(1) A legally registered chemical product production enterprise or pharmaceutical production enterprise.
(2) Having production equipment, storage facilities and pollutant treatment facilities that meet the national standards.
(3) Having a strict production safety management system and an emergency plan for sudden environmental incidents.
(4) The legal representative and technical and management personnel of the enterprise have relevant knowledge of safe production and precursor chemicals, and have no record of drug crimes.
(five) other conditions stipulated by laws, regulations and rules. Those who apply for the production of Class I pharmaceutical precursor chemicals shall also set up TV monitoring facilities and alarm devices networked with public security organs in key areas such as storage places. Article 8 Applications for the production of Class I pharmaceutical precursor chemicals shall be examined and approved by the food and drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government; Applications for the production of Class I non-pharmaceutical precursor chemicals shall be examined and approved by the safety production supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The administrative department prescribed in the preceding paragraph shall, within 60 days from the date of receiving the application, examine the application materials submitted by the applicant. To meet the requirements, issue a production license, or mark it on the relevant production license that the enterprise has obtained; If the license is not granted, the reasons shall be explained in writing. When examining the application materials for the production license of Class I precursor chemicals, on-the-spot verification and expert review may be conducted as required. Article 9 To apply for dealing in precursor chemicals of Category I, the applicant shall meet the following conditions, and shall be examined and approved by the administrative department as stipulated in Article 10 of these Regulations before operating:
(1) It is a legally registered chemical product trading enterprise or pharmaceutical trading enterprise.
(2) Having business premises that meet the requirements of the state and need to store and keep precursor chemicals, and having storage facilities that meet the technical standards of the state.
(3) Having a management system for precursor chemicals and a sound sales network.
(4) The legal representative and sales management personnel of the enterprise have relevant knowledge of precursor chemicals and have no record of drug crimes.
(five) other conditions stipulated by laws, regulations and rules. Article 10 The application for dealing in precursor chemicals of Class I drugs shall be examined and approved by the State Council of the US Food and Drug Administration; Applications for operating Class I non-pharmaceutical precursor chemicals shall be examined and approved by the safety production supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The administrative department prescribed in the preceding paragraph shall, within 30 days from the date of receiving the application, examine the application materials submitted by the applicant. If it meets the requirements, it shall be issued a business license, or marked on the relevant business license that the enterprise has obtained; If the license is not granted, the reasons shall be explained in writing. When examining the application materials for the business license of Class I precursor chemicals, on-site verification may be conducted when necessary. Article 11 A production enterprise that has obtained the production license for precursor chemicals of Category I or gone through the filing procedures for precursor chemicals of Category II and III in accordance with the provisions of Paragraph 1 of Article 13 of these Regulations may distribute the precursor chemicals produced by the enterprise. However, those who set up sales outlets outside the factory to distribute Class I precursor chemicals shall obtain business licenses in accordance with the provisions of these Regulations. Unilateral preparations of Class I pharmaceutical precursor chemicals shall be distributed by designated narcotic drug trading enterprises and shall not be retailed. Article 12 An enterprise that has obtained a license for the production and operation of precursor chemicals of Category I shall register the change of business scope with the administrative department for industry and commerce on the strength of the license. Without the change of registration, the production and operation of precursor chemicals of Category I shall not be carried out. If the license for the production and operation of precursor chemicals of Category I is revoked according to law, the administrative department shall notify the administrative department for industry and commerce within 5 days from the date of making the revocation decision; An enterprise whose license has been revoked shall promptly go to the administrative department for industry and commerce to change its business scope or cancel its registration. Article 13 Whoever produces Class II and Class III precursor chemicals shall, within 30 days from the date of production, report the varieties and quantities produced to the safety production supervision and management department of the municipal people's government where the district is located for the record. Business of precursor chemicals of Category II shall, within 30 days from the date of business, report the variety, quantity and main flow of business to the safety production supervision and management department of the municipal people's government located in the district for the record; Whoever deals in precursor chemicals of Category III shall, within 30 days from the date of operation, report the variety, quantity and main flow of business to the safety production supervision and management department of the local people's government at the county level for the record. The administrative departments prescribed in the preceding two paragraphs shall issue a record certificate on the date of receiving the record materials. Chapter III Article 14 To apply for the purchase of precursor chemicals of Category I, the applicant shall submit the following documents, which shall be examined and approved by the administrative department as stipulated in Article 15 of these Regulations, and obtain the purchase license:
(1) A business enterprise shall submit a business license and a certificate of legal use.
(two) other organizations to submit the registration certificate (establishment approval document) and legal use certificate. Article 15 An application for purchasing precursor chemicals of Class I drugs shall be examined and approved by the food and drug supervision and administration department of the local people's government of the province, autonomous region or municipality directly under the Central Government; Applications for purchasing Class I non-pharmaceutical precursor chemicals shall be examined and approved by the public security organs of the local people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The administrative department specified in the preceding paragraph shall examine the application materials and certification materials submitted by the applicant within 10 days from the date of receiving the application. To meet the requirements, issue a procurement license; If the license is not granted, the reasons shall be explained in writing. When examining the application materials for the purchase license of Class I precursor chemicals, on-site verification may be conducted when necessary. Article 16 A medical institution holding a signature card for purchasing narcotic drugs and psychotropic substances of Category I need not apply for a purchase license to purchase precursor chemicals of Category I.. Individuals are not allowed to buy Class I and Class II precursor chemicals. Article 17 Whoever purchases Class II and Class III precursor chemicals shall file the purchased varieties and quantities with the public security organ of the local people's government at the county level before purchasing. Individuals who buy a small amount of potassium permanganate for their own use do not need to put on record. Article 18 When selling Class I precursor chemicals, business units shall check the purchase license and the identity certificate of the agent. If the procurement is entrusted, the entrusted documents held by the purchaser shall also be examined. Business units can only sell precursor chemicals of Category I after checking and keeping the copies of the above-mentioned certification materials; If suspicious circumstances are found, they should immediately report to the local public security organ. Article 19 A business unit shall establish a sales ledger for precursor chemicals, and truthfully record the varieties, quantities, dates and buyers of the products sold. Copies of sales ledger and certification materials shall be kept for 2 years for future reference. The sale of precursor chemicals of Category I shall be reported to the local public security organ for the record within 5 days from the date of sale; Units using precursor chemicals of Category I shall establish a ledger for use and keep it for 2 years for future reference. The sales of Class II and Class III precursor chemicals shall be reported to the local public security organ for the record within 30 days from the date of sales. Chapter IV Article 20 If the precursor chemicals of Category I are transported across the municipal administrative areas with districts (municipalities directly under the Central Government are cross-city boundaries) or across the county-level administrative areas in key areas with severe drug control situation determined by the public security department of the State Council, they shall be examined and approved by the public security organs of the municipal people's government with districts at the place of departure; The transportation of Class II precursor chemicals shall be examined and approved by the public security organ of the people's government at the county level where it is transported. The transportation of precursor chemicals can only be carried out after obtaining the transportation license after examination and approval. The transportation of precursor chemicals of Category III shall be filed with the public security organ of the people's government at the county level in the place of transportation before transportation. The public security organ shall issue a filing certificate on the day of receiving the filing materials. Article 21 When applying for a transport license for precursor chemicals, a contract for the purchase and sale of precursor chemicals shall be submitted. If the owner is an enterprise, submit a business license. If the client is from another organization, submit the registration certificate (approval document); If the owner is an individual, a personal identification certificate shall be submitted. The agent shall also submit his identity certificate. The public security organ shall examine the application materials submitted by the applicant within 10 days from the date of receiving the application for the transportation license of precursor chemicals of category I and within 3 days from the date of receiving the application for the transportation license of precursor chemicals of category II. To meet the requirements, issue a transport license; If the license is not granted, the reasons shall be explained in writing. When examining the application materials for the transportation license of Class I precursor chemicals, on-site verification may be conducted when necessary. Article 22 Anyone who is allowed to transport precursor chemicals of Category I shall hold a valid transport license ... Anyone who is allowed to transport precursor chemicals of Category II shall be issued a transport license valid for 3 months; If the transportation safety is in good condition within 6 months, a transportation license valid for 12 months will be issued. The license for the transportation of precursor chemicals shall specify the variety, quantity, place of transportation, owner, consignee, carrier and the type of transportation license. Article 23 If ephedrine samples used for teaching and scientific research are less than 65,438,000 grams, ephedrine in small packages used for preparation formula of medical institutions, ephedrine tablets purchased by medical institutions or narcotic drug trading enterprises are less than 60,000 tablets, and ephedrine injection15,000 tablets are less than 65,438,000 grams, and the owner or carrier holds the purchase license certificate or narcotic drug allocation form obtained according to law, it is not necessary to apply for the transportation license of precursor chemicals. Article 24 If the shipper entrusts transportation, the carrier shall examine the transportation license or filing certificate provided by the shipper, and check whether the goods transported are consistent with the varieties of precursor chemicals specified in the transportation license or filing certificate. In case of non-conformity, it shall not be carried. When transporting precursor chemicals, the transport personnel shall carry the transport license or filing certificate with them from the time of shipment. The public security organ shall inspect the transportation process of precursor chemicals. The transportation of precursor chemicals shall comply with the provisions of the state on the transportation of goods. Article 25 Due to the need of treating diseases, patients, close relatives of patients or people entrusted by patients may carry the precursor chemicals of Category I with them on the strength of medical diagnosis certificates issued by medical institutions and personal identification certificates, but the maximum dosage of a single medical prescription shall not be exceeded. The maximum dose of a single medical prescription shall be stipulated and published by the health authorities in the State Council. Chapter V Article 26 To apply for the import and export of precursor chemicals, the following materials shall be submitted, which shall be examined and approved by the competent commercial department of the State Council or the competent commercial department of the people's government of the province, autonomous region or municipality directly under the Central Government entrusted by it, and the import and export activities shall be carried out only after obtaining the import and export license:
(a) a copy of the registration certificate of foreign trade operators (joint annual inspection certificate of foreign-invested enterprises)
(2) A copy of the business license
(3) License or filing certificate for the production, operation and purchase of precursor chemicals.
(four) a copy of the import or export contract (agreement)
(5) the identity certificate of the agent. To apply for an export license for precursor chemicals, a certificate of legal use of precursor chemicals issued by the competent government department of the importer or a guarantee document for the legal use of precursor chemicals by the importer shall also be submitted. Article 27 The competent commercial department that accepts the application for import and export of precursor chemicals shall, within 20 days from the date of receiving the application materials, examine the application materials and conduct on-site verification when necessary. If it meets the requirements, an import or export license shall be issued; If the license is not granted, the reasons shall be explained in writing. Before making a licensing decision, the relevant commercial authorities shall obtain the consent of the US Food and Drug Administration in the State Council for importing the precursor chemicals of Class I drugs. Article 28. Ephedrine and other precursor chemicals under key monitoring scope shall be imported and exported by enterprises approved by the State Council commerce department in conjunction with relevant departments in the State Council. Article 29 The State implements an international verification system for the import and export of precursor chemicals. The catalogue of international verification of precursor chemicals and the specific verification measures shall be formulated and promulgated by the competent commerce department of the State Council in conjunction with the public security department of the State Council. Time spent on international verification is not counted in the license period. In addition to international verification measures, other control measures can be implemented for exporting precursor chemicals and chemicals other than those specified in these regulations to countries or regions with serious drug manufacturing and drug trafficking activities. Specific measures shall be formulated and promulgated by the the State Council Municipal Department of Commerce in conjunction with the the State Council Public Security Department, the General Administration of Customs and other relevant departments. Article 30 Whoever imports, exports or transits, transshippes or transports precursor chemicals shall truthfully declare to the customs and submit the import and export license. The customs shall go through the formalities of customs clearance with the permit. The provisions of the preceding paragraph shall apply to the entry and exit of precursor chemicals between overseas and bonded areas, export processing zones and other special customs supervision areas and bonded places. Precursor chemicals do not need to apply for import and export licenses for precursor chemicals when entering or leaving the bonded areas, such as bonded areas and export processing zones, or between the above-mentioned special customs supervision areas and bonded areas. When importing Class I pharmaceutical precursor chemicals, the Customs Clearance Form for Imported Drugs issued by the food and drug supervision and administration department shall also be submitted. Article 31 Drugs, precursor chemicals, medicines and Category I potassium permanganate carried by entry-exit personnel shall be limited to their own personal use and in reasonable quantities, and shall be subject to customs supervision. Entry-exit personnel shall not carry precursor chemicals other than those specified in the preceding paragraph. Chapter VI Article 32 The public security organs, food and drug supervision and administration departments, production safety supervision and administration departments, commerce departments, health departments, price departments, railway departments, transportation departments, industrial and commercial administration departments, environmental protection departments and customs of the people's governments at or above the county level shall, within their respective functions and duties, strengthen the management of the production, operation, purchase, transportation, price and price of precursor chemicals. Investigate and deal with illegal production, operation, purchase, transportation or smuggling of precursor chemicals according to law. When supervising and inspecting precursor chemicals, the competent administrative department specified in the preceding paragraph may inspect the site according to law, consult and copy relevant materials, record relevant information, and detain relevant evidential materials and illegal articles; When necessary, the relevant places may be temporarily sealed up. Units or individuals under inspection shall truthfully provide relevant information, materials and articles, and may not refuse or conceal them. Article 33 Precursor chemicals collected according to law shall be kept and recovered under the supervision of the public security organs, customs or competent environmental protection departments of the people's governments of provinces, autonomous regions, municipalities directly under the Central Government or cities divided into districts, or shall be destroyed by qualified units under the supervision of competent environmental protection departments in accordance with the relevant provisions of environmental protection laws and administrative regulations. Among them, the collected Class I drugs and precursor chemicals will be destroyed. If illegal precursor chemicals units or individuals are unable to provide storage, recovery or destruction expenses, the storage, recovery or destruction expenses shall be paid from the recovered income or charged from the anti-drug funds of the relevant administrative departments. Article 34 Where precursor chemicals are lost, stolen or robbed, the case-causing unit shall immediately report to the local public security organ, and at the same time report to the food and drug supervision and administration department, production safety supervision and administration department, commerce department or health department of the local people's government at the county level. The public security organ that receives the report shall promptly file a case for investigation and report to the public security organ at the next higher level; The relevant administrative departments shall report to the public security organs step by step and cooperate with the investigation. Article 35 Where a license for precursor chemicals is obtained or revoked according to law, the relevant administrative department shall notify the relevant public security organ and the administrative department for industry and commerce; The administrative department for industry and commerce shall notify the relevant public security organs and administrative departments of the change or cancellation of registration of enterprises that produce and operate precursor chemicals according to law. Article 36 Units that produce, manage, purchase, transport or import and export precursor chemicals shall report the production, management, purchase, transport or import and export of precursor chemicals in the previous year to the licensing or filing administrative departments and public security organs before March 3 1 every year; Conditional production, management, procurement, transportation or import and export units can establish computer networking with relevant administrative departments and report relevant business conditions in a timely manner. Article 37 The relevant administrative departments of the people's governments at or above the county level shall strengthen coordination and establish a notification and exchange mechanism for the management, supervision and inspection of precursor chemicals and case handling. Chapter VII Article 38 Whoever, in violation of the provisions of these Regulations, produces, deals in, purchases or transports precursor chemicals without permission or filing, falsifies application materials to obtain licenses for the production, trading, purchase and transportation of precursor chemicals, uses others or forged, altered or invalid licenses to produce, trade in, purchase or transport precursor chemicals, or illegally produces, deals in, purchases or transports precursor chemicals, The raw materials used for the illegal production of precursor chemicals and the equipment and tools illegally produced, managed, purchased and transported shall be confiscated by the public security organs, and a fine of not more than 20 times the value of precursor chemicals illegally produced, managed, purchased and transported 10 yuan shall be imposed. If the value less than 20 times is less than 10000 yuan, a fine of1shall also be imposed. Illegal income, confiscate the illegal income; If there is a business license, the business license shall be revoked by the administrative department for industry and commerce; If a crime is constituted, criminal responsibility shall be investigated according to law. Within three years from the date of making the decision on administrative punishment, the relevant administrative departments may stop accepting applications for production, operation, purchase, transportation or import and export licenses of precursor chemicals. Article 39 Whoever, in violation of the provisions of these Regulations, smuggles precursor chemicals shall be confiscated by the customs; If there are illegal gains, the illegal gains shall be confiscated and administrative penalties shall be imposed in accordance with customs laws and administrative regulations; If a crime is constituted, criminal responsibility shall be investigated according to law. Fortieth in violation of the provisions of this Ordinance, any of the following acts shall be given a warning by the administrative department responsible for supervision and management, ordered to make corrections within a time limit, and fined more than 50,000 yuan 10000 yuan; Precursor chemicals produced, sold or purchased in violation of regulations may be confiscated; If no correction is made within the time limit, it shall be ordered to suspend production and business for rectification within a time limit; Overdue rectification, revoke the corresponding license:
(a) the production, management, purchase, transportation, import and export units of precursor chemicals fail to establish a safety management system as required.
(2) Lending the license or filing certificate to others for use.
(3) Producing, trading or purchasing precursor chemicals in quantities exceeding the permitted varieties.
(four) the production, operation and purchase units do not record or truthfully record the transaction, do not keep the transaction records as required, or do not truthfully and timely record the sales to the public security organs and relevant administrative departments.
(5) Failing to report the loss, theft or robbery of precursor chemicals in time, thus causing serious consequences.
(6) Trading precursor chemicals in cash or in kind, except that individuals legally purchase drugs for precursor chemicals of Category I and Category III.
(seven) the product packaging and instructions for use of precursor chemicals do not meet the requirements of these regulations.
(eight) the production and business units of precursor chemicals do not truthfully or timely report the annual production, distribution and inventory to the relevant administrative departments and public security organs. If an enterprise fails to change its business scope or cancel its registration at the administrative department for industry and commerce after its license for the production and operation of precursor chemicals has been revoked according to law, the precursor chemicals shall be confiscated and fined in accordance with the provisions of the preceding paragraph. Article 41 If the transported precursor chemicals do not conform to the varieties, quantities, entry places, consignors, consignees and carriers specified in the transport license or filing certificate of precursor chemicals, or the transport license is inappropriate, or the transport personnel do not carry the transport license or filing certificate all the way, the public security organ shall order them to stop for rectification and impose a fine of not less than 5,000 yuan but not more than 50,000 yuan; If there is a qualification for the transport of dangerous goods, the competent department of transportation may revoke its transport qualification according to law. If the precursor chemicals carried by individuals do not meet the variety and quantity requirements, the precursor chemicals shall be confiscated and a fine of 1000 yuan to 5000 yuan shall be imposed. Article 42 Where a unit or individual that produces, deals in, purchases, transports or imports or exports precursor chemicals refuses to accept the supervision and inspection by the relevant administrative department, the administrative department responsible for supervision and management shall order it to make corrections and give a warning to the directly responsible person in charge and other directly responsible personnel; If the circumstances are serious, the unit shall be fined between 1000 yuan and 50000 yuan, and the directly responsible person in charge and other directly responsible personnel shall be fined between 1000 yuan and 5000 yuan; Those who violate the administration of public security shall be given administrative penalties for public security according to law; If a crime is constituted, criminal responsibility shall be investigated according to law. Article 43 Any staff member of the administrative department in charge of precursor chemicals shall permit but not permit, abuse the permit without permission, refuse to put on record according to law or commit other acts of abuse of power, dereliction of duty or favoritism, and shall be given administrative sanctions according to law; If a crime is constituted, criminal responsibility shall be investigated according to law. Chapter VIII Article 44 The license for the production, management, purchase, transportation and import and export of precursor chemicals shall be formulated by the relevant administrative departments in the State Council in accordance with the division of responsibilities, and the producers shall be responsible for supervision. Article 45 These Regulations shall come into force on June 1 65438+1October1day, 2005. Those who have been engaged in the production, management, purchase, transportation, import and export of precursor chemicals before the implementation of these regulations shall re-apply for licenses in accordance with the provisions of these regulations within 6 months from the date of implementation of these regulations.
Legal basis: Regulations on the Administration of Precursor Chemicals
Article 1 These Regulations are formulated for the purpose of strengthening the management of precursor chemicals, standardizing the production, management, purchase, transportation and import and export of precursor chemicals, preventing precursor chemicals from being used to manufacture drugs, and maintaining economic and social order.
Article 2 The State implements a classified management and licensing system for the production, management, purchase, transportation, import and export of precursor chemicals.
Precursor chemicals are divided into three categories. The first category is the main raw materials that can be used to make drugs, and the second and third categories are the chemical formulas that can be used to make drugs. The specific classification and varieties of precursor chemicals are listed in the schedule of this Ordinance.
If the classification and varieties of precursor chemicals need to be adjusted, the public security department of the State Council shall, jointly with the drug supervision and administration department, the production safety supervision and administration department, the commerce department, the health department and the General Administration of Customs of the State Council, put forward a plan and submit it to the State Council for approval.
Where the people's governments of provinces, autonomous regions and municipalities directly under the Central Government think it is necessary to adjust the classification or increase the varieties beyond the provisions of these Regulations within their respective administrative areas, they shall put forward a plan to the public security department of the State Council, and the public security department of the State Council, together with the relevant administrative departments of the State Council, shall report it to the State Council for approval.
Article 3 The public security department, drug supervision and administration department, production safety supervision and administration department, commerce department, health department, General Administration of Customs, price department, railway department, transportation department, market supervision and administration department and ecological environment department of the State Council are responsible for the management of precursor chemicals throughout the country within their respective functions and duties. The relevant administrative departments of the local people's governments at or above the county level shall be responsible for the management of precursor chemicals within their respective administrative areas within the scope of their respective duties.