The Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government (the Drug Administration), and the Food and Drug Administration of Xinjiang Production and Construction Corps:

The Rules on the Application of Administrative Penalty Discretion for Drugs and Medical Devices have been deliberated and adopted at the executive meeting of the State Food and Drug Administration, and are hereby issued. Please follow them and do a good job in publicity and training, and earnestly implement them in law enforcement.

State Food and Drug Administration
November 2, 2012

　　　　　　　　　　  Rules for the Application of Administrative Penalty Discretion on Drugs and Medical Devices

　　　　　　　　　　　　　　　　 Chapter I General Provisions

Article 1 In order to regulate the exercise of administrative penalty discretion by food and drug supervision and administration departments, these rules are formulated in accordance with the opinions of the State Council on strengthening the Construction of a Government ruled by Law and other laws, regulations and rules, accurately applying the Administrative punishment Law, the Drug Administration Law, the regulations for the implementation of the Drug Administration Law and the regulations on the Supervision and Administration of Medical Devices.

Article 2 The term "administrative penalty discretion" as mentioned in these rules refers to the independent decision-making power enjoyed by the food and drug supervision and administration department on the type and range of administrative penalty in accordance with the provisions of laws, regulations and rules when making administrative penalty.

Article 3 These Rules shall apply to the food and drug regulatory authorities in handling illegal cases of drugs and medical devices and exercising their discretion in administrative punishment.

Article 4 When exercising the discretion of administrative penalty, the food and drug regulatory department shall follow the principle of statutory punishment, the principle of fairness and justice, the principle of equal punishment, and the principle of combining administrative punishment with education.

　　　　　　　　　　　　　　　　Chapter II Entity Rules

Article 5 For an illegal act committed by a party, a heavier punishment, a general punishment, a lighter punishment or a mitigated punishment shall be given in accordance with the facts, nature, circumstances, risk of the product and the degree of social harm of the illegal act.

Article 6 If a party is under any of the following circumstances, he shall be given a heavier punishment according to law:
(I) passing off narcotic drugs, psychotropic drugs, toxic drugs for medical use or radioactive drugs as other drugs, or passing off other drugs as the above-mentioned drugs;
(II) the production and sale of fake and inferior medicines mainly targeted at pregnant women, infants and children;
The biological products, blood products and injectable drugs produced and sold by the (III) are counterfeit or inferior drugs;
(IV) the production, sale and use of fake drugs, substandard drugs or medical devices that do not meet the standards, resulting in personal injury consequences;
(V) production, sale, use of fake drugs, substandard drugs or substandard medical devices, repeated offending after treatment;
(VI) refuses or evades supervision and inspection, or forges, destroys or conceals relevant evidence and materials, or uses seized or impounded articles without authorization;
(VII) in the period of natural disasters, accident disasters, public health events, social events and other emergencies, the production and sales of drugs used to deal with emergencies are fake drugs or inferior drugs, or the production and sales of medical devices used to deal with emergencies meet the standards
Other circumstances of severe punishment as prescribed by (VIII) laws, regulations and rules.

Article 7 Under any of the following circumstances, the party concerned shall be given a lighter or mitigated administrative punishment according to law:
(I) taking the initiative to eliminate or mitigate the harmful consequences of illegal acts of drugs and medical devices;
(II) illegal acts of drugs and medical devices under the coercion of others;
(III) cooperate with the food and drug regulatory department to investigate and deal with illegal acts of drugs and medical devices and has rendered meritorious service;
(IV) others that should be given a lighter or mitigated punishment according to law.

Article 8 If the party's illegal act is minor and promptly corrected, and no harmful consequences have been caused,
In line with the "Administrative Punishment Law" Article 25, Article 26 of the provisions of the non-administrative punishment, administrative punishment.
If the illegal act is not discovered within two years, administrative punishment shall be imposed. Except as otherwise provided by law.

Article 9 General punishment refers to the administrative punishment given in accordance with the law within the range of legal punishment if the illegal act of the party concerned does not have the circumstances of heavier punishment, lighter or mitigated administrative punishment or administrative punishment.

Article 10 In any of the following circumstances, the party concerned shall be punished in accordance with the "serious circumstances" stipulated in the laws, regulations and rules governing the supervision of drugs and medical devices:
(I) illegal addition of pharmaceutical ingredients or illegal use of raw materials in the production of drugs, and the drugs produced are counterfeit drugs;
Illegal use of auxiliary materials in the production of (II) drugs, and the drugs produced are inferior drugs, causing serious consequences;
The (III) does not engage in the production and operation of drugs and medical devices in accordance with the statutory conditions and requirements, or produces and sells drugs and medical devices that do not meet the statutory requirements, resulting in serious consequences;
(IV) pharmaceutical and medical device business enterprises fail to establish or fail to implement the inspection and acceptance system for the purchase of drugs and medical devices, resulting in serious consequences;
(V) drug or medical device manufacturers find that the drugs or medical devices they produce have hidden dangers that may cause damage to human health and life, do not notify the seller to stop selling, do not inform consumers to stop using, do not take the initiative to recall products, and do not report to the food and drug supervision and administration department, causing serious consequences;
(VI) a drug or medical device business enterprise discovers that the drugs or medical devices it sells have hidden dangers that may cause damage to human health and life, does not immediately stop selling the product, does not notify the manufacturer or supplier, and does not report to the food and drug supervision and administration department, causing serious consequences;
(VII) refuses or evades supervision and inspection, or forges, destroys or conceals relevant evidence materials, or uses sealed up or seized items without authorization, making it difficult to recover fake drugs, inferior drugs or medical devices that do not meet the standards, and the harm is difficult to eliminate or cause serious consequences;
(VIII) other "serious" circumstances.
The term "causing serious consequences" in this article includes situations that cause personal injury and serious social harm. The consequences of personal injury refer to injuries above minor injuries, disabilities above minor injuries, dysfunction caused by organ and tissue injuries and other situations that seriously endanger human health.

Article 11 If a pharmaceutical trading enterprise or medical institution does not violate the relevant provisions of the Drug Administration Law and the regulations on the implementation of the Drug Administration Law, and has the following circumstances at the same time, it shall generally be regarded as "sufficient evidence" in accordance with Article 81 of the regulations on the implementation of the Drug Administration Law, and the counterfeit drugs, substandard drugs and illegal income sold or used shall be confiscated in accordance with the provisions of this article. However, other administrative penalties may be exempted.
The (I) purchase channel is legal, and the drug production license or drug trading license, business license, power of attorney and audit certificate, drug qualification certificate, sales bill and other certificates provided by the supplier are true and legal;
(II) drug procurement and receipt records, storage inspection and acceptance records are true and complete;
The storage, maintenance, sale, outbound review and transportation of (III) drugs have not violated relevant regulations and have true and complete records.

Article 12 If the illegal act of the party concerned has a heavier punishment, and at the same time has a lighter or mitigated administrative punishment, it shall be comprehensively judged in the light of the circumstances of the case.

Article 13 The amount of fine shall be determined according to the following criteria: general punishment shall be the middle limit of the statutory penalty range, heavier punishment shall be above the middle limit (no middle limit) and below the upper limit of the statutory penalty range, lighter punishment shall be below the middle limit (no middle limit) and above the lower limit of the statutory penalty range, and mitigated punishment shall be below the lower limit (no lower limit) of the statutory penalty range.

　　　　　　　　　　　　　　　Chapter III Procedural Rules

Article 14 When conducting case investigation and imposing administrative punishment, the food and drug regulatory department shall order the party who has evidence to prove that there is an illegal act to correct or correct the illegal act within a time limit.

Article 15 Before making a decision on administrative penalty, the food and drug regulatory department shall collect evidence that may affect the discretion of administrative penalty in accordance with the law, comprehensively and objectively.

Article 16 In the process of administrative penalty discretion, the food and drug regulatory department must fully listen to the statements and arguments of the parties concerned. The facts, reasons and evidence put forward by the parties shall be reviewed; if the facts, reasons or evidence put forward by the parties are established, they shall be adopted.

Article 17 The person in charge of the food and drug supervision and administration department shall collectively discuss and decide on the administrative penalty for complicated or major illegal acts.

Article 18 When the food and drug regulatory department makes a decision on administrative penalty, it shall state the reasons for the discretion in the decision on administrative penalty.

Article 19 When the food and drug supervision and administration department holds a hearing, the case investigators shall put forward the illegal facts, evidence, administrative punishment suggestions and discretionary reasons of the parties concerned.
The presiding officer of the hearing shall fully listen to the statements, arguments and cross-examination opinions put forward by the parties.

Article 20 When the administrative law enforcement personnel of the food and drug supervision and administration department apply summary procedures to illegal acts, they shall make reasonable discretion.

　　　　　　　　　　　　　　　Chapter IV Supervision Rules

Article 21 the food and drug supervision and administration departments at all levels shall strengthen the standardization of administrative law enforcement, standardize the discretion of administrative punishment, implement the responsibility system of administrative law enforcement and the accountability system of fault, and establish and improve the supervision mechanism of administrative penalty discretion.

Article 22 The food and drug supervision and administration departments at or above the provincial level shall, in light of the actual local work, establish a guidance system for typical cases of administrative penalty discretion. Through the typical case analysis and practical training and other ways, standardize the exercise of administrative penalty discretion.

Article 23 The food and drug supervision and administration departments at all levels shall supervise and inspect the exercise of administrative penalty discretion by means of administrative law enforcement supervision and inspection, administrative penalty case file review, etc. If it is found that the discretion of administrative punishment is improperly exercised, it shall take the initiative to correct it in a timely manner.

Article 24 The food and drug supervision and administration department at a higher level shall strengthen the guidance and supervision of the exercise of the administrative penalty discretion of the food and drug supervision and administration department at a lower level, and if it finds that the discretion is obviously improper, it shall be ordered to make corrections within a time limit; if it fails to make corrections within the time limit, it shall have the right to change or cancel it.

　　　　　　　　　　　　　Chapter V Supplementary Provisions

Article 25 The provincial food and drug supervision and administration department shall, in accordance with laws, regulations, rules and these rules, formulate and revise the administrative penalty discretion benchmark.
Discretionary benchmark refers to the specific norms for the exercise of discretion in the implementation of administrative punishment, in accordance with the provisions of laws, regulations and rules, taking into account the facts, nature, circumstances, product risk and social harm degree of the illegal act, and reasonably applying the type and range of punishment, in accordance with these rules.

Article 26 These Rules shall come into force as of January 1, 2013.