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Government Documents
Government Documents
UPDATED: December 14, 2006 NO.48 NOV.30, 2006
Provisions on the Management of Import and Export of Precursor Chemicals
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Promulgated by the Ministry of Commerce on September 21, 2006 and effective 30 days from its promulgation

Chapter I General Provisions

Article 1 Pursuant to stipulations in the Foreign Trade Law of the People's Republic of China, the Regulations 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 Appendix to the Regulations on the Administration of Precursor Chemicals. Catalogue is seen in Appendix to these Provisions.

Article 3 The state shall implement a license control management system over the import and export of precursor chemicals. License shall be applied for import or export of precursor chemicals in any form.

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 responsibilities.

The foreign trade and economic cooperation bureaus in provinces, autonomous regiones, municipalities and cities separately designated in the state plan (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 primary examination of import and export of precursor chemicals and approval of license of import and export of some precursor chemicals in their respective regions.

Local bureaus at the county level or above 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 sell in domestic market their finished products and byproducts that are precursor chemicals, corresponding license of import (export) shall be got firstly according to these Provisions, based on which relevant procedures shall be handled.

Article 7 Provided that there are precursor chemicals in the mixtures, dealers shall convert the amount of precursor chemicals and file applications for import (export) license, except for the compounding medicine preparations with precursor chemicals.

Article 8 Import and export of precursor chemicals samples shall be filed application for import (export) license according to these Provisions.

Article 9 Trans-boundary, transit transportation, passing-by transportation of precursor chemicals shall be filed application for import (export) license according to these Provisions.

Article 10 Import and export of precursor chemicals between areas outside China and special supervised areas by the customs and bonded areas such as bonded zones, export processing zones, etc. shall be filed application for import (export) license according to these Provisions.

Entrance and exit of precursor chemicals between home areas and special supervised areas by the customs and bonded areas such as bonded zones, export processing zones, etc., or between the above special supervised areas by the customs and bonded areas need not to be filed application for import (export) license.

Article 11 Dealers shall declare to the customs according to the facts and submit import (export) license when import or export precursor chemicals. The customs go through formalities of examination and clearance based on the license. If importing precursor chemicals of pharmaceutical in the first catalogue, dealers shall also submit customs clearance forms of imported pharmaceutical produced by the food and drugs supervision and management department.

Article 12 Any person enters or exits China with precursor chemicals medicine preparations and potassium permanganate listed in the first catalogue of the Regulations on the Administration of Precursor Chemicals shall take them for self-use and within a reasonable amount limit, and be supervised by the customs.

Any person enters or exits China 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 measures are to be separately constituted.

Article 14 Ephedrine and other precursor chemicals under prior supervision by the state 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 measures are to be separately constituted.

Chapter II Application and Examination of Import and Export License

Article 15 Dealers who apply for importing and exporting of precursor chemicals shall fill in the "Application Form for Importing (Exporting) Precursor Chemicals" according to the facts, accurately, and fully via e-government platform of dual-use items and technologies 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 three days from the day on which they receive the data. Where the requirements are met, the bureaus shall inform the dealers online to submit written materials. Where the requirements are not met, 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 identity evidence for the one who handles the formalities.

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

Provincial bureaus may require the dealers to submit the original copies of the above materials if they have queries on the duplicated copies.

Where the written materials are incomplete or inconsistent with the statutory form, provincial bureaus shall inform the dealers all that need to be redressed within five days from the day on which the materials are received. If the bureaus fail to give a notice exceeding the time limit, the application may be deemed to be accepted on the day when the materials are received.

Article 18 For the import and export application for precursor chemicals in the third catalogue of import and export that need no international check, provincial bureaus shall examine the written materials and e-data the dealers submitted within five 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 time limit, issue the 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 dealers in writing and account for the reasons.

Article 19 For the import and export application for precursor chemicals in the first and second catalogues and in the 3rd that need international check, provincial bureaus shall handle the preliminary examination within three days from the day when the complete and eligible written materials are received.

For the application for precursor chemicals in the first and second catalogues that need no international check and have gone through the preliminary examination, provincial bureaus shall turn over the e-data to the Ministry of Commerce for recording. For the precursor chemicals that need international check and have gone through the preliminary examination, provincial bureaus shall turn over the written materials and e-data to the Ministry of Commerce for check.

Article 20 For the import and export application for precursor chemicals in the first and second catalogues that need no international check, the Ministry of Commerce shall examine within eight 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 Official Reply on Import (Export) Dual-Use Items and Technologies within two days from the day on receipt of the approval decision. Where the license is disapproved, provincial bureaus shall inform the dealers in writing and account for the reasons.

Article 21 For the import application for precursor chemicals that need international check, the Ministry of Commerce shall examine within eight 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 application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the Official Reply on Import Dual-Use Items and Technologies within two days from the day on which the approval decision is received. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the reasons.

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 five 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 within three days of receiving the result of international check and inform the provincial bureaus. Where the application is approved, provincial bureaus shall issue the Official Reply on Export Dual-Use Items and Technologies within two days from the day on which the approval decision is received. Where the license is disapproved, provincial bureaus shall inform the dealer in writing and account for the reasons.

The time for international check is not included into the above time limit of license.

Article 23 For the import application for pharmaceutical precursor chemicals in the first catalogue, the Ministry of Commerce shall ask for the approval from the food and drugs supervision and management department under the State Council before approving the license.

For the export application for pharmaceutical precursor chemicals in the first catalogue, if the purchasing license is required after getting the export license, the dealers shall apply for the purchasing license to the provincial food and drugs 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 items and technologies import and export management of the Ministry of Commerce.

Article 26 Dealers shall apply for the Import and Export License of Dual-Use Items and Technologies with the Official Reply on Import and Export of Precursor Chemicals in accordance with the Management Measures on Import and Export License of Dual-Use Items and Technologies and relevant regulations.

Chapter III Application and Examination of Import and Export License by Foreign-Funded Enterprises

Article 27 Foreign-funded enterprises who apply for importing and exporting of precursor chemicals shall fill in 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 in 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 three 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, foreign-funded enterprises shall submit the written materials to provincial bureaus as follows:

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

(2) The approval certificate (duplicate) marked with United Annual Inspection Passed;

(3) The duplicate of the copy of Business License;

(4) The provincial bureaus' approval document of establishing such enterprises, and the contract of joint venture or cooperative operation, 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 identity evidence for the one who handles the formalities.

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

Foreign-funded enterprises shall also submit the report on applying for importing precursor chemicals, including the enterprises' 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 five days from the day on which the materials are received. If the bureaus fail to give a reply within the time limit, the application may be deemed to be accepted on the day when the materials are received.

Article 30 For the import and export application for precursor chemicals in the third catalogue that need no international check, provincial bureaus shall examine the written materials and e-data the foreign-funded enterprises submitted within five 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 time limit, issue the 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 reasons.

Article 31 For the import and export application for precursor chemicals in the first and second catalogues and in the third catalogue that need international check, provincial bureaus shall handle the preliminary examination within three days from which the complete and eligible written materials are received.

For the application for precursor chemicals in the first and second catalogues that need no international check and have gone through the preliminary examination, provincial bureaus shall turn over the e-data to the Ministry of Commerce for check. For the precursor chemicals that need international check and have gone through the preliminary examination, provincial bureaus shall turn over the written materials and e-data to the Ministry of Commerce for check.

Article 32 For the import application for precursor chemicals in the first and second catalogues that need no international check, the Ministry of Commerce shall examine within eight days from the day on which the e-data provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus.

Where the import application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the Official Reply on Foreign-Funded Enterprise Import Precursor Chemicals within two days from receipt of the approval decision. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprise in writing and account for the reasons.

Article 33 For the export application for precursor chemicals in the first and second catalogues that need no international check, the Ministry of Commerce shall examine within 10 days from the day on which the e-data and written materials provincial bureaus turned over are received, decide whether the license is approved or not, and inform the provincial bureaus. Where the export application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the Official Reply on Foreign-Funded Enterprise Export Precursor Chemicals within the above time limit. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprise in writing and account for the reasons.

Article 34 For the import application for precursor chemicals that need international check, the Ministry of Commerce shall examine within eight days from the day on which the e-data 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 application is approved by the Ministry of Commerce according to the preceding paragraph, provincial bureaus shall issue the Official Reply on Foreign-Funded Enterprise Import Precursor Chemicals within two days from the day on receipt of the approval decision. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprise in writing and account for the reasons.

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 five days from the day on which the written materials and e-data 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 within five days upon receipt of the result of international check. Where the application is approved, the Ministry of Commerce shall issue the Official Reply on Foreign-Funded Enterprise Export Precursor Chemicals within the above time limit and provincial bureaus shall inform the foreign-funded enterprises. Where the license is disapproved, provincial bureaus shall inform the foreign-funded enterprises in writing and account for the reasons.

The time for international check is not concluded into the above time limit.

Article 36 For the import application for pharmaceutical precursor chemicals in the first catalogue by foreign-funded enterprises, the Ministry of Commerce shall ask for the approval from the food and drugs supervision and management department under the State Council before making the approval decision.

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

Article 37 During the examination of precursor chemicals import and export license by foreign-funded enterprises, the Ministry of Commerce may field check the substantial contents of the application materials.

Article 38 The Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals shall be covered with the seal of provincial bureaus.

Article 39 Foreign-Funded Enterprises may inquire the relevant process and result of application via the Foreign-Funded Enterprise Import and Export Management Network.

Article 40 Foreign-funded enterprises shall apply for the Import and Export License of Dual-Use Items and Technologies with the Official Reply on Foreign-Funded Enterprise Import (Export) Precursor Chemicals in accordance with the Management Measures 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 perform the supervision and inspection responsibility for precursor chemicals import and export in their localities in accordance with these Provisions and other relevant laws and regulations, checking and punishing 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 units and individuals shall timely provide the relevant information, materials and articles according to the facts, and shall not 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 authority. The reported commercial authority shall report to the upper authorities level by level, and cooperate with the public security organ to investigate.

Article 44 Dealers shall establish 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 be kept for inspection for at least two years. Special personnel shall be assigned for the work related to precursor chemicals import and export.

Article 45 when dealers know or shall know, or are informed by commercial authorities that the precursor chemicals they plan to import or export may flow into illegal channels, they shall terminate the contract performance in time, and report to relevant commercial authorities.

Provided that dealers violate these Provisions or the precursor chemicals they plan to import or export are possibly 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 transactions.

Article 46 Dealers shall, before March 31 each year, report to provincial bureaus and local public security organs their precursor chemicals import or export in the previous year.

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

If conditions permit, dealers may connect their computer networks with those of provincial bureaus in order to report the relevant import and export in time.

Chapter V Legal Liabilities

Article 47 If the dealers import and export precursor chemicals without license or overrun the license, or violate Article 12 of these Provisions, the customs shall punish them according to relevant laws and regulations. If the violation constitutes a crime, they shall be subject to criminal responsibilities.

Article 48 If the dealers violate these Provisions 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 yuan to 50,000 yuan:

(1) Failed to establish a sound internal management system according to these Provisions;

(2) Having lent its import and export license to others;

(3) Failed to report in time when precursor chemicals are lost, stolen, and robbed during the import and export and serious consequences are caused.

Article 49 If the dealers violate Articles 45 and 46 of these Provisions, the Ministry of Commerce may warn, order to correct in limited time, and sentence a fine of less than 30,000 yuan.

Article 50 Where dealers or individuals reject the supervision and inspection by provincial bureaus, the Ministry of Commerce may order to correct, and give warning to the liable persons in charge and other directly liable persons. If the error is of a serious nature, the units shall be sentenced a fine of 10,000 yuan to 50,000 yuan, and the liable persons in charge and other directly liable persons shall be sentenced a fine of 1,000 yuan to 5,000 yuan.

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 within three years, or may prohibit the law violator to engage in relevant business of import and export precursor chemicals within a time limit of one to three years.

Article 52 Where the staff in provincial bureaus abuses his power, 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 Official Reply on Import (Export) Dual-Use Items and Technologies and the 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) are inconsistent with these Provisions, the Interim Provisions are to prevail.

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 Order, No.4, 1999), Notice of the Ministry of Foreign Trade and Economic Cooperation on Foreign-Funded Enterprise Precursor Chemicals Import and Export Approval Principles and Procedure (MOFTEC Letter, No.197, 1997 ) are repealed at the same time.

(Source: www.fdi.gov.cn)



 
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