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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.
Promulgated by The Ministry of Commerce on 2006-9-21 |
