Precursor Chemical Management Regulations (Full Text)
Chapter I General Provisions Article 1 In order to strengthen the management of precursor chemicals, regulate the production, operation, purchase, transportation, import and export of precursor chemicals, prevent precursor chemicals from being used in the manufacture of drugs, and maintain the economy. And social order, formulate this regulation.
Article 2 The State shall implement a system of classified management and licensing for the production, management, purchase, transportation, import, and export of precursor chemicals.
Precursor chemicals are divided into three categories. The first type is the main raw material that can be used for making poisons, and the second and third types are chemical formulations that can be used for making poisons. The specific categories and varieties of precursor chemicals are listed in the Schedule to this Regulation.
If the categories and varieties of precursor chemicals need to be adjusted, the public security department of the State Council shall, together with the food and drug supervision and administration department of the State Council, the production safety supervision and management department, the competent commerce department, the competent health department and the General Administration of Customs, submit the plan to the State Council for approval.
The people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are of the opinion that it is necessary to adjust the classification within these administrative regions or to add varieties other than those provided for in these Regulations. They shall propose to the public security department of the State Council, and the public security department of the State Council shall, together with the relevant administrative department of the State Council, propose a plan and report it to the State Council for approval. .
Article 3 Public Security Department of the State Council, Food and Drug Supervision and Administration Department, Work Safety Supervision and Administration Department, Commercial Administration Department, Health Administration Department, General Administration of Customs, Price Administration Department, Railway Administration Department, Traffic Competent Authority, Industry and Commerce Administration Department, and Environmental Protection The competent authorities are responsible for the management of precursor chemicals throughout the country within their respective areas of responsibility. The relevant administrative departments of the local people's governments at or above the county level shall be responsible for the precursor chemicals within their administrative areas within their respective scope of duties. Product management work.
Local people's governments at or above the county level shall strengthen their leadership over the management of precursor chemicals and promptly coordinate and resolve problems in the management of precursor chemicals.
Article 4 The product packaging and instructions for use of precursor chemicals shall indicate the product name (including scientific name and common name), chemical molecular formula and composition.
Article 5 The production, management, purchase, transportation, import, and export of precursor chemicals shall not only comply with the provisions of these Regulations, but also belong to medicines and dangerous chemicals, and shall also abide by laws and other administrative regulations on medicines and dangers. Chemical regulations.
It is forbidden to smuggle or illegally produce, operate, purchase, transfer or transport precursor chemicals.
It is forbidden to use cash or in-kind transactions for precursor chemicals. However, except for individuals who legally purchase pharmaceutical precursor chemicals and the third precursor chemicals in the first category.
Units that manufacture, manage, purchase, transport, import, and export precursor chemicals shall establish a system for the management of precursor chemicals within the unit.
Article 6 The State encourages the public security organs and other relevant administrative authorities to report illegal activities involving precursor chemicals. The department receiving the report shall keep the informer confidential. Where the report is true, the people's government at or above the county level and the relevant administrative department in charge shall reward it.
Chapter II Production and Operational Management Article 7 An application for the production of a precursor chemicals of the first type shall meet the following conditions, and shall be subject to the approval of the competent administrative department as prescribed in Article 8 of these Regulations, and the production license may be used for production. :
(1) A chemical product manufacturing enterprise or a pharmaceutical production enterprise that is legally registered;
(2) There are production facilities, storage facilities and pollutant treatment facilities that meet the national standards;
(3) There are strict safety production management systems and emergency plans for environmental emergencies;
(4) The legal representative of the enterprise and the technical and managerial personnel have relevant knowledge of safety production and precursor chemicals, and there is no record of drug crimes;
(5) Other conditions stipulated by laws, regulations and rules.
To apply for the production of pharmaceutical precursor chemicals in the first category, television monitoring facilities and alarm devices networked with public security agencies should also be set up in key areas such as warehouses.
Article 8 The application for the production of precursor chemicals in the first category of pharmaceuticals shall be subject to the examination and approval of the State Council's food and drug supervision and administration department; the provinces, autonomous regions, and provinces shall apply for the production of non-pharmaceutical precursor chemicals in the first category. The people's government of the municipality directly under the jurisdiction of the People's Government shall have the approval of the production safety supervision and administration department.
The competent administrative department as prescribed in the preceding paragraph shall examine the application materials submitted by the applicant within 60 days from the date of receipt of the application. If a company meets the requirements, it shall be issued a production license, or be marked on the relevant production license that the company has obtained; if it is not approved, the reasons shall be stated in writing.
When reviewing the application materials for the first type of precursor chemicals production licenses, field inspections and expert assessments may be conducted as required.
Article 9 An application for operating the first type of precursor chemicals shall meet the following requirements, and be subject to the approval of the competent administrative department as prescribed in Article 10 of these Regulations, and after obtaining an operating license, it may carry out business operations:
(1) A chemical product operating company or a pharmaceutical business enterprise that is legally registered;
(2) Where there are business premises that conform to the requirements of the State, and where it is necessary to store and keep precursor chemicals, it shall also have storage facilities that meet the national technical standards;
(3) There is a management system for precursor chemicals and a sound sales network;
(4) The legal representatives of the company and the sales and management personnel have relevant knowledge of precursor chemicals, and there are no criminal records of drugs;
(5) Other conditions stipulated by laws, regulations and rules.
Article 10 An application for operating a pharmaceutical precursor chemicals in the first category shall be subject to the examination and approval of the food and drug supervision and administration department of the State Council; the province, autonomous region, and the provincial government shall apply for operating the non-pharmaceutical precursor chemicals in the first category. The people's government of the municipality directly under the jurisdiction of the People's Government shall have the approval of the production safety supervision and administration department.
The administrative department specified in the preceding paragraph shall examine the application materials submitted by the applicant within 30 days from the date of receipt of the application. In case of compliance with the regulations, an operating license shall be issued, or the relevant business license already obtained by the enterprise shall be marked; if it is not permitted, the reasons shall be stated in writing.
When reviewing the application materials for the first type of precursor chemicals business licenses, field inspections may be conducted as required.
Article 11 A production enterprise that has obtained a production license for a precursor chemical of the first category or that has already fulfilled the filing requirements for a second- and third-class precursor chemical product in accordance with the provisions of the first paragraph of Article 13 of these regulations may be resold Production of precursor chemicals. However, if a sales outlet is set up outside the factory to distribute the first type of precursor chemicals, it shall obtain a business license in accordance with the provisions of these Regulations.
Drugs in the first category that are precursor chemicals for precursor chemicals are distributed by designated companies operating narcotic drugs and must not be retailed.
Article 12 An enterprise that has obtained a permit for the production and operation of a precursor chemical of the first category shall, with its production and business license, go to the administrative department for industry and commerce to go through the change of business scope. Without modification registration, the first type of precursor chemicals may not be produced or operated.
Where the production license for Class 1 precursor chemicals is revoked according to law, the competent administrative department shall notify the administration for industry and commerce within 5 days from the date of making the revocation decision; the licensee shall withdraw its license to the administration of industry and commerce in time. The department handles changes in the business scope or the company cancels registration.
Article 13 For the production of Class II or Class III precursor chemicals, the production, variety, quantity, etc., shall be submitted to the local people's government at the city level for safe production supervision within 30 days from the date of production. Management records.
Those operating Type II precursor chemicals shall, within 30 days from the date of operation, report the variety, quantity, and main flow of operations to the local district-level municipal people's government safety production supervision and management department for record; The third type of precursor chemicals shall, within 30 days from the date of operation, record the variety, quantity, and main flow of operations, etc., to the safety production supervision and administration department of the local people's government at the county level.
The competent administrative departments specified in the preceding two paragraphs shall issue a filing certificate on the day of receipt of the filing materials.
Chapter III Purchase Management Article 14 When applying for the purchase of Class I precursor chemicals, the following documents shall be submitted, and the purchase authorization shall be obtained through the examination and approval of the competent administrative department as prescribed in Article 15 of these Regulations:
(1) Proof of the business license required by the operating company to submit its business license and legal use;
(2) Other organizations submit registration certificates (establishment approval documents) and proof of legal use needs.
Article 15 An application for the purchase of precursor chemicals in the first category shall be examined and approved by the food and drug supervision and administration department of the local people's government of the province, autonomous region, or municipality directly under the Central Government; Chemicals shall be examined and approved by the public security organs of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government.
The competent administrative department as prescribed in the preceding paragraph shall examine the application materials and certificates submitted by the applicant within 10 days from the date of receipt of the application. Those who meet the regulations shall be issued with a purchase license; if they do not, the reasons shall be stated in writing.
When reviewing the application materials for the first type of precursor chemicals purchase licenses, field inspections may be conducted as required.
Article 16 A medical institution that holds a narcotic drug or a first-class psychoactive drug purchaser of a seal card purchases a drug precursor chemical in the first category does not need to apply for a purchase license for a precursor chemical in the first category.
Individuals must not purchase Class I or Class II precursor chemicals.
Article 17 For the purchase of Class 2 or Class 3 precursor chemicals, the type and quantity required for purchase shall be filed with the local public security organ at the county level prior to purchase. Individuals who purchase small amounts of potassium permanganate for personal use do not need to be put on record.
Article 18 When operating units sell the first type of precursor chemicals, they shall check the purchase license and the identity certificate of the handler. For entrusted purchasing, the entrustment documents held by the purchaser should also be inspected.
The business unit can only sell the first type of precursor chemicals after checking and keeping the copies of the above certification materials. If any suspicious situation is found, it shall immediately report to the local public security agency.
Article 19 An operating entity shall establish sales ledgers for precursor chemicals, truthfully record the varieties, quantities, dates, purchasers, etc. of the sales. A copy of the sales account and certification materials should be kept for 2 years for future reference.
Sales of Class I precursor chemicals shall be reported to the local public security authorities for record within 5 days from the date of sale. Units using Class I precursor chemicals shall establish and use ledgers and keep them for two years for future reference.
The sales of Type II and Type III precursor chemicals shall be reported to the local public security authorities for record within 30 days from the date of sale.
Chapter IV Transportation Management Article 20 Municipality-level administrative regions (municipalities are cross-municipal boundaries) in cross-district jurisdictions or transporting Class I precursor chemicals across county-level administrative regions in key areas with severe anti-drug situation determined by the public security department of the State Council For those products, they shall be examined and approved by the public security organs of the people's government at the municipal level in the place where they are shipped out; where the second type of precursor chemicals are to be transported, they shall be examined and approved by the public security organs of the people's governments at the county level where they are shipped out. Only after obtaining approval for the transportation of precursor chemicals, can it be transported.
The transportation of Class III precursor chemicals shall be filed with the public security organ of the county-level people's government of the place of export before the transportation. The public security organ shall issue a certificate of registration on the day of receipt of the filing materials.
Article 21 When applying for a license for the transport of precursor chemicals, a purchase and sales contract for chemicals for the production of chemicals shall be submitted. If the owner of the goods is an enterprise, he shall submit a business license; if the owner of the goods is another organization, he shall submit a registration certificate (establishment approval document). The owner is personal and should submit his personal identification. The handler should also submit his identity certificate.
The public security organ shall, within 10 days from the date of receipt of the application for the first type of precursor chemicals transport permit, and within 3 days of receiving the second type of precursor chemical transport permit application, apply the application materials submitted by the applicant. Review. Those who meet the regulations shall be issued a transport license; if they are not permitted, the reasons shall be stated in writing.
When reviewing the application materials for the Type 1 precursor chemicals transport permit, field inspections may be conducted as required.
Article 22 An effective transport permit shall be issued for permitting the transport of Class I precursor chemicals.
For those who are allowed to transport Type II precursor chemicals, a valid transport permit for three months will be issued; if the transport is in good condition within six months, a valid transport permit for 12 months will be issued.
The permit for the production of precursor chemicals shall specify the type, quantity, place of import, the owner and consignee of the precursor chemicals to be transported, the status of the carrier, and the type of transportation permit.
Article 23 Samples of ephedrine under 100 grams for use in teaching and scientific research and small-wrapped ephedrine for use in formulation of medical institutions, and medical institutions or narcotic drug dealers purchase ephedrine tablets below 60,000 tablets, injections l. 50,000 or less, if the owner or carrier holds a clear purchase license or an anesthetic transfer order obtained in accordance with the law, there is no need to apply for a permit to transport precursor chemicals.
Article 24 If the goods are entrusted to be transported by the shipper, the carrier shall check the transport license or record filing certificate provided by the shipper, and check whether the situation of the precursor chemicals contained in the transported goods and the transport license or the record certificate is in line with the situation. Inconsistent, may not be carried.
For the transportation of precursor chemicals, the transport personnel shall carry the transport license or record certification from the beginning of shipment. The public security organs shall carry out inspections during the transportation of precursor chemicals.
The transportation of precursor chemicals shall comply with the State's regulations on the transportation of goods.
Article 25 For the treatment of diseases, patients, near relatives of patients, or persons entrusted by patients may carry the first class of pharmaceutical precursor chemicals with their medical certificates issued by medical institutions and their own identity certificates. Formulations, but must not exceed the maximum dose of a medical prescription.
The maximum dosage of medical prescriptions for leaflets shall be prescribed and announced by the competent health authority of the State Council.
Chapter V Import and Export Administration Article 26 When applying for importing or exporting precursor chemicals, the following materials shall be submitted, and the import shall be subject to examination and approval by the competent commercial authority of the State Council or the competent commerce department of the people's government of the province, autonomous region or municipality directly under the Central Government. Or import licenses may only be used for import and export activities:
(1) A copy of the registration record of the foreign trade operator (certificate of joint inspection by the foreign-funded enterprise);
(b) a copy of the business license;
(3) Production, operation, purchase licenses or record-proof certificates of precursor chemicals;
(4) copies of import or export contracts (agreements);
(5) The identity certification of the handler.
In applying for an export license for precursor chemicals, it is also necessary to submit a certificate for the legal use of precursor chemicals issued by the competent department of the government of the importing country or a guarantee document for the legitimate use of the importer.
Article 27 The competent commerce department that accepts applications for the import or export of precursor chemicals shall, within 20 days from the date of receipt of the application materials, review the application materials and conduct field verification when necessary. In case of compliance with the regulations, an import or export license shall be issued; if it is not approved, the reasons shall be explained in writing.
For import of precursor chemicals in the first category of drugs, the relevant commercial authorities shall obtain the consent of the food and drug supervision and administration department of the State Council before making a licensing decision.
Article 28 Ephedrine and other precursor chemicals that fall within the scope of the key monitoring articles shall be imported and exported by the competent commercial authorities of the State Council in conjunction with the enterprises approved by the relevant departments of the State Council.
Article 29 The State shall implement an international verification system for the import and export of precursor chemicals. The list of international inspections of precursor chemicals and the specific measures for verification shall be prescribed and announced by the competent commerce department of the State Council in conjunction with the public security department of the State Council.
The time used for international verification is not counted within the permit period.
For exporting precursor chemicals to countries or regions with severe drug manufacturing and trafficking conditions, as well as chemicals other than those prescribed in these Regulations, other regulatory measures may be implemented in addition to international verification measures. Specific measures shall be met by the State Council's competent commercial authority and the State Council public security. Departments, the General Administration of Customs and other relevant departments provide and announce.
Article 30 Any import, export or transit, transshipment, or shipment of precursor chemicals shall be truthfully declared to the customs and submitted for import or export licenses. Customs will go through customs formalities with a permit.
The provisions of the preceding paragraph shall apply to precursor chemicals that enter or leave the country outside the bonded areas, export processing zones, or customs special supervision areas or bonded areas.
Where the precursor chemicals are imported and exported between the territory and bonded customs, export processing zones or other special customs supervision areas or bonded sites, or are in or out of the special customs supervision areas or bonded sites mentioned above, there is no need to apply for the import of precursor chemicals or export license.
Imported pharmaceutical precursor chemicals in the first category shall also be submitted to the customs clearance form for imported drugs issued by the food and drug supervision and administration department.
Article 31 Inbound and outbound personnel carrying the precursor chemicals and drug preparations and potassium permanganate in the first category shall be limited to a reasonable amount for their own use and shall be subject to customs supervision.
Persons entering or exiting the country are not allowed to carry precursor chemicals other than those prescribed in the preceding paragraph.
Chapter VI Supervision and Inspection Article 32 Public security organs, food and drug supervision and administration departments, production safety supervision and management departments, commerce departments, health departments, price departments, railway departments, and communications departments of people's governments at or above the county level The administrative departments for industry and commerce, the competent department of environmental protection and the customs shall, in accordance with the provisions of these Regulations and relevant laws and administrative regulations, strengthen the production, operation, purchase, transportation, price, and import of precursor chemicals within their respective scope of duties. And the supervision and inspection of exports; the illegal production, management, purchase, transportation of precursor chemicals, or smuggling of precursor chemicals shall be investigated and dealt with according to law.
The competent administrative department as prescribed in the preceding paragraph may, during the supervision and inspection of precursor chemicals, check the site according to law, consult and copy the relevant materials, record the relevant conditions, seize relevant evidential materials and illegal articles, and if necessary, temporarily seal the relevant sites. .
The unit or individual being inspected shall truthfully provide relevant information, materials and articles and shall not refuse or hide.
Article 33 For the precursor chemicals collected and seized in accordance with law, the precursor chemicals shall be differentiated under the supervision of the public security organs, customs or environmental protection authorities of the people’s governments of provinces, autonomous regions, municipalities directly under the Central Government, or cities divided into districts. The different conditions of the product shall be stored and recycled or, in accordance with the relevant provisions of environmental protection laws and administrative regulations, shall be destroyed by a qualified unit under the supervision of the competent department of environmental protection. Among them, the precursor chemicals that were collected and seized in the first category were all destroyed.
Where an entity or individual that violates the responsibility of precursor chemicals fails to provide the cost of custody, recovery or destruction, the cost of custody, recovery or destruction shall be expended in the proceeds of recovery, or shall be set aside in the anti-drug funds of the relevant administrative department in charge.
Article 34 Where a precursor chemical is lost, stolen or robbed, the case-handling unit shall immediately report it to the local public security organ, and simultaneously report to the local county-level people's government food and drug supervision and management department, and safety production supervision and management department. , commerce authorities or health authorities. The public security organ that receives the report shall file a case for investigation and prosecution in time, and report it to the public security organ at the next higher level; the relevant administrative department in charge shall report it to the public and coordinate with the public security organ for investigation.
Article 35 The relevant competent administrative department shall notify the relevant public security organs and the administrative departments for industry and commerce about the licensing of precursor chemicals and the revocation of the licenses according to law; the administrative departments for industry and commerce shall change the production and management of precursor chemicals companies according to law. Or cancel the registration of the relevant public security organs and administrative departments.
Article 36 Any entity that manufactures, sells, purchases, transports or imports or exports precursor chemicals shall, before March 31st of each year, report to the administrative department in charge of approval or filing with the public security agency and the agency for the record. The production, operation, purchase, transportation or import and export of chemicals; units with conditional production, operation, purchase, transportation, or import or export may establish computer networks with the relevant administrative authorities and promptly report relevant operations.
Article 37 The relevant administrative department of the people's government at or above the county level shall strengthen coordination and cooperation, establish a notification and exchange mechanism for the management of precursor chemicals, supervision and inspection and the handling of cases.
Chapter VII Legal Liabilities Article 38 Anyone who, in violation of the provisions of these Regulations, manufactures, operates, purchases or transports precursor chemicals without permission or records, falsifies the application materials, defrauds the production, operation, purchase or transportation of precursor chemicals. If a permit or use of another person’s forged, altered, or invalid license produces, manages, purchases, or transports precursor chemicals, the public security agency shall confiscate precursor chemicals illegally produced, traded, purchased or transported. The raw materials used to illegally manufacture precursor chemicals and the equipment, tools that illegally produce, manage, purchase, or transport precursor chemicals are at least 10 times the value of precursor chemicals that are illegally produced, sold, purchased, or transported. If the fine is less than twice the value, if the value of goods is less than 10 thousand yuan, a fine of 10,000 yuan shall be imposed; if there is any illegal income, the illegal income shall be confiscated; if there is a business license, the business administration authority shall revoke the business license; if it constitutes a crime, it shall be Be held criminally responsible.
For a unit or individual that has violated the law as prescribed in the preceding paragraph, the relevant administrative department may, within three years from the date of making the administrative penalty decision, stop accepting applications for the manufacture, operation, purchase, transportation, import, or export license of precursor chemicals.
Article 39 Where anyone smuggles precursor chemicals in violation of the provisions of these Regulations, the customs shall confiscate the smuggled precursor chemicals; if there are illegal gains, the illegal gains shall be confiscated and the administrative penalty shall be imposed according to the customs laws and administrative regulations; If a crime is committed, criminal responsibility shall be investigated according to law.
Article 40 Whoever violates the provisions of these Regulations and commits any of the following acts shall be given a warning by the competent administrative department responsible for supervision and administration, ordered to make corrections within a time limit, imposed a fine of 10,000 yuan or more and 50,000 yuan or less; The precursor chemicals that are operated or purchased may be confiscated; if they are not corrected within the time limit, they shall be ordered to suspend production for business for a period of time; if the overdue reorganization fails, the corresponding permit shall be revoked:
(1) Failing to establish a safety management system according to regulations for the production, operation, purchase, transportation, or import or export of precursor chemicals;
(2) the transfer of the permit or the filing certificate to another person's use;
(3) Producing, operating, or purchasing precursor chemicals beyond the permitted varieties or quantities;
(4) The production, business, or purchasing unit does not record or faithfully record the transaction status, does not keep the transaction records according to regulations, or fails to truthfully or timely report the sales situation to the public security organ and relevant administrative department in charge;
(5) The precursor chemicals were lost, stolen, or were not reported promptly after they were robbed, causing serious consequences;
(6) Except for individuals purchasing legitimate precursor chemicals and pharmaceutical preparations in the first category and Class III precursor chemicals, the use of cash or in-kind transactions for precursor chemicals;
(7) The product packaging and instructions for use of precursor chemicals do not comply with the requirements of these Regulations;
(8) The entity that manufactures or manages precursor chemicals does not report the annual production, distribution, inventory, etc. to the relevant competent administrative department and public security organ truthfully or on time.
After an enterprise's production license for precursor chemicals is revoked in accordance with the law, if it fails to go to the administrative department of industry and commerce to change the business scope or cancel the registration of the enterprise in a timely manner, the precursor chemicals shall be confiscated according to the provisions of the preceding paragraph, and a fine shall be imposed concurrently.
Article 41 The precursor chemicals that are transported are inconsistent with the types, quantities, places of import, shippers, consignees, carriers, etc. as stated in the transport permit or recordable proof of the precursor chemicals, and the transport permit. If the type is improper, or the transporter fails to carry the transport permit or registration certificate in full, the public security organ shall order it to stop the rectification, impose a fine of not less than 5,000 yuan and not more than 50,000 yuan, and if the transport of dangerous goods is qualified, the competent transport authority may revoke the same according to law. Transportation qualification.
If individuals carry precursor chemicals that do not meet the requirements for varieties and quantities, precursor chemicals shall be confiscated and fines ranging from 1,000 yuan to 5,000 yuan shall be imposed.
Article 42 Any entity or individual that manufactures, operates, purchases, transports or imports or exports precursor chemicals shall refuse to accept the supervision and inspection of the relevant administrative department in charge, and shall be ordered to correct by the competent administrative department responsible for the supervision and administration. Directly responsible supervisors and other directly responsible personnel shall give warnings; if the circumstances are serious, a fine of 10,000 yuan up to 50,000 yuan shall be imposed on the unit, and the directly responsible person in charge and other directly responsible personnel shall be charged between 1,000 yuan and 5,000 yuan. Penalties; If there are violations of public security management practices, public security management punishments shall be imposed according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
Article 43: In the management work, the staff of the competent administrative department for precursor chemicals shall have the permission to permit the license without permission, and should not permit the license to be abused. It is not admissible for the record according to law, and other acts of abuse of power, dereliction of duty, or favoritism and malpractice are prohibited. Administrative sanctions shall be imposed according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
Chapter VIII Supplementary Provisions Article 44 The licenses for the production, operation, purchase, transportation, import, and export of precursor chemicals shall be stipulated by the competent administrative department of the State Council according to their own duties and shall be supervised by the producer.
Article 45 This Regulation shall come into force on November 1, 2005.
Any entity that has engaged in the production, operation, purchase, transportation, import, or export of precursor chemicals prior to the implementation of this Regulation shall, within six months from the date on which this Regulation is implemented, reapply for permission in accordance with the provisions of these Regulations.
Schedule:
Classification and Classification of Precursor Chemicals Catalogue Category 1 1.1-Phenyl-2-acetone 2.3,4-Methylenedioxyphenyl-2-acetone 3. Piperonal aldehyde 4. Baicalein 5. Scutellariae oil 6. Isosafromine 7.N-acetylanthranilic acid 8. Anthranilic acid 9. Lysergic acid*
10. Ergotamine*
11. Ergometrine*
12. Ephedrine, pseudoephedrine, ephedrine, norephedrine, methylephedrine, ephedra extract, or ephedra extract powder, etc.
The second category 1. Phenylacetic acid 2. Acetic anhydride 3. Chloroform 4. Ether 5. Piperidine The third category 1. Toluene 2. Acetone 3. Methyl ethyl ketone 4. Potassium permanganate 5. Sulfuric acid 6. Hydrochloric acid instructions:
1. Salts that may be present in substances listed in the first and second categories are also included in the regulation.
2. The categories marked with * are the precursor chemicals in the first category, and the precursor chemicals in the first category include APIs and their single preparations.
Chapter I General Provisions Article 1 In order to strengthen the management of precursor chemicals, regulate the production, operation, purchase, transportation, import and export of precursor chemicals, prevent precursor chemicals from being used in the manufacture of drugs, and maintain the economy. And social order, formulate this regulation.
Article 2 The State shall implement a system of classified management and licensing for the production, management, purchase, transportation, import, and export of precursor chemicals.
Precursor chemicals are divided into three categories. The first type is the main raw material that can be used for making poisons, and the second and third types are chemical formulations that can be used for making poisons. The specific categories and varieties of precursor chemicals are listed in the Schedule to this Regulation.
If the categories and varieties of precursor chemicals need to be adjusted, the public security department of the State Council shall, together with the food and drug supervision and administration department of the State Council, the production safety supervision and management department, the competent commerce department, the competent health department and the General Administration of Customs, submit the plan to the State Council for approval.
The people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are of the opinion that it is necessary to adjust the classification within these administrative regions or to add varieties other than those provided for in these Regulations. They shall propose to the public security department of the State Council, and the public security department of the State Council shall, together with the relevant administrative department of the State Council, propose a plan and report it to the State Council for approval. .
Article 3 Public Security Department of the State Council, Food and Drug Supervision and Administration Department, Work Safety Supervision and Administration Department, Commercial Administration Department, Health Administration Department, General Administration of Customs, Price Administration Department, Railway Administration Department, Traffic Competent Authority, Industry and Commerce Administration Department, and Environmental Protection The competent authorities are responsible for the management of precursor chemicals throughout the country within their respective areas of responsibility. The relevant administrative departments of the local people's governments at or above the county level shall be responsible for the precursor chemicals within their administrative areas within their respective scope of duties. Product management work.
Local people's governments at or above the county level shall strengthen their leadership over the management of precursor chemicals and promptly coordinate and resolve problems in the management of precursor chemicals.
Article 4 The product packaging and instructions for use of precursor chemicals shall indicate the product name (including scientific name and common name), chemical molecular formula and composition.
Article 5 The production, management, purchase, transportation, import, and export of precursor chemicals shall not only comply with the provisions of these Regulations, but also belong to medicines and dangerous chemicals, and shall also abide by laws and other administrative regulations on medicines and dangers. Chemical regulations.
It is forbidden to smuggle or illegally produce, operate, purchase, transfer or transport precursor chemicals.
It is forbidden to use cash or in-kind transactions for precursor chemicals. However, except for individuals who legally purchase pharmaceutical precursor chemicals and the third precursor chemicals in the first category.
Units that manufacture, manage, purchase, transport, import, and export precursor chemicals shall establish a system for the management of precursor chemicals within the unit.
Article 6 The State encourages the public security organs and other relevant administrative authorities to report illegal activities involving precursor chemicals. The department receiving the report shall keep the informer confidential. Where the report is true, the people's government at or above the county level and the relevant administrative department in charge shall reward it.
Chapter II Production and Operational Management Article 7 An application for the production of a precursor chemicals of the first type shall meet the following conditions, and shall be subject to the approval of the competent administrative department as prescribed in Article 8 of these Regulations, and the production license may be used for production. :
(1) A chemical product manufacturing enterprise or a pharmaceutical production enterprise that is legally registered;
(2) There are production facilities, storage facilities and pollutant treatment facilities that meet the national standards;
(3) There are strict safety production management systems and emergency plans for environmental emergencies;
(4) The legal representative of the enterprise and the technical and managerial personnel have relevant knowledge of safety production and precursor chemicals, and there is no record of drug crimes;
(5) Other conditions stipulated by laws, regulations and rules.
To apply for the production of pharmaceutical precursor chemicals in the first category, television monitoring facilities and alarm devices networked with public security agencies should also be set up in key areas such as warehouses.
Article 8 The application for the production of precursor chemicals in the first category of pharmaceuticals shall be subject to the examination and approval of the State Council's food and drug supervision and administration department; the provinces, autonomous regions, and provinces shall apply for the production of non-pharmaceutical precursor chemicals in the first category. The people's government of the municipality directly under the jurisdiction of the People's Government shall have the approval of the production safety supervision and administration department.
The competent administrative department as prescribed in the preceding paragraph shall examine the application materials submitted by the applicant within 60 days from the date of receipt of the application. If a company meets the requirements, it shall be issued a production license, or be marked on the relevant production license that the company has obtained; if it is not approved, the reasons shall be stated in writing.
When reviewing the application materials for the first type of precursor chemicals production licenses, field inspections and expert assessments may be conducted as required.
Article 9 An application for operating the first type of precursor chemicals shall meet the following requirements, and be subject to the approval of the competent administrative department as prescribed in Article 10 of these Regulations, and after obtaining an operating license, it may carry out business operations:
(1) A chemical product operating company or a pharmaceutical business enterprise that is legally registered;
(2) Where there are business premises that conform to the requirements of the State, and where it is necessary to store and keep precursor chemicals, it shall also have storage facilities that meet the national technical standards;
(3) There is a management system for precursor chemicals and a sound sales network;
(4) The legal representatives of the company and the sales and management personnel have relevant knowledge of precursor chemicals, and there are no criminal records of drugs;
(5) Other conditions stipulated by laws, regulations and rules.
Article 10 An application for operating a pharmaceutical precursor chemicals in the first category shall be subject to the examination and approval of the food and drug supervision and administration department of the State Council; the province, autonomous region, and the provincial government shall apply for operating the non-pharmaceutical precursor chemicals in the first category. The people's government of the municipality directly under the jurisdiction of the People's Government shall have the approval of the production safety supervision and administration department.
The administrative department specified in the preceding paragraph shall examine the application materials submitted by the applicant within 30 days from the date of receipt of the application. In case of compliance with the regulations, an operating license shall be issued, or the relevant business license already obtained by the enterprise shall be marked; if it is not permitted, the reasons shall be stated in writing.
When reviewing the application materials for the first type of precursor chemicals business licenses, field inspections may be conducted as required.
Article 11 A production enterprise that has obtained a production license for a precursor chemical of the first category or that has already fulfilled the filing requirements for a second- and third-class precursor chemical product in accordance with the provisions of the first paragraph of Article 13 of these regulations may be resold Production of precursor chemicals. However, if a sales outlet is set up outside the factory to distribute the first type of precursor chemicals, it shall obtain a business license in accordance with the provisions of these Regulations.
Drugs in the first category that are precursor chemicals for precursor chemicals are distributed by designated companies operating narcotic drugs and must not be retailed.
Article 12 An enterprise that has obtained a permit for the production and operation of a precursor chemical of the first category shall, with its production and business license, go to the administrative department for industry and commerce to go through the change of business scope. Without modification registration, the first type of precursor chemicals may not be produced or operated.
Where the production license for Class 1 precursor chemicals is revoked according to law, the competent administrative department shall notify the administration for industry and commerce within 5 days from the date of making the revocation decision; the licensee shall withdraw its license to the administration of industry and commerce in time. The department handles changes in the business scope or the company cancels registration.
Article 13 For the production of Class II or Class III precursor chemicals, the production, variety, quantity, etc., shall be submitted to the local people's government at the city level for safe production supervision within 30 days from the date of production. Management records.
Those operating Type II precursor chemicals shall, within 30 days from the date of operation, report the variety, quantity, and main flow of operations to the local district-level municipal people's government safety production supervision and management department for record; The third type of precursor chemicals shall, within 30 days from the date of operation, record the variety, quantity, and main flow of operations, etc., to the safety production supervision and administration department of the local people's government at the county level.
The competent administrative departments specified in the preceding two paragraphs shall issue a filing certificate on the day of receipt of the filing materials.
Chapter III Purchase Management Article 14 When applying for the purchase of Class I precursor chemicals, the following documents shall be submitted, and the purchase authorization shall be obtained through the examination and approval of the competent administrative department as prescribed in Article 15 of these Regulations:
(1) Proof of the business license required by the operating company to submit its business license and legal use;
(2) Other organizations submit registration certificates (establishment approval documents) and proof of legal use needs.
Article 15 An application for the purchase of precursor chemicals in the first category shall be examined and approved by the food and drug supervision and administration department of the local people's government of the province, autonomous region, or municipality directly under the Central Government; Chemicals shall be examined and approved by the public security organs of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government.
The competent administrative department as prescribed in the preceding paragraph shall examine the application materials and certificates submitted by the applicant within 10 days from the date of receipt of the application. Those who meet the regulations shall be issued with a purchase license; if they do not, the reasons shall be stated in writing.
When reviewing the application materials for the first type of precursor chemicals purchase licenses, field inspections may be conducted as required.
Article 16 A medical institution that holds a narcotic drug or a first-class psychoactive drug purchaser of a seal card purchases a drug precursor chemical in the first category does not need to apply for a purchase license for a precursor chemical in the first category.
Individuals must not purchase Class I or Class II precursor chemicals.
Article 17 For the purchase of Class 2 or Class 3 precursor chemicals, the type and quantity required for purchase shall be filed with the local public security organ at the county level prior to purchase. Individuals who purchase small amounts of potassium permanganate for personal use do not need to be put on record.
Article 18 When operating units sell the first type of precursor chemicals, they shall check the purchase license and the identity certificate of the handler. For entrusted purchasing, the entrustment documents held by the purchaser should also be inspected.
The business unit can only sell the first type of precursor chemicals after checking and keeping the copies of the above certification materials. If any suspicious situation is found, it shall immediately report to the local public security agency.
Article 19 An operating entity shall establish sales ledgers for precursor chemicals, truthfully record the varieties, quantities, dates, purchasers, etc. of the sales. A copy of the sales account and certification materials should be kept for 2 years for future reference.
Sales of Class I precursor chemicals shall be reported to the local public security authorities for record within 5 days from the date of sale. Units using Class I precursor chemicals shall establish and use ledgers and keep them for two years for future reference.
The sales of Type II and Type III precursor chemicals shall be reported to the local public security authorities for record within 30 days from the date of sale.
Chapter IV Transportation Management Article 20 Municipality-level administrative regions (municipalities are cross-municipal boundaries) in cross-district jurisdictions or transporting Class I precursor chemicals across county-level administrative regions in key areas with severe anti-drug situation determined by the public security department of the State Council For those products, they shall be examined and approved by the public security organs of the people's government at the municipal level in the place where they are shipped out; where the second type of precursor chemicals are to be transported, they shall be examined and approved by the public security organs of the people's governments at the county level where they are shipped out. Only after obtaining approval for the transportation of precursor chemicals, can it be transported.
The transportation of Class III precursor chemicals shall be filed with the public security organ of the county-level people's government of the place of export before the transportation. The public security organ shall issue a certificate of registration on the day of receipt of the filing materials.
Article 21 When applying for a license for the transport of precursor chemicals, a purchase and sales contract for chemicals for the production of chemicals shall be submitted. If the owner of the goods is an enterprise, he shall submit a business license; if the owner of the goods is another organization, he shall submit a registration certificate (establishment approval document). The owner is personal and should submit his personal identification. The handler should also submit his identity certificate.
The public security organ shall, within 10 days from the date of receipt of the application for the first type of precursor chemicals transport permit, and within 3 days of receiving the second type of precursor chemical transport permit application, apply the application materials submitted by the applicant. Review. Those who meet the regulations shall be issued a transport license; if they are not permitted, the reasons shall be stated in writing.
When reviewing the application materials for the Type 1 precursor chemicals transport permit, field inspections may be conducted as required.
Article 22 An effective transport permit shall be issued for permitting the transport of Class I precursor chemicals.
For those who are allowed to transport Type II precursor chemicals, a valid transport permit for three months will be issued; if the transport is in good condition within six months, a valid transport permit for 12 months will be issued.
The permit for the production of precursor chemicals shall specify the type, quantity, place of import, the owner and consignee of the precursor chemicals to be transported, the status of the carrier, and the type of transportation permit.
Article 23 Samples of ephedrine under 100 grams for use in teaching and scientific research and small-wrapped ephedrine for use in formulation of medical institutions, and medical institutions or narcotic drug dealers purchase ephedrine tablets below 60,000 tablets, injections l. 50,000 or less, if the owner or carrier holds a clear purchase license or an anesthetic transfer order obtained in accordance with the law, there is no need to apply for a permit to transport precursor chemicals.
Article 24 If the goods are entrusted to be transported by the shipper, the carrier shall check the transport license or record filing certificate provided by the shipper, and check whether the situation of the precursor chemicals contained in the transported goods and the transport license or the record certificate is in line with the situation. Inconsistent, may not be carried.
For the transportation of precursor chemicals, the transport personnel shall carry the transport license or record certification from the beginning of shipment. The public security organs shall carry out inspections during the transportation of precursor chemicals.
The transportation of precursor chemicals shall comply with the State's regulations on the transportation of goods.
Article 25 For the treatment of diseases, patients, near relatives of patients, or persons entrusted by patients may carry the first class of pharmaceutical precursor chemicals with their medical certificates issued by medical institutions and their own identity certificates. Formulations, but must not exceed the maximum dose of a medical prescription.
The maximum dosage of medical prescriptions for leaflets shall be prescribed and announced by the competent health authority of the State Council.
Chapter V Import and Export Administration Article 26 When applying for importing or exporting precursor chemicals, the following materials shall be submitted, and the import shall be subject to examination and approval by the competent commercial authority of the State Council or the competent commerce department of the people's government of the province, autonomous region or municipality directly under the Central Government. Or import licenses may only be used for import and export activities:
(1) A copy of the registration record of the foreign trade operator (certificate of joint inspection by the foreign-funded enterprise);
(b) a copy of the business license;
(3) Production, operation, purchase licenses or record-proof certificates of precursor chemicals;
(4) copies of import or export contracts (agreements);
(5) The identity certification of the handler.
In applying for an export license for precursor chemicals, it is also necessary to submit a certificate for the legal use of precursor chemicals issued by the competent department of the government of the importing country or a guarantee document for the legitimate use of the importer.
Article 27 The competent commerce department that accepts applications for the import or export of precursor chemicals shall, within 20 days from the date of receipt of the application materials, review the application materials and conduct field verification when necessary. In case of compliance with the regulations, an import or export license shall be issued; if it is not approved, the reasons shall be explained in writing.
For import of precursor chemicals in the first category of drugs, the relevant commercial authorities shall obtain the consent of the food and drug supervision and administration department of the State Council before making a licensing decision.
Article 28 Ephedrine and other precursor chemicals that fall within the scope of the key monitoring articles shall be imported and exported by the competent commercial authorities of the State Council in conjunction with the enterprises approved by the relevant departments of the State Council.
Article 29 The State shall implement an international verification system for the import and export of precursor chemicals. The list of international inspections of precursor chemicals and the specific measures for verification shall be prescribed and announced by the competent commerce department of the State Council in conjunction with the public security department of the State Council.
The time used for international verification is not counted within the permit period.
For exporting precursor chemicals to countries or regions with severe drug manufacturing and trafficking conditions, as well as chemicals other than those prescribed in these Regulations, other regulatory measures may be implemented in addition to international verification measures. Specific measures shall be met by the State Council's competent commercial authority and the State Council public security. Departments, the General Administration of Customs and other relevant departments provide and announce.
Article 30 Any import, export or transit, transshipment, or shipment of precursor chemicals shall be truthfully declared to the customs and submitted for import or export licenses. Customs will go through customs formalities with a permit.
The provisions of the preceding paragraph shall apply to precursor chemicals that enter or leave the country outside the bonded areas, export processing zones, or customs special supervision areas or bonded areas.
Where the precursor chemicals are imported and exported between the territory and bonded customs, export processing zones or other special customs supervision areas or bonded sites, or are in or out of the special customs supervision areas or bonded sites mentioned above, there is no need to apply for the import of precursor chemicals or export license.
Imported pharmaceutical precursor chemicals in the first category shall also be submitted to the customs clearance form for imported drugs issued by the food and drug supervision and administration department.
Article 31 Inbound and outbound personnel carrying the precursor chemicals and drug preparations and potassium permanganate in the first category shall be limited to a reasonable amount for their own use and shall be subject to customs supervision.
Persons entering or exiting the country are not allowed to carry precursor chemicals other than those prescribed in the preceding paragraph.
Chapter VI Supervision and Inspection Article 32 Public security organs, food and drug supervision and administration departments, production safety supervision and management departments, commerce departments, health departments, price departments, railway departments, and communications departments of people's governments at or above the county level The administrative departments for industry and commerce, the competent department of environmental protection and the customs shall, in accordance with the provisions of these Regulations and relevant laws and administrative regulations, strengthen the production, operation, purchase, transportation, price, and import of precursor chemicals within their respective scope of duties. And the supervision and inspection of exports; the illegal production, management, purchase, transportation of precursor chemicals, or smuggling of precursor chemicals shall be investigated and dealt with according to law.
The competent administrative department as prescribed in the preceding paragraph may, during the supervision and inspection of precursor chemicals, check the site according to law, consult and copy the relevant materials, record the relevant conditions, seize relevant evidential materials and illegal articles, and if necessary, temporarily seal the relevant sites. .
The unit or individual being inspected shall truthfully provide relevant information, materials and articles and shall not refuse or hide.
Article 33 For the precursor chemicals collected and seized in accordance with law, the precursor chemicals shall be differentiated under the supervision of the public security organs, customs or environmental protection authorities of the people’s governments of provinces, autonomous regions, municipalities directly under the Central Government, or cities divided into districts. The different conditions of the product shall be stored and recycled or, in accordance with the relevant provisions of environmental protection laws and administrative regulations, shall be destroyed by a qualified unit under the supervision of the competent department of environmental protection. Among them, the precursor chemicals that were collected and seized in the first category were all destroyed.
Where an entity or individual that violates the responsibility of precursor chemicals fails to provide the cost of custody, recovery or destruction, the cost of custody, recovery or destruction shall be expended in the proceeds of recovery, or shall be set aside in the anti-drug funds of the relevant administrative department in charge.
Article 34 Where a precursor chemical is lost, stolen or robbed, the case-handling unit shall immediately report it to the local public security organ, and simultaneously report to the local county-level people's government food and drug supervision and management department, and safety production supervision and management department. , commerce authorities or health authorities. The public security organ that receives the report shall file a case for investigation and prosecution in time, and report it to the public security organ at the next higher level; the relevant administrative department in charge shall report it to the public and coordinate with the public security organ for investigation.
Article 35 The relevant competent administrative department shall notify the relevant public security organs and the administrative departments for industry and commerce about the licensing of precursor chemicals and the revocation of the licenses according to law; the administrative departments for industry and commerce shall change the production and management of precursor chemicals companies according to law. Or cancel the registration of the relevant public security organs and administrative departments.
Article 36 Any entity that manufactures, sells, purchases, transports or imports or exports precursor chemicals shall, before March 31st of each year, report to the administrative department in charge of approval or filing with the public security agency and the agency for the record. The production, operation, purchase, transportation or import and export of chemicals; units with conditional production, operation, purchase, transportation, or import or export may establish computer networks with the relevant administrative authorities and promptly report relevant operations.
Article 37 The relevant administrative department of the people's government at or above the county level shall strengthen coordination and cooperation, establish a notification and exchange mechanism for the management of precursor chemicals, supervision and inspection and the handling of cases.
Chapter VII Legal Liabilities Article 38 Anyone who, in violation of the provisions of these Regulations, manufactures, operates, purchases or transports precursor chemicals without permission or records, falsifies the application materials, defrauds the production, operation, purchase or transportation of precursor chemicals. If a permit or use of another person’s forged, altered, or invalid license produces, manages, purchases, or transports precursor chemicals, the public security agency shall confiscate precursor chemicals illegally produced, traded, purchased or transported. The raw materials used to illegally manufacture precursor chemicals and the equipment, tools that illegally produce, manage, purchase, or transport precursor chemicals are at least 10 times the value of precursor chemicals that are illegally produced, sold, purchased, or transported. If the fine is less than twice the value, if the value of goods is less than 10 thousand yuan, a fine of 10,000 yuan shall be imposed; if there is any illegal income, the illegal income shall be confiscated; if there is a business license, the business administration authority shall revoke the business license; if it constitutes a crime, it shall be Be held criminally responsible.
For a unit or individual that has violated the law as prescribed in the preceding paragraph, the relevant administrative department may, within three years from the date of making the administrative penalty decision, stop accepting applications for the manufacture, operation, purchase, transportation, import, or export license of precursor chemicals.
Article 39 Where anyone smuggles precursor chemicals in violation of the provisions of these Regulations, the customs shall confiscate the smuggled precursor chemicals; if there are illegal gains, the illegal gains shall be confiscated and the administrative penalty shall be imposed according to the customs laws and administrative regulations; If a crime is committed, criminal responsibility shall be investigated according to law.
Article 40 Whoever violates the provisions of these Regulations and commits any of the following acts shall be given a warning by the competent administrative department responsible for supervision and administration, ordered to make corrections within a time limit, imposed a fine of 10,000 yuan or more and 50,000 yuan or less; The precursor chemicals that are operated or purchased may be confiscated; if they are not corrected within the time limit, they shall be ordered to suspend production for business for a period of time; if the overdue reorganization fails, the corresponding permit shall be revoked:
(1) Failing to establish a safety management system according to regulations for the production, operation, purchase, transportation, or import or export of precursor chemicals;
(2) the transfer of the permit or the filing certificate to another person's use;
(3) Producing, operating, or purchasing precursor chemicals beyond the permitted varieties or quantities;
(4) The production, business, or purchasing unit does not record or faithfully record the transaction status, does not keep the transaction records according to regulations, or fails to truthfully or timely report the sales situation to the public security organ and relevant administrative department in charge;
(5) The precursor chemicals were lost, stolen, or were not reported promptly after they were robbed, causing serious consequences;
(6) Except for individuals purchasing legitimate precursor chemicals and pharmaceutical preparations in the first category and Class III precursor chemicals, the use of cash or in-kind transactions for precursor chemicals;
(7) The product packaging and instructions for use of precursor chemicals do not comply with the requirements of these Regulations;
(8) The entity that manufactures or manages precursor chemicals does not report the annual production, distribution, inventory, etc. to the relevant competent administrative department and public security organ truthfully or on time.
After an enterprise's production license for precursor chemicals is revoked in accordance with the law, if it fails to go to the administrative department of industry and commerce to change the business scope or cancel the registration of the enterprise in a timely manner, the precursor chemicals shall be confiscated according to the provisions of the preceding paragraph, and a fine shall be imposed concurrently.
Article 41 The precursor chemicals that are transported are inconsistent with the types, quantities, places of import, shippers, consignees, carriers, etc. as stated in the transport permit or recordable proof of the precursor chemicals, and the transport permit. If the type is improper, or the transporter fails to carry the transport permit or registration certificate in full, the public security organ shall order it to stop the rectification, impose a fine of not less than 5,000 yuan and not more than 50,000 yuan, and if the transport of dangerous goods is qualified, the competent transport authority may revoke the same according to law. Transportation qualification.
If individuals carry precursor chemicals that do not meet the requirements for varieties and quantities, precursor chemicals shall be confiscated and fines ranging from 1,000 yuan to 5,000 yuan shall be imposed.
Article 42 Any entity or individual that manufactures, operates, purchases, transports or imports or exports precursor chemicals shall refuse to accept the supervision and inspection of the relevant administrative department in charge, and shall be ordered to correct by the competent administrative department responsible for the supervision and administration. Directly responsible supervisors and other directly responsible personnel shall give warnings; if the circumstances are serious, a fine of 10,000 yuan up to 50,000 yuan shall be imposed on the unit, and the directly responsible person in charge and other directly responsible personnel shall be charged between 1,000 yuan and 5,000 yuan. Penalties; If there are violations of public security management practices, public security management punishments shall be imposed according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
Article 43: In the management work, the staff of the competent administrative department for precursor chemicals shall have the permission to permit the license without permission, and should not permit the license to be abused. It is not admissible for the record according to law, and other acts of abuse of power, dereliction of duty, or favoritism and malpractice are prohibited. Administrative sanctions shall be imposed according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
Chapter VIII Supplementary Provisions Article 44 The licenses for the production, operation, purchase, transportation, import, and export of precursor chemicals shall be stipulated by the competent administrative department of the State Council according to their own duties and shall be supervised by the producer.
Article 45 This Regulation shall come into force on November 1, 2005.
Any entity that has engaged in the production, operation, purchase, transportation, import, or export of precursor chemicals prior to the implementation of this Regulation shall, within six months from the date on which this Regulation is implemented, reapply for permission in accordance with the provisions of these Regulations.
Schedule:
Classification and Classification of Precursor Chemicals Catalogue Category 1 1.1-Phenyl-2-acetone 2.3,4-Methylenedioxyphenyl-2-acetone 3. Piperonal aldehyde 4. Baicalein 5. Scutellariae oil 6. Isosafromine 7.N-acetylanthranilic acid 8. Anthranilic acid 9. Lysergic acid*
10. Ergotamine*
11. Ergometrine*
12. Ephedrine, pseudoephedrine, ephedrine, norephedrine, methylephedrine, ephedra extract, or ephedra extract powder, etc.
The second category 1. Phenylacetic acid 2. Acetic anhydride 3. Chloroform 4. Ether 5. Piperidine The third category 1. Toluene 2. Acetone 3. Methyl ethyl ketone 4. Potassium permanganate 5. Sulfuric acid 6. Hydrochloric acid instructions:
1. Salts that may be present in substances listed in the first and second categories are also included in the regulation.
2. The categories marked with * are the precursor chemicals in the first category, and the precursor chemicals in the first category include APIs and their single preparations.
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