Regulations On Administration Of Precursor Chemicals

Original Language Title: 易制毒化学品管理条例

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People's Republic of China promulgated by Decree No. 445 of the regulations on administration of precursor chemicals Executive meeting of the State Council on August 17, 2005 the 102th passed, are hereby promulgated and, as of November 1, 2005.
August 26, 2005, Prime Minister Wen Jiabao administration of precursor chemicals Regulations Chapter I General provisions article in order to strengthen the administration of precursor chemicals, standardizing production of precursor chemicals, operation, purchase, transport and import and export Act to prevent precursor chemicals used to manufacture drugs, maintaining economic and social order, this Ordinance is enacted.
Article States for precursor chemicals in production, management, purchasing, transport and classification management and import and export licensing system. Precursor chemicals are divided into three categories. First class can be used in the manufacture of the main raw material, category II and category III can be used for manufacture of chemical dispensing.
Specific categories of precursor chemicals and variety by this Ordinance listed in the schedule.
Classification and varieties of precursor chemicals need to be adjusted, by the public security department under the State Council in conjunction with the food and drug administration, work safety supervision and Management Department, Business Department, Health Department and the Customs General Administration, a proposal submitted to the State Council for approval.
People's Governments of provinces, autonomous regions and municipalities considered necessary within their respective administrative areas classification or increase of varieties other than those provided for by this Ordinance shall be submitted to the public security department under the State Council shall be formulated by the public security authorities and the relevant administrative departments of the State Council put forward the proposals, approved by the State Council. Third article State police sector, and food drug supervision management sector, and safety supervision management sector, and business competent sector, and health competent sector, and customs, and price competent sector, and railway competent sector, and traffic competent sector, and business administration sector, and environmental protection competent sector in their of duties range within, is responsible for national of easy business HIV chemicals about management work; County above place levels Government about administrative competent sector in their of duties range within,
Responsible for the administration of precursor chemicals management.
Local people's Governments at or above the county level shall strengthen leadership of the precursor chemicals management, timely solution of problems in the administration of precursor chemicals.
Fourth precursor chemicals in the product packaging and manuals, should be labelled with the names (scientific names and common names), the chemical formula and composition.
Article fifth precursor chemicals in production, management, purchase, transport and import and export, in addition to compliance with the provisions of this Ordinance, belongs to medicine and hazardous chemicals should also abide by the law and other regulations on drugs and relevant provisions in the dangerous chemicals.
Prohibited to smuggle or illegally produce, operate, purchase, transfer, transport of precursor chemicals. Prohibition of the use of cash or in-kind trade of precursor chemicals.
However, individual legal purchases of first drug class drug precursor chemicals in preparation and third-class except for precursor chemicals.
Production, management, purchasing, transportation and import and export of precursor chemicals, and precursor chemicals shall establish an internal management system. Sixth the State encourages to the public security organs and other relevant administrative departments to report illegal activities involving precursor chemicals. Complaint Department should keep their informants confidential.
On the truth of the report, the people's Government above the county level and relevant competent administrative departments shall be rewarded.
Second chapter production, and business management seventh article application production first class easy business HIV chemicals, should has following conditions, and by this Ordinance eighth article provides of administrative competent sector approval, made production license Hou, party can for production: (a) is law registration of chemical products production enterprise or drug production enterprise; (ii) has meet national standards of production equipment, and warehouse facilities and pollutants processing facilities; (three) has strictly of safety management system and environment burst event emergency plans;
(D) the legal representative of the enterprise and technology, managers have the safety knowledge of drugs and precursor chemicals, drug-free criminal record; (v) other conditions stipulated by laws, rules and regulations.
Application in the production of the first class of drug precursor chemicals category, should also be in storage sites and other key regions, set up TV monitoring facilities as well as networking with public security organs of the alarm device.
Eighth in production the first drug in the class category of precursor chemicals, approved by the food and drug supervision and administration departments of the State Council; application in the production of the first class non-drug precursor chemicals, the people's Governments of provinces, autonomous regions and municipalities directly under the safe production supervision and Administration Department for approval. Administrative authorities stipulated in the preceding paragraph shall, within 60 days from the date of receipt of the application, review the application materials submitted by the applicant.
In conformity with the provisions and issue production licenses, or in related production licenses of the enterprises have made an indication on; no permission, and shall state the reasons in writing.
Review of precursor chemicals in category production license application materials, as needed, can be carried out on-site verification and expert review.
Nineth article application business first class easy business HIV chemicals, should has following conditions, and by this Ordinance tenth article provides of administrative competent sector approval, made business license Hou, party can for business: (a) is law registration of chemical products business enterprise or drug business enterprise; (ii) has meet national provides of business places, need store, and custody easy business HIV chemicals of, also should has meet national technology standard of warehouse facilities; (three) has easy business HIV chemicals of business management system and sound of sales network;
(D) the legal representative of the enterprise and sales and management staff has the knowledge of precursor chemicals, drug-free criminal record; (v) other conditions stipulated by laws, rules and regulations.
Tenth application for business/the first drug in the class type of precursor chemicals, approved by the food and drug supervision and administration departments of the State Council; apply first class non-drug precursor chemicals, the people's Governments of provinces, autonomous regions and municipalities directly under the safe production supervision and Administration Department for approval. Administrative Department for the provisions of the preceding paragraph shall from the date of receipt of the application in the 30th, review of application materials submitted by the applicant.
In conformity with the provisions and granted operating licenses or marked on the business license of the enterprise has been made; no permission, and shall state the reasons in writing.
Review of precursor chemicals in category business license application materials, as needed, can be carried out on-site verification. 11th made the first such precursor chemicals production licenses or in accordance with the first paragraph of this section 13th has fulfilled the second class and third class record of precursor chemicals manufacturers, distribution and production of precursor chemicals.
However, the set up sales outlets outside the factory distribution of precursor chemicals in first class, business license shall, in accordance with the provisions of this Ordinance.
First class of drugs in pharmaceutical preparations of precursor chemicals, distribution by designated management enterprises of narcotic, and not retail. 12th first class precursor chemicals production, business license of the Enterprise shall use production or business operation license to register with the Administrative Department for industry and Commerce change of business scope.
Without a change, may not be the first such precursor chemicals in production and management.
First class production of precursor chemicals, the license is revoked, the competent administrative departments shall, from the date of revocation decision informed the administration of industry and commerce in the 5th; revoked the license of the enterprise, time should be given to the Administrative Department for industry and Commerce scope changes or cancellation of registration of enterprises.
13th production of precursor chemicals in category II and category III shall be from the date of production in the 30th, variety and quantity of production, and so on, to the seat of the district people's Government municipal work safety supervision and management departments of the record.
Business second class easy business HIV chemicals of, should since business of day up 30th within, will business of varieties, and number, and main flows, situation, to location of set district of city level government safety supervision management sector record; business third class easy business HIV chemicals of, should since business of day up 30th within, will business of varieties, and number, and main flows, situation, to location of County government safety supervision management sector record.
The administrative departments of the provisions of the preceding two paragraphs shall be issued a registration certificate on the day of receipt of filing.
Purchase management article 14th chapter for the purchase of precursor chemicals in first class, shall submit the following documents by the 15th of the Ordinance stipulates that administrative authorities, purchase license: (a) the venture business license and lawful use certificate; (b) other organizations submit a registration certificate (established approval document) and lawful use to prove.
15th applicants for the class of drugs in the first class of precursor chemicals, the local provinces, autonomous regions, or municipalities directly under the food and Drug Administration approval applicants for the first category of non-drug precursor chemicals, the local public security authorities of the people's Governments of provinces, autonomous regions and municipalities. Administrative Department for the provisions of the preceding paragraph shall from the date of receipt of the application in the 10th, to review the application materials and documents submitted by the applicant.
In conformity with the provisions and to purchase a license; no permission, and shall state the reasons in writing.
Reviewing the first such precursor chemicals purchase permits to apply for materials, if necessary, can be carried out on-site verification.
16th narcotic, psychotropic drugs to purchase a signature card medical institutions to buy precursor chemicals in drug classes in the first class, they do not apply for the first such precursor chemicals purchase permits.
Individuals may purchase of precursor chemicals in first and second class. Article 17th purchase of precursor chemicals in category II and category III, should you need to purchase before buying the variety, quantity, to the local people's Governments at the county level public security organ for the record.
Personal use to purchase small amounts of potassium permanganate, no record. Article 18th units sold the first such precursor chemicals shall examine the purchased licenses and agent identification.
To delegate purchase and also examine principal instruments held by the purchaser.
Business units in the identification is correct, retiring after the copies of the documents mentioned above, shall be sold the first such precursor chemicals and found suspicious circumstances, it should be immediately reported to the local public security authorities. Article 19th unit shall establish the sale of precursor chemicals account, record type, quantity, date of sale, purchase, and so on. Sales ledgers and copies of documents shall be kept for 2 years for reference.

First sale of precursor chemicals shall be from the date of sale within the 5th report to the local public security organ for the record; the first units of such precursor chemicals shall establish the use account, and save for 2 years for reference.
Class II and class III sales of precursor chemicals shall be from the date of sale reported to the local public security organ for the record in the 30th. Fourth chapter transport management 20th article across set district of city level administrative (municipalities for across city territories) or in State police sector determine of drug situation severe of focus area across County Administrative transport first class easy business HIV chemicals of, by shipped out to of set district of city level Government police organ approval; transport second class easy business HIV chemicals of, by shipped out to of County Government police organ approval.
After acquiring the precursor chemicals transport permit the examination and approval, before transport. Transport of precursor chemicals in third class shall, prior to shipping out of the county public security organ for the record.
The public security organs shall be issued a registration certificate on the day of receipt of filing. Precursor chemical section 21st transport license shall submit the contract of purchase and sale of precursor chemicals, the owner is the Enterprise shall submit a license; the owner of other organizations shall submit the registration certificate (established approval document); the owner is an individual, shall submit his or her personal identity.
Agent shall also submit my identification. The public security organ shall receive the first date on which the application for leave to transport such precursor chemicals within 10th, received the second precursor chemicals within 3rd day of transportation license application, review the application materials submitted by the applicant.
In conformity with the provisions issued to transport permit; no permission, and shall state the reasons in writing.
Review of precursor chemicals in category transport permit application materials, as needed, can be carried out on-site verification.
Article 22nd of licensed transportation of such precursor chemicals, issued a valid transportation permit.
To permit transport of precursor chemicals in second class, transport permits issued for 3 months; 6 months transport safety is in good condition, transport permits issued for 12 months.
Precursor chemicals transport permit shall set forth the intention to transport the precursor chemicals of varieties, quantities, shipments, shippers and consignees, carriers and transport licenses.
23rd transport for use in teaching and research of 100 grams of ephedrine samples and small packages for formulation of medical institutions to use ephedrine and narcotic drugs in medical institutions or enterprises to buy 60,000 ephedrine tablets, injections l.5 million below the owner or holder of the carrier purchased lawfully obtained permits or redeployment of one narcotic, they do not apply for shipment authorization of precursor chemicals.
Article 24th being engaged by an owner of transport, the carrier should be the identification of the owner to provide transport license or registration certificate, and verify the shipment and transport license or record-keeping certification set out in variety of precursor chemicals, such as the compatibility of incompatible, not carriers. Transport of precursor chemicals, transport personnel should be full since shipments carrying transport license or registration certificate.
Public security organs shall, in checks during transport of precursor chemicals.
Transport of precursor chemicals, shall comply with the national provisions relating to the transport of goods.
25th due to treatment of diseases, the patient, close relatives or patients with the persons entrusted with the medical certificate issued by a medical diagnosis and my identity, can carry the first drug in the class type of pharmaceutical preparation of precursor chemicals, but shall not exceed the maximum dose of a medical prescription.
Medical prescription dose, by the health authority under the State Council and promulgated. Fifth chapter imports, and export management 26th article application imports or export easy business HIV chemicals, should submitted following material, by State business competent sector or its delegate of province, and autonomous regions, and municipalities Government business competent sector approval, made imports or export license Hou, party can engaged in imports, and export activities: (a) foreign trade operators record registration proved (foreign investment enterprise joint annual qualified certificate) copies; (ii) license copy; (three) easy business HIV chemicals production, and business, and
Buy a license or registration certificate, (iv) the import or export contracts (agreements) copy; (v) the managing human identity.
Apply for permission to export of precursor chemicals, should also be submitted to the competent Department of the Government of the importing party the legitimate use of precursor chemicals issued by certification or assurance of the legitimate use of the importing party files. Article 27th precursor chemicals import and export applications business Department shall from the date of receipt of the application materials in the 20th, to review the application materials and, if necessary, can be carried out on-site verification.
In conformity with the provisions and issue of an import or export permit; no permission, and shall state the reasons in writing.
To import the first drug in the class of precursor chemicals, related departments of commercial administration before licensing decisions are made, should ask the food and drug supervision and administration departments of the State Council's consent.
28th ephedrine precursor chemicals subject to monitored items, by the commercial Administrative Department of the State Council in conjunction with the relevant departments of the State Council approved import and export. 29th State of precursor chemicals import and export international verification system.
List of precursor chemicals international verification and the verification of specific measures prescribed by the commercial Administrative Department of the State Council in conjunction with the public security departments, publication.
International verification time is not calculated within the license period.
Of drug manufacturing and trafficking situation affected countries or exports of precursor chemicals, as well as the provisions of this Ordinance other than chemicals, can be outside international verification measures in the implementation of other control measures, specific measures for the commercial Administrative Department of the State Council in conjunction with the Police Department, General Administration of customs and other relevant departments, published. 30th the import, export or transit of precursor chemicals, transport, transportation, shall to the Customs Declaration and submission of import or export licences.
Customs permit for customs procedures.
Outside of precursor chemicals and free trade zone, export processing zones and other special customs supervision zones, bonded between the sites coming and going, the provisions of the preceding paragraph shall apply.
Precursor chemicals within bonded areas, export processing zones and other special customs supervision zones, bonded places between the incoming and outgoing, or in the special customs supervision, bonded areas between the incoming and outgoing, they do not apply for precursor chemicals for import or export licences.
Import the first drug in the class of precursor chemicals, should also be submitted to the food and Drug Administration issued by customs clearance of imported drugs.
31st article turnover boundary personnel carry the first drug in the class category of precursor chemicals drug preparations and potassium permanganate, shall be limited to personal use and a reasonable number, and subject to customs control.
Entry and exit of personnel are not allowed to carry precursor chemicals other than those provided for in the preceding paragraph. Sixth chapter supervision check 32nd article County above Government police organ, and food drug supervision management sector, and safety supervision management sector, and business competent sector, and health competent sector, and price competent sector, and railway competent sector, and traffic competent sector, and business administration sector, and environmental protection competent sector and customs, should in accordance with this Ordinance and about legal, and administrative regulations of provides, in their of duties range within, strengthening on easy business HIV chemicals production, and business, and purchase, and transport, and price and imports, and
Export supervision and inspection on illegal production, management, purchase and transport of precursor chemicals, or the smuggling of precursor chemicals, be investigated and prosecuted according to law.
Administrative authorities stipulated in the preceding paragraph at the time of the supervision and inspection of precursor chemicals, it may check out live, read, and copy the relevant information, recording the situation, seizing evidence related to the materials and items, if necessary, you can temporarily seized the premises.
Inspected unit or individual shall provide relevant information and materials, and shall not refuse or conceal. 33rd article on law collection, and seized of easy business HIV chemicals, should in province, and autonomous regions, and municipalities or set district of city level Government police organ, and customs or environmental protection competent sector of supervision Xia, difference easy business HIV chemicals of different situation for custody, and recycling, or in accordance with environmental protection legal, and administrative regulations of about provides, by has qualification of units in environmental protection competent sector of supervision Xia destroyed.
Among them, the seizure, seized precursor chemicals in drug classes in the first class, will be destroyed.
Precursor chemicals illegal units or individuals unable to provide storage, recycling or destruction costs, storage, recycling or destruction of cost recovery income expenses, or expenses in the relevant Administrative Department of anti-drug funding. Article 34th precursor chemicals is lost, stolen, robbed, incidence of unit should be immediately reported to the local public security authorities, and report to the local people's Governments at the county level food and drug supervision and Management Department, responsible for production safety supervision and administration departments, business or health authorities.
Received a report of the public security organ shall promptly filed investigation and report to the public security organs at higher levels; the relevant administrative departments should escalate and cooperate with the public security organs investigated and dealt with.
35th precursor chemicals in relevant administrative department shall license and revoked the license of information relating to public security and industry and commerce administration departments; industrial and commercial administrative departments shall precursor chemicals in production and management enterprises shall be altered or cancellation of registration of information relating to public security organs and administrative authorities.
36th article production, and business, and purchase, and transport or imports, and export easy business HIV chemicals of units, should Yu annual March 31 Qian to license or record of administrative competent sector and police organ report this units last year degrees easy business HIV chemicals of production, and business, and purchase, and transport or imports, and export situation; has conditions of production, and business, and purchase, and transport or imports, and export units, can and about administrative competent sector established computer networking, timely informed about business situation.
37th people's Governments above the county level the relevant administrative departments should strengthen coordination and cooperation, establishment of management, supervision and inspection of precursor chemicals as well as cases dealing with notification, exchange mechanism. The seventh chapter legal liability

38th article violation this Ordinance provides, without license or record unauthorized production, and business, and purchase, and transport easy business HIV chemicals, forged application material cheat easy business HIV chemicals production, and business, and purchase or transport license, using others of or forged, and variable made, and failure of license production, and business, and purchase, and transport easy business HIV chemicals of, by police organ confiscated illegal production, and business, and purchase or transport of easy business HIV chemicals, and for illegal production easy business HIV chemicals of raw materials and illegal production, and business, and
Purchase or transport easy business HIV chemicals of equipment, and tool, at illegal production, and business, and purchase or transport of easy business HIV chemicals goods value 10 times times above 20 times times following of fine, goods value of 20 times times insufficient 10,000 yuan of, by 10,000 yuan fine; has illegal proceeds of, confiscated illegal proceeds; has license of, by business administration sector revoked license; constitute crime of, law held criminal.
Units or individuals for violations of the provisions of the preceding paragraph, the relevant administrative departments can be made within 3 years from the date of the decision on administrative penalty, discontinued its production of precursor chemicals, operate, purchase, transport or import or export permit application.
39th in violation of the provisions of this Ordinance, the smuggling of precursor chemicals and confiscated by Customs and smuggling of precursor chemicals has illegally obtained, confiscation of illegal income, and given administrative punishment in accordance with customs legislation, administrative regulations constitutes a crime, criminal responsibility shall be investigated according to law. 40th article violation this Ordinance provides, has following behavior one of of, by has supervision management duties of administrative competent sector give warning, ordered deadline corrected, at 10,000 yuan above 50,000 yuan following of fine; on violation provides production, and business, and purchase of easy business HIV chemicals can be confiscated; late not corrected of, ordered deadline discontinued closed reorganization; late reorganization not qualified of, revoked corresponding of license: (a) easy business HIV chemicals production, and business, and purchase, and transport or imports, and Export units not by provides established security management system of; (ii) will license or record proved lent others using of; (three) beyond license of varieties, and number production, and business, and purchase easy business HIV chemicals of; (four) production, and business, and purchase units not records or not truthfully records trading situation, and not by provides save trading records or not truthfully, and not timely to police organ and about administrative competent sector record sales situation of; (five) easy business HIV chemicals lost, and was stolen, and was Rob Hou not timely report,
Caused serious consequences of; (six) except personal legal purchase first class in the of drug class easy business HIV chemicals drug preparations and third class easy business HIV chemicals outside, using cash or real for easy business HIV chemicals trading of; (seven) easy business HIV chemicals of products packaging and using manual not meet this Ordinance provides requirements of; (eight) production, and business easy business HIV chemicals of units not truthfully or not on time to about administrative competent sector and police organ report annual production, and distribution and inventory, situation of.
Precursor chemicals in enterprise production license was revoked after failing to the Administrative Department for industry and Commerce scope changes or cancellation of registration of enterprises, in accordance with the provisions of the preceding paragraph, for precursor chemicals and confiscated, and a fine.
41st article transport of easy business HIV chemicals and easy business HIV chemicals transport license or record proved contains ming of varieties, and number, and shipped into to, and owner and the consignee, and carrier, situation inconsistent, transport license type improper, or transport personnel not full carry transport license or record proved of, by police organ ordered stopped shipped rectification, at 5000 Yuan above 50,000 yuan following of fine; has dangerous items transport qualification of, transport competent sector can law revoked its transport qualification.
Precursor chemicals carried by individuals do not comply with the variety and quantity of confiscated precursor chemicals, of up to between 5000 and 1000 Yuan fine. 42nd article production, and business, and purchase, and transport or imports, and export easy business HIV chemicals of units or personal refused to accept about administrative competent sector supervision check of, by has supervision management duties of administrative competent sector ordered corrected, on directly is responsible for of competent personnel and other directly responsibility personnel give warning; plot serious of, on units at 10,000 yuan above 50,000 yuan following of fine, on directly is responsible for of competent personnel and other directly responsibility personnel at 1000 Yuan above 5000 Yuan following of fine
; There are acts violating the Administration, they shall be given administrative penalties for public security constitutes a crime, criminal responsibility shall be investigated according to law.
Article 43rd Administrative Department staff in the management of precursor chemicals should be permitted working without permission, which permission should not permit, failing to accept the record, as well as other acts of abuse of power, negligence, malpractice, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
Eighth chapter supplementary articles article 44th of precursor chemicals production, management, purchase, transport and import and export permits, by the relevant administrative departments under the State Council shall be designed and produced in accordance with their respective responsibilities.
45th article of the regulations come into force on November 1, 2005.
Before the implementation of this Ordinance, has been engaged in precursor chemicals production, management, purchase, transport or import and export business, shall, within 6 months from the date of enforcement of this Act, in accordance with the provisions of this Ordinance apply for permission. Schedule: precursor chemicals classification and the list of varieties of the first class 1. 1-phenyl acetone 2. 3,4-methylene oxide phenyl acetone 3. Piperonyl aldehyde 4. Safrole 5. Sassafras oil 6. Effects of safrole 7. N-acetylanthranilic acid 8. Anthranilic acid 9. Lysergic acid * 10. Ergotamine * 11. Ergometrine * 12. Ephedrine, pseudoephedrine, racemic ephedrine, norephedrine, methyl ephedrine, ephedra extract substances such as ephedrine, ephedra extract powder * type II 1. Acid 2. Acetic anhydride 3. Chloroform 4. Diethyl ether 5. Piperidine category III 1. P-2. Acetone 3. Methyl ethyl ketone 4. Potassium permanganate 5. Sulphuric acid 6.
Hydrochloride Description: a, first class, second class, the salts of the substances listed there may be, and under its control. The second, marked with * as the first drug in the class type of precursor chemicals, the first class of drug precursor chemicals category includes old drugs and preparations.

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