent veterinary department under the State Council and the drug regulatory.
Article 89 These regulations shall enter into force on November 1, 2005. The “Measures for the Control of Anesthetic Drugs” promulgated by the State Council on November 28, 1987 and the “Measures for the Control of Psychoactive Drugs” promulgated by the State Council on December 27, 1988 shall b
e abrogated therefrom.
Approved by:MINISTRY OF COMMERCE,PRC |
