contents:

· Chapter One General Provisions

· Chapter 2 Production and Operation Management

· Chapter 3 Purchase Management

· Chapter 4 Transportation Management

· Chapter 5 Import and Export Management

· Chapter VI Supervision and Inspection

· Chapter VII Legal Liability

· Chapter 8 Supplementary Provisions

Chapter 1: 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 economic and social order, these regulations are formulated .

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 for drug production, and the second and third categories are chemical formulations that can be used for drug production. The specific classification and varieties of precursor chemicals are listed in the attached table of these regulations.

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

If the people's government of a province, autonomous region, or municipality directly under the Central Government deems it necessary to adjust the classification within its administrative area or add varieties other than those specified in these Regulations, it shall submit a proposal to the public security department of the State Council, and the public security department of the State Council in conjunction with the relevant administrative department of the State Council shall propose a plan and submit it to the State Council for approval. .

Article 3

The public security department of the State Council, the drug regulatory department, the safety production supervision and management department, the commercial department, the health department, the General Administration of Customs, the price department, the railway department, the transportation department, the market supervision and management department, and the ecological environment department in their respective Within the scope of their duties, they are responsible for the management of precursor chemicals nationwide; the relevant administrative departments of the local people's governments at or above the county level are responsible for the management of precursor chemicals within their respective administrative areas. .

The local people's governments at or above the county level shall strengthen leadership over the management of precursor chemicals, and coordinate and solve the 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's name (including scientific name and common name), chemical molecular formula and composition.

The fifth

The production, operation, purchase, transportation, import and export of precursor chemicals shall not only comply with the provisions of these Regulations, but shall also comply with laws and other administrative regulations on drugs and hazardous chemicals. The relevant provisions.

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

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

Units producing, operating, purchasing, transporting, importing and exporting precursor chemicals shall establish an internal management system for precursor chemicals.

Article 6

The State encourages to report illegal activities involving precursor chemicals to 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 relevant administrative departments shall give rewards.

Chapter 2: Production and Operation Management

Article 7

To apply for the production of Category I precursor chemicals, the following conditions shall be met, and the production may only be carried out after the approval of the competent administrative department as prescribed in Article 8 of these Regulations and the obtaining of the production license:

(1) Belonging to a legally registered chemical product manufacturing enterprise or pharmaceutical manufacturing enterprise;

(2) It has production equipment, storage facilities and pollutant treatment facilities that meet national standards;

(3) It has a strict safety production management system and an emergency response plan for environmental emergencies;

(4) The legal representative and technical and management personnel of the enterprise have relevant knowledge of safe production and precursor chemicals, and no criminal record of drugs;

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

To apply for the production of precursor chemicals in the first category, television monitoring facilities and alarm devices connected to the public security organs should also be installed in key areas such as storage sites.

eighth

Applications for the production of pharmaceutical precursor chemicals in the first category shall be examined and approved by the drug supervision and administration department of the people's government of provinces, autonomous regions, and municipalities directly under the Central Government; applications for the production of non-pharmaceutical precursor chemicals in the first category shall be approved by the province, Approval by the work safety supervision and management department of the people's government of autonomous regions and municipalities directly under the Central Government.

The administrative department specified in the preceding paragraph shall examine the application materials submitted by the applicant within 60 days from the date of receipt of the application. For those complying with the regulations, a production license shall be issued or marked on the relevant production licenses already obtained by the enterprise; if the license is not granted, the reasons shall be stated in writing.

When reviewing the application materials for the production license of precursor chemicals in Category I, on-site inspection and expert review may be carried out as needed.

Article 9

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

(1) Belonging to a legally registered chemical product operating enterprise or pharmaceutical operating enterprise;

(2) It has business premises that comply with national regulations, and if it is necessary to store and keep precursor chemicals, it shall also have storage facilities that comply with national technical standards;

(3) It has a management system for precursor chemicals and a sound sales network;

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

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

Article 10

Applications for the management of pharmaceutical precursor chemicals in the first category shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government; applications for the management of non-pharmaceutical precursor chemicals in the first category shall be approved by the province, Approval by the work safety supervision and management department of the people's government of autonomous regions and municipalities directly under the Central Government.

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. For those complying with the regulations, a business license shall be issued or 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 precursor chemicals in Category I, on-site verification may be carried out as needed.

Article 11

A production enterprise that has obtained the production license for precursor chemicals in Category I or has fulfilled the filing procedures of Category II and Category III precursor chemicals in accordance with the first paragraph of Article 13 of these Regulations may sell self-produced precursor chemicals. Toxic chemicals. However, if a sales outlet is set up outside the factory to distribute the precursor chemicals of the first category, the business license shall be obtained in accordance with the provisions of these Regulations.

The unilateral preparations of precursor chemicals in the first category shall be distributed by designated narcotic drugs and shall not be retailed.

Article 12

An enterprise that has obtained a license for the production and operation of precursor chemicals in the first category shall go to the market supervision and management department for registration of changes in the business scope with the production and operation license. Without alteration of registration, the production and operation of the precursor chemicals of Category I shall not be carried out.

If the production and operation licenses of precursor chemicals of the first category are revoked in accordance with the law, the administrative department shall notify the market supervision and management department within 5 days from the date of the revoking decision; the enterprises whose licenses have been revoked shall go to the market for supervision and management in a timely manner The department handles changes in business scope or deregistration of enterprises.

Article 13

The production of the second and third types of precursor chemicals shall, within 30 days from the date of production, report the type and quantity of the production to the safety production supervision and management department of the municipal people’s government at the districted level of the place where it is located.

Those dealing in the second category of precursor chemicals shall, within 30 days from the date of operation, report the types, quantities, and main flow directions of their operations to the work safety supervision and management department of the municipal people's government at the districted level for the record; For the third category of precursor chemicals, within 30 days from the date of operation, the types, quantities, and main flow directions of the operations shall be reported to the local county-level people's government for the safety production supervision and management department for the record.

The competent administrative department stipulated in the preceding two paragraphs shall issue a filing certificate on the day when the filing materials are received.

Chapter 3: Purchase Management

Article 14

To apply for the purchase of Category I precursor chemicals, the following documents shall be submitted, and the purchase license shall be obtained after the approval of the administrative department as specified in Article 15 of these Regulations:

(1) The operating enterprise submits the enterprise business license and the legal use certification;

(2) Other organizations submit registration certificates (establishment approval documents) and proofs required for legal use.

Article 15

An application for the purchase of pharmaceutical precursor chemicals in the first category shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located; an application for the purchase of non-pharmaceutical precursor chemicals in the first category shall be approved by The local province, autonomous region, and the administrative department specified 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. If the regulations are met, a purchase permit shall be issued; if the permit is not granted, the reasons shall be explained in writing.

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

Article 16

Medical institutions that hold a stamp card for the purchase of narcotic drugs and first-class psychoactive drugs are not required to apply for a first-class precursor chemicals purchase license if they purchase the first-class drug precursor chemicals.

Individuals are not allowed to purchase the first and second types of precursor chemicals.

Article 17

Those who purchase the second and third categories of precursor chemicals shall file the required varieties and quantities with the public security organs of the people's government at the county level before purchasing. Those who purchase a small amount of potassium permanganate for personal use do not need to file.

Article 18

When a business unit sells precursor chemicals of Category I, it shall check the purchase license and the identity certificate of the person in charge. For entrusted agents, the entrustment documents held by the purchaser shall also be checked.

The business unit may not sell the precursor chemicals of the first category until it has checked the correctness and kept the copies of the above-mentioned certification materials; if any suspicious situation is discovered, it shall immediately report to the local public security organ.

Article 19

The business unit shall establish a sales ledger for precursor chemicals, and truthfully record the types, quantities, dates, and purchasers sold. The copy of the sales account and certification materials should be kept for 2 years for future reference.

The sales of the precursor chemicals of the first category shall be reported to the local public security organ for record within 5 days from the date of sale; the user of the precursor chemicals of the first category shall establish a usage account and keep it for 2 years for future reference.

The sales of the second and third categories of precursor chemicals shall be reported to the local public security organ for the record within 30 days from the date of sale.

Chapter 4: Transportation Management

Article 20

Where the transportation of precursor chemicals in Category I across county-level administrative regions across the city-level administrative region (a municipality directly under the Central Government is across the city boundary) or in key areas with severe drug control situations determined by the public security department of the State Council, the transportation of precursor chemicals in the first category shall be determined by the designation of the place of shipment. The public security organ of the people's government at the city level of the district shall approve the examination and approval; the transportation of precursor chemicals of the second category shall be examined and approved by the public security organ of the people's government at the county level in the place where it is shipped. The transportation can only be carried out after obtaining the transportation permit for precursor chemicals after approval.

The transportation of precursor chemicals of Category III shall be filed with the public security organ of the county-level people's government at the place of transportation before transportation. The public security organ shall issue a filing certificate on the day of receipt of the filing materials.

Article 21

To apply for the transportation permit of precursor chemicals, the purchase and sale contract for the transaction of drug-making chemicals shall be submitted. If the owner is an enterprise, the business license shall be submitted; if the owner is another organization, the registration certificate (establishment approval document) shall be submitted; the owner is an individual. , Should submit his personal identification certificate. The handling person should also submit his identity certificate.

The public security organ shall, within 10 days from the date of receipt of the application for the transportation permit for precursor chemicals of the first category, and within 3 days from the date of receipt of the application for the transportation permit for precursor chemicals of the second category, conduct a review of the application materials submitted by the applicant. Review. If the regulations are met, a transportation permit shall be issued; if the permit is not granted, the reasons shall be stated in writing.

When reviewing the application materials for the transportation permit of precursor chemicals in Category I, on-site inspections may be carried out as needed.

Article 22

If the transportation of precursor chemicals of Category I is permitted, a valid transportation permit shall be issued.

Those who are permitted to transport the precursor chemicals of Category II shall be issued with a three-month transport permit; for those with good transport safety within six months, a 12-month effective transport permit will be issued.

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

Article 23

Transport of ephedrine samples of less than 100 grams for teaching and scientific research and small packages of ephedrine for preparations of medical institutions, as well as the purchase of less than 60,000 ephedrine tablets and 15,000 injections by medical institutions or narcotics business enterprises Below, if the owner or carrier holds a purchase license certificate or an narcotics allocation form obtained in accordance with the law, there is no need to apply for a transportation license for precursor chemicals.

Article 24

When accepting the transportation entrusted by the owner of the cargo, the carrier shall check the transportation license or the record certificate provided by the owner, and check whether the goods transported are consistent with the types of precursor chemicals specified in the transportation license or the record certificate; if they do not match, Not allowed for carriage.

For the transportation of precursor chemicals, the transportation personnel shall carry the transportation license or record certificate throughout the whole process from the start of the shipment. The public security organs shall conduct inspections during the transportation of precursor chemicals.

The transportation of precursor chemicals shall abide by the state regulations on cargo transportation.

Article 25

Due to the need for treatment of diseases, the patient, the patient’s close relatives or the person entrusted by the patient can carry with them the precursor chemicals in the first category with the medical certificate issued by the medical institution and their identity certificate, but no more than The maximum dose of a single medical prescription.

The maximum dosage of a single medical prescription shall be stipulated and announced by the competent health department of the State Council.

Chapter 5: Import and Export Management

Article 26

To apply for the import or export of precursor chemicals, the following materials shall be submitted, which shall be approved by the competent commercial department of the State Council or the competent commercial department of the people's government of the province, autonomous region, or municipality directly under the Central Government entrusted by it, and can only engage in import or export after obtaining an import or export license Activity:

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

(2) A copy of the business license;

(3) Production, operation, purchase license or record certificate of precursor chemicals;

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

(5) The identity certificate of the handling person.

Those who apply for the export license of precursor chemicals shall also submit a certificate of legal use of precursor chemicals issued by the competent government department of the importing party or a guarantee document for the legal use of the importing party.

Article 27

The competent commercial department that accepts applications for the import and export of precursor chemicals shall examine the application materials within 20 days from the date of receipt of the application materials, and may conduct on-site inspections when necessary. If the requirements are met, 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 competent commercial authority shall obtain the approval of the drug regulatory authority under the State Council before making a licensing decision.

Article 28

Ephedrine and other precursor chemicals that belong to the scope of key items to be monitored are imported and exported by enterprises approved by the competent commerce department of the State Council in conjunction with relevant departments of the State Council.

Article 29

The state implements an international inspection system for the import and export of precursor chemicals. The catalogue of precursor chemicals for international verification and the specific measures for verification shall be formulated and promulgated by the competent commercial department of the State Council in conjunction with the public security department of the State Council.

The time used for international verification is not included in the license period.

For the export of precursor chemicals and chemicals other than those specified in these Regulations to countries or regions with serious drug manufacturing and trafficking, other control measures may be implemented in addition to international verification measures. The specific measures shall be determined by the competent commercial department of the State Council in conjunction with the public security department of the State Council. Regulations and announcements made by relevant departments such as the department and the General Administration of Customs.

Article 30

Anyone who imports, exports or transits, transits, or transports precursor chemicals shall truthfully declare to the customs and submit an import or export license. The customs shall go through customs clearance procedures with the permit.

The provisions of the preceding paragraph shall apply to the entry and exit of precursor chemicals between overseas and bonded areas, export processing zones and other special customs supervision areas and bonded places.

Precursor chemicals entering and exiting between China and bonded areas, export processing zones and other special customs supervision areas or bonded sites, or between the aforementioned customs special supervision areas and bonded sites, do not need to apply for the import of precursor chemicals or export license.

When importing pharmaceutical precursor chemicals in the first category, a customs clearance form for imported drugs issued by the drug supervision and administration department shall also be submitted.

Article 31

Entry and exit persons who carry the precursor chemicals and potassium permanganate in the first category shall be limited to their own use and in reasonable quantities, and shall be subject to customs supervision.

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

Chapter 6: Supervision and Inspection

Article 32

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

When conducting the supervision and inspection of precursor chemicals, the competent administrative department mentioned in the preceding paragraph may inspect the site, consult and copy relevant materials, record relevant information, seize relevant evidence materials and illegal articles according to law; when necessary, it may temporarily seal up relevant places. .

The unit or individual under inspection shall truthfully provide relevant information, materials and articles, and shall not refuse or conceal it.

Article 33

Precursor chemicals seized and seized in accordance with the law shall be conducted under the supervision of the public security organs, customs or the competent department of ecological environment of the people's government at the province, autonomous region, municipality directly under the Central Government, or municipalities divided into districts, distinguishing precursor chemicals in different situations. Storage, recycling, or destruction in accordance with the relevant provisions of environmental protection laws and administrative regulations by a qualified unit under the supervision of the competent department of ecological environment. Among them, all the precursor chemicals in the first category that are confiscated and seized will be destroyed.

Where a unit or individual who violates the law of precursor chemicals is unable to provide the cost of storage, recovery or destruction, the cost of storage, recovery or destruction shall be expensed in the recovery income, or be included in the anti-drug funds of the relevant administrative department.

Article 34

If precursor chemicals are lost, stolen, or robbed, the unit that committed 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 responsible for drug supervision and management, safety production supervision and management, and commerce authority Or health authorities. The public security agency that receives the report shall promptly file the case for investigation, and report to the higher-level public security agency; the relevant administrative department shall report it level by level and cooperate with the public security agency in its investigation and punishment.

Article 35

Relevant administrative departments shall notify the relevant public security organs and market supervision and management departments of the licensing of precursor chemicals and the revocation of the license according to law; the market supervision and management departments shall change or cancel the registration of enterprises producing and operating precursor chemicals in accordance with the law Notify relevant public security organs and administrative departments.

Article 36

Units producing, operating, purchasing, transporting, importing, or exporting precursor chemicals shall report to the competent administrative department and public security organs that permit or record the production, production and export of precursor chemicals in the previous year before March 31 of each year. Operating, purchasing, transporting or importing and exporting; qualified production, operating, purchasing, transporting or importing or exporting units may establish a computer network with relevant administrative departments to report relevant operating conditions in a timely manner.

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 notification and exchange mechanism for the management of precursor chemicals, supervision and inspection, and case handling.

Chapter 7: Legal Liability

Article 38

Violate the provisions of these regulations, produce, operate, purchase, and transport precursor chemicals without permission or record, forge application materials to defraud the production, operation, purchase or transportation license of precursor chemicals, use others, or forge or change For the production, operation, purchase, or transportation of precursor chemicals with a manufacturing or invalid license, the public security organs shall confiscate the illegally produced, operated, purchased or transported precursor chemicals and the raw materials used for the illegal production of precursor chemicals As well as equipment and tools for illegal production, operation, purchase or transportation of precursor chemicals, a fine of 10 times or more and less than 20 times the value of the illegal production, operation, purchase or transportation of precursor chemicals, and 20 times the value of the goods If the amount is less than 10,000 yuan, a fine of 10,000 yuan shall be imposed; if there is illegal income, the illegal income shall be confiscated; if there is a business license, the business license shall be revoked by the market supervision and management department; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law.

For units or individuals that have violated the law in the preceding paragraph, the relevant administrative department may stop accepting applications for the production, operation, purchase, transportation or import and export licenses of precursor chemicals within 3 years from the date of the administrative penalty decision.

Article 39

In violation of the provisions of these Regulations, the smuggling of precursor chemicals shall be confiscated by the customs; where there are illegal gains, the illegal gains shall be confiscated, and administrative penalties shall be imposed in accordance with customs laws and administrative regulations; if a crime is constituted, it shall be investigated in accordance with the law criminal responsibility.

Article 40

Violation of the provisions of these Regulations and any of the following behaviors shall be given a warning by the administrative department responsible for supervision and management, and shall be ordered to make corrections within a time limit, and a fine of 10,000 yuan up to 50,000 yuan shall be imposed; for violations of the provisions of production, operation, and purchase Precursor chemicals can be confiscated; if they fail to make corrections within the time limit, they shall be ordered to suspend production and business for rectification within a time limit; if they fail to pass the rectification within the time limit, the corresponding license shall be revoked:

(1) The production, operation, purchase, transportation or import or export of precursor chemicals fails to establish a safety management system in accordance with regulations;

(2) Lending the license or record certificate to others for use;

(3) Production, operation, or purchase of precursor chemicals in excess of the permitted variety and quantity;

(4) The production, operation, or purchasing unit does not record or truthfully records the transaction situation, does not keep the transaction record in accordance with the regulations, or does not truthfully or timely file the sales situation with the public security organ and the relevant administrative department;

(5) Failure to report promptly after the precursor chemicals are lost, stolen, or robbed, causing serious consequences;

(6) Except for the legal purchase by individuals of the precursor chemicals in the first category of pharmaceutical preparations and the third category of precursor chemicals, the use of cash or in kind for the transaction of precursor chemicals;

(7) The product packaging and instructions for use of precursor chemicals do not meet the requirements of these regulations;

(8) The unit that produces or sells precursor chemicals does not truthfully or fails to report to the relevant administrative departments and public security organs on annual production, distribution, and inventory conditions.

After an enterprise’s production and operation license for precursor chemicals is revoked in accordance with the law, and if it fails to go to the market supervision and management department to change the business scope or cancel the registration of the enterprise in time, the precursor chemicals shall be confiscated and a fine shall be imposed in accordance with the provisions of the preceding paragraph.

Article 41

The transported precursor chemicals do not match the type, quantity, place of shipment, owner, consignee, and carrier specified in the transportation license or filing certificate of the precursor chemicals, the type of transportation license is improper, or the transportation Personnel who fail to carry the transportation permit or record certificate shall be ordered by the public security organs to stop the transportation for rectification and impose a fine of not less than 5,000 yuan but not more than 50,000 yuan; if they are qualified for the transportation of dangerous goods, the transportation authority may revoke their transportation qualifications in accordance with the law.

If an individual carries precursor chemicals that do not meet the variety and quantity requirements, the precursor chemicals shall be confiscated and a fine of not less than 1,000 yuan but not more than 5,000 yuan shall be imposed.

Article 42

If a unit or individual that produces, manages, purchases, transports, or imports or exports precursor chemicals refuses to accept the supervision and inspection of the relevant administrative department, the administrative department with supervisory and management duties shall order corrections, and the directly responsible persons in charge shall be ordered to make corrections. And other persons directly responsible; if the circumstances are serious, the unit shall be fined not less than 10,000 yuan but not more than 50,000 yuan, and the directly responsible person in charge and other directly responsible persons shall be fined not less than 1,000 yuan but not more than 5,000 yuan; violations of public order Those who manage acts shall be given public security management penalties in accordance with the law; those who constitute a crime shall be investigated for criminal responsibility in accordance with the law.

Article 43

If the staff of the administrative department of precursor chemicals have permission but not permission, abuse permission when permission should not be permitted, fail to accept filing in accordance with the law, and other acts of abuse of power, negligence of duty, or malpractice for personal gain, administrative sanctions shall be given in accordance with the law. ;Constitute a crime, be held criminally responsible.

Chapter 8: Supplementary Provisions

Article 44

The production, operation, purchase, transportation and import and export licenses of precursor chemicals shall be regulated and produced by the relevant administrative departments of the State Council in accordance with their respective duties.

Article 45

These regulations shall come into force on November 1, 2005.

China's current "Classification and Variety Catalog of Precursor Chemicals" is divided into three categories

the first sort

1. 1—Phenyl-2-acetone

2 3,4-methylenedioxyphenyl-2-acetone

3. Piperonal

4. Safrole

5. Sassafras oil

6. Isosafrole

7N-Acetylanthranilic acid

8. anthranilic acid

9. Lysergic acid*

10. Ergotamine*

11. Ergonovine*

12. Ephedrine, pseudoephedrine, racemic ephedrine, norephedrine, methylephedrine, ephedra extract, ephedra extract powder and other ephedrine substances*

Second category

1. Phenylacetic acid

2. Acetic anhydride

3. Trichloromethane

4. Ether

5. Piperidine

6 Methyl α-phenylacetoacetate,

7 α-acetoacetanilide,

8 3,4-methylenedioxyphenyl-2-propanone glycidic acid

9 3,4-Methylenedioxyphenyl-2-propanone glycidyl ester

The third category

1. Toluene

2. Acetone

3. Methyl ethyl ketone

4. Potassium permanganate

5. Sulfuric acid

6. Hydrochloric acid

7 Benzene acetonitrile,

8 γ-butyrolactone

illustrate

1. Salts that may exist in the substances listed in the first and second categories are also subject to control.

2. The varieties marked with * are pharmaceutical precursor chemicals in the first category, and the pharmaceutical precursor chemicals in the first category include raw materials and their unilateral preparations.

Matters needing attention in import and export links

It is stipulated in Chapter 5 (Import/Export Management) of the "Regulations on the Administration of Precursor Chemicals" No. 445 of the State Council. Before the import and export of precursor chemicals, the consignee or consignor shall submit to the customs "the production, operation, purchase license or record certificate of precursor chemicals".

Special reminder is that some import and export goods are mixtures, the ingredients of which involve precursor chemicals; but their product names are not precursor chemicals. For example, the product name is liquid epoxy resin, which contains epoxy resin and the third type of precursor chemicals toluene or acetone. Does the consignee or consignor need to apply for a "precursor chemical production, operation, purchase license or record certificate"?

Regarding matters concerning the content of the mixture, the Ministry of Commerce and the Customs respectively made the following regulations

1. The  Ministry of Commerce Announcement No. 23 of 2007 "Specific Provisions on the Administration of Import and Export of Mixtures Containing Precursor Chemicals" (Issued Date: 2007-05-16)
"Mixture" means:
(1) Containing toluene , Acetone, methyl ethyl ketone, sulfuric acid and one of the four precursor chemicals with a proportion higher than 40% (exclusive) and goods with a proportion of hydrochloric acid higher than 10% (exclusive);
(2) Containing the above 5 In addition to the "Precursor Chemicals Import and Export Management Catalogue" listed in other precursor chemicals.
Except for compound pharmaceutical preparations containing precursor chemicals.
Operators shall apply for permission in accordance with the "Regulations" to import and export the above-mentioned mixtures.
 Goods containing one of the five precursor chemicals such as toluene, acetone, methyl ethyl ketone, sulfuric acid, and hydrochloric acid with a proportion lower than the above-mentioned prescribed content do not belong to the “mixture” mentioned in Article 7 of the “Regulations”. Operators do not need to apply for permission in accordance with the "Regulations" for importing and exporting the above-mentioned goods.
  When handling customs clearance procedures, operators shall truthfully declare the content of precursor chemicals and actively produce relevant certificates.

2. The  Ministry of Commerce/Customs places the import and export of precursor chemicals under the management of "Dual-Use Items" ; the latest regulation is the Announcement No. 75 of 2020 issued by the Ministry of Commerce/General Administration of Customs on December 31, 2020 The "Dual-use Items and Technology Import and Export License Management Catalog" will be implemented from January 2021.

According to the "Export Control Law of the People's Republic of China", "Administrative Measures for the Import and Export License of Dual-use Items and Technologies" (Order No. 29, 2005 of the General Administration of Customs of the Ministry of Commerce) and the "Import and Export Tariffs of the People's Republic of China" in 2021, the Ministry of Commerce China and the General Administration of Customs have adjusted the "Dual-use Items and Technologies Import and Export License Management Catalog", and now the adjusted "Dual-use Items and Technologies Import and Export License Management Catalog" (see attachment) is published.

Imported radioactive isotopes shall be submitted to the Ministry of Ecology and Environment for approval in accordance with the "Regulations on the Safety and Protection of Radioisotopes and Radiation Devices" and the "Administrative Measures for the Import and Export Licenses of Dual-use Items and Technologies", and then apply for them at the Quota License Office of the Ministry of Commerce Import license for dual-use items and technologies. The import operator shall go through the import formalities with the customs on the strength of the dual-use item and technology import license.

This announcement will be officially implemented on January 1, 2021, and the "Dual-use Items and Technology Import and Export License Management Catalog" promulgated by the Ministry of Commerce and the General Administration of Customs in 2019 Announcement No. 68 shall be repealed at the same time.