News Information

(Promulgated on August 26, 2005 by Order No. 445 of the State Council of the People's Republic of China, revised for the first time in accordance with the "Decision of the State Council on Amending Certain Administrative Regulations" on July 29, 2014, revised for the second time in accordance with the "Decision of the State Council on Amending Certain Administrative Regulations" on February 6, 2016, revised for the third time in accordance with the "Decision of the State Council on Amending Certain Administrative Regulations" on September 18, 2018)

Chapter I General Provisions

Article 1 These Regulations are formulated 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 to manufacture drugs, and maintain economic and social order.

Article 2 The state implements a classified management and licensing system for the production, operation, purchase, transportation, import and export of precursor chemicals.

Precursor chemicals are divided into three categories. The first category is the main raw materials that can be used to make drugs, and the second and third categories are chemical additives that can be used to make drugs. The specific classifications and varieties of precursor chemicals are listed in the appendix to these Regulations.

If the classification and variety of precursor chemicals need to be adjusted, the public security department of the State Council shall, together with the drug supervision and administration department, production safety supervision and administration department, commerce department, health department and the General Administration of Customs of the State Council, propose a plan and submit it to the State Council for approval.

If the people's governments of provinces, autonomous regions and municipalities directly under the Central Government deem it necessary to adjust the classification or add varieties other than those specified in these Regulations within their administrative regions, they shall submit a proposal to the public security department of the State Council, which shall, together with the relevant administrative departments of the State Council, propose a plan and submit it to the State Council for approval.

Article 3 The public security department, drug supervision and administration department, production safety supervision and administration department, commerce department, health department, General Administration of Customs, price department, railway department, transportation department, market supervision department and ecological environment department of the State Council shall be responsible for the relevant management of precursor chemicals throughout the country within their respective responsibilities; the relevant administrative departments of local people's governments at or above the county level shall be responsible for the relevant management of precursor chemicals within their administrative regions within their respective responsibilities.

Local people's governments at or above the county level shall strengthen leadership over the management of precursor chemicals and coordinate and solve problems in the management of precursor chemicals in a timely manner.

Article 4 The product packaging and instructions for use of precursor chemicals shall indicate the product name (including scientific name and common name), chemical formula and composition.

Article 5 In addition to complying with the provisions of these Regulations, the production, operation, purchase, transportation, import and export of precursor chemicals, if they are drugs and dangerous chemicals, shall also comply with the relevant provisions of laws and other administrative regulations on drugs and dangerous chemicals.

It is prohibited to smuggle or illegally produce, operate, purchase, transfer and transport precursor chemicals.

It is prohibited to use cash or physical objects to trade precursor chemicals. However, individuals legally purchase pharmaceutical preparations of pharmaceutical precursor chemicals in the first category and precursor chemicals in the third category.

Units that produce, operate, purchase, transport, import and export precursor chemicals shall establish an internal precursor chemical management system.

Article 6 The state encourages reporting of illegal acts involving precursor chemicals to the public security organs and other relevant administrative departments. The department receiving the report shall keep the reporter confidential. If the report is true, the people's government at or above the county level and the relevant administrative departments shall give rewards.

Chapter II Production, Operation and Management

Article 7 Applications for the production of Category I precursor chemicals shall meet the following conditions and be subject to approval by the administrative department specified in Article 8 of these Regulations. Production may only be carried out after obtaining a production license:

(i) A chemical product manufacturer or pharmaceutical manufacturer registered in accordance with the law;

(ii) Having production equipment, storage facilities and pollutant treatment facilities that meet national standards;

(iii) Having a strict production safety management system and emergency plans for environmental emergencies;

(iv) The legal representative and technical and management personnel of the enterprise have relevant knowledge of production safety and precursor chemicals and have no drug-related criminal records;

(v) Other conditions specified by laws, regulations and rules.

Applicants for the production of Category I pharmaceutical precursor chemicals shall also install television monitoring facilities and alarm devices connected to the public security organs in key areas such as storage sites.

Article 8 Applications for the production of the first category of pharmaceutical precursor chemicals shall be approved by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government; applications for the production of the first category of non-pharmaceutical precursor chemicals shall be approved by the work safety supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.

The administrative departments specified in the preceding paragraph shall review the application materials submitted by the applicant within 60 days from the date of receipt of the application. For those that meet the requirements, a production license shall be issued, or the license shall be marked on the relevant production license that the enterprise has obtained; if the license is not granted, the reasons shall be stated in writing.

When reviewing the application materials for the production license of the first category of precursor chemicals, on-site verification and expert review may be carried out as needed.

Article 9: To apply for the operation of the first category of precursor chemicals, the following conditions shall be met and the operation may only be carried out after approval by the administrative department specified in Article 10 of these Regulations and obtaining a business license:

(1) A chemical product business enterprise or a pharmaceutical business enterprise registered in accordance with the law;

(2) Having a business site that complies with national regulations, and if it needs to store and keep precursor chemicals, it shall also have storage facilities that meet national technical standards;

(3) Having a business management system and a sound sales network for precursor chemicals;

(4) The legal representative of the enterprise and the sales and management personnel have relevant knowledge of precursor chemicals and have no drug crime record;

(5) Other conditions specified by laws, regulations and rules.

Article 10: Applications for the operation of the first category of pharmaceutical precursor chemicals shall be approved by the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government; applications for the operation of the first category of non-pharmaceutical precursor chemicals shall be approved by the work safety supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government.

The administrative department specified in the preceding paragraph shall review the application materials submitted by the applicant within 30 days from the date of receipt of the application. For those that meet the requirements, a business license shall be issued, or the license shall be marked on the relevant business license that the enterprise has obtained; if the license is not granted, the reasons shall be stated in writing.

When reviewing the application materials for the business license of the first category of precursor chemicals, on-site verification may be carried out as needed.

Article 11 A production enterprise that has obtained a production license for the first category of precursor chemicals or has completed the registration procedures for the second and third category of precursor chemicals in accordance with the first paragraph of Article 13 of these Regulations may distribute the precursor chemicals produced by itself. However, if a sales outlet is established outside the factory to distribute the first category of precursor chemicals, a business license shall be obtained in accordance with the provisions of these Regulations.

The single-prescription preparations of pharmaceutical precursor chemicals in the first category shall be distributed by designated narcotic drug operating enterprises and shall not be sold in retail.

Article 12 An enterprise that has obtained a production and operation license for the first category of precursor chemicals shall go to the market supervision and management department to register the change of business scope with its production and operation license. Without change registration, the production and operation of the first category of precursor chemicals shall not be carried out.

If the production and operation license of the first category of precursor chemicals is revoked according to law, the administrative department shall notify the market supervision and management department within 5 days from the date of making the revocation decision; the enterprise whose license is revoked shall promptly go to the market supervision and management department to handle the change of business scope or enterprise cancellation registration.

Article 13: If the second and third category precursor chemicals are produced, the varieties and quantities of production shall be filed with the local municipal people's government safety supervision and management department within 30 days from the date of production.

If the second category of precursor chemicals are operated, the varieties, quantities, main flows, etc. of the operation shall be filed with the local municipal people's government safety supervision and management department within 30 days from the date of operation; if the third category of precursor chemicals are operated, the varieties, quantities, main flows, etc. of the operation shall be filed with the local county people's government safety supervision and management department within 30 days from the date of operation.

The administrative department specified in the first two paragraphs shall issue a registration certificate on the day of receiving the registration materials.

Chapter III Purchase Management

Article 14: To apply for the purchase of the first category of precursor chemicals, the following documents shall be submitted and approved by the administrative department specified in Article 15 of these Regulations to obtain a purchase license:

(i) Business enterprises shall submit business licenses and proof of legal use needs;

(ii) Other organizations shall submit registration certificates (establishment approval documents) and proof of legal use needs.

Article 15: Applications for the purchase of the first category of pharmaceutical precursor chemicals shall be approved by the drug supervision and administration departments of the provincial, autonomous regional and municipal people's governments where they are located; applications for the purchase of the first category of non-pharmaceutical precursor chemicals shall be approved by the public security organs of the provincial, autonomous regional and municipal people's governments where they are located.

The administrative department specified in the preceding paragraph shall review the application materials and documents submitted by the applicant within 10 days from the date of receipt of the application. A purchase license shall be issued to those who meet the requirements; if the license is not granted, the reasons shall be stated in writing.

When reviewing the application materials for the purchase license of the first category of precursor chemicals, on-site verification may be carried out as needed.

Article 16: Medical institutions holding the purchase seal card for narcotic drugs and first-class psychotropic drugs do not need to apply for a purchase license for first-class precursor chemicals when purchasing pharmaceutical precursor chemicals in the first class.

Individuals are not allowed to purchase first-class and second-class precursor chemicals.

Article 17: When purchasing second-class and third-class precursor chemicals, the types and quantities to be purchased shall be registered with the public security organs of the county-level people's government where they are located before purchase. Individuals who purchase a small amount of potassium permanganate for their own use do not need to register.

Article 18: When selling first-class precursor chemicals, business units shall check the purchase license and the identity certificate of the person handling the purchase. For entrusted purchases, the entrustment documents held by the purchaser shall also be checked.

Business units may sell first-class precursor chemicals only after checking and retaining copies of the above-mentioned certification materials; if any suspicious circumstances are found, they shall immediately report to the local public security organs.

Article 19 Business units shall establish sales records of precursor chemicals and truthfully record the types, quantities, dates, purchasers, etc. of sales. Sales records and copies of supporting materials shall be kept for 2 years for future reference.

Sales of Category I precursor chemicals shall be reported to the local public security organs for record within 5 days from the date of sale; users of Category I precursor chemicals shall establish usage records and keep them for 2 years for future reference.

Sales of Category II and Category III precursor chemicals shall be reported to the local public security organs for record within 30 days from the date of sale.

Chapter IV Transportation Management

Article 20 Transportation of Category I precursor chemicals across municipal administrative regions (across municipal boundaries for municipalities directly under the Central Government) or across county administrative regions in key areas with severe drug control situations determined by the public security department of the State Council shall be approved by the public security organs of the municipal people's government at the place of departure; transportation of Category II precursor chemicals shall be approved by the public security organs of the county people's government at the place of departure. Transportation is permitted only after obtaining a transportation license for precursor chemicals after approval.

If a third-category precursor chemical is transported, it shall be registered with the public security organ of the county-level people's government at the place of transport before transportation. The public security organ shall issue a registration certificate on the day of receiving the registration materials.

Article 21: When applying for a permit for the transportation of precursor chemicals, a purchase and sale contract for the trading of precursor chemicals shall be submitted. If the owner is an enterprise, a business license shall be submitted; if the owner is another organization, a registration certificate (establishment approval document) shall be submitted; if the owner is an individual, his/her personal identity certificate shall be submitted. The person handling the matter shall also submit his/her identity certificate.

The public security organ shall review the application materials submitted by the applicant within 10 days from the date of receipt of the application for the transportation permit of the first-category precursor chemical and within 3 days from the date of receipt of the application for the transportation permit of the second-category precursor chemical. A transportation permit shall be issued to those who meet the requirements; if the permit is not granted, the reasons shall be stated in writing.

When reviewing the application materials for the transportation permit of the first-category precursor chemical, an on-site inspection may be carried out as needed.

Article 22: A one-time valid transportation permit shall be issued to those who are permitted to transport the first-category precursor chemical.

For those who are allowed to transport the second category of precursor chemicals, a transportation license valid for 3 months shall be issued; if the transportation safety is good within 6 months, a transportation license valid for 12 months shall be issued.

The transportation license for precursor chemicals shall state the type, quantity, destination, owner and consignee, carrier and type of transportation license of the precursor chemicals to be transported.

Article 23: For the transportation of ephedrine samples of less than 100 grams for teaching and scientific research, small packages of ephedrine for medical institutions to prepare formulations, and medical institutions or narcotic drug business enterprises to purchase ephedrine tablets of less than 60,000 tablets and injections of less than 15,000, the owner or carrier shall not be required to apply for a transportation license for precursor chemicals if the owner or carrier holds a purchase license certificate or narcotic drug transfer order obtained in accordance with the law.

Article 24: When accepting the transportation entrusted by the owner, the carrier shall check the transportation license or registration certificate provided by the owner, and check whether the transported goods are consistent with the types of precursor chemicals stated in the transportation license or registration certificate; if they are not consistent, the transportation shall not be carried out.

When transporting precursor chemicals, the transport personnel shall carry the transport license or registration certificate throughout the journey from the start of transportation. The public security organs shall conduct inspections during the transportation of precursor chemicals.

When transporting precursor chemicals, the relevant national regulations on cargo transportation shall be observed.

Article 25: For the purpose of treating diseases, patients, their close relatives or persons entrusted by patients may carry with them pharmaceutical preparations of precursor chemicals in the first category with a medical diagnosis issued by a medical institution and their own identity certificate, but the maximum dose of a single medical prescription shall not be exceeded.

The maximum dose of a single medical prescription shall be stipulated and announced by the health authority of the State Council.

Chapter V Import and Export Management

Article 26: When applying for the import or export of precursor chemicals, the following materials shall be submitted. After approval by the competent commerce department of the State Council or the competent commerce department of the provincial, autonomous region or municipal people's government entrusted by it, and obtaining an import or export license, the import or export activities may be carried out:

(i) A copy of the registration certificate of the foreign trade operator;

(ii) A copy of the business license;

(iii) The production, operation and purchase license or registration certificate of precursor chemicals;

(iv) A copy of the import or export contract (agreement);

(v) The identity certificate of the person handling the matter.

When applying for the export license of precursor chemicals, the certificate of legal use of precursor chemicals issued by the competent government department of the importing party or the guarantee document of legal use by the importing party shall also be submitted.

Article 27: The competent commerce department that accepts the application for the import or export of precursor chemicals shall review the application materials within 20 days from the date of receipt of the application materials, and may conduct on-site verification if necessary. For those that meet the requirements, an import or export license shall be issued; if the license is not granted, the reasons shall be stated in writing.

For the import of pharmaceutical precursor chemicals in the first category, the relevant commerce department shall obtain the consent of the drug supervision and administration department of the State Council before making a licensing decision.

Article 28 Precursor chemicals such as ephedrine that are subject to key monitoring items shall be imported and exported by enterprises approved by the commerce department of the State Council in conjunction with relevant departments of the State Council.

Article 29 The State implements an international verification system for the import and export of precursor chemicals. The international verification catalog of precursor chemicals and the specific methods of verification shall be formulated and announced by the commerce department of the State Council in conjunction with the public security department of the State Council.

The time used for international verification shall not be counted within the license period.

For the export of precursor chemicals and chemicals other than those specified in these Regulations to countries or regions where drug manufacturing and trafficking are serious, other control measures may be implemented in addition to international verification measures. The specific methods shall be formulated and announced by the commerce department of the State Council in conjunction with the public security department of the State Council, the General Administration of Customs and other relevant departments.

Article 30. If a person imports, exports, or transits, transfers, or transports precursor chemicals, he shall declare to the customs truthfully and submit an import or export license. The customs shall handle customs clearance formalities based on the license.

The preceding paragraph shall apply to the import and export of precursor chemicals between foreign countries and bonded areas, export processing zones, and other special customs supervision areas and bonded places.

No application for an import or export license for precursor chemicals is required if precursor chemicals are imported or exported between the country and bonded areas, export processing zones, and other special customs supervision areas and bonded places, or between the above-mentioned special customs supervision areas and bonded places.

When importing pharmaceutical precursor chemicals in the first category, an import drug clearance certificate issued by the drug supervision and administration department shall also be submitted.

Article 31. Personnel entering or leaving the country shall carry with them pharmaceutical preparations and potassium permanganate of pharmaceutical precursor chemicals in the first category, which shall be limited to their own use and reasonable quantity, and shall be subject to customs supervision.

Personnel entering or leaving the country shall not carry with them precursor chemicals other than those specified in the preceding paragraph.

Chapter VI Supervision and Inspection

Article 32 The public security organs of the people's governments at or above the county level, the departments responsible for drug supervision and administration, the production safety supervision and administration departments, the competent commerce departments, the competent health departments, the competent price departments, the competent railway departments, the competent transportation departments, the competent market supervision and administration departments, the competent ecological environment departments and the customs shall, in accordance with the provisions of these Regulations and relevant laws and administrative regulations, strengthen the supervision and inspection of the production, operation, purchase, transportation, price, import and export of precursor chemicals within their respective responsibilities; the illegal production, operation, purchase, transportation or smuggling of precursor chemicals shall be investigated and dealt with in accordance with the law.

When conducting supervision and inspection of precursor chemicals, the administrative departments specified in the preceding paragraph may inspect the site, review and copy relevant materials, record relevant circumstances, and seize relevant evidence materials and illegal items in accordance with the law; if necessary, they may temporarily seal off relevant places.

The inspected units or individuals shall truthfully provide relevant circumstances, materials and items and shall not refuse or conceal them.

Article 33: Precursor chemicals seized or seized according to law shall be stored or recovered according to different conditions of precursor chemicals under the supervision of the public security organs, customs or ecological environment authorities of the people's governments of provinces, autonomous regions, municipalities directly under the Central Government or cities divided into districts, or destroyed by qualified units under the supervision of the ecological environment authorities in accordance with the relevant provisions of environmental protection laws and administrative regulations. Among them, all pharmaceutical precursor chemicals in the first category shall be destroyed.

If the illegal unit or individual of precursor chemicals is unable to provide the cost of storage, recovery or destruction, the cost of storage, recovery or destruction shall be paid from the recovery income or listed in the anti-drug funds of the relevant administrative departments.

Article 34: If precursor chemicals are lost, stolen or robbed, the unit reporting the case shall immediately report to the local public security organ, and at the same time report to the local county-level people's government department responsible for drug supervision and management, production safety supervision and management department, business department or health department. The public security organ that receives the report shall promptly file a case for investigation and handle it, and report it to the superior public security organ; the relevant administrative departments shall report it step by step and cooperate with the public security organ in the investigation and handling.

Article 35 The relevant administrative departments shall inform the relevant public security organs and market supervision and administration departments of the licenses of precursor chemicals and the revocation of licenses in accordance with the law; the market supervision and administration departments shall inform the relevant public security organs and administrative departments of the changes or cancellations of registration of enterprises producing and operating precursor chemicals in accordance with the law.

Article 36 Units that produce, operate, purchase, transport or import or export precursor chemicals shall report to the administrative departments that license or file the case and the public security organs before March 31 of each year on the production, operation, purchase, transportation or import and export of precursor chemicals in the previous year; production, operation, purchase, transportation or import and export units that have the conditions may establish a computer network with the relevant administrative departments to promptly report the relevant business conditions.

Article 37 The relevant administrative departments of the people's governments at or above the county level shall strengthen coordination and cooperation and establish a reporting and communication mechanism for the management of precursor chemicals, supervision and inspection, and case handling.

Chapter VII Legal Liability

Article 38 Anyone who violates the provisions of these Regulations by producing, operating, purchasing or transporting precursor chemicals without permission or filing, forging application materials to obtain a license for the production, operation, purchase or transportation of precursor chemicals, or using another person's license or a forged, altered or expired license to produce, operate, purchase or transport precursor chemicals shall be confiscated by the public security organ the precursor chemicals illegally produced, operated, purchased or transported, the raw materials used for the illegal production of precursor chemicals, and the equipment and tools for the illegal production, operation, purchase or transportation of precursor chemicals, and shall be fined not less than 10 times but not more than 20 times the value of the precursor chemicals illegally produced, operated, purchased or transported. If 20 times the value of the goods is less than 10,000 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 market supervision and management department shall revoke the business license; if a crime is constituted, criminal liability shall be investigated in accordance with the law.

For any unit or individual that has committed any illegal act as provided for in the preceding paragraph, the relevant administrative department may stop accepting its application for production, operation, purchase, transportation, import or export license for precursor chemicals within 3 years from the date of making the administrative penalty decision.

Article 39: If anyone violates the provisions of these Regulations and smuggles precursor chemicals, the customs shall confiscate the smuggled precursor chemicals; if there is any illegal proceeds, the illegal proceeds shall be confiscated and administrative penalties shall be imposed in accordance with customs laws and administrative regulations; if a crime is constituted, criminal liability shall be investigated in accordance with the law.

Article 40. Any person who violates the provisions of these Regulations and commits any of the following acts shall be given a warning by the administrative department responsible for supervision and management, ordered to make corrections within a time limit, and fined not less than RMB 10,000 but not more than RMB 50,000; the precursor chemicals produced, sold or purchased in violation of the provisions may be confiscated; if the person fails to make corrections within the time limit, he shall be ordered to suspend production and business within a time limit for rectification; if the rectification fails to meet the requirements within the time limit, the corresponding license shall be revoked:

(i) The unit producing, selling, purchasing, transporting or importing or exporting precursor chemicals fails to establish a safety management system as required;

(ii) The license or registration certificate is lent to others for use;

(iii) The number of varieties and quantities of precursor chemicals are produced, sold or purchased in excess of the permitted number;

(iv) The unit producing, selling or purchasing fails to record or record the transaction truthfully, fails to keep the transaction records as required, or fails to register the sales truthfully and timely with the public security organs and relevant administrative departments;

(v) The loss, theft or robbery of precursor chemicals is not reported in time, resulting in serious consequences;

(vi) Except for individuals who legally purchase pharmaceutical preparations of the first category of precursor chemicals and third category precursor chemicals, use cash or physical objects to trade precursor chemicals;

(vii) The product packaging and instructions for use of precursor chemicals do not comply with the requirements of these Regulations;

(viii) The units that produce and sell precursor chemicals fail to report the annual production, distribution and inventory information to the relevant administrative departments and public security organs truthfully or on time.

If the production and operation license of an enterprise's precursor chemicals is revoked according to law and it fails to promptly go to the market supervision and management department to handle the change of business scope or enterprise cancellation registration, the precursor chemicals shall be confiscated and a fine shall be imposed in accordance with the provisions of the preceding paragraph.

Article 41: If the transported precursor chemicals do not conform to the type, quantity, destination, owner and consignee, carrier, etc. stated in the transport license or filing certificate for precursor chemicals, the type of transport license is inappropriate, or the transport personnel do not carry the transport license or filing certificate throughout the journey, the public security organ shall order the suspension of operation for rectification and impose a fine of not less than RMB 5,000 but not more than RMB 50,000; if there is a dangerous goods transport qualification, the transport authority may revoke its transport qualification in accordance with the law.

If an individual carries precursor chemicals that do not conform to the type and quantity regulations, the precursor chemicals shall be confiscated and a fine of not less than RMB 1,000 but not more than RMB 5,000 shall be imposed.

Article 42 If an entity or individual producing, operating, purchasing, transporting, importing or exporting precursor chemicals refuses to accept supervision and inspection by the relevant administrative department, the administrative department responsible for supervision and management shall order it to make corrections and give a warning to the directly responsible supervisor and other directly responsible persons; if the circumstances are serious, the entity shall be fined not less than RMB 10,000 but not more than RMB 50,000, and the directly responsible supervisor and other directly responsible persons shall be fined not less than RMB 1,000 but not more than RMB 5,000; if there is any violation of public security management, public security management punishment shall be imposed in accordance with the law; if a crime is constituted, criminal liability shall be investigated in accordance with the law.

Article 43 If the staff of the administrative department responsible for precursor chemicals fails to grant permission when it should, abuses permission when it should not, fails to accept filing in accordance with the law, and other acts of abusing power, neglecting duties, or engaging in malpractice for personal gain in their management work, they shall be given administrative sanctions in accordance with the law; if a crime is constituted, criminal liability shall be investigated in accordance with the law.

Chapter VIII Supplementary Provisions

Article 44 The relevant administrative departments of the State Council shall prescribe and supervise the production of licenses for the production, operation, purchase, transportation, import and export of precursor chemicals in accordance with their respective responsibilities.

Article 45 These Regulations shall come into force on November 1, 2005.

Anyone who has been engaged in the production, operation, purchase, transportation, import or export of precursor chemicals before the implementation of these Regulations shall reapply for a license in accordance with the provisions of these Regulations within 6 months from the date of implementation of these Regulations.