Welcome Guest    
You are using Guest Account
Chinese Version
 
 
 
REGULATION ON THE ADMINISTRATION OF PRECURSOR CHEMICALS
 
(Order of the State Council (Order No. 445), August 26, 2005: adopted at the 102nd executive meeting of the State Council on August 17th, 2005, and shall come into force as of November 1, 2005)
     
     
SUBJECT : PRECURSOR CHEMICALS
ISSUING DEPARTMENT : THE STATE COUNCIL OF THE PEOPLE'S REPUBLIC OF CHINA
ISSUE DATE : 08/26/2005
IMPLEMENT DATE : 11/01/2005
LENGTH : 6,212 words
TEXT :
TABLE OF CONTENTS

CHAPTER I GENERAL PROVISIONS
CHAPTER II MANAGEMENT OF PRODUCTION AND OPERATION
CHAPTER III ADMINISTRATION OF PURCHASE
CHAPTER IV ADMINISTRATION OF TRANSPORTATION
CHAPTER V ADMINISTRATION OF IMPORT AND EXPORT
CHAPTER VI SUPERVISION AND INSPECTION
CHAPTER VII LEGAL LIABILITIES
CHAPTER VIII SUPPLEMENTARY PROVISIONS


CHAPTER I GENERAL PROVISIONS

Article 1. The present Regulation is formulated for the purpose of intensifying the administration of precursor chemicals, regulating the production, operation, purchase, transportation and import and export of precursor chemicals, preventing the use of precursor chemicals to manufacture drugs and maintaining the economic and social order.


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

The precursor chemicals are classified into three categories. Category I refers to the major materials that may be used to produce drugs. Categories II and III refer to the chemical auxiliary substances that may be used to produce drugs. The specific classification and varieties of precursor chemicals are shown in the attachment of the present Regulation.

Where the classification or variety of precursor chemicals requires any adjustment, the department of public security of the State Council shall, in collaboration with the supervisory and administrative department of food and drugs, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health and the General Administration of Customs of the State Council, report it to the State Council for approval.

Where the people's government of the province, autonomous region or municipality directly under the Central Government believes it necessary to adjust the classification of precursor chemicals or to add any other variety beyond those prescribed in the present Regulation within its administrative division, it shall set forth a suggestion to the department of public security of the State Council. The department of public security of the State Council shall, in collaboration with the relevant administrative departments of the State Council, raise a proposal and report it to the State Council for approval.


Article 3. The department of public security, the supervisory and administrative department of food and drugs, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health, the General Administration of Customs, the administrative department of price, the administrative department of railways, the administrative department of communications, the administrative department for industry and commerce and the administrative department of environmental protection of the State Council shall, according to their respective functions and duties, take charge of the relevant administration of precursor chemicals throughout the country. The relevant administrative departments of all the people's governments at the county level or above shall, according to their respective functions and duties, take charge of the relevant administration of the precursor chemicals within their administrative divisions.

All the people's governments at the county level or above shall intensify the leadership in the administration of precursor chemicals, and coordinate and solve any problem arising from the administration of precursor chemicals in a timely manner.


Article 4. The product name (including the scientific name and the generally used name), chemical molecular formula and ingredients shall be indicated in the packaging and instructions of products of precursor chemicals.


Article 5. For the production, operation, purchase, transportation and import and export of precursor chemicals, not only the relevant provisions of the present Regulation shall be observed, but also, where it belongs to pharmaceuticals or dangerous chemicals, the relevant provisions of the laws and other administrative regulations on pharmaceuticals and dangerous chemicals shall be abided by.

It's prohibited to smuggle or illegally produce, operate, purchase, transfer or transport any precursor chemicals.

It's prohibited to trade in precursor chemicals by means of cash or in-kind, with the exception of any case whereby an individual legally purchases the pharmaceutical preparations of precursor chemicals under the item of pharmaceuticals in Category I or the precursor chemicals in Category III.

An entity that engages in the production, operation, purchase and transportation and import and export of precursor chemicals shall establish an internal management system of precursor chemicals.


Article 6. The state encourages the tip-off of any irregularity involving precursor chemicals to the relevant administrative departments such as the public security organ. The department that has received a tip-off shall keep confidential for the relevant tip-off maker. Where a tip-off has been verified, the people's government at the county level or above and the relevant administrative department shall grant an award to the relevant tip-off maker.



CHAPTER II MANAGEMENT OF PRODUCTION AND OPERATION

Article 7. An entity, which applies for producing the precursor chemicals in Category I, shall meet the following requirements and shall obtain the production license upon the examination and approval of the administrative department prescribed in Article 8 of the present Regulation before any production:

(1) Having been legally registered as a production enterprise of chemical products or pharmaceuticals;

(2) Having the production equipment, warehousing facilities and waste disposal facilities that comply with the state standards;

(3) Having a strict management system of work safety and the reserve plan for environmental emergencies;

(4) The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of work safety as well as of precursor chemicals and having no criminal record; and

(5) Satisfying any other requirement prescribed by any law, regulation or rule.

An entity that applies for producing the precursor chemicals under the item of pharmaceuticals in Category I shall not only meet the aforesaid requirements but also establish television supervision and control facilities and the alarming facilities that are connected to the network of the public security organ in key areas such as warehousing places.


Article 8. An application for producing the precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the State Council. An application for producing the precursor chemicals under any item other than pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the people's government of the province, autonomous region or municipality directly under the Central Government.

The administrative departments prescribed in the preceding paragraph shall, within 60 days as of receiving an application, carry out an examination on the application materials submitted by the applicant. For any application that meets the relevant provisions, it shall issue a production license or make an indication on the relevant production license that has been obtained by the relevant enterprise. In the case of disapproval, a written explanation shall be given.

The administrative departments may, when carrying out an examination on the application materials for the production license of precursor chemicals in Category I, organize an on-the-spot inspection and expert appraisal when necessary.


Article 9. An enterprise, which applies for operating the precursor chemicals in Category I, shall meet the following requirements and shall obtain the operation license upon the examination and approval of the administrative department prescribed in Article 10 of the present Regulation before any operation:

(1) Having legally been registered as an operation enterprise of chemical products or pharmaceuticals;

(2) Having a business place that meets the provisions of the state, and when it requires to store or keep any precursor chemicals, having the warehousing facilities that meet the technical standards of the state;

(3) Having an operational and management system of precursor chemicals as well as complete sales network;

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

(5) Satisfying any other requirement prescribed by any law, regulation or rule.


Article 10. An application for operating the precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the State Council. An application for operating the precursor chemicals under any item other than pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the people's government of the province, autonomous region or municipality directly under the Central Government.

The administrative departments prescribed in the preceding paragraph shall, within 30 days as of receiving an application, carry out an examination on the application materials submitted by the applicant. For any application that meets the relevant provisions, it shall issue an operation license or make an indication on the relevant operation license that has been obtained by the relevant enterprise. In the case of disapproval, a written explanation shall be given.

The administrative departments may, when carrying out an examination on the application materials for operation license of the precursor chemicals in Category I, organize an on-the-spot inspection when necessary.


Article 11. A production enterprise that has obtained the production license of precursor chemicals in Category I or has gone through the archival formalities of the precursor chemicals in Category II or III according to the provisions of paragraph 1 of Article 13 of the present Regulation may undertake the sale of self-produced precursor chemicals. However, an enterprise that has a sales network of precursor chemicals in Category I outside its factory shall obtain the operation license according to the provisions of the present Regulation.

The pharmaceutical single preparations of the precursor chemicals under the item of pharmaceuticals in Category I shall be distributed by the designated operation enterprise of narcotic drugs and shall not be retailed.


Article 12. An enterprise that has obtained the production or operation license of the precursor chemicals in Category I shall go to the administrative department of industry and commerce to handle the formalities for the alteration of its business scope upon the strength of its production or operation license. Without the registration of alteration, no enterprise may carry out any production or operation of the precursor chemicals in Category I.

Where any production or operation license of the precursor chemicals in Category I is revoked according to law, the administrative department shall inform the department of industry and commerce within 5 days as of making the decision on revocation. The enterprise whose license has been revoked shall go to the administrative department of industry and commerce to handle the formalities for altering its business scope or for enterprise termination registration in a timely manner.


Article 13. An enterprise that produces the chemicals liable to producing chemicals in Category II or III shall, within 30 days as of production, report information such as variety and quantity to the supervisory and administrative department of work safety of the municipal people's government of the local districted city for archival filing.

An enterprise that operates the chemicals liable to producing chemicals in Category II shall, within 30 days as of operation, report information such as variety, quantity and major flow to the supervisory and administrative department of work safety of the municipal people's government of the local districted city for archival filing. An enterprise that operates the chemicals liable to producing chemicals in Category III shall, within 30 days as of operation, report information such as variety, quantity and major flow to the supervisory and administrative department of work safety of the county local people's government of its locality for archival filing.

The administrative departments prescribed in the preceding two paragraphs shall issue the archival filing certification on the very day when it receives the archival filing materials.



CHAPTER III ADMINISTRATION OF PURCHASE

Article 14. An enterprise that applies for purchasing the precursor chemicals in Category I shall submit the following certificates and shall obtain the purchase license upon the examination and approval of the administrative department prescribed in Article 15 of the present Regulation:

(1) The business license and the certification of legal use and demand submitted by the operation enterprise;

(2) The registration certificate (approval certificate for establishment) and the certification of legal use and demand submitted by any other organization.


Article 15. An application for purchasing the precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the people's government of the province, autonomous region or municipality directly under the Central Government where the applicant is located. An application for purchasing the precursor chemicals under any item other than pharmaceuticals in Category I shall be subject to the examination and approval of public security organ of the people's government of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

The administrative departments prescribed in the preceding paragraph shall, within 10 days as of receiving an application, carry out an examination on the application materials and certificates submitted by an applicant. For an application that meets the relevant provisions, it shall issue a purchase certificate; in the case of disapproval, it shall give a written explanation.

The administrative departments may, when carrying out an examination on the application materials for purchasing precursor chemicals in Category I, carry out an on-the-spot inspection when necessary.


Article 16. Where a medical institution purchases the precursor chemicals under the item of pharmaceuticals in Category I upon the strength of the signature card for purchasing narcotic and psychotropic pharmaceuticals in Category I, it need not apply for the purchase license of precursor chemicals in Category I.

No individual may purchase any precursor chemicals in Category I or II.


Article 17. An entity that purchases any precursor chemicals in Category II or III shall, before the purchase, report the variety and quantity in demand to the public security organ of the local people's government at the county level for archival filing. Any purchase of a little potassium permanganate for individual self-use need not be put on archives.


Article 18. An operation entity that sells the precursor chemicals in Category I shall examine the purchase license and the identity certification of the handling person. In the case of an entrusted purchase, the relevant entrustment document held by the purchaser shall be subject to examination.

An operation entity may sell the precursor chemicals in Category I only if no error is found through the examination and after the photocopies of the aforesaid materials are preserved and, when finding any suspected case, shall immediately report it to the local public security organ.


Article 19. An operation entity shall establish a sales account of the precursor chemicals and record the varieties, quantities, date and purchasers in a faithful manner. The sales account and photocopies of the certification materials shall be preserved for 2 years for reference and examination.

The sales information of precursor chemicals in Category I shall be reported to the local public security organ within 5 days as of the sales day. An entity that uses the precursor chemicals in Category I shall establish the use account and preserve it for 2 years for reference and examination.

The sales information of precursor chemicals in Category II or III shall be reported to the local public security organ for archival filing within 30 days as of the sales day.



CHAPTER IV ADMINISTRATION OF TRANSPORTATION

Article 20. The transportation of precursor chemicals in Category I across the administrative regions of districted cities (across the municipal boundary in the case of municipalities directly under the Central Government) or across the administrative regions of counties within the key regions where the anti-drug situation is severe, which are determined by the public security department of the State Council, shall be subject to the examination and approval of the public security organ of the municipal people's government of the districted city where the transportation starts. The transportation of precursor chemicals in Category II shall be subject to the examination and approval of the public security organ of the people's government at the county level where the transportation starts. The transportation may be carried out only after the transportation license of precursor chemicals is obtained upon examination.

The transportation of precursor chemicals in Category III shall, before it starts, be put on archives in the local public security organ of the people's government at the county level where the transportation starts. The public security organ shall issue the archival filing certification as of the very day when it receives the archival materials.


Article 21. An applicant that applies for the transportation of precursor chemicals shall submit the contract on purchase and sale of precursor chemicals. Where the consignor is an enterprise, it shall submit its business license. Where the consignor is any other organization, the registration certificate (approval document for establishment) shall be submitted. Where the consignor is an individual, the individual identity certification shall be submitted. The relevant handling person shall submit his identity certification.

The public security organ shall, within 10 days as of receiving an application for the transportation license of precursor chemicals in Category I or within 3 days as of receiving an application for the transportation license of precursor chemicals in Category II, carry out an examination on the application materials submitted by an applicant. For those that meet the provisions, the transportation license shall be issued. In the case of disapproval, a written explanation shall be given.

In the examination of application materials for the transportation license of precursor chemicals in Category I, an on-the-spot examination may be carried out when necessary.


Article 22. For the transportation of precursor chemicals in Category I approved, a transportation license valid for once shall be issued.

For the transportation of precursor chemicals in Category II approved, a transportation license with a valid term of 3 months shall be issued. Where the transportation safety condition is good for 6 months, a transportation license with a valid term of 12 months shall be issued.

On the transportation license of precursor chemicals, matters such as the variety of the to-be transported precursor chemicals, their quantity, destination, consignor and consignee, and the carrier as well as the category of the transportation license shall be indicated.


Article 23. For the transportation of the sample of ephedrine of less than 100g for teaching or scientific research, the ephedrine in small package used for the preparation and prescription of medical institutions or the ephedrine pills of less than 60,000 purchased by a medical institution or an operation enterprise of narcotic drugs or injection preparations of less than 15,000, where the relevant consignor or carrier holds the purchase license or the allocating list of narcotic drugs legally obtained, no application for the transportation license of precursor chemicals shall be necessary.


Article 24. When accepting the entrustment of transportation from a consignor, a carrier shall examine the transportation license or archival filing certification provided by the consignor and shall check whether or not the goods to be transported are in consistency with information such as the variety of precursor chemicals indicated on the transportation license or the archival filing certification. In the case of inconsistency, no goods may be transported.

In the transportation of precursor chemicals, the transportation personnel shall carry the transportation license or the archival filing certification along with them throughout the course. The public security organ shall carry out examination in the course of transportation of precursor chemicals.

The transportation of precursor chemicals shall be subject to the provisions of the state on transportation of goods.


Article 25. For the demand of medical treatment of diseases, a patient, his close relative or a person entrusted by the patient may, upon the strength of the medical diagnosis produced by a medical institution and his identity certification, carry along with him the medical preparation of precursor chemicals under the item of pharmaceuticals in Category I, which shall not surpass the maximum dosage of a single medical prescription.

Maximum dosage of a single medical prescription shall be approved and published by the health authorities of the State Council.



CHAPTER V ADMINISTRATION OF IMPORT AND EXPORT

Article 26. An applicant that applies for the import or export of precursor chemicals shall submit the following materials and shall obtain the import or export license upon the examination and approval of the administrative department of commerce of the State Council or the administrative department of commerce of the province, autonomous region or the municipality directly under the Central Government entrusted by the administrative department of commerce of the State Council before engaging in the import or export:

(1) The photocopy of the registration certification of the business operator of foreign trade (the certification of foreign-funded enterprises passing the annual joint examination);

(2) The duplicate of the business license;

(3) The licenses of production, operation, or purchase of precursor chemicals or the archival filing certification;

(4) The duplicate of the contract (agreement) of import or export; and

(5) The identity certification of the handling person.

An applicant that applies for the export license of precursor chemicals shall also submit the certification of legal use of precursor chemicals produced by the administrative department of the government where the import party is located or the guaranty documents of legal use of the import party.


Article 27. The administrative department of commerce that accepts an application for the import and export of precursor chemicals shall, within 20 days as of receiving the application materials, carry out an examination on the application materials and may, when necessary, carry out an on-the-spot inspection. For those that satisfy the relevant provisions, the administrative department of commerce shall issue the import or export license; in the case of disapproval, a written explanation shall be given.

For the import of precursor chemicals under the item of pharmaceuticals in Category I, the relevant administrative department of commerce shall, before making any decision on licensing, obtain the agreement of the supervisory and administrative department of food and drugs of the State Council.


Article 28. Precursor chemicals such as ephedrine that fall into the scope of highlighted supervisory articles shall be imported or exported by the enterprises verified by the administrative department of commerce of the State Council in collaboration with the relevant departments of the State Council.


Article 29. The state adopts an international examination system for the import and export of precursor chemicals. The international examination catalogue of precursor chemicals and the specific measures for examination shall be formulated and promulgated by the administrative department of commerce of the State Council in collaboration with the department of public security of the State Council.

The time for the international examination shall not be calculated into the licensing term.

For the export of precursor chemicals and the varieties of chemicals beyond the provisions of the present Regulation to a country or area where the manufacture or traffic of drugs is severe, other controlling measures beyond the measures for international examination may be implemented. The specific measures shall be formulated and promulgated by the relevant departments as the administrative department of commerce of the State Council in collaboration with the administrative department of public security organ and the General Administration of Customs.


Article 30. Any import, export or territory transition, transshipment or through transportation of precursor chemicals shall be declared to the customs in a faithful manner and the relevant import or export license shall be submitted. The customs shall handle the formalities for customs clearance according to the relevant license.

The precursor chemicals that are transferred between a foreign country and any of such special customs surveillance areas and bonded places bonded zones and export processing areas within the Chinese territory shall be governed by the preceding paragraph.

Where the precursor chemicals are transferred between a place within the Chinese territory and any of such special customs surveillance areas and bonded places bonded zones and export processing areas or between the aforesaid special customs surveillance areas and bonded places, it is not necessary to apply for the import or export license of precursor chemicals.

For the import of the precursor chemicals under the item of pharmaceuticals in Category I, the notice of customs clearance of imported pharmaceuticals produced by the supervisory and administrative department of food and drugs shall be submitted.


Article 31. Where any person carries along with him any pharmaceutical preparation of precursor chemicals under the item of pharmaceuticals in Category I or potassium permanganate into or out of the Chinese territory, it should be for the purpose of self-use and within a reasonable quantity and be subject to the supervision of the customs.

Any person into or out of the Chinese territory shall not carry along with him any precursor chemicals other than those prescribed in the preceding paragraph.



CHAPTER VI SUPERVISION AND INSPECTION

Article 32. The public security organ, the supervisory and administrative department of food and drugs, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health, the administrative department of price, the administrative department of railways, the administrative department of communications, the administrative department of industry and commerce, the administrative department of environmental protection of the people's government above the county level as well as the customs shall, according to the present Regulation and the provisions of the relevant laws and administrative regulations, on the basis of their respective functions and duties, intensify the supervision and inspection of the production, operation, purchase, transportation, price and import and export of precursor chemicals. Any illegal production, operation, purchase and transportation of precursor chemicals or any smuggling concerned shall be investigated into and punished according to law.

The administrative departments prescribed in the preceding paragraph may, when carrying out the supervision and inspection of precursor chemicals, check the scene, consult and photocopy the relevant materials, record the relevant information, detain the relevant evidential materials and illegal articles and may, when necessary, temporarily seal up the relevant place.

The entity or individual inspected shall provide the relevant information, materials and articles in a faithful manner and shall not make any rejection or concealing.


Article 33. The precursor chemicals confiscated or tracked down and seized shall be kept and reclaimed in light of different cases of precursor chemicals under the supervision of the public security organ or the administrative department of environmental protection of the people's government of the province, autonomous region, municipality directly under the Central Government or the districted city or under the supervision of the customs, or shall, according to the relevant provisions of environmental protection laws and administrative regulations, be destroyed by an entity with the relevant qualification under the supervision of the administrative department of environmental protection. In particular, the precursor chemicals under the item of pharmaceuticals in Category I confiscated or tracked downed and seized shall be destroyed without exception.

Where an entity or individual that has any irregularity concerning the precursor chemicals fails to afford the expenses for storing, reclaiming or destroying the chemicals, the said expenses shall be paid via the gains generated from the reclaiming or shall be allotted in the anti-drug expenses of the relevant administrative department.


Article 34. Where any precursor chemicals is lost, stolen or robbed, the entity to which the crime has been committed shall immediately report it to the local public security organ and shall, at the same time, report it to the supervisory and administrative department of food and drugs, the supervisory and administrative department of work safety, the administrative department of commerce or the administrative department of health of the local people's government at the county level. The public security organ that has received a report of case shall file the case and carry out an investigation immediately and shall report it to the public security organ at a higher level. The relevant administrative department shall report the case in a level-by-level manner to its superior organs and shall coordinate in the investigation of the public security organ.


Article 35. The relevant administrative department shall notify the relevant public security organ and the administrative department of industry and commerce of the licensing of precursor chemicals as well as the revocation of license according to law. The administrative department of industry and commerce shall notify the relevant public security organ and the administrative department of the registration alteration or writing-off of the enterprises that engage in the production or operation of precursor chemicals.


Article 36. An entity that engages in the production, operation, purchase, transportation or import or export of precursor chemicals shall, before March 31st of each year, report the production, operation, purchase, transportation or import or export of precursor chemicals in the previous year to the administrative department in charge of licensing and the public security organ in charge of archival filing. An entity that engages in the production, operation, purchase, transportation or import or export of precursor chemicals with mature conditions may establish a network with the relevant administrative departments so as to notify the relevant business operations in a timely manner.


Article 37. The relevant administrative departments of the people's government at the county level or above shall intensify the coordination and cooperation and establish a notification and exchange mechanism for the administration, supervision and inspection and case handling of precursor chemicals.



CHAPTER VII LEGAL LIABILITIES

Article 38го Where any entity violates the provisions of the present Regulation by unlawfully engaging in any production, operation, purchase or transportation of precursor chemicals without any license or archival filing, forging any application material to cheat for any license of production, operation, purchase or transportation, using other's license or forging, altering any invalid license to undertake the production, operation, purchase or transportation of precursor chemicals, the public security organ shall confiscate the precursor chemicals illegally produced, operated, purchased or transported, the raw materials for illegal production of precursor chemicals as well as the equipment and tools for the illegal production, operation, purchase or transportation of chemicals liable to producing chemicals. And it shall impose a fine of 10 times up to 20 times of the commodity value of the precursor chemicals illegally produced, operated, purchased or transported. Where 20 times of the commodity value fails to reach 10,000 yuan, the fine shall be 10,000 yuan. The relevant illegal proceeds, if any, shall be confiscated. The relevant business license, if any, shall be revoked by the administrative department of industry and commerce. Where a crime is constituted, the relevant violator shall be subject to criminal liabilities.

For an entity or individual that has any irregularity prescribed in the preceding paragraph, the relevant administrative department may, within 3 years as of the administrative sanction is made, cease the acceptance of its/his application for a license of production, operation, purchase, transportation or import or export of precursor chemicals.


Article 39. Where an entity or individual violates the provisions of the present Regulation by smuggling the precursor chemicals, the customs shall confiscate the precursor chemicals. The illegal proceeds, if any, shall be confiscated and an administrative sanction shall be given according to the customs laws and administrative regulations. Where a crime is constituted, the relevant violator shall be subject to criminal liabilities.


Article 40. Where an entity violates the present Regulation by having any of the following acts, the competent administrative department with the functions of supervision and administration shall give a warning and order it to correct within a time limit and impose a fine of 10,000 yuan up to 50,000 yuan. The precursor chemicals produced, operated or purchased in violation of the relevant provisions may be confiscated. Where an entity fails to make correction with the prescribed period, it shall be ordered to cease its production and operation for rectification within a time limit. Where an entity fails to pass the examination upon its rectification within the time limit, its relevant license shall be revoked:

(1) Where an entity that undertakes the production, operation, purchase, transportation or import or export of precursor chemicals fails to establish a security management system according to the relevant regulations;

(2) Where an entity lends its license or archival filing certification to any other person;

(3) Where an entity produces, operates or purchases any precursor chemicals beyond the scope of variety and quantity prescribed in the license;

(4) Where an entity that undertakes the production, operation, purchase of precursor chemicals fails to record the information of transaction or fails to make record in a faithful manner, fails to keep the record of transaction according to the relevant provisions or fails to report the information of archival filing and sale to the public security organ and the relevant administrative departments in a timely and faithful manner;

(5) Where an entity fails to report in a timely manner, when the precursor chemicals are lost, stolen or robbed, and thus incurs any serious consequence;

(6) Where an entity uses cash or in-kind to conduct any transaction of precursor chemicals beyond those under the item of pharmaceuticals in Category I as well as those in Category III legally purchased for self-use;

(7) Where the product packages or instructions of precursor chemicals fail to comply with the provisions of the present Regulation; or

(8) Where an entity that undertakes the production or operation of precursor chemicals fails to report its annual production, sale or storage to the relevant administrative department and the public security organ in a faithful and timely manner.

After an operation license of an enterprise for production and operation of precursor chemicals is revoked according to law and where the relevant enterprise fails to go to the administrative department of industry and commerce to handle the formalities for alteration of business scope or writing-off of its registration in a timely manner, the precursor chemicals shall be confiscated and a fine shall be imposed upon the enterprise according to the provisions of the preceding paragraph.


Article 41. Where the precursor chemicals in transportation fail to comply with information such as the variety, quantity, destination, consignor, consignee or carrier indicated in the transportation license or archival filing certification of precursor chemicals, or where the category of the transportation license is improper or where the personnel in charge of transportation fail to carry along with them the transportation license or archival filing certification throughout the transportation, the public security organ shall order it to cease the transportation for rectification and correction and impose upon it a fine of 5,000 yuan to 50,000 yuan. Where the enterprise has the qualifications for transportation of dangerous articles, the administrative department of transportation may revoke the relevant transportation qualifications according to law.

Where the precursor chemicals carried along by an individual fails to comply with the variety or quantity prescribed, the chemicals shall be confiscated and a fine of 1,000 yuan up to 5,000 yuan shall be imposed.


Article 42. Where an entity or individual that engages in the production, operation, purchase or import or export of precursor chemicals refuses to accept the supervision and inspection of the relevant administrative department, the competent administrative department with the functions and duties of supervision and administration shall order it to correct and give a warning to the principal held directly responsible as well as any other person-in-charge held directly responsible. In the case of serious circumstances, a fine of 10,000 yuan up to 50,000 yuan shall be imposed upon the entity, and a fine of 1,000 yuan up to 5,000 yuan shall be imposed upon the principal held directly responsible as well as any other person-in-charge held directly responsible. For any act in violation of the administration of public security, a punishment of administration of public security shall be given according to law. Where a crime is constituted, the relevant violator shall be subject to criminal liabilities.


Article 43. Any staff member of the administrative department in charge of precursor chemicals who fails to grant any license to anyone that meets the relevant provisions or grants any license to anyone that fails to meet the relevant provisions or abuses his power, neglects his duty or practices any fraud shall be given an administrative sanction. Where a crime is constituted, the relevant violator shall be subject to criminal liabilities.



CHAPTER VIII SUPPLEMENTARY PROVISIONS

Article 44. The formats of licenses for the production, operation, purchase, transportation and import or export of precursor chemicals shall be formulated by the relevant administrative departments of the State Council according to their respective functions and duties and shall be printed under the supervision thereof.


Article 45. The present Regulation shall come into force as of November 1, 2005.

An entity that has engaged in the production, operation, purchase, transportation or import or export of precursor chemicals before the implementation of the present Regulation shall, within 6 months as of implementation of the present Regulation, make a new application for the relevant license according to the provisions of the present Regulation.



Attachment: Catalogue of Classification and Varieties of Precursor chemicals



ATTACHMENT:

CATALOGUE OF CLASSIFICATION AND VARIETIES OF PRECURSOR CHEMICALS

CATEGORY I

1. 1-phenyl-2-propanone
2. 3,4-Methylenedioxyphenyl-2-propanone
3. piperonal
4. safrole
5. sassafras oil
6. iso-safrole
7. n-acetyl o-amino benzoic acid
8. o-amino benzoic acid
9. ergotic acid*
10. ergotamine*
11. ergobasine*
12. Substances in the category of ephedrine such as ephedrine, pseudo ephedrine, mesoephedrine, phenylpropanolamine, methylephedrine, ephedrine extractum, ephedrine extractum powder



CATEGORY II

1. phenyl acetic acid
2. acetic oxide
3. chloroform
4. ether
5. piperidine



CATEGORY III

1. toluene
2. acetic oxide acetone
3. methyl ether ketone
4. polsassium permanganate
5. sulphuric acid
6. hydrochloric acid



Notes:

1. The saline chemical that may exist in the substances listed in Category I or II shall be incorporated into control.
2. The varieties marked with "*" shall be precursor chemicals under the item of pharmaceuticals in Category I, which include the pharmaceutical raw materials and the single preparation thereof.
For More Articles Subscribe

To view more Information on this Law
please login

Login
Password
Not a subscriber yet? Click here
Copyright 2002 NovexCn.com