Issuing Unit: Standing Committee of the National People's Congress Update Time: 2015-05-05 17:15:48 Effective time: 2013-12-28 timeliness: current validity
(September 20, 1984, the 7th meeting of the 6th National People's Congress of the National People's Congress, adopted the 20th meeting of the Standing Committee of the Ninth National People's Congress of the Ninth National People's Congress on February 28, 2001. On the 28th, the sixth meeting of the Standing Committee of the Twelfth National People's Congress "Decision on Amending Seven Laws of the People's Republic of China Marine Environmental Protection Law" was revised.
Catalog
Chapter 2 Drug Production Enterprise Management
Chapter III Drug Management Enterprise Management
Chapter 4 Drug Management of Medical Institutions
Chapter 6 Management of Pharmaceutical Packaging
Chapter 7 Drug Price and Advertising Management
Chapter 9 Legal Responsibility
Chapter 1 General Principles
Article 1 In order to strengthen drug supervision and management，Guarantee drug quality，Guarantee human medication safety，Maintain the legitimate rights and interests of people's health and medication，Special Formation of this Law。
Article 2 The development of medicines engaged in drugs in the People's Republic of China、Production、Business、Units or individuals using and supervised and managed，Must follow this law。
Article 3 The development of modern medicine and traditional medicine for the country，Give full play to its prevention、The role of medical and health care。
National protection of wild medicinal materials and encourage the cultivation of Chinese medicinal materials.
Article 4 State encourages research and creation of new drugs，Protection citizen、Research on legal persons and other organizations、The legitimate rights and interests of the development of new drugs。
Article 5 The director of the State Council's Drug Supervision and Administration Department is in charge of the National Drug Supervision and Management。The relevant departments of the State Council are responsible for supervision and management related to drug -related drugs within their respective duties。
province、Autonomous Region、The Drug Supervision and Management Department of the People's Government of the Municipality directly under the Central Government is responsible for the drug supervision and management of the administrative area。province、Autonomous Region、The relevant departments of the people's government of the municipality directly under the Central Government are responsible for the supervision and management of drug -related drugs within their respective responsibilities。
The drug supervision and management department of the State Council shall cooperate with the State Council's economic comprehensive authority，Implement the development plan and industrial policy formulated by the country formulated by the state。
Sixth Drug Supervision and Administration Department set up or determined drug inspection agency，Undertake the pharmaceutical inspection work required for drug approval and drug quality supervision and inspection in accordance with the law。
Chapter 2 Drug Production Enterprise Management
Article 7 Opening a drug production enterprise，It must be provided by the location of the enterprise、Autonomous Region、The drug supervision and management department of the people's government of the municipality approved and issued to the "Drug Production License"。No "Drug Production License"，Do not produce medicines。
"Drug Production License" shall indicate the validity period and production scope，Re -review of the issue of expiration。
The drug supervision and management department approves the opening of drug production enterprises，Except for the conditions specified in Article 8 of this Law，It should also be in line with the development plan and industrial policy of the pharmaceutical industry formulated by the state，Prevent duplicate construction。
Article 8 Open a drug production enterprise，Must have the following conditions:
(1) Pharmacy and technicians with qualifications in accordance with the law、Engineering and technical personnel and corresponding technical workers;
(2) Factory with compatible with its drug production、Facilities and sanitary environments;
(3) Agency that can conduct quality management and quality inspection of the drugs produced、Personnel and necessary instruments and equipment;
(4) Rules and regulations that ensure the quality of drugs.
9 Pharmaceutical manufacturers must organize production in accord。The drug supervision and management department shall certify whether the drug production enterprise meets the requirements of the "Management of Drug Production Quality" in accordance with regulations;，Send a certification certificate。
Specific Implementation Measures for the Management of Quality Management of Drug Production、Implementation steps shall be stipulated by the State Council's drug supervision and management department。
Article 10 Except for the production of Chinese medicine slices，Drugs must be produced in accordance with the production process approved by the national drug standards and the medical supervision and management department of the State Council，Production records must be complete and accurate。Drug production enterprises change the production process that affects the quality of drugs，It must be reported to the original approval department for review and approval。
Chinese medicine tablets must be produced in accordance with national drug standards; national drug standards are not specified，Must be according to the province、Autonomous Region、The processing specifications formulated by the drug supervision and management department of the people's government of the municipality directly under the Central Government。province、Autonomous Region、The processing specifications formulated by the drug supervision and management department of the people's government directly under the Central Government shall be reported to the medical supervision and management department of the State Council for filing。
Article 11 The raw materials required for producing drugs、Accessories，It must meet the medicinal requirements。
Article 12 Drug production enterprises must test the quality of the drugs they produce;、Autonomous Region、Chinese medicine drinking tablets formulated by the drug supervision and management department of the people's government directly under the Central Government，Do not obtain a factory。
Article 13 of the province、Autonomous Region、Approve the drug supervision and management department of the people's government directly under the Central Government，Drug manufacturers can accept commissioned production drugs。
Chapter III Drug Management Enterprise Management
Article 14 Open a drug wholesale enterprise，It must be provided by the location of the enterprise、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government is approved and issued to the "Drug Business License";，It must be approved and issued by the local drug supervision and management department at or above the county level of the enterprise.。No "Drug Business License"，Do not operate medicines。
"Drug Business License" shall indicate the validity period and business scope，Re -review of the issue of expiration。
The drug supervision and management department approves the opening of drug business enterprises，Except in accordance with the conditions specified in Article 15 of this Law，It should also follow the principles of reasonable layout and facilitate the purchase of medicines for the masses。
Article 15 The following conditions must have the following conditions:
(1) Pharmacy and technical personnel with qualifications in accordance with the law;
(2) A business place that is compatible with the drugs that is operated、Equipment、Warehousing facilities、Sanitary environment;
(3) Quality management agencies or personnel that are compatible with the drugs they are operating;
(4) Rule and regulations that guarantee the quality of the drugs operated.
Article 16 Drug operation enterprises must operate drugs in accordance with the "Drug Operation Quality Management Specifications" formulated by the State Council's Drug Supervision and Management Department。The drug supervision and management department shall certify whether the drug operating enterprise meets the requirements of the “Drug Operation Quality Management” in accordance with regulations;，Send a certification certificate。
Specific Implementation Measures of the "Specifications for the Management of Drug Operations"、Implementation steps shall be stipulated by the State Council's drug supervision and management department。
Article 17 Drug operating enterprises purchase medicines，It must be established and executed for the inspection inspection acceptance system，Qualified Drug Qualification Certificate and other signs;，No purchase。
Article 18 Drug Operating Enterprise Purchase and Sale for Pharmaceuticals，Must have a real and complete purchase and sale record。Purchasing records must indicate the common name of the medicine、Dosage form、Specification、Batch number、Validity period、Manufacturer、Buy (sales) cargo unit、Buy (sales) number of goods、Purchase price、Buying (sales) delivery date and other content stipulated by the State Council's drug supervision and management department。
Article 19 Drug operating enterprises must sell medicines accurately，and correctly explain the usage、Dosage and precautions;，Drugs listed on the prescription must not change or use it without authorization。Prescription with compatible taboos or super doses，Should refuse the deployment; if necessary，The doctor's doctor corrects or signed it，can be prepared。
Pharmaceutical business enterprises to sell Chinese medicinal materials must be marked.
Article 20 Drug operating enterprises must formulate and implement the drug storage system，Take the necessary refrigeration、Anti -frozen、moisture -proof、Anti -insects、Rat -proof and other measures，Guarantee drug quality。
Drugs entering the warehouse and outbound must implement the inspection system.
stake online sports betting21 The trading market in the urban and rural market can sell Chinese medicinal materials，Except the State Council's other regulations。
Urban and rural market trade markets shall not sell medicines other than Chinese medicinal materials，But pharmaceutical retail enterprises holding the "Drug Operation License" can sell drugs other than Chinese medicinal materials outside the urban and rural market trade market。Specific measures shall be stipulated by the State Council。[
Chapter 4 Drug Management of Medical Institutions
Article 22 Medical institutions must be equipped with pharmacy and technicians that have been qualified in accordance with the law。Non -pharmaceutical technical personnel shall not directly engage in pharmaceutical technical work。
Article 23 Medical Institution Preparation Preparation，It must be passed through the province where it is located、Autonomous Region、A review and consent of the health administrative department of the people's government of the municipality directly under the Central Government，From the province、Autonomous Region、Approve the drug supervision and management department of the people's government directly under the Central Government，issued to the "Medical Institution Preparation License"。No "Medical Institution Permit"，Do not prepare preparations。
"Medical Institutional Permits" shall be indicated when the validity period should be marked，Re -review of the issue of expiration。
Twenty -four medical institutions formula for preparations，It must have facilities that can ensure the quality of the preparation、Management System、Testing instruments and hygiene conditions。
Article 25 Preparations prepared by medical institutions，It should be a variety that is not available in the market and there is no supply on the market，and the province where it is located、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government can be prepared after approval。The preparation of the preparation must be inspected in accordance with the regulations; the qualified，Use the doctor's prescription to use in this medical institution。In special cases，State Council or province、Autonomous Region、Approval of the drug supervision and management department of the people's government of the municipality directly under the Central Government，Preparation preparations prepared by medical institutions can be adjusted between designated medical institutions。
Preparation prepared by medical institutions shall not be sold in the market.
Article 26 Medical institutions purchase medicines，It must be established and executed for the inspection inspection acceptance system，Qualified Drug Qualification Certificate and other signs;，No purchase and use。
Article 27 The prescription of the pharmacy personnel of the medical institution，Must be checked，Drugs listed on the prescription must not change or use it without authorization。Prescription with compatible taboos or super doses，Should refuse the deployment; if necessary，The doctor's doctor corrects or signed it，can be prepared。
Article 28 of the medical institution must formulate and implement the drug storage system，Take the necessary refrigeration、Anti -frozen、moisture -proof、Anti -insects、Rat -proof and other measures，Guarantee drug quality。[4]
Chapter 5 Drug Management
Article 29 Develop a new medicine，It must be truthfully submitted to the development method in accordance with the regulations of the State Council's drug supervision and management department、Quality indicator、Pharmacology and toxicological test results and other relevant information and samples，After being approved by the State Council's Drug Supervision and Management Department，Fang can conduct clinical trials。Methods for identifying the qualifications of drug clinical trial institutions，from the Drug Supervision and Administration Department of the State Council、The health administrative department of the State Council is jointly formulated。
New drugs that complete clinical trials and pass approval，Approved by the Drug Supervision and Administration Department of the State Council，Send to the new medicine certificate。
Article 30 Drugs' non -clinical safety evaluation research institutions and clinical trial institutions must implement the quality management specifications of drug non -clinical research、Drug clinical trial quality management specifications。
Drug non -clinical research quality management specifications、The quality management specification of the drug clinical trials is formulated by the department determined by the State Council。
Article 31 What produces new drugs or drugs that existing national standards，It must be approved by the State Council's Drug Supervision and Management Department，Paper to the drug approval number; but，Production of Chinese medicinal materials and Chinese medicine slices that are not implemented by the production number management。Chinese medicinal materials for implementing approval number management、The catalog of traditional Chinese medicine drinking tablets is formulated by the State Council's Drug Supervision and Administration Department in conjunction with the State Council's Chinese Medicine Management Department。
After obtaining the drug approval number of the pharmaceutical manufacturer，Fang can produce this medicine。
Article 32 Drugs must meet national drug standards。Traditional Chinese medicine drinking tablets shall be implemented in accordance with the provisions of Article 10 of this Law。
The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the Drug Supervision and Administration Department of the State Council are national drug standards。
Organization of the Pharmacopoeia Board of the Drug Administration of the State Council，Responsible for the formulation and revision of national drug standards。
Drug inspection agencies of the State Council's Drug Supervision and Management Department are responsible for calibrating the standard of national drugs、control products。
Article 33: Organizes Pharmacy、Medicine and other technical personnel，A review of the new medicine，Repeat the medicine that has been approved for production。
Article 34 Drug Production Enterprise、Drug business enterprises、Medical institutions must have drug production、Enterprises qualified to buy medicines; but，Purchase Chinese medicine materials without implementing approval number management。
Article 35: State of the State of Anesthesia Pharmaceutical、Psychiatric drugs、Medical toxic drugs、Radioxids，Special management。Management measures are formulated by the State Council。
Article 36 The country implements the protection system of traditional Chinese medicines。Specific measures are formulated by the State Council。
Article 37 The State's Classification Management System for Pharmaceutical Prescription Drugs and African Medicine Classification。Specific measures are formulated by the State Council。
Article 38 The efficacy of the prohibition of imports is not uncertain、Pharmaceuticals that are highly adverse or other reasons to harm to human health。
Article 39 Drug Import，It must be reviewed by the State Council's Drug Supervision and Management Department，After review, confirmation meets the quality standard、Safe and effective，can be approved in import，Paled to import drug registration certificate。
Medical units urgently needed in clinical needs or a small amount of medicines imported by individuals，Go through import procedures in accordance with relevant national regulations。
Article 40 Drugs must import from ports allowed by drug imports，and register for the drug supervision and management department of the port where the imported drugs are located。The release of the "Imported Drug Clearance List" issued by the Customs with the Drug Supervision and Administration Department。No "Import Drug Clearance Flies"，Customs must not release。
The drug supervision and management department where the port is located shall notify the drug inspection agency in accordance with the regulations of the State Council's Drug Supervision and Administration Department，and charges the inspection fee in accordance with the provisions of Article 41 of this law。
Port allowing drug imports by the State Council will be proposed by the State Council's Drug Supervision and Administration with the General Administration of Customs，Report to the State Council for approval。
Article 41 The Drug Supervision and Administration Department of the State Council is before or imported by the following drugs，Specifying drug inspection agencies for inspection; inspection unqualified，Do not sell or import:
(1) Biological products stipulated by the drug supervision and management department of the State Council;
(2) The medicine sold in China for the first time;
(3) Other medicines stipulated by the State Council.
The inspection fee items and charging standards of the drug listed in the preceding paragraph shall be approved and announced by the financial department of the State Council in conjunction with the State Council's price authority。Inspection fee collection methods shall be formulated by the financial department of the State Council in conjunction with the State Council's drug supervision and management department。
Article 42 The drug supervision and management department of the State Council has a drug that has been approved for production or imported，Organized surveys should be organized;、Pharmaceuticals that are highly adverse or other reasons to harm to human health，The approval number should be revoked or the imported drug registration certificate。
Pharmaceuticals that have been revoked or imported drug registered certificates，Do not produce or import、Sales and use;，Supervision or treatment by the local drug supervision and management department。
Article 43 The state implements a drug reserve system.
major disaster situations in China、When the epidemic and other emergencies，The departments stipulated by the State Council can emergency call for enterprise medicines。
Article 44 Drugs that are insufficient in China，The State Council has the right to limit or prohibit exports。
45 Import、Export anesthesia drugs and psychiatric drugs within the scope of the state，The "Import Publication Certificate" issued by the Drug Supervision and Administration of the State Council must be held、"Export Permit"。
Article 46 new discovery and medicinal materials quoted from abroad，Article 46 new discovery and medicinal materials quoted from abroad，Fang can be sold。
47 Administrative Measures for Regional Folk School of Folk Schools，Formulated by the State Council's Drug Supervision and Administration Department in conjunction with the State Council's Chinese Medicine Management Department。
Article 48 prohibits production (including preparation，The same below)、Sales fake medicine。
There is one of the following situations, it is a fake medicine:
(1) The ingredients contained in the medicine do not match the ingredients specified in the national drug standards;
(2) Pharmaceutical impersonation of medicine or pretending to this medicine with other medicines。
There are medicines with one of the following circumstances, according to fake medicines:
(1) The drug supervision and management department of the State Council stipulates that it is prohibited;
(2) The production must be approved in accordance with this law without approved production、Import，or if it must be tested in accordance with this law, it is sold without inspection;
(3) Severence;
(4) Polluing;
(5) Use the production number of the approval number in accordance with this law without obtaining the approved number of materials;
(6) The indication or function indicated by the Indications exceeds the scope of the specified scope。
Article 49 prohibits the production and sales of inferior drugs.
The content of the ingredients of the drug does not meet the national drug standards，For inferior medicine。
Drugs with one of the following circumstances, according to inferior drugs:
(1) If the validity period is not indicated or the validity period is not indicated;
(2) If you do not indicate or change the production batch number;
(3) exceeds the validity period;
(4) The packaging materials and containers that directly contact the drugs are not approved;
(5) Add color agent without authorization、preservatives、Fast、Sastera and auxiliary materials;
(6) Others who do not comply with drug standards.
Article 50 of the drug names included in the national drug standards are common names for drugs。Already used as a common name for medicine，This name must not be used as a drug trademark。
Article 51 Drug Production Enterprise、Pharmaceutical business enterprises and medical institutions directly contact the staff of the drug，You must conduct a health check every year。A disease with infectious diseases or other diseases that may pollute drugs，Do not engage in work that directly contacts medicines。
Chapter 6 Management of Pharmaceutical Packaging
Article 52 of the packaging materials and containers that directly contact drugs，It must meet the medicinal requirements，Conforms to protect human health、Standards for safety，And the drug supervision and management department is approved when approval the drugs。
Drug production enterprises shall not use the packaging materials and containers that are not approved directly contacting drugs。
Packaged materials and containers for unqualified direct contact drugs，The drug supervision and management department is ordered to stop using it。
Article 53 Drug packaging must be suitable for the requirements of drug quality，Convenient storage、Transportation and medical use。
Traveling Chinese medicinal materials must be packaged。On each piece of packaging，The name of the product must be indicated、Place of origin、Date、Call out unit，and attached a sign of qualified quality。
Article 54 Drug packaging must be printed or labeled and attached to the instructions。
Tags or instructions must indicate the common name of the medicine、ingredients、Specification、Production Enterprise、Approval number、Product batch number、Production date、Validity period、Indications or functions、Usage、Dosage、Contraindications、Adverse reactions and precautions。
Anesthesiologist、Psychiatric drugs、Medical toxic drugs、Radioxids、Tags for external medicines and non -prescription medicines，It must be printed with specified signs。
Chapter 7 Drug Price and Advertising Management
55 drugs that implement market adjustments in accordance with the law，Production enterprise of drugs、Business enterprises and medical institutions shall be in accordance with fairness、Reasonable and honest credit、The principle of quality and price consistency formulate price，Provide a reasonable price of drugs for the drug。
Production enterprise of drugs、Operating enterprises and medical institutions shall comply with the provisions of the competent price management department of the State Council on the management of drug prices，Formulate and indicate the retail price of drugs，Price fraud behavior of prohibiting the interests of the interests of the drug use。
Fifty -six drug production enterprises、Business Enterprise、Medical institutions shall provide information on the actual purchase and selling price of their drugs to the government price authority in accordance with the law。
Article 57 Medical institutions shall provide patients with the price list of the drugs used; medical insurance designated medical institutions shall also truthfully announce the price of their common medicines，Strengthen the management of reasonable medication。Specific measures shall be stipulated by the health administrative department of the State Council。
Article 58 production enterprises that are prohibited from drugs、Operating enterprises and medical institutions giving it secretly outside the drug purchase and sale、Receive buckle or other interests。
Production enterprises that prohibit drugs are prohibited、The person in charge of the medical institution of the business or its agent in any name、Drug purchaser、Doctors and other relevant personnel use property or other interests。The person in charge of the prohibition of medical institutions、Drug purchaser、Doctors or other relevant personnel who receive drugs in any name、The property or other interests given by the business or its agent。
Article 59 Drug advertisements must pass through the province of the enterprise、Autonomous Region、Approve the drug supervision and management department of the people's government directly under the Central Government，Paper to the drug advertising approval number;，No release。
Pharmaceutical medicines can be jointly designated by the health administrative department of the State Council and the drug supervision and management department of the State Council、Introduction to Pharmaceutical Professional Journal，But you must not publish an advertisement in the mass communication medium or the advertising propaganda of the public as the object in other ways。
Article 60 Drug Advertising content must be true、Legal，The instructions approved by the State Council's Drug Supervision and Administration Department are subject to，Do not contain false content。
Drug advertisements must not include an assertion or guarantee of unscientific exponent effects; state organs shall not be used、Medical Research Unit、academic institutions or experts、Scholar、Physician、The name and image of the patient will be proof。
Non -drug advertisements must not have the propaganda of drugs.
Article 61 province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government shall check the drug advertisement approved，Advertising for violating this Law and the Advertising Law of the People's Republic of China，It shall notify the advertising supervision and administration authority and make suggestions for handling，Advertising supervision and management organs shall make treatment in accordance with the law。
Article 62 Drug Price and Advertising，This method does not specify，Applicable "Price Law of the People's Republic of China"、Regulations of the "Advertising Law of the People's Republic of China"。
Chapter 8 Drug Supervision
Article 63 The drug supervision and management department has the right to follow the law、The provisions of administrative regulations shall be reported to the development of drugs and production of drugs and the production of drugs、Operations and medical institutions using drugs to supervise and inspect，Relevant units and individuals must not refuse and conceal。
Drug supervision and management department for supervision and inspection，Must show the certificate file，The technical secrets and business secrets of the inspector known to the supervision and inspection should be kept secret。
Article 64 The drug supervision and management department shall be based on the needs of the supervision and inspection，It can be checked for the quality of the drug。Spring inspection inspection should be sampled in accordance with regulations，Do not charge any fee。The cost required in accordance with the prescribed by the State Council。
The drug supervision and management department can take seizure for evidence to prove that the drugs that may endanger human health and their related materials can be seized、Administrative compulsory measures detained，and make administrative treatment decisions within seven days; drugs need to be tested，Make an administrative processing decision within 15 days from the date of the inspection report。
Article 65 of the State Council and Provincial Council、Autonomous Region、The pharmaceutical supervision and management department of the people's government of the municipality directly under the Central Government shall regularly announce the results of the drug quality spot check and inspection; improper announcement，It must be corrected within the scope of the original announcement。
Article 66，You can apply or determine the pharmaceutical inspection agency for the original pharmaceutical inspection institution or the upper -level pharmaceutical inspection institution for the pharmaceutical inspection institution from seven days from the date of receiving the results of the drug test.，You can also apply or determine the pharmaceutical inspection agency for the State Council's Drug Supervision and Administration of the State Council。Drug inspection institutions that accept renewal must make re -inspection conclusions within the time stipulated by the State Council's Drug Supervision and Administration。
Article 67 The drug supervision and management department shall be in accordance with regulations，According to the "Specification of the Quality Management of Drug Production"、"Specification of Drug Business Quality Management"，For the certified pharmaceutical production enterprise、Follow -up inspection after certification for drug business enterprises。
Article 68 The local people's government and the drug supervision and management department shall not require the implementation of drug tests、Approval and other means restrictions or excludes non -regional pharmaceutical manufacturers in accordance with the regional regulations in accordance with the regulations of this Law to enter the region。
Article 69 The drug supervision and management department and the pharmaceutical inspection institutions they set up and the determined institutions that are determined by drug inspection shall not participate in drug production and operation activities，It must not be recommended or produced in its name、Supervision and sales medicine。
Drug Supervision and Administration Department and the pharmaceutical inspection agencies they set up and the staff who are determined by the agency specializing in drug inspection shall not participate in drug production and operation activities。
Article 70。Drug Production Enterprise、Drug business enterprises and medical institutions must often inspect the unit produced by the unit、Business、Drug quality used、curative effect and response。It is found that a serious adverse reaction that may be related to medication，It must be timely province、Autonomous Region、Report on the Drug Supervision and Administration Department of the People's Government of the Municipal People's Government and the Health Administrative Department。The specific measures are formulated by the State Council's drug supervision and management department in conjunction with the State Council's health administrative department。
Drugs that have confirmed a serious adverse reaction，State Council or province、Autonomous Region、The drug supervision and management department of the people's government of the municipality may take stop production、Sales、Emergency control measures used，and should be organized within five days，The decision of administrative treatment in accordance with the law within 15 days from the date of the appraisal conclusion。
Article 71 Drug Production Enterprise、Pharmaceutical inspection institutions or personnel of drug business enterprises and medical institutions，The business guidance of the pharmaceutical inspection agency set by the local drug supervision and management department should be accepted。[
Chapter 9 Legal Responsibility
Article 72 No "Drug Production License"、"Drug Business License" or "Medical Institution Preparation License" production of drugs、Drugs，Banned by law，Conflict illegal production、Drugs and illegal income sold，illegal production、Sell medicines (including the sold and unprecedented medicines，The same below) The amount of the value of the value of the value My stake betting appof more than five times the value of the value of the goods is doubled; the crime is constituted，Criminal responsibility for investigation in accordance with the law。
Article 73 Production、Selling fake medicine，Conflict illegal production、Drugs and illegal income sold，illegal production、Feming the amount of drug value My stake betting appof more than five times the value of drugs is sold;，Order to stop production、Stop business rectification;，Flowing "Drug Production License"、"Drug Operation License" or "Medical Institutional Preparation License"; constitutes a crime，Criminal responsibility for investigation in accordance with the law。
Article 74 Production、Sales of inferior drugs，Conflict illegal production、Drugs and illegal income sold，illegal production、Fine fines of double the value of drugs and less than three times the value of the goods;，Order to stop production、Stop business and rectify or revoke the drug approval certificate、Flowing "Drug Production License"、"Drug Operation License" or "Medical Institutional Preparation License"; constitutes a crime，Criminal responsibility for investigation in accordance with the law。
Article 75 engaged in production、Sales fake medicine and production、Enterprises or other units with severe plots of inferior drugs，Its directors and other persons directly responsible for direct responsible persons shall not engage in drug production within ten years、Business Activity。
Producers are specifically used to produce fake medicines、The original auxiliary materials of inferior drugs、Packaging materials、Production equipment，Confession。
Article 76 Knowing or knowing that it is a fake and inferior drug and provides transportation for it、Keep、Warehousing and other convenient conditions，Breed all transport、Keep、Warehouse income，Packed of fines of more than 50 % of illegal income of more than 50 %;，Criminal responsibility for investigation in accordance with the law。
Article 77 Passionate medicine、Punishment notice of inferior drugs，The results of the quality inspection of the drug inspection institution must be stated; but，Article 48 (1) of this Law (1)、(2)、(5)、(6) item and Article 49, except, except。
Article 78 Drug Production Enterprise、Business Enterprise、Drug non -clinical safety evaluation research institution、Drug clinical trial institutions have not implemented the "Specifications for the Management of Drug Production Quality"、"Specification of Drug Business Quality Management"、Drug non -clinical research quality management specifications、Drug Clinical Test Quality Management Specification，Give warning，Order to correct correction within a time limit;，Order to stop production、Stop business and rectification，and fined 5,000 yuan to less than 20,000 yuan;，Flowing "Drug Production License"、"Drug Business License" and the qualifications of the drug clinical trial institution。
Article 79 Drug Production Enterprise、Operating enterprises or medical institutions violate the provisions of Article 34 of the Law，From no "Drug Production License"、"Pharmaceutical Business License" enterprise purchased drugs，Order to correct，Medicine that confiscates illegal purchases，Purchase of fines My stake betting appof more than five times the value of the drug value of the drug in illegal purchase;，Confession of illegal income; serious circumstances，Flowing "Drug Production License、"Drug Business License" or a medical institution practice license。
Article 80 Pharmaceuticals that have obtained drug import registration certificates，Registration for the pharmaceutical supervision and management department where the port where the drug is allowed to be imported by the medicine is not registered，Give warning，Order to correct correction within a time limit;，Rejuvenation of imported drug registration certificates。
Article 81 Forge、STC、Buying and selling、rental、A license or a drug approval document，Confession of illegal income，Pauncia of more than three times the illegal obtained more than three times the fine; if no illegal income，Fined fines of more than 100,000 yuan or less; if the circumstances are serious,，and revoke the seller、Caorator、Dedicated "Drug Production License"、"Drug Business License"、"Medical Institutional Permit" or revoked the approval document of the drug;，Criminal responsibility for investigation in accordance with the law。
Article 82 violates the provisions of this Law，Provide false certificates、File and data sample or take other deception methods to obtain "Drug Production License"、"Drug Business License"、"Medical Institution Permit" or the drug approval certificate，Flowing "Drug Production License"、"Drug Business License"、"Medical Institutional Permit" or the Certificate of Approval Certificate for Drugs，It does not accept its application within five years，and fined a fine of 10,000 yuan to 30,000 yuan。
Article 83 Medical institutions sell their preparations in the market，Order to correct，Conflict preparations for illegal sales，Packed on a fine of double the value of the illegal sales preparations of more than three times;，Confession of illegal income。
Article 84 Drug operating enterprises violate Article 18 of this Law、Article 19 stipulated，Order to correct，Give warning;，A revoking "Drug Business License"。
Article 85 of the drug logo does not comply with Article 54 of this Law，Except in accordance with the law、Foreign outside the inferior drug theory，Order to correct，Give warning;，Rejuvenation of the approval document of the drug。
Article 86 Drug Inspection Institution issued a false inspection report，For the crime，Press criminal liability according to law; not constitute a crime，Order to correct，Give warning，A fine of 30,000 yuan and 50,000 yuan for the unit will be punished;、Withdrawal、Fleereating punishment，Paunction of fines below 30,000 yuan;，Confession of illegal income; serious circumstances，Rejected its inspection qualification。The test results issued by the drug inspection agency are not true，What caused loss，Should bear the corresponding compensation liability。
Article 87 of this law, administrative punishment specified in Article 73 to 87，Divided by the Drug Supervision and Administration Department of the County level in accordance with the division of responsibilities stipulated by the State Council's Drug Supervision and Administration;、"Drug Business License、"Medical Institution Permit License"、Practice permit for medical institution or revoking the drug approval certificate，from the original certificate、The approved department decides。
Article 88 violates Article 55 of this law、Article 56 Regulations on the management of drug price，Punishment in accordance with the "Price Law of the People's Republic of China"。
Production enterprise of drugs in the 89th drug、Business Enterprise、Medical institutions are giving secretly in the purchase and sale of drugs、receiving rebates or other interests，Production enterprise of drugs、The person in charge of the medical institution of the business or its agent gives it、Drug purchaser、Doctors and other relevant personnel who use property or other interests，Fund of 10,000 yuan or less than 200,000 yuan by the Administrative Department of the Industrial and Commercial Administration，If you have illegal income，It is confiscated; if the circumstances are serious，Drug production enterprises were revoked by the administrative department of industry and commerce、Business license for drug business enterprises，and notify the drug supervision and management department，A revoked "Drug Production License" was revoked by the drug supervision and management department、"Drug Operation License"; constitutes a crime，Criminal responsibility for investigation in accordance with the law。
Production enterprise of medicines in Article 90、The person in charge of the business enterprise、Purchase personnel and other relevant personnel will receive other manufacturers in the purchase and sale of drugs、The property or other interests given by the business or its agent，Give a punishment in accordance with the law，Confession of illegal income;，Criminal responsibility for investigation in accordance with the law。
The person in charge of the medical institution、Drug purchaser、Doctors and other relevant personnel accept drug production enterprises、Drug business enterprises or property or other interests given by their agents，Disposes by the health administrative department or the unit，Confession of illegal income; practicing physician with serious violations of the law，It is revoked by the health administrative department to revoke its practice certificate; constitutes a crime，Criminal responsibility for investigation in accordance with the law。
Article 91: 违 违 违，Punishment in accordance with the "Advertising Law of the People's Republic of China"，and the drug supervision and management department issued by the advertising approval number to revoke the advertising approval number，Application for advertising approval of the variety without accepting the type of advertising in one year; constitutes a crime，Criminal responsibility for investigation in accordance with the law。
Drug Supervision and Administration Department performs duties to perform censorship of drug advertisements，Approved advertisements are false or other violations of laws、The content of administrative regulations，Direct administrative sanctions to the person in charge and other directly responsible persons in accordance with the law;，Criminal responsibility for investigation in accordance with the law。
Production Enterprise of the 92nd Drugs、Business Enterprise、Medical institutions violate the provisions of this Law，The damage to the drug user，Affordable for compensation in accordance with the law。
Article 93 The drug supervision and management department violates the provisions of this Law，One of the following behaviors，It is ordered by its superior authority or supervisory authority to order to recover the certificate issued by illegal、Revisible Drug Approval Certificate File，Direct administrative sanctions to the person in charge and other directly responsible persons in accordance with the law;，Criminal responsibility in accordance with the law:
(1) For the "Specifications for the Management of Drug Production Quality"、Enterprises in the "Regulations on the Management of Drug Operations" are issued to the certification that meets the relevant specifications，Or or the responsibilities of the tracking inspection of the tracking inspection of the enterprise who obtained the certification，If an enterprise that does not meet the certification conditions does not order it to correct or revoke its certification in accordance with the law;
(2) To the "Drug Production License" for units that do not meet the legal conditions、"Drug Business License" or "Medical Institution Preparation License";
(3) For drugs that do not meet the import conditions, they will issue a certificate of registration of imported drugs;
(4) Approved clinical trials for not having clinical trial conditions or production conditions、Send to the new medicine certificate、Sending to the drug approval number。
Article 94 The drug supervision and management department or the pharmaceutical inspection institution it sets or it has a determined institution that specializes in drug inspection to participate in drug production and operation activities，It is ordered by its superior organs or supervision organs to correct，It is confiscated with illegal income; if the circumstances Stake Sports Bettingare serious，Give administrative sanctions to the directly responsible supervisors and other direct responsible persons in accordance with the law。
Drug Supervision and Management Department or the pharmaceutical inspection agency it sets or it is determined，Give administrative sanctions in accordance with the law。
Article 95 of the drug supervision and management department or its settings、The determined pharmaceutical inspection agency will collect inspection fees illegally in the drug supervision and inspection，The government department is ordered to return it to，Give administrative sanctions to the directly responsible supervisors and other direct responsible persons in accordance with the law。Pharmaceutical inspection agencies with serious plots of receiving inspection fees illegal illegal，Rejected its inspection qualification。
Article 96 The drug supervision and management department shall perform the supervision and inspection responsibility in accordance with the law，Supervision has obtained the "Drug Production License"、"Drug Operation License" Enterprises are engaged in drug production、Business Activity。
"Drug Production License" has been obtained、Enterprise production of "Drug Operation License"、Sales fake medicine、Bad drugs，Except for investigating the legal responsibility of the enterprise in accordance with the law，Defeatting job、The drug supervision and management department of malfeasance is directly responsible for the person in charge and other direct responsible persons to give administrative sanctions in accordance with the law;，Criminal responsibility for investigation in accordance with the law。
Article 99 The drug supervision and management department of the drug supervision and management department violates the administrative behavior of the lower drug supervision and management department，Order to correct correction within a time limit;，Have the right to change or revoke。
Article 98 Drug supervision and management personnel abuse their powers、徇 Private fraud、Attention，For the crime，Criminal responsibility in accordance with the law; it does not constitute a crime，Give administrative sanctions in accordance with the law。
Article 99 The "Drug Production License" is revoked in accordance with this law、"Drug Business License"，The drug supervision and management department notified the industrial and commercial administrative department to handle changes or cancellation registration。
Article 100 The value of the goods stipulated in this chapter is illegal production、Calculation of the price of drugs for sales; if there is no price，Based on the market price of similar drugs。
Chapter 10 Attachment
101 The meaning of the following words in this method is:
Drug，refers to the use for prevention、Treatment、Diagnose the disease of the person，Destinations to regulate people's physiological functions and stipulate that there are indications or functions.、Materials for usage and dosage，Including Chinese medicinal materials、Traditional Chinese Medicine Drinking Film、antibiotics、Chemical ingredients and their preparations、antibiotics、Biochemical Drugs、Radioxids、serum、Vaccine、Blood products and diagnostic medicines。
Accessories，refers to the gymma and additional agent used in the production of drugs and preparations。
Drug Production Enterprise，refers to the specialized enterprise of the production of drugs or a part -time enterprise。
Drug business enterprises，refers to a specialized enterprise or a part -time enterprise for business drugs。
Planting of Chinese medicinal materials in 102、Administrative measures for collection and breeding，Formulate by the State Council。
Article 103 The state implements special management of the circulation of preventive biological products。Specific measures are formulated by the State Council。
Article 104 The specific measures for the implementation of this law of the Chinese People's Liberation Army，from the State Council、The Central Military Commission is formulated in accordance with this Law。
Article 105 This law will be implemented from December 1, 2001。
