Source: China People's Congress Network

Drug Management Law of the People's Republic of China (revised in 2019)

(September 20, 1984, the 7th Meeting of the Standing Committee of the 6th National People's Congress, passed the first revision of the 20th meeting of the Standing Committee of the 9th National People's Congress on February 28, 2001. On December 28th, the sixth meeting of the Executive Committee of the Twelfth National People's Congress "Decision on Amending the Seven Laws of the People's Republic of China Marine Environmental Protection Law" was the first amendments to the first amendment.

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Chapter 1 General Principles
Chapter 2 Drug Development and Registration
Chapter III Drug List License Holders
Chapter 4 Drug Production
Chapter 5 Drug Operation
Chapter 6 Medical Institutional Pharmaceutical Management
Chapter VII Drugs Management
Chapter 8 Drug Price and Advertising
Chapter 9 Drug Reserve and Supply
Chapter 10 Supervision and Management
Chapter 11 Legal Responsibility
Chapter 12 Attachment

Chapter 1 General Principles

Article 1 In order to strengthen drug management，Guarantee drug quality，Ensure the safety and legitimate rights and interests of public medication，Protection and promotion of public health，Develop this law。
II: Entering Drug Development in the People's Republic of China、Production、Business、Use and supervise and manage activities，Applicable this Law。
Drugs referred to this law，refers to preventing prevention、Treatment、Diagnose the disease of the person，A destination to regulate the physiological function of people and stipulate that there are indications or functions.、Materials for usage and dosage，Including Chinese medicine、Chemical drugs and biological products。
Article 3 Drug management shall focus on people's health，Adhere to risk management、Full of control、Principles of Social Co -governance，Create science、Strict supervision and management system，Comprehensive improvement of drug quality，Safety of ensuring medicine、Effective、。
Article 4 National Development of Modern and Traditional Medicine，Give full play to prevention、The role of medical and health care。
National protection of wild medicinal materials resources and traditional Chinese medicine varieties，Encourage the cultivation of Chinese medicinal materials。
Article 5 State encourages research and creation of new drugs，Protection citizen、Research on legal person and other organizations、The legitimate rights and interests of the development of new drugs。
6 The State's System of Pharmaceutical License of Drug Management Pharmaceutical Management。Drug listing license holder holders the development of drugs in accordance with the law、Production、Business、Use the safety of medicines in the whole process、Effectiveness and quality controllability is responsible。
Article 7 engaged in medicine development、Production、Business、Use activity，It should abide by the law、Regulations、Regulations、Standards and specifications，Make sure the whole process information is true、Accurate、Complete and traceable。
Article 8 The Drug Supervision and Administration Department of the State Council is in charge of 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 responsibilities。The Drug Supervision and Administration Department of the State Council cooperates with the relevant departments of the State Council，Implement the development plan and industrial policy of the national pharmaceutical industry。
Provincial、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。Set the city level、The departments of the county -level people's government assumed the duties of drug supervision and management (hereinafter referred to as the drug supervision and management department) are responsible for the drug supervision and management of the administrative area。Relevant departments of local people's governments at or above the county level are responsible for supervision and management related to drug -related supervisors within their respective responsibilities。
Article 9 The local people's governments at or above the county level are responsible for the supervision and management of drug supervision and management in this administrative area，Unified Leaders、Organization、Coordinating drug supervision and management in this administrative area and response to the emergencies of drug safety，Establish and improve the mechanism and information sharing mechanism of drug supervision and management。
Article 10 The people's governments at or above the county level shall incorporate drug safety work into the national economic and social development plan at this level，Including drug safety work funds in the government budget at this level，Strengthen the construction of drug supervision and management，Provide protection for drug safety work。
Article 11 The pharmaceutical supervision and management department sets or designated or designated drug professional and technical institutions，Responsible for the review of drug supervision and management in accordance with the law、Test、Check、Monitoring and evaluation work。
Article 12 The State Establishs and Poly Drug Traceability System。The Drug Supervision and Administration Department of the State Council shall formulate a unified pharmaceutical traceability standard and specification，Promoting drug traceability information to enlighten each other，Realize drug traceability。
Establishing a drug alert system for the country，Monitor the adverse reactions of drugs and other harmful reactions related to medication、Identification、Evaluation and control。
Article 13 The people's governments at all levels and their relevant departments、The Pharmaceutical Industry Association, etc.，The popularization of knowledge such as drug safety laws and regulations and other knowledge。
News media should carry out public welfare propaganda for knowledge and regulations such as drug safety laws and regulations，Public opinion supervision of drugs illegal behavior。Propaganda and reports about drugs should be comprehensive、Science、Objective、Justice。
Article 14 The Drug Industry Association shall strengthen industry self -discipline，Establish and improve industry specifications，Promoting the construction of the industry integrity system，Guide and urge members to carry out activities such as drug production and operation in accordance with the law。
Article 15 of the people's governments at or above the county level and their relevant departments to the development of drugs、Production、Business、Units and individuals who make outstanding contributions in the work and supervision and management work，Give commendation in accordance with relevant national regulations、Reward。

Chapter 2 Drug Development and Registration

Article 16 State supports clinical value -oriented、Drug innovation with clear or special effects on people's diseases，Encourage new treatment mechanism、Diseases or rare diseases that are seriously endangered with life、The development of new drugs such as multi -targeted systemic adjustment and intervention functions for the human body，Promoting drug technology progress。
The state encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out research on traditional Chinese medicine science and technology and drug development，Establish and improve the technical evaluation system that conforms to the characteristics of traditional Chinese medicine，Promoting Chinese medicine inheritance innovation。
The state takes effective measures，Encourage the development and innovation of children's medicine，Support the development of new varieties of children's medicines that meet the physiological characteristics of children's physiological characteristics、Dosage and specifications，Priority review and approval of children's medicine。
Article 17 engaged in drug development activities，It should abide by the quality management specifications of the non -clinical research of drugs、Drug clinical trial quality management specifications，Make sure the entire process of drug development continues to meet legal requirements。
Drug non -clinical research quality management specifications、Drug Clinical Test Quality Management specifications are formulated by the State Council's Drug Supervision and Administration Department in conjunction with the relevant departments of the State Council。
Article 18 Carry out drug non -clinical research，It should comply with relevant national regulations，Persons who are compatible with research projects、venue、Equipment、Instrument and management system，Guaranteed relevant data、The authenticity of the data and samples。
Article 19 Carry out the clinical trial of drugs，Should be truthfully submitted to the development method in accordance with the regulations of the State Council's Drug Supervision and Administration、Quality indicator、Pharmacology and toxicological test results and other related data、Information and sample，Approved by the State Council's Drug Supervision and Administration Department。The drug supervision and management department of the State Council shall decide whether to agree and notify the clinical trial applicant within 60 working days from the date of the application of clinical trials，Unexpectedly not notified，See Agree。Where，Carrying out biological equivalent test，Report to the State Council's Drug Supervision and Administration Department for Filing。
Perform clinical trials of drugs，It should be performed at the clinical trial agency with the corresponding conditions。Pharmaceutical clinical trial institutions implement filing management，Specific measures shall be by the State Council's drug supervision and management department、Commonly formulated the State Council's Health and Health authorities。
Article 20 Carry out clinical trials of drugs，It should meet the ethical principles，Develop a clinical trial plan，Examination and approval by the Ethics Committee。
The Ethical Committee shall establish a ethical review work system，Ensure that the ethical review process is independent、Objective、Justice，Supervision specifications to conduct clinical trials of drugs，Guarantee the legitimate rights and interests of the subject，Maintenance of public interests。
Article 21 Performal clinical trials of drugs，Details such as the purpose and risk of clinical trials should be truthfully explained to the subject or the guardian，Obtained an informed consent of the subject or the guardian's voluntary signing，and take effective measures to protect the legitimate rights and interests of the subjects。
Twenty -two drug clinical trials，Discovery the safety problem or other risks，Applicants for clinical trials should adjust the clinical trial plan in time、Paradse or terminate clinical trials，Report to the drug supervision and management department of the State Council。When necessary，The drug supervision and management department of the State Council may order the clinical trial plan、Paradse or terminate clinical trials。
Article 23 Drugs that are used for clinical trials for the treatment of serious life and no effective treatment of diseases，Medical observation may benefit，and meet the ethical principles，Example、After the consent of informedness, you can use patients with the same condition in institutions that conduct clinical trials。
Article 24 Drugs listed in China，It shall be approved by the Drug Supervision and Administration Department of the State Council，Obtain a drug registration certificate; but，Chinese medicinal materials and Chinese medicine slices that have not been implemented for approval management。Chinese medicinal materials for approval management、The catalog of traditional Chinese medicine drinking tablets is formulated by the State Council's drug supervision and management department in conjunction with the State Council ’s Chinese medicine department。
Apply for drug registration，Should provide real、Enough、Reliable data、Information and sample，Prove the safety of the drug、Validity and quality controllability。
Article 25 of the medicine to apply for registration，The Drug Supervision and Administration Department of the State Council shall organize pharmacy、Medical and other technical personnel to review,Safety of drugs、Validity and Quality Control and Quality Management of the applicant、Risk prevention and control and liability compensation for review;，Issuing Drug Registration Certificate。
When the drug supervision and management department of the State Council is approved for drugs，Review and approval of chemical raw materials，For related auxiliary materials、Packaged materials and containers of direct contact with drugs and containers 1 and review，The quality standard for medicines、Production process、Tags and instructions are approved。
Auxiliary materials referred to in this law，refers to the gymma and additional agent used in the production of drugs and preparations。
Article 26 The diseases that are severely endangered with life and have no effective treatment methods and the medicines that are urgently needed in public health，Drug clinical trial existing data shows the efficacy and predict its clinical value，You can attach conditional approval，and the relevant matters in the pharmaceutical registration certificate。
Article 27 The Drug Supervision and Administration Department of the State Council shall improve the system of drug review and approval，Strengthening capacity building，Establish a sound communication、Expert consultation and other mechanisms，Optimized review approval process，Improve the efficiency of review and approval。
The review conclusion and basis for approval of listed drugs shall be disclosed in accordance with the law，Accept social supervision。The business secrets learned in the review and approval should be kept secret。
Article 28 Drugs shall meet the national drug standards。Drug quality standards approved by the State Council ’s drug supervision and management department are higher than those of national drug standards，Implement according to the approved drug quality standards;，It should meet the approved drug quality standards。
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。
The Drug Supervision and Administration Department of the State Council, in conjunction with the State Council's Health and Health Administration, organizes the Pharmacopoeia Committee，Responsible for the formulation and revision of national drug standards。
The Drug Supervision and Administration Department of the State Council sets up or designated by the designated pharmaceutical inspection agency is responsible for calibrating the standard of national drugs、Control products。
Article 29: The name of the drug names included in the national drug standard is the common name of the drug。Already used as a common name for medicine，This name must not be used as a drug trademark。

Chapter III Drug List License Holders

Article 30 Pharmaceutical listing license holder refers to the enterprise or drug development institution that obtains the drug registration certificate。
Drug listing license holders shall be in accordance with the provisions of this Law，Non -clinical study of medicines、Clinical Test、Production and operation、Research after listing、Adverse reactions monitoring and reporting and processing responsibility。Others engaged in drug development、Production、Business、Storage、Transportation、Used units and individuals to assume corresponding responsibilities in accordance with the law。
The legal representative of the holder of the drug listing permit、The main person in charge is fully responsible for the quality of the medicine。
Article 31 Drug listing license holder shall establish a drug quality assurance system，Equipped with specialized personnel independently responsible for drug quality management。
Drug listing permit holders shall be a trustee drug manufacturer、The quality management system of drug business enterprises conduct regular review，Supervise its continuous quality assurance and control ability。
Article 32 of the Pharmaceutical Local License holder can produce drugs by themselves，You can also entrust drug production enterprises to produce。
Pharmaceutical listing permit holder to produce drugs，Drug production licenses shall be obtained in accordance with the provisions of this law;，It should be entrusted to eligible My stake betting appstake online sports bettingpharmaceutical manufacturers。Drug listing license holders and trustee manufacturers shall sign a commission agreement and quality agreement，and strictly fulfill the obligations agreed in the agreement。
The Drug Supervision and Administration Department of the State Council formulates the guidelines for the production quality agreement for drug commission，Guidance、Supervisor the obligation to ensure the quality assurance of the drug quality of the drug for the supervision of the drug listing permit。
Blood Products、Anesthesiologist、Psychiatric drugs、Medical toxic drugs、Pharmaceuticals are easy to produce and chemicals must not be commissioned; but，The Drug Supervision and Administration Department of the State Council has other regulations。
Article 33 of the Pharmaceutical Local License Owner shall establish a pharmaceutical listing and release regulations，Review the drugs released by the drug production enterprise，After the signature of the quality of the authority, it can be released。It does not meet the national drug standard，No release。
Article 34 The Pharmaceutical License holder can sell the medicines for their own drug registration certificate，You can also commission drug business enterprises for sale。Pharmaceutical listing permit holders who are engaged in drug retail activities，Drug business license should be obtained。
Drug listing license holder sells drugs，It should have the conditions stipulated in Article 52 of this Law;，It should be entrusted to qualified drug business enterprises。Drug listing license holders and entrusted business enterprises shall sign a commission agreement，and strictly fulfill the obligations agreed in the agreement。
Article 35 of the Pharmaceutical Local Permit holder、Pharmaceutical Production Enterprise、Drug operating enterprise commissioned storage、Transportation drugs，Evaluate the quality assurance and risk management capabilities of the trustee，Signed a commission agreement with it，The quality responsibility of the drug is agreed、Operating rules and other content，and supervise the recipient。
Article 36 Pharmaceutical Local License Holder、Pharmaceutical Production Enterprise、Drug business enterprises and medical institutions shall establish and implement the pharmaceutical traceability system，Provides traceability information in accordance with regulations，Guaranteed drug traceability。
Article 37 The holder of the drug listing permit shall establish an annual report system，Drug production and sales every year、Research after listing、Risk management and other conditions to the province in accordance with regulations、Autonomous Region、Report on the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government。
Article 38 of the Pharmaceutical Listing Licensing Holders for Overseas Enterprises，It should be performed by the obligation to fulfill the obligation of drug listing permits in China，The holder of the drug listing license holder assumes the joint responsibility。
Article 39 The relevant obligations of the Chinese medicine beverage production enterprise performed the drug listing license holder，Production of Chinese medicine drinks、Sales implementation full process management，Establish a traceability system for Chinese medicine drinking tablets，Guaranteed Chinese medicine tablets safety、Effective、traceable。
Article 40 Approved by the State Council's Drug Supervision and Management Department，Pharmaceutical listing license holders can transfer drugs listing permits。The transferee should have to ensure drug safety、Quality management of validity and quality controllability、Risk prevention and control and liability compensation，Performing the obligations of the holder of the drug listing permit。

Chapter 4 Drug Production

Article 41，It should be in the province where it is located、Autonomous Region、Approval of the Drug Supervision and Administration Department of the People's Government of the Municipal Municipality，Obtaining a drug production license。Without a drug production license，Do not produce medicines。
Drug production license shall be indicated in the validity period and production scope，Re -review of the issue of the expiration。
Article 42: engaged in drug production activities，The following conditions should be available:
(1) Pharmacy and technicians with qualifications in accordance with the law、Engineering and technical personnel and corresponding technical workers;
(2) There are factories that are compatible with drug production、Facilities and sanitary environments;
(3) Organization of quality management and quality inspection of the drugs produced、Personnel and necessary instruments and equipment;
(4) rules and regulations with the quality of drugs，and meet the requirements of the Drug Supervision and Administration of the State Council in accordance with the requirements of the quality management of drug production formulated by this law。
Article 43，It should abide by the quality management specifications of drug production，Establish and improve the quality management system of drug production，Make sure the entire process of drug production continues to meet legal requirements。
Legal representative of pharmaceutical manufacturers、The main person in charge is fully responsible for the company's drug production activities。
Article 44 Drugs shall be produced in accordance with the production process approved by the national drug standards and the production process approved by the drug supervision and management department。Production、Inspection records should be complete and accurate，No fabrication。
Chinese medicine drinks should be produced in accordance with national drug standards; national drug standards are not specified，It should 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。Provincial、Autonomous Region、The production specifications formulated by the drug supervision and management department of the people's government of the municipality directly under the Central Government shall be reported to the medical supervision and management department of the State Council for filing。Not in line with national drug standards or not follow the province、Autonomous Region、The Pharmaceutical Supervision and Administration Department of the People's Government of the Municipal Municipality，Do not obtain a factory、Sales。
Article 45 of the raw materials required for production of drugs、Accessories，It should meet the medicinal requirements、Related requirements of the quality management specifications of drug production。
Production medicine，The supply of raw materials shall be on the supply、Suppliers such as auxiliary materials and other materials for review，Guaranteed purchase、The raw material used、Accessories and other materials meet the requirements of the previous paragraph。
Article 46 Packaging materials and containers that directly contact drugs，It should meet the medicinal requirements，Conforming to protect human health、Standards for safety。
Packaged materials and containers for unqualified direct contact drugs，The drug supervision and management department is ordered to stop using it。
Article 47 Drug production enterprises shall perform quality inspection of drugs。It does not meet the national drug standard，Do not obtain a factory。
Pharmaceutical manufacturers should establish a pharmaceutical factory release regulations，Determine the standard for the release of the factory、Condition。Meet the standard、Condition，After the signature of the quality of the authority, it can be released。
Article 48 Drug packaging shall be suitable for the requirements of drug quality，Convenient storage、Transportation and medical use。
Shipping Chinese medicinal materials should be packaged。On each piece of packaging，The name of the product should be indicated、Place of origin、Date、Supply Unit，also attached a sign of qualified quality。
Article 49 Drug packaging shall be printed or labeled and attached with a manual。
Tags or instructions shall indicate the common name of the medicine、ingredients、Specification、Listing license holder and its address、Production enterprise and its address、Approval number、Product batch number、Production date、Validity period、Indications or functions、Usage、Dosage、contraindications、Adverse reactions and precautions。Tag、The text in the manual should be clear，Production date、Emphasized period and other matters should be significantly marked，Easy recognition。
Anesthesiologist、Psychiatric drugs、Medical toxic drugs、Radial drugs、Tags for external medicines and non -prescription medicines、Manual，The specified signs should be printed。
Article 50 of the Pharmaceutical Local Licensing Holder、Pharmaceutical Production Enterprise、Staff directly contacting drugs in drug business enterprises and medical institutions，A health check every year should be performed。A disease with infectious diseases or other diseases that may pollute drugs，Do not engage in work that directly contacts medicines。

Chapter 5 Drug Operation

Article 51，It should be in the province where it is located、Autonomous Region、Approval of the Drug Supervision and Administration Department of the People's Government of the Municipal Municipality，Obtaining a drug business license。Entering the retail activities of drugs，It should be approved by the drug supervision and management department of the local people's government at or above the county level，Obtaining a drug business license。Without a drug business license，Do not operate medicines。
Drug business license shall indicate the validity period and business scope，Re -review of the issue of the expiration。
Drug Supervision and Administration Department Implementation Drug Operation License，Except for the conditions in accordance with Article 52 of this Law，It should also follow the principle of facilitation of drug purchase。
Article 52 shall be engaged in the following conditions:
(1) Pharmacists or other pharmacy technicians who have been qualified in accordance with the law;
(2) There are business places that are compatible with the drugs that are operated、Equipment、Warehousing facilities and sanitary environments;
(3) Quality management agencies or personnel that are compatible with the drugs they operate;
(4) rules and regulations with the quality of drugs，and meet the requirements of the drug supervision and management department of the State Council in accordance with the requirements of the drug management quality management specifications formulated by the law。
Article 53，It should abide by the quality management specifications of drug business，Establish and improve the quality management system of drug business，Make sure the entire process of drug operations continues to meet legal requirements。
State Encouragement、Guide drug retail chain operation。Enterprise Headquarters engaged in the retail chain of drugs，The unified quality management system should be established，Performance of the management responsibility for the business activities of the retail enterprises。
Legal representative of drug business enterprises、The main person in charge is fully responsible for the company’s drug business activities。
Article 54 The State's Classification Management System for Pharmaceutical Prescription Drugs and African Medicine Classification。The specific measures are formulated by the State Council's drug supervision and management department in conjunction with the State Council's health and health authority。
Article 55 of the Pharmaceutical Local Licensing Holder、Pharmaceutical Production Enterprise、Drug operating enterprises and medical institutions shall be the holder of the drug listing permit or have drug production、Enterprises qualified to buy medicines; but，In addition to purchasing Chinese medicine materials that have not been implemented for approval management。
Fifty -six -drug business enterprise purchases drugs，It should be established and implemented for the inspection inspection acceptance system，Qualified Drug Qualification Certificate and other signs;，No purchase and sales。
Fifty -seventh pharmaceutical business enterprise purchase and sell medicine，Should be true、Complete purchase and sale records。Purchasing and selling records should indicate the common name of the medicine、Format、Specification、Product batch number、Validity period、Located License Holder、Production Enterprise、Buying and selling unit、Number of purchases and sales、Purchase price、Purchase and sales date and other content stipulated by the State Council's drug supervision and management department。
Fifty -eighth pharmaceutical business enterprise retail drugs shall be accurate，and correctly explain the usage、Dosage and precautions;，Drugs listed on the prescription must not be changed or used for permission。Prescription with compatible taboos or over -doses，Should refuse the deployment; if necessary，The doctor of the prescription correction or redirection，can be prepared。
Drug operating enterprises sell Chinese medicinal materials，It should be marked with origin。
Pharmacists or other pharmacy and technicians that have been qualified according to law are responsible for the management of the company's medicine、Prescription review and deployment、Reasonable medication guidance and other work。
Article 59 Drug business enterprises shall 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 and warehouses shall implement the inspection system.
Article 60 The trading market in the urban and rural market can sell Chinese medicinal materials，Except for the State Council's other regulations。
Article 61 Pharmaceutical Local Permit holder、Drug business companies sell drugs through the Internet，It should abide by the relevant regulations of the drug operation of this law。The specific management measures are formulated by the State Council's drug supervision and management department in conjunction with the State Council's health and health authorities and other departments。
Vaccine、Blood Products、Anesthesiologist、Psychiatric drugs、Medical toxic drugs、Radial drugs、Pharmaceuticals such as vulnerability toxic chemicals and other countries shall not be sold on the Internet。
Article 62 The third -party platform provider of the drug network transaction shall shall be in accordance with the provisions of the Drug Supervision and Administration Department of the State Council，Provincial province in your place、Autonomous Region、The Drug Supervision and Management Department of the People's Government of the Municipality directly under the Central Government。
Third -party platform providers shall be the holder of the drug listing license to enter the platform in accordance with the law、The qualifications of drug business enterprises are reviewed，Make sure it meets its legal requirements，and manage the drug business behavior on the platform。
Third -party platform providers found the drug listing license holder who entered the platform operation、Drug operating enterprises have violated the behavior stipulated in this Law，It should be stopped and immediately reported to the drug supervision and management department of the county -level people's government at the prefecture -level people's government;，It should stop providing online trading platform services。
Article 63 new discovery and medicinal materials quoted from overseas，After being approved by the State Council's Drug Supervision and Management Department，Fang can be sold。
Article 64 Drugs shall be imported from ports allowed by drug imports，And the company that is imported from imported drugs will record the drug supervision and management department where the port is located。The customs clearance procedures for the import drug customs clearance order issued by the customs by the Customs Supervision and Administration Department。For the customs clearance order without imported drugs，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 Administration。
Port allowing drug imports by the State Council is proposed by the State Council's Drug Supervision and Administration with the General Administration of Customs，Report to the State Council for approval。
Article 65 of the medical institution for importing a small amount of medicines in urgently needed to import a small amount of medicines，The province authorized by the State Council ’s drug supervision and management department or the State Council、Autonomous Region、Approval of the People's Government of the Municipality directly under the Central Government，can be imported。Imported medicines should be used in specific medical institutions for specific medical purposes。
Individual self -use carries a small amount of medicine，Apply in accordance with relevant national regulations。
Article 66 Import、Export anesthesia drugs and psychiatric drugs within the scope of the state regulations，The import allowance certificate issued by the Drug Supervision and Administration of the State Council should be held、Export allowance certificate。
Article 67 The efficacy of the prohibition of imports is inaccurate、Pharmaceuticals that have a large adverse reaction or harm to human health due to other reasons。
Article 68. Article 68 The Drug Supervision and Administration Department of the State Council is before or imported by the following drugs，Drug inspection agencies should be specified for inspection; those who have not passed the inspection or are not qualified，Do not sell or import:
(1) Drugs sold in China for the first time;
(2) Biological products stipulated by the drug supervision and management department of the State Council;
(3) Other medicines stipulated by the State Council.

Chapter 6 Medical Institutional Pharmaceutical Management

Article 69 Medical institutions shall be equipped with pharmacists or other pharmacy and technicians who have been identified in accordance with the law，Responsible for the drug management of the unit、Prescription review and deployment、Reasonable medication guidance and other work。Non -pharmaceutical technical personnel shall not directly engage in pharmaceutical technical work。
Seventy medical institutions purchase medicines，It should be established and implemented for the inspection inspection acceptance system，Qualified Drug Qualification Certificate and other signs;，No purchase and use。
71st medical institutions should have a place that is compatible with the drugs used、Equipment、Warehousing facilities and sanitary environment，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。
Article 72 Medical institutions shall adhere to safety and effectiveness、Principles of reasonable economic Stake Sports Bettingmedication，Follow the principle of stake sports betting appguidance of clinical application of drugs、Reasonable medication such as clinical diagnosis and treatment guidelines and drug manuals，Prescription for physicians、Approval of the appropriateness of the doctor's advice。
Other drug use units other than medical institutions，It should abide by the provisions of the use of drugs on medical institutions in this law。
Article 73 Pharmacist or other pharmacist or other pharmacy and technicians in accordance with the law，It should be checked，Drugs listed on the prescription must not be changed or used for permission。Prescription with compatible taboos or over -doses，Should refuse the deployment; if necessary，The doctor of the prescription correction or redirection，can be prepared。
Article 74 Medical Institution Preparation Preparation，It should be in the province where it is located、Autonomous Region、Approval of the Drug Supervision and Administration Department of the People's Government of the Municipal Municipality，Obtain a medical institution preparation permit。For a medical institution's preparation permit，Do not prepare preparations。
Dores permits for medical institutions shall be marked with validity period，Re -review of the issue of the expiration。
Article 75 of the medical institution preparation preparation，Facilities that can ensure the quality of the preparation、Management System、Test the instrument and sanitary environment。
Preparation of medical institutions，It should be carried out in accordance with the approved process，The required raw materials、Accessories and packaging materials shall meet the medicinal requirements。
Article 76 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 of the location、Autonomous Region、Approved by the Drug Supervision and Administration Department of the People's Government of the Municipal Municipal Government; but，The law has other regulations on the preparation of traditional Chinese medicine preparations。
Preparation prepared by medical institutions shall perform quality inspection in accordance with regulations; qualified，Use the doctor's prescription in this unit。Drug supervision and management department or province of the State Council、Autonomous Region、Approval of the Drug Supervision and Administration Department of the People's Government of the Municipal Municipality，Preparation prepared by medical institutions can be used between designated medical institutions。
Preparations prepared by medical institutions shall not be sold in the market.

Chapter VII Drugs Management

Article 77 Drug listing license holders shall formulate risk management plans after the drug listing，Research after actively carried out drugs，Safety of drugs、Effectivity and quality controller further confirm，Strengthen the continuous management of listed medicines。
Article 78 Pharmaceuticals approved for conditions，Drug listing permit holders shall take corresponding risk management measures，and complete relevant studies in accordance with the requirements within the prescribed period; the research fails to complete the study in accordance with the requirements or prove that its benefit is greater than the risk，The Drug Supervision and Administration Department of the State Council shall deal with it in accordance with the law，until the cancellation of the drug registration certificate。
Article 79 changes in the production process of drugs，According to its safety of drugs、The risk of effectiveness and quality controllability and the degree of influence，Classified management。belonging to major changes，It shall be approved by the Drug Supervision and Administration Department of the State Council，Other changes shall be filed or reported。
Drug listing permit holders shall be in accordance with the provisions of the Drug Supervision and Management Department of the State Council，Comprehensive evaluation、Verify changes for drug safety、Effects of effectiveness and quality controllability。
Article 80 Pharmaceutical Local Licensing Holders shall carry out adverse reaction monitoring after the drug listing，Active collection、Tracking Analysis Suspected Drug Adverse Reaction Information，Timely risk control measures for drugs that have been recognized risks。
Article 81 Pharmaceutical Local License Holder、Pharmaceutical Production Enterprise、Drug business enterprises and medical institutions should often inspect the unit produced by the unit、Business、Drug quality used、curative effect and adverse reactions。Discover suspected adverse reactions，Report to the drug supervision and management department and the competent health and health authority in time。The specific measures are formulated by the State Council's drug supervision and management department in conjunction with the State Council's health and health authority。
Drugs that have confirmed serious adverse reactions，by the State Council ’s drug supervision and management department or province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government adopts stop production according to the actual situation、Sales、Use emergency control measures such as use，should be organized within five days，The decision to make administrative treatment decisions in accordance with the law within 15 days from the date of the appraisal conclusion。
Article 82 Drugs have quality problems or other safety hazards，Drug listing permit holders shall immediately stop sales，Inform relevant drug business enterprises and medical institutions to stop sales and use，Recall the medicines that have been sold，Timely public recall information，If necessary, stop production immediately，and the recall and treatment of drugs、Autonomous Region、Report on the Drug Supervision and Administration Department of the People's Government of the Municipal People's Government and the competent health department of health and health。Pharmaceutical Production Enterprise、Drug business enterprises and medical institutions should cooperate。
Drug listing permit holder shall recall the medicine and not recall the medicine in accordance with the law，Provincial、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government shall order it to recall。
Article 83 Drug Localkeeper holders shall be safe for the available drugs、Effective and Quality Control of the Mass Control Periodic Evaluation。When necessary，The drug supervision and management department of the State Council may order the drug listing license holder to conduct a listing evaluation or directly organize the evaluation of listing。
Evaluation，Inaccurate efficacy、Pharmaceuticals that have a large adverse reaction or harm to human health due to other reasons，The drug registration certificate should be canceled。
Pharmaceuticals that have been canceled for the drug registration certificate，Do not produce or import、Sales and use。
Has been canceled drug registration certificate、Pharmaceuticals exceeding the validity period, etc.，It shall be supervised and destroyed by the drug supervision and management department or adopted other harmless treatment in accordance with the law。

Chapter 8 Drug Price and Advertising

Article 84: The State improving the drug procurement management system，Monitor the price of drugs，Carry out cost price survey，Strengthen drug price supervision and inspection，Check the price monopoly in accordance with the law、Price and other drug prices such as illegal behavior，Maintenance of drug price order。
Article 85 Pharmaceuticals that implement market adjustments in accordance with the law，Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug business enterprises and medical institutions should be fair、Reasonable and honest credit、The principle of quality and price consistency formulate price，Provide a reasonable price of drugs for the drug。
Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug operating enterprises and medical institutions shall comply with the regulations on the management of drug price management in the competent drug price of the State Council，Formulate and indicate the retail price of drugs，Forbidden huge profits、Price monopoly and price fraud。
Article 86 Pharmaceutical Local Permits holder、Pharmaceutical Production Enterprise、Drug business enterprises and medical institutions shall provide information on the actual purchase and sales price of the drug to the drug price authority in accordance with the law。
Article 87 Medical institutions shall provide patients with the price list of the medicines used，The price of its commonly used medicines in accordance with regulations，Strengthening reasonable medication management。The specific measures are formulated by the competent health department of the State Council。
Article 88 prohibit the drug listing permit holder、Pharmaceutical Production Enterprise、Drug operating enterprises and medical institutions will be given in the purchase and sale of drugs、Receive buckle or other unfair interests。
Forbidden drug listing permit holder、Pharmaceutical Production Enterprise、Drug business enterprises or agents give the person in charge of medical institutions that use their drugs in any name、Drug purchaser、Doctor、Pharmacists and other relevant personnel or other unfair interests。The person in charge of the prohibition of medical institutions、Drug purchaser、Doctor、Pharmacists or other relevant personnel receive the drug listing permit holder in any name、Pharmaceutical Production Enterprise、Drug operating enterprises or agents or other unfair interests。
Article 89 Drug Advertising shall be provinces where the advertiser is located、Autonomous Region、The advertising review agency approved by the people's government directly under the Central Government;，No release。
The content of the 90th drug advertisement should be true、Legal，Drugs approved by the State Council's Drug Supervision and Administration Department，Do not contain false content。
Drug advertisements must not contain representation effect、An assertion or guarantee of security; do not use state organs、Scientific Research Unit、Academic Institution、Industry Association or Expert、Scholar、Doctor、Pharmacist、Recommended in the name or image of patients, etc.、Proof。
Non -drug ads shall not have the publicity of drugs.
Article 91 Drug Price and Advertising，This method has not been prescribed，Applicable "Price Law of the People's Republic of China"、"Anti -Monopoly Law of the People's Republic of China"、"The People's Republic of China Anti -Unfair Competition Law"、"Advertising Law of the People's Republic of China" and other regulations。

Chapter 9 Drug Reserve and Supply

Article 92 The state implements a drug reserve system，Establish a central and local two -level pharmaceutical reserves。
You can call the medicine urgently、Epidemic or other emergencies，In accordance with the provisions of the Capital Law of the People's Republic of China，You can call the medicine urgently。
Article 93 The state implements a basic drug system，Select the appropriate amount of basic drug varieties，Strengthen organizational production and reserves，Improve the supply capacity of basic drugs，Meeting the basic medication needs of the disease prevention and treatment。
Article 94 The State Establishing a Drug Supply and Demand Monitoring System，Timely collection and summary analysis of shortage of drug supply and demand information，Early warning of shortage drugs，Take response measures。
Article 95 The state of the state implements a shortage of drug list management system。The specific measures are formulated by the State Council's health and health authorities in conjunction with the State Council's drug supervision and management department and other departments。
Drug listing permit holders to stop producing shortage drugs，shall be in accordance with regulations to the Drug Supervision and Administration Department of the State Council or the province、Autonomous Region、Report on the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government。
Article 96 The state encourages the development and production of shortage drugs，shortage drugs for clinical urgently needed、New medicines for preventing and treating major infectious diseases and rare diseases give priority to review and approval。
Article 97 For shorts of shortage medicines，The State Council can restrict or prohibit exports。When necessary，The relevant departments of the State Council can adopt organizational production、Price intervention and expansion of imports，Guarantee drug supply。
Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug operating enterprises shall guarantee the production and supply of drugs in accordance with the regulations。

Chapter 10 Supervision and Management

Article 98 prohibits production (including preparation，Same below)、Sales、Use fake medicine、Infinite medicine。
One of the following situations, it is a fake medicine:
(1) The ingredients contained in the medicine do not match the composition specified by the national drug standard;
(2) Pharmaceutical impersonation of medicine or pretending to such a medicine with other medicines;
(3) Molester medicines;
(4) Indications or functions indicated by the drugs are beyond the specified scope。
One of the following situations, for inferior drugs:
(1) The content of the pharmaceutical composition does not meet the national drug standards;
(2) Plug -in medicines;
(3) Drugs that have not been indicated or changed;
(4) Drugs that have not indicated or changed the product number;
(5) Drugs exceeding the validity period;
(6) Drugs that add preservatives and auxiliary materials without authorization;
(7) Other drugs that do not meet the drug standards.
Prohibit the production document production of not obtained drug approval documents、Imported drugs; forbidden use of the not review in accordance with regulations、Approving the raw medicine、Packaging materials and container production drugs。
Article 99 The drug supervision and management department shall be in accordance with the law、Regulations of regulations for the development of drugs、Production、Drugs such as operation and drug use units for supervision and inspection，If necessary, you can develop for drugs、Production、Business、Using units and individuals providing products or services for an extension check，Relevant units and individuals shall cooperate，Do not refuse and conceal。
The drug supervision and management department shall implement key supervision and inspection of high -risk drugs。
For evidence to prove that there may be hidden safety hazards，The drug supervision and management department shall be based on supervision and inspection，Aversion should be adopted、Interview、Rectification and suspension of production within a time limit、Sales、Use、Import and other measures，and promptly announce the results of the inspection processing。
Drug supervision and management department for supervision and inspection，The document should be presented，The business secrets known to the supervision and inspection should be kept secret。
Article 100 Drug Supervision and Administration Department according to the needs of supervision and management，It can be inspected and inspected the quality of the drug。Spring inspection inspection should be sampled in accordance with regulations，Do not charge any fees; samples should be purchased for samples。The cost required in accordance with the prescribed by the State Council。
Drugs that have evidence proved to endanger human health and their related materials，Drug supervision and management department can seize、See，and make an administrative treatment decision within seven days; the drug needs to be tested，It shall make an administrative processing decision within 15 days from the date of the inspection report。
Article 101 State Council and Provincial Council、Autonomous Region、The drug 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 should be corrected within the scope of the original announcement。
Article 102 The parties have objections to the results of the drug test，You can apply or designated or designated drug inspection institutions to apply or designated drug inspection institutions for the original pharmaceutical inspection institution or the previous level of drug supervision and management departments from seven days from the date of receiving the results of the drug inspection.，You can also apply or designated or designated by the Drug Supervision and Administration of the State Council to apply for re -inspection。Drug inspection institutions accepted the re -inspection shall make re -inspection conclusions within the time stipulated by the State Council's Drug Administration。
Article 103 The drug supervision and management department shall be a holder of the drug listing permit、Pharmaceutical Production Enterprise、Drug business enterprises and drug non -clinical safety evaluation research institutions、Drug clinical trial institutions, etc., abide by the quality management specifications of drug production、Drug business quality management specifications、Drug non -clinical research quality management specifications、Drug clinical trial quality management specifications and other conditions for inspection，Supervise its continuous meetings of legal requirements。
104 State Establishment of Professionalization、Specialized Drug Inspector Team。Inspectors should be familiar with drug laws and regulations，Pharmaceutical expertise。
Article 105 Drug Supervision and Administration Department establishes a drug listing license holder、Pharmaceutical Production Enterprise、Pharmaceutical business enterprise、Drug non -clinical safety evaluation research institutions、Drug Clinical Trial Institutions and Medical Institutions Drug Safety Credit Credit Archives，Record license issuance、Results of daily supervision and inspection、Investigation and punishment of illegal behavior，Announce to the society and update to the society in accordance with the law;，Increase the frequency of supervision and inspection，And can implement joint punishment in accordance with national regulations。
Article 1006 Drug Supervision and Administration Department shall announce the email address of the department、Phone，Accepting consultation、Complaint、Report，and answer in time in accordance with the law、A verification、Treatment。Report to verify the truth，Reward the reporter in accordance with relevant regulations。
The drug supervision and management department shall keep confidential information on the information of the reporter，Protect the legitimate rights and interests of the reporter。The reporter's report is located，This unit cannot be lifted、Change the labor contract or other ways to retaliate against the reporter。
107 State Drug Safety Information Unified Announcement System。The overall situation of national drug safety、Drug safety risk warning information、Major drug safety incidents and their investigation processing information, and other information that the State Council is determined。Drug safety risk warning information and major drug safety events and their investigation processing information are limited to，can also be from the relevant province、Autonomous Region、The Pharmaceutical Supervision and Administration Department of the Municipal People's Government directly under the Central Government。The above information shall not be released without authorization。
Announced drug safety information，Should be timely、Accurate、Comprehensive，Make the necessary instructions，Avoid misleading。
No unit or individual may be fabricated、Safety information spreading false drugs。
Article 108 people's governments at or above the county level shall formulate emergency plans for drug safety incidents。Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug operating enterprises and medical institutions shall formulate stake sports betting appthe drug safety event disposal My stake betting appplan of the unit，Organize training and emergency drills。
Drug safety incident，The people's governments at or above the county level shall immediately organize the response work in accordance with the emergency plan; the relevant units shall take effective measures immediately for disposal，Prevent hazards expand。
Article 109 Drug Supervision and Administration Department fails to discover the systemic risk of drug safety in time，Failure to eliminate hidden dangers in the supervision and management area，The drug supervision and management department of the people's government or higher -level people's governments shall interview their main responsible persons。
The local people's government has not fulfilled drug safety responsibilities，Failure to eliminate hidden dangers of major drug safety in time，The drug supervision and management department of the higher -level people's government or the superior people's government shall make an interview with the principals of its main leaders。
The department and the local people's governments should take measures immediately，Rectification of drug supervision and management。
Interviews and rectifications shall be included in the evaluation of drug supervision and management of relevant departments and local people's governments、Evaluation Record。
Article 110 The local people's government and their drug supervision and management departments shall not require the implementation of drug tests、Approval and other means restrictions or excludes non -regional drug listing licenses、Drugs produced by pharmaceutical manufacturers enter the region。
Article 111 Drug supervision and management department and its settings or designated drug professional and technical institutions shall not participate in drug production and operation activities，It must not be recommended or produced in its name、Supervision and sales medicine。
Pharmaceutical Supervision and Administration Department and its settings or designated drug professional and technical institutions shall not participate in drug production and operation activities。
Article 112 The State Council's anesthesia drugs、Psychiatric drugs、Medical toxic drugs、Radial drugs、Pharmaceutical Easy toxic chemicals, etc. There are other special management regulations，According to its regulations。
Article 113 The Drug Supervision and Administration Department found that drugs illegal acts are suspected of crime，The case should be transferred to the public security organs in time。
Do not need to investigate criminal responsibility or be exempted from criminal punishment，But the administrative responsibility should be investigated，Public security organs、People's Procuratorate、The People's Court shall transfer the case to the drug supervision and management department in a timely manner。
Public security organs、People's Procuratorate、The People's Court invites the drug supervision and management department、The competent department of the ecological environment and other departments provide inspection conclusions、Determination of opinions and assistance to the medicine involved in the case，Relevant departments shall provide timely，Assistance。

Chapter 11 Legal Responsibility

Article 114 violates the provisions of this Law，For the crime，Criminal responsibility for investigation in accordance with the law。
Article 115 No Drug Production License、Drug business license or medical institution preparation license production、Selling medicine，Order to close，Confine illegal production、Drugs and illegal income sold，Put in illegal production、Sell medicines (including the medicines that have been sold and unprecedented，The same below) The value of the value of the value of more than fifteen times and less than thirty times; the value of the value of less than 100,000 yuan，Calculated at 100,000 yuan。
Article 116 production、Selling fake drugs，Confine illegal production、Drugs and illegal income sold，Order to stop production and stop business and rectify，Follow -up drug approval document，Put in illegal production、Fined fines of more than fifteen times or less than thirty times of the value of the drug sold;，Calculated at 100,000 yuan; serious plot，Flowing drug production license、Drug business license or medical institution preparation permit，It does not accept the corresponding application in ten years;，It is forbidden to import its drugs within ten years。
Article 117 production、Sales of inferior drugs，Confine illegal production、Drugs and illegal income sold，Put in illegal production、fines sold for more than ten times the value of the drug value of more than ten times or less; illegal production、Wholesale drug value is less than 100,000 yuan，Calculated at 100,000 yuan，The value of the drug value of illegal retail is less than 10,000 yuan，Calculated at 10,000 yuan;，Order to stop production and stop business and rectify until the drug approval document is revoked、Drug production license、Drug business license or medical institution preparation permit。
Production、Traditional Chinese medicines sold for sale do not meet drug standards，It does not affect security、Effective，Order to correct the time limit，Give warning; you can be fined for 100,000 yuan and 500,000 yuan。
Production Article 138、Sales fake medicine，or production、Sales of inferior drugs and serious circumstances，For the legal representative、Main person in charge、Direct responsible persons and other responsible persons，The income from the units during the occurrence of illegal acts，Bundes of more than 30 % of the income of more than three0 % of the income，Lifetime forbidden to engage in drug production and operation activities，and detention by the Public Security Organ Office for 5 days and less than 15 days。
Producers are specifically used to produce fake medicines、The raw materials of inferior drugs、Accessories、Packaging materials、Production equipment is confiscated。
Article 119 Pharmaceutical Units use fake medicine、Bad drugs，According to the sales fake medicine、Penalties for retail inferior drugs; if the circumstances are serious，Legal representative、Main person in charge、Direct responsible persons in charge and other responsible personnel have the practice certificate of medical and health personnel，It should also revoke a practice certificate。
Article 120 knows or should be known to be fake medicines、Bad drugs or drugs specified in Article 124, paragraph 1, paragraph 1 (1) of this law，Provide it for it、Transportation and other convenient conditions，​​confused all storage、Transportation income，Paimant fined more than five times more than five times more illegal income; if the circumstances are serious，Packed of fines of more than five times more than fifteen times of illegal income; illegal income with less than 50,000 yuan，Calculated at 50,000 yuan。
Article 121 Passion -fake medicine、The penalty decision of inferior drugs，The quality inspection conclusion of the pharmaceutical inspection institution should be stated in accordance with the law。
Article 122 Forge、STC、rental、Lending、illegal trading license or drug approval document，Confine illegal income，Pauncia of more than five times more than five times the illegal obtained;，Paper with more than five times more than fifteen times of illegal income，Flowing drug production license、Drug business license、Medical Institutional Permits or Drug Approval Certificate，For the legal representative、Main person in charge、Direct responsible persons and other responsible persons，penalties of 20,000 yuan and more than 200,000 yuan，It is forbidden to engage in drug production and operation activities in ten years，and can be detained by the Public Security Organ Office for 5 days and less than 15 days;，Calculated at 100,000 yuan。
Article 123 Provide false certificates、Data、Information、Sample or other means to deceive clinical trial permits、Drug production license、Drug business license、Permits of the medical institution for preparation license or drug registration，Rejuvenation related license，No corresponding application will not be accepted in ten years，Put a fine of more than 500,000 yuan and 5 million yuan;，For the legal representative、Main person in charge、Direct responsible persons and other responsible persons，penalties of 20,000 yuan and more than 200,000 yuan，It is forbidden to engage in drug production and operation activities in ten years，and detention by the Public Security Organ Office for 5 days and less than 15 days。
Article 124 violates the provisions of this Law，There is one of the following behaviors，Confine illegal production、Import、Drugs and illegal income sold by illegal production for illegal production、Accessories、Packaging materials and production equipment，Order to stop production and stop business and rectify，Put in illegal production、Import、Fined fines of more than fifteen times or less than thirty times of the value of the drug sold;，Calculated at 100,000 yuan; serious plot，The approved certification documents of the drug are revoked until the drug production license is revoked、Drug business license or medical institution preparation permit，For the legal representative、Main person in charge、Direct responsible persons and other responsible persons，The income from the units during the occurrence of illegal acts，Bundes of more than 30 % of the income of more than three0 % of the income，Ten years until it is forbidden to engage in drug production and operation activities，and detention by the Public Security Organ Office for 5 days and less than 15 days:
(1) The production of no drug approval documents、Imported drugs;
(2) Use of a drug approval document production obtained by a deception method、Imported drugs;
(3) Production drugs for using unspeakable and approved and approved;
(4) Sales of drugs should be sold without inspection;
(5) Production、Sales of drugs that the Drug Supervision and Administration Department of the State Council is prohibited;
(6) Broken production and inspection records;
(7) Make major changes in the drug production process without approval。
Pharmaceuticals specified in the first to third paragraph of the pre -sale paragraph，or the use of the medicines of the first paragraph of the previous paragraph of the drug use unit，Punishment in accordance with the provisions of the previous paragraph; if the circumstances are serious,，The legal representative of the drug use unit、Main person in charge、Direct responsible persons in charge and other responsible personnel have the practice certificate of medical and health personnel，It should also revoke a practice certificate。
Drugs that have been legally listed in a small number of overseas are not imported without approval，Light plot，Can be reduced or punished in accordance with the law。
Article 125 violates the provisions of this Law，There is one of the following behaviors，Confine illegal production、Drugs and illegal income and packaging materials sold、container，Order to stop production and stop business and rectify，Put a fine of more than 500,000 yuan and 5 million yuan;，Follow -up drug approval document、Drug production license、Drug business license，For the legal representative、Main person in charge、Direct responsible supervisors and other responsible personnel are fines of 20,000 yuan and more than 200,000 yuan，Ten years until life -prohibit drug production and operation activities:
(1) Clinical trials of drugs without approval;
(2) Packaged materials or container producing drugs using unruly direct contact drugs，or selling such medicines;
(3) Using unruly labels and manuals.
Article 126 Except for the situation specified in this law，Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Pharmaceutical business enterprise、Drug non -clinical safety evaluation research institutions、Drug clinical trial institutions and other do not comply with drug production quality management specifications、Drug business quality management specifications、Drug non -clinical research quality management specifications、Drug clinical trial quality management specifications，Order to correct the time limit，Give warning;，fines of 100,000 yuan or less than 500,000 yuan;，penalties of 500,000 yuan and more than 2 million yuan，Order to stop production and stop business and rectify until the drug approval document is revoked、Drug production license、Drug business license, etc.，Drug non -clinical safety evaluation research institutions、Drug clinical trial institutions shall not conduct drug non -clinical safety evaluation research within five years、Drug Clinical Test，For the legal representative、Main person in charge、Direct responsible persons and other responsible persons，The income from the units during the occurrence of illegal acts，Putting more than 10 % of the revenue of more than 10 % of the revenue，Ten years until it is forbidden to engage in drug production and operation and other activities。
Article 127 violates the provisions of this Law，There is one of the following behaviors，Order to correct the time limit，Give warning;，Fined fines of 100,000 yuan or less than 500,000 yuan:
(1) Carrying out biological equivalent tests have not been recorded;
(2) During the clinical trial of the drug，Discover safety issues or other risks，Clinical trial applicants have not adjusted the clinical trial plan in time、Paradse or terminate clinical trials，or not reporting to the drug supervision and management department of the State Council;
(3) Failure to establish and implement a drug traceability system in accordance with regulations;
(4) Failure to submit an annual report in accordance with regulations;
(5) Failure to record or report changes in the production process in the production of drugs in accordance with regulations;
(6) The risk management plan after the drug listing is not formulated;
(7) Research or evaluation after the pharmaceutical listing is not carried out in accordance with regulations。
Article 128 shall be in accordance with the fake medicine in accordance with the law、Outside the punishment of inferior drugs，Drug packaging is not printed in accordance with regulations、Labels or instructions，Tag、The instructions do not indicate the relevant information or printed the specified signs in accordance with the regulations，Order to correct，Give warning;，Flowing drug registration certificate。
Article 129 violates the provisions of this Law，Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug business enterprises or medical institutions do not have a drug listing holder or have drug production、Enterprises who are qualified to buy medicines，Order to correct，Conflict drugs and illegal income for illegal purchase，Purchase of fines of more than ten times the value of the drug value of the drug in illegal purchases;，Putting a fine of more than ten times the amount of the goods value of more than ten times and less than thirty times，Follow -up drug approval document、Drug production license、Drug business license or practicing permit for medical institutions;，Calculated at 50,000 yuan。
Article 130 violates the provisions of this Law，Drug operating enterprises purchase and sell medicines for no record in accordance with regulations，retail drugs have not been properly explained、Dosage and other matters，or if the prescription is not deployed in accordance with the regulations，Order to correct，Give warning;，Flowing drug business license。
Article 131 violates the provisions of this Law，The provider of the third -party platform of the drug network transaction has not fulfilled the qualification review、Report、Stop providing obligations such as online trading platform services，Order to correct，Confine illegal income，Put a fine of more than 200,000 yuan or less;，Order to stop business and rectify，Pauncia for fines of two million yuan and 5 million yuan。
Pharmaceuticals that have obtained drug registration certificates in Article 132，Filial Pharmaceutical Supervision and Administration Department, where the port where the drug is allowed to be allowed to be imported，Order to correct the time limit，Give warning;，Flowing drug registration certificate。
Article 133 violates the provisions of this Law，Medical institutions sell their prepared preparations on the market，Order to correct，Confiscamentation of illegal sales preparations and illegal income，Putting fines of more than five times the value of the illegal sales preparations of the illegal sales preparation;，Posted a fine of more than five times the value of the goods; the value of the value of less than 50,000 yuan，Calculated at 50,000 yuan。
Article 134 The holder of the Pharmaceutical Listing Permits fails to conduct a drug adverse reaction monitoring or report suspected drug adverse reactions in accordance with regulations，Order to correct the time limit，Give warning;，Order to stop production and stop business and rectify，Pauncia a fine of 100,000 yuan and less than one million yuan。
Drug operating enterprises have not reported to the suspected adverse reaction of drugs in accordance with the regulations，Order to correct the time limit，Give warning;，Order to stop production and stop business and rectify，Paimant fined with 50,000 yuan and 500,000 yuan。
Medical institutions fail to report suspected drug adverse reactions in accordance with regulations，Order to correct the time limit，Give warning;，penalties of 50,000 yuan and 500,000 yuan。
Article 135 Pharmaceutical Local License held in the province、Autonomous Region、After the Drug Supervision and Administration of the People's Government of the Municipality directly under the Central Government, after ordering it to recall，refusal to recall，Feming the value of the recalled drug value of more than ten times or less; the value of the value of less than 100,000 yuan，Calculated at 100,000 yuan; serious plot，Follow -up drug approval document、Drug production license、Drug business license，For the legal representative、Main person in charge、Direct responsible persons and other responsible persons，penalties of 20,000 yuan and more than 200,000 yuan。Pharmaceutical Production Enterprise、Pharmaceutical business enterprise、Medical institutions refuse to cooperate with the recall，penalties of 100,000 yuan and 500,000 yuan。
Article 136 The Pharmaceutical Local License of the Pharmaceutical Localkeeper is a foreign enterprise，The designated corporate legal person in China does not perform relevant obligations in accordance with the provisions of this Law，Applicable to the provisions of the legal liability of the drug listing permit for this law。
Article 137 with one of the following behaviors，Penalty penalties within the penalty stipulated in this Law:
(1) Anesthesia drugs、Psychiatric drugs、Medical toxic drugs、Radial drugs、Pharmaceutical Easy toxic chemicals pretend to be other medicines，or impersonate the above medicines with other medicines;
(2) Production、Sales for pregnant women、Children are fake medicines that mainly use objects、Inferior medicine;
(3) Production、The biological products sold are fake medicines、Inferior medicine;
(4) Production、Sales fake medicine、Infinite medicine，Causes the consequences of personal injury;
(5) Production、Sales fake medicine、Infinite medicine，Criminals after handling;
(6) Rejects、Escape Supervision and Inspection，Forgery、Destruction、Hidden relevant evidence materials，or use sealing without authorization、Seeded items。
Article 138 The pharmaceutical inspection institution issued a false inspection report，Order to correct，Give warning，Fined fines of more than 200,000 yuan and less than one million yuan on the unit; relegation will be relegated to the directors and other directly responsible persons in accordance with the law、Withdrawal、Fleement punishment，Confine illegal income，Paunted a fine of less than 50,000 yuan; if the circumstances are serious,，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 139 This law administrative penalty stipulated in Article 115 to 138，The drug supervision and management department of the people's government at or above the county level decides in accordance with the division of responsibilities;、A revoking license，Approved by the original、The department decided to issue a certificate。
Article 140 Pharmaceutical Local Permits holder、Pharmaceutical Production Enterprise、Drug operating enterprises or medical institutions violate the provisions of this Law，The drug supervision and management department stake betting appor the competent health and health stake betting appauthorities order to dismiss，fines of 50,000 yuan and more than 200,000 yuan。
Article 141 Pharmaceutical Local License Holders、Pharmaceutical Production Enterprise、Drug business enterprises or medical institutions give in drug purchase and sale、Accept the rebate or other unfair interests，Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug operating enterprise or agent given the person in charge of the medical institution that uses their drugs、Drug purchaser、Doctor、Pharmacists and other relevant personnel or other unfair interests，The market supervision and management department confiscates illegal income，Put a fine of more than 300,000 yuan and less than 3 million yuan;，A revoking drug listing permit holder、Pharmaceutical Production Enterprise、Business license for drug business enterprises，And the drug approval document was revoked by the drug supervision and management department、Drug production license、Drug business license。
Pharmaceutical listing license holder、Pharmaceutical Production Enterprise、Drug business enterprises in drug development、Production、Bringing to state staff，For the legal representative、Main person in charge、Direct responsible supervisors and other responsible personnel are prohibited from engaging in drug production and operation activities for life。
Article 142 Pharmaceutical Local License Holders、Pharmaceutical Production Enterprise、The person in charge of the drug business enterprise、Purchase personnel and other relevant personnel have received the licensee of other drug listing permits during the purchase and sale of drugs、Pharmaceutical Production Enterprise、The property given by a pharmaceutical business enterprise or an agent or other unfair interests，Confine illegal income，Punishment is given according to law; if the circumstances are serious，It is forbidden to engage in drug production and operation activities within five years。
The person in charge of the medical institution、Drug purchaser、Doctor、Pharmacists and other relevant personnel who receive drug listing permits holders、Pharmaceutical Production Enterprise、The property given by a pharmaceutical business enterprise or an agent or other unfair interests，Disposted by the competent department of health and health，confiscation of illegal income; serious circumstances，It should also revoke its practice certificate。
Article 143 violates the provisions of this Law，Formulating、Safety information spreading false drugs，It constitutes a violation of public security management behaviors，Public security management punishment by public security organs。
Article 144 Pharmaceutical Local License Holders、Pharmaceutical Production Enterprise、Drug business enterprises or medical institutions violate the provisions of this Law，The damage caused by the medication，Bersed compensation responsibility in accordance with the law。
    It is damaged due to the quality of drugs，Victims can be permitted by the drug listing、Drug production enterprises request compensation for losses，You can also from drug business enterprises、Medical institutions request compensation for losses。Receive the request for compensation from the victim，The first responsible system should be implemented，Compensation first; pay first after paying first，Can be pursued in accordance with the law。
Production fake medicine、Bad medicine or knowing that it is a fake medicine、Inferior drugs are still sold、Use，The victim or their close relatives except for compensation for losses，You can also request a compensation of ten times the price or three times the loss; the amount of compensation is less than 1,000 yuan，is 1,000 yuan。
Article 145 Drug Supervision and Administration Department or its settings、The designated drug professional and technical institution participates in the production and operation activities of drug production，Correct from its superior authorities，confiscation of illegal income; serious circumstances，Display punishments of the directors and other directly responsible persons in accordance with the law。
Drug Supervision and Administration Department or Settings、The staff of the designated pharmaceutical professional and technical institutions participate in the drug production and operation activities，Give punishment in accordance with the law。
Article 146 Drug Supervision and Administration Department or its settings、The specified pharmaceutical inspection institution illegally collects inspection fees，It is ordered by relevant government departments to return it to，Display punishments of the person in charge and other directly responsible persons in accordance with the law; the serious circumstances，Rejected its inspection qualification。
Article 147 violates the provisions of this Law，The drug supervision and management department has one of the following behaviors，The relevant license should be revoked，Display punishments of the person in charge and other direct responsible persons according to law:
(1) The drug clinical trial is approved without the conditions;
(2) A certificate of pharmaceutical registration certificate that does not meet the qualified drugs;
(3) Issuing drug production licenses to units that do not meet the requirements、Drug business license or medical institution preparation permit。
Article 148 violates the provisions of this Law，The local people's governments at or above the county level have one of the following actions，Remembrance or sanction of directors and other directly responsible personnel;，Give a downgrade、Withdrawal or fired punishment:
(1) concealment、Lie Bao、Slowly report、Demonstration of drug safety incidents;
(2) Failure to eliminate hidden dangers of major regional drug safety in time，Causes particularly major drug safety events in this administrative area，or major drug safety incidents in a row;
(3) Performing the poor responsibility，Caused serious adverse effects or major losses。
Article 149 violates the provisions of this Law，Drug Supervision and Management and other departments have one of the following behaviors，Remember or punish the person in charge and other directly responsible personnel;，Gives downgrade or dismissal;，Give fired punishment:
(1) concealment、Lie Bao、Slowly report、Demonstration of drug safety incidents;
(2) The drug safety illegal behavior discovered did not investigate and dealt with in time;
(3) Drug safety systemic risk is not found in time，or the hidden dangers of drug safety hazards in the supervision and management area are not eliminated in time，Caused a serious impact;
(4) Others do not perform their duties of drug supervision and management，Caused serious adverse effects or major losses。
Article 150 Drug supervision and management personnel abuse their powers、徇 Private fraud、Attention，Give punishment in accordance with the law。
Investigation and punishment、Inferior drugs have lost their job、Activity of malfeasance，The supervisor and other direct responsible persons who are directly responsible for the drug supervision and management department will be re -punished according to law。
Article 151 The value of the goods stipulated in this chapter is illegal production、Calculation of the price of sales of drugs; if there is no price，Based on the market price of similar drugs。

Chapter 12 Attachment

Article 152 Planting Chinese medicinal materials、Management of collection and breeding，According to relevant laws、Regulations on regulations。
Article 153 Management Measures for Regional Folk School of Following Political Sciences，Formulated by the State Council's Drug Supervision and Administration Department in conjunction with the State Council's Chinese Medicine Department。
Article 154 The specific measures of the Chinese People's Liberation Army and the Chinese People's Armed Police Force，from the State Council、The Central Military Commission is formulated in accordance with this Law。
Article 155 This Law will be implemented from December 1, 2019。