Laws of the People's Republic of China

No. 7

Provisions on the Management of Import and Export of Precursor Chemicals has been discussion passed by the 5th ministry matter conference of the Ministry of Commerce May, 17. 2006, and is promulgated now, and goes to effect 30 days from its promulgation. Minister of the Ministry of Commerce, Bo Xilai

Sept. 21, 2006

PROVISIONS ON THE MANAGEMENT OF IMPORT AND EXPORT OF PRECURSOR CHEMICALS Chapter I General provisions

Article 1

Pursuant to stipulations in the Foreign Trade Law of the People's Republic of China, the Regulation on the Administration of Precursor Chemicals, and other relevant laws and administrative regulations, these provisions are hereby formulated to strengthen management of import and export of precursor chemicals and prevent them getting in the illegal drug making channel.

Article 2

Precursor chemicals in these provisions refer to main raw materials and chemicals that can be used for drug making listed in the Regulation on the Administration of Precursor Chemicals appendix. Catalogue is seen in Appendix.

Article 3

The State shall implement a license control management system over the import and export of precursor chemicals. To import or export precursor chemicals in any form shall apply for the license.

Article 4

The Ministry of Commerce shall take charge of management of import and export of precursor chemicals in the whole of China. Other departments of the State Council shall take charge of relevant management within their own responsibility.

The foreign trade and economic cooperation bureaus at the provincial, autonomous regional and municipal level and in cities separately listed in State budgets (hereinafter referred to as provincial bureaus) shall take charge of management of import and export of precursor chemicals in their respective regions, and shall, commissioned by the Ministry of Commerce, take charge of the elementary examination and approval of license of import and export of precursor chemicals in their respective regions.

Local bureaus upwards county level shall take charge of the supervision and inspection over import and export of precursor chemicals in their respective regions.

Article 5

Import and export of precursor chemicals through foreign communication, exchange, cooperation, transference, assistance, service, etc shall apply for the import (export) license according to these provisions.

Article 6

Dealers engaged in the import and export of precursor chemicals (hereinafter referred to as dealers) import and export precursor chemicals in processing trade or their finished products and byproducts by processing are precursor chemicals that need to sell in domestic market, corresponding license of import (export) shall be got firstly according to these provisions, based on which to handle with relevant procedures.

Article 7

Provided that there are precursor chemicals in the mixtures, dealers shall convert the amount of precursor chemicals and files applications to import (export) license, except for the compounding medicine preparations with precursor chemicals.

Article 8

Import and export of precursor chemicals samples shall file application to import (export) license according to these provisions.

Article 9

Trans-boundary, transit transportation, passing-by transportation of precursor chemicals shall file application to import (export) license according to these provisions.

Article 10

Precursor chemicals imported and exported between overseas and custom special supervised areas and tariff free sites as tariff free zone, export processing zone, etc shall file application to import (export) license according to these provisions.

Precursor chemicals imported and exported between home and custom special supervised areas and tariff free sites as tariff free zone, export processing zone, etc, or between the above custom special supervised areas and tariff free sites, need not file application to import (export) license.

Article 11

Dealers shall declare to custom according to the facts and submit import (export) when import and export precursor chemicals. Custom goes through customs formalities, examination and clearance based on the license. The dealers importing of precursor chemicals of pharmaceutical in the 1st catalogue shall also submit import of pharmaceutical going through customs formalities produced by the food and pharmaceutical supervision and management department.

Article 12

Any person entries and exits who takes precursor chemicals medicine preparations and potassium permanganate listed in the 1st catalogue of the Ordinance on Precursor Chemical Management shall take them for self-use and within a reasonable amount limit, and be supervised by the custom.

Any person entries and exits cannot take precursor chemicals not in the preceding provision.

Article 13

The State shall implement international check and examination to import and export of part of precursor chemicals. The management measure is to be constituted else.

Article 14

Ephedrine and others within the shall only be imported and exported by enterprises checked and ratified by the Ministry of Commerce, together with the relevant departments under the State Council. The management measure is to be constituted else.

Chapter II Application and examination of import and export license

Article 15

Dealers who apply for importing and exporting of precursor chemicals shall fill out the "Application Form for Importing (Exporting) Precursor Chemicals" according to the facts, accurately, and fully via e-government platform of dual-use matter and technology import and export management of the Ministry of Commerce, and submit e-data.

Article 16

Provincial bureaus shall examine the import and export application e-data within 3 days from the day on which they receive the data. Where the dealers conform to the requirements, the bureaus shall inform them online to submit written materials. Where the dealers do not conform to the requirements, the bureaus shall account for the reasons online and return the data to the dealers who have to re-apply.

Article 17

After receiving the notice to submit written materials, the dealers shall submit the written materials to provincial bureaus as follows:

(1)

the original copy of "Application Form for Importing (Exporting) Precursor Chemicals" signed by the dealer and covered with the seal of the enterprise.

(2)

the duplicate of the Registration Form for Foreign Trade Dealers;

(3)

the duplicate of the copy of Business License;

(4)

License of Precursor Chemicals production, operation, and purchase or registration evidence;

(5)

the duplicate of Import or Export Contract (Agreement);

(6)

the duplicate of ID evidence for the one whom acts

Dealers shall also submit the import permit (duplicate) or lawful guaranty letter for use (original) issued by competent governmental department of the import country when applying for license of exporting precursor chemicals.

Where the written materials are incomplete or inconsistent with the statutory form, provincial bureaus shall inform the dealer all that need to be redressed within 5 days from the day on which the materials are received. If the bureaus fail to give a reply after the expiry, the application may be deemed to be accepted on the day the materials are received.

Article 18

For the import and export application for precursor chemicals in the 3rd import and export catalogue that need no international check, provincial bureaus shall examine the written materials and e-data the dealer submitted within 5 days from the day on which the complete and eligible written materials are received, and decide whether to issue the license or not.

Where the license is approved, provincial bureaus shall, within the above expiry, issue the "List of Official Reply on Import (Export) Dual-Use Items and Technologies", and submit the e-data to the Ministry of Commerce for recording. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the disapproval.

Article 19

For the import and export application for precursor chemicals in the 1st, 2nd catalogues and in the 3rd that need international check, provincial bureaus shall handle the elementary examination within 3 days from which the complete and eligible written materials are received.

For the application for precursor chemicals in the 1st, 2nd catalogues that have gone through the elementary examination, provincial bureaus shall turn over the e-data to the Ministry of Commerce. For the precursor chemicals that need international check that have gone through the elementary examination, provincial bureaus shall turn over the written materials and e-data to the Ministry of Commerce.

Article 20

For the import and export application for precursor chemicals in the 1st, 2nd catalogues that need no international check, the Ministry of Commerce shall examine within 8 days from the day on which the e-date provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus.

Where the import and export application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the "List of Official Reply on Import (Export) Dual-Use Items and Technologies" within 2 days from the day on which the decision on license approval. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the disapproval.

Article 21

For the import application for precursor chemicals that need international check, the Ministry of Commerce shall examine within 8 days from the day on which the e-date and written materials provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus.

Where the import and export application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the "List of Official Reply on Import (Export) Dual-Use Items and Technologies" within 2 days from the day on which the decision on license approval. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the disapproval.

To meet the international check requirement by the competent governmental department of precursor chemicals export country or region, the Ministry of Commerce shall, with the Ministry of Public Security, check the relevant matters of precursor chemicals the dealer imports.

Article 22

For the export application for precursor chemicals that need international check, the Ministry of Commerce shall examine within 5 days from the day on which the written materials and e-date provincial bureaus turned over are received. Where the application is consistent with the statutory form, the Ministry of Commerce will handle the check.

The Ministry of Commerce shall make the decision on whether to approve or not and inform the provincial bureaus. Where the application is approved, provincial bureaus shall issue the "List of Official Reply on Import (Export) Dual-Use Items and Technologies" within 2 days from the day on which the decision on license approval. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the disapproval.

The time for international check is not counted within the above expiry.

Article 23

For the import application for pharmaceutical precursor chemicals in the 1stcatalogue, the Ministry of Commerce shall ask for the approval from the food and pharmaceutical supervision and management department under the State Council.

For the export application for pharmaceutical precursor chemicals in the 1stcatalogue, if the purchasing license is required after getting the export license, the dealer shall apply for the purchasing license to the provincial food and pharmaceutical supervision and management bureaus.

Article 24

During the examination of precursor chemicals import and export license, the Ministry of Commerce may field check the substantial contents of the application materials.

Article 25

Dealers may inquire the relevant process and result of the application via the e-government platform of dual-use matter and technology import and export management of the Ministry of Commerce.

Article 26

Dealers shall apply for receiving the Import and Export License of Dual-Use Items and Technologies with the List of Official Reply on Import and Export of Precursor Chemicals in accordance with the Management Measure on Import and Export License of Dual-Use Items and Technologies and relevant regulations.

Chapter III Foreign-funded enterprise import and export license application and examination

Article 27

Foreign-funded enterprises who apply for importing and exporting of precursor chemicals shall fill out the "Foreign-Funded Enterprises Application Form for Importing (Exporting) Precursor Chemicals" according to the facts, accurately, and fully via foreign-funded enterprise import and export management network, and submit e-data. If the application form is filled out not via the network, provincial bureaus shall input the information into the above network according to the standard.

Article 28

Provincial bureaus shall examine the import and export application e-data within 3 days from the day on which they receive the data. Where the foreign-funded enterprises conform to the requirements, the bureaus shall inform them online to submit written materials. Where the enterprises do not conform to the requirements, the bureaus shall account for the reasons online and return the data to the dealers who have to re-apply.

Article 29

After receiving the notice to submit written materials, the foreign-funded enterprises shall submit the written materials to provincial bureaus as follows:

(1)

the original copy of "Foreign-Funded Enterprise Application Form for Importing (Exporting) Precursor Chemicals" signed by the dealer and covered with the seal of the enterprise.

(2)

the Authorized Certificate (duplicate) marked with United Annual Inspection Passed;

(3)

the duplicate of the copy of Business License;

(4)

the provincial bureau's approval document of such enterprise's establishment, and the contract of joint venture or Charter, and capital examination report;

(5)

License of Precursor Chemicals production, operation, and purchase or registration evidence;

(6)

the duplicate of Import or Export Contract (Agreement);

(7)

the duplicate of ID evidence for the one whom acts

Foreign-funded enterprises shall also submit the import permit (duplicate) or lawful guaranty letter for use (original) issued by competent governmental department of the import country when applying for license of exporting precursor chemicals.

Foreign-funded enterprises shall also submit the report on applying for importing precursor chemicals, including the enterprise's account for its supervision methods, and guaranty letter for not using precursor chemicals to make illegal drugs.

Where the provincial bureaus hold doubts to materials required in this article, they may require foreign-funded enterprises to submit original copies of the above materials to inspect.

Where the written materials are incomplete or inconsistent with the statutory form, provincial bureaus shall inform the enterprise all that need to be redressed within 5 days from the day on which the materials are received. If the bureaus fail to give a reply after the expiry, the application may be deemed to be accepted on the day the materials are received.

Article 30

For the import and export application for precursor chemicals in the 3rd import and export catalogue that need no international check, provincial bureaus shall examine the written materials and e-data the foreign-funded enterprises submitted within 5 days from the day on which the complete and eligible written materials are received, and decide whether to issue the license or not.

Where the license is approved, provincial bureaus shall, within the above expiry, issue the "List of Official Reply on Import (Export) Dual-Use Items and Technologies", and submit the e-data to the Ministry of Commerce for recording. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterpriser in writing and account for the disapproval.

Article 31

For the import and export application for precursor chemicals in the 1st, 2nd catalogues and in the 3rd that need international check, provincial bureaus shall handle the elementary examination within 3 days from which the complete and eligible written materials are received.

For the application for precursor chemicals in the 1st, 2nd catalogues that have gone through the elementary examination, provincial bureaus shall turn over the e-data to the Ministry of Commerce. For the precursor chemicals that need international check that have gone through the elementary examination, provincial bureaus shall turn over the written materials and e-data to the Ministry of Commerce.

Article 32

For the import application for precursor chemicals in the 1st, 2nd catalogues that need no international check, the Ministry of Commerce shall examine within 8 days from the day on which the e-date provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus.

Where the import and export application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the "List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals" within 2 days from the day on which the decision on license approval. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprise in writing and account for the disapproval.

Article 33

For the export application for precursor chemicals in the 1st, 2nd catalogues that need no international check, the Ministry of Commerce shall examine within 10 days from the day on which the e-date and written materials provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus. Where the import and export application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the "List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals" within the above expiry. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprise in writing and account for the disapproval.

Article 34

For the import application for precursor chemicals that need international check, the Ministry of Commerce shall examine within 8 days from the day on which the e-date and written materials provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus.

Where the import and export application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the "List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals" within 2 days from the day on which the decision on license approval. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprise in writing and account for the disapproval.

To meet the international check requirement by the competent governmental department of precursor chemicals export country or region, the Ministry of Commerce shall, with the Ministry of Public Security, check the relevant matters of precursor chemicals the foreign-funded enterprise imports.

Article 35

For the export application for precursor chemicals that need international check, the Ministry of Commerce shall examine within 5 days from the day on which the written materials and e-date provincial bureaus turned over are received. Where the application is consistent with the statutory form, the Ministry of Commerce will handle the check.

The Ministry of Commerce shall make the decision on whether to approve or not and inform the provincial bureaus. Where the application is approved, provincial bureaus shall issue the "List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals" within 5 days from the day on which the decision on license approval. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the disapproval.

The time for international check is not counted within the above expiry.

Article 36

For the import application for pharmaceutical precursor chemicals in the 1stcatalogue, the Ministry of Commerce shall ask for the approval from the food and pharmaceutical supervision and management department under the State Council.

For the export application for pharmaceutical precursor chemicals in the 1stcatalogue, if the purchasing license is required after getting the export license, the foreign-funded enterprise shall apply for the purchasing license to the provincial food and pharmaceutical supervision and management bureaus.

Article 37

During the examination of foreign-funded enterprise precursor chemicals import and export license, the Ministry of Commerce may field check the substantial contents of the application materials.

Article 38

The "List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals" shall be covered with the seal of provincial bureau.

Article 39

Foreign-Funded Enterprises may inquire the relevant process and result of the application via the Foreign-Funded Enterprise Import and Export Management Network.

Article 40

Dealers shall apply for receiving the Import and Export License of Dual-Use Items and Technologies with the List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals in accordance with the Management Measure on Import and Export License of Dual-Use Items and Technologies and relevant regulations.

Chapter IV Supervision and inspection

Article 41

Commercial authorities above the county level shall strictly performance the supervision and inspection responsibility for local precursor chemicals import and export in accordance with these provisions and other relevant laws and regulations, check and punish the illegal actions according to law.

Article 42

When supervising and inspecting the dealers, commercial authorities above the county level may inspect the field, check and copy relevant materials, record relevant information, detain correlative evidence and articles, and when necessary, may close down the relevant site temporarily.

Relevant unit and individual shall timely provide the relevant information, materials and articles according to the facts, and cannot reject or hide the facts.

Article 43

The unit where precursor chemicals in import and export are lost, stolen, or robbed shall immediately report to local public security organ and commercial authorities. The commercial authority received the report shall report to the upper authorities level-by-level, and cooperate with the public security organ to spy.

Article 44

Dealers shall build a sound internal management system of precursor chemicals import and export, and a sound file management of precursor chemicals import and export with which the files shall keep for inspection for at least 2 years. A person or persons shall specially assigned for the work related to precursor chemicals import and export.

Article 45

when dealers know or shall know, or are informed by the provincial bureaus that the precursor chemicals planned to import or export may flow into illegal channel, they shall terminate the contract performance in time, and report to relevant commercial authority.

Provided that dealers violates these provisions or the precursor chemicals planned to import or export have risk of being used to make illegal drugs, the Ministry of Commerce or provincial bureaus may annul the Import (Export) License issued. Dealers shall take measures to stop the relevant transaction.

Article 46

Dealers shall, before Mar. 31 each year, report to provincial bureaus and local public security organ their precursor chemicals import or export in the previous year.

The dealers importing and exporting PRECURSOR CHEMICALS of pharmaceutical shall also report their import and export of pharmaceutical precursor chemicals to the local food and pharmaceutical supervision and management department. Provincial bureaus shall collect the precursor chemicals import or export within their local administrative area and report to the Ministry of Commerce.

The conditional dealers may build computer network with provincial bureaus so that to report the relevant import and export in time.

Chapter V Legal liability

Article 47

If the dealer imports and exports precursor chemicals without license or extending the license, or violating the Article 12 of these provisions, the customs shall handle and punish according to the relevant laws and regulations. If the violation constitutes a crime, they shall be subject to criminal responsibilities.

Article 48

If the dealer violates these provisions and with one of the following actions, the Ministry of Commerce may warn, order to correct in limited time, and sentence a fine of 10,000 to 50,000:

(1)

Dealer not to build a sound internal management system according to these provisions;

(2)

to lend its import and export license to others;

(3)

not to report in time when precursor chemicals are lost, stolen, and robbed during the import and export and results to serious consequences.

Article 49

If the dealer violates Article 45 , 46 of these provisions, the Ministry of Commerce may warn, charge to correct in limited time, and sentence a fine of less than 30,000.

Article 50

Dealers or individual who reject the supervision and inspection by provincial bureaus, the Ministry of Commerce may order to correct, and give warning to the liable person in charge and other directly liable persons. In serious situation, the unit shall be sentenced a fine of 10,000 to 50,000, and the liable person in charge and other directly liable persons shall be sentenced a fine of 1,000 to 5,000.

Article 51

From the day on which the relevant administrative punishment decision or the criminal punishment verdict goes into effect, the Ministry of Commerce may not accept the law violator's application for license of within 3 years, or may prohibit the law violator to engage in relevant business of import and export precursor chemicals within a time limit of 1 to 3 years.

Article 52

Where the staffer in provincial bureaus abuses his powers, neglects his duties, and practices favoritism and fraudulence in import and export precursor chemicals management, administrative sanction shall be imposed, and if a crime is constituted, he shall be subject to criminal liabilities in accordance with the law.

Chapter VI Supplementary Provisions

Article 53

the "List of Official Reply on Import (Export) Dual-Use Items and Technologies" and the "List of Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals" are printed with a pattern regulated and supervised by the Ministry of Commerce.

Article 54

Where Interim Provisions on the Administration of the Export of Precursor Chemicals to Particular Countries (Regions) is inconsistent with these provisions, the Interim provisions are to abide.

Article 55

These provisions shall come into force 30 days after the promulgation. The former Provisions on the Management of Import and Export of Precursor Chemicals (former MOFTEC, 1999, No. 4 Order), Notice of Ministry of Foreign Trade Economic Cooperation on "Foreign-Funded Enterprise Precursor Chemicals Import and Export Approval Principles and Procedure" (1997, MOFTEC, 3rd Letter Zi, No. 197 ) are repealed at the same time.