Provisions on administrative punishment procedures for food and drugs

Provisions on Procedures for Administrative Punishment of Food and Drug Article 1 In order to standardize the exercise of administrative punishment by food and drug supervision and management departments and protect the legitimate rights and interests of citizens, legal persons and other organizations, in accordance with the Administrative Punishment Law of the People's Republic of China (hereinafter referred to as the Administrative Punishment Law), the Administrative Compulsory Law of the People's Republic of China (hereinafter referred to as the Administrative Compulsory Law), the Food Safety Law of People's Republic of China (PRC) and the Food Safety Law of People's Republic of China (PRC),

Article 2 The food and drug supervision and administration departments shall abide by these provisions when imposing administrative penalties on units and individuals that violate the laws, regulations and rules governing the management of food, health food, medicines, cosmetics and medical devices.

Article 3 The food and drug supervision and administration department shall follow the principles of openness, fairness and impartiality when imposing administrative punishment, and ensure that the facts are clear, the evidence is conclusive, the procedures are legal, the laws, regulations and rules are accurately applied, and the law enforcement documents are standardized.

Article 4 Citizens, legal persons or other organizations have the right to state and defend the administrative punishment given by the food and drug supervision and administration department; Those who refuse to accept the administrative punishment have the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

Article 5 The food and drug supervision and administration department shall establish a supervision system for administrative punishment.

The food and drug supervision and administration department at a higher level shall supervise the administrative punishment imposed by the food and drug supervision and administration department at a lower level. The food and drug supervision and administration department at a higher level shall order the food and drug supervision and administration department at a lower level to correct the illegal or inappropriate administrative punishment decision; If no correction is made within the time limit, it shall be changed or revoked according to law. Article 6 Administrative punishment shall be under the jurisdiction of the food and drug supervision and administration department in the place where the illegal act occurred.

Article 7 The food and drug supervision and administration departments of counties (districts) and cities (prefectures) shall have jurisdiction over cases of food and drug administrative punishment within their respective administrative areas according to their functions and powers.

The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to their functions and powers, have jurisdiction over major and complicated cases of food and drug administrative punishment within their respective administrative areas.

China Food and Drug Administration has jurisdiction over cases that should be punished by itself and major and complicated cases of food and drug administrative punishment that occur nationwide.

The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government may, in accordance with laws, regulations and rules, and in combination with local conditions, stipulate the specific division of labor within their respective administrative areas.

Article 8 The food and drug supervision and administration department at or above the county level may, within the statutory authority, entrust an organization that meets the conditions stipulated in Article 19 of the Administrative Punishment Law to implement administrative punishment.

The entrusted organization shall, within the scope of entrustment, make specific administrative acts in the name of the entrusted department. The entrusting department shall guide and supervise the administrative punishment behavior of the entrusted organization and its related administrative law enforcement behavior, and bear legal responsibility for the consequences of this behavior.

Article 9 Food and drug supervision and administration institutions established by county-level food and drug supervision and administration departments in towns or regions shall exercise the power of administrative punishment in accordance with the provisions of laws, regulations and rules.

Article 10 If two or more food and drug supervision and administration departments have jurisdiction over the same illegal act of the parties concerned, the food and drug supervision and administration department that filed the case first shall have jurisdiction. Jurisdiction disputes shall be settled through consultation; If negotiation fails, it shall be submitted to the food and drug supervision and administration department at the next higher level for designated jurisdiction.

Article 11 When the food and drug supervision and administration department at a higher level deems it necessary, it may directly investigate and deal with cases under the jurisdiction of the food and drug supervision and administration department at a lower level, or it may transfer cases under its jurisdiction to the food and drug supervision and administration department at a lower level for investigation.

If the food and drug supervision and administration department at a lower level cannot exercise jurisdiction over the cases under its jurisdiction for special reasons, it may report to the food and drug supervision and administration department at a higher level for jurisdiction or designate jurisdiction.

Article 12 The food and drug supervision and administration department at a higher level shall, after receiving a jurisdiction dispute or making a request for designation of jurisdiction, make a decision on designation of jurisdiction within 10 working days, and notify the lower departments in writing.

Thirteenth food and drug supervision and management departments found that the case does not belong to their own jurisdiction, it should be promptly transferred to the competent food and drug supervision and management departments or relevant administrative departments for handling.

The transferred food and drug supervision and administration department shall inform the transferred food and drug supervision and administration department of the investigation results of the case in a timely manner; If it is considered that the transfer is improper, it shall report to the food and drug supervision and administration department at the next higher level and shall not be transferred again.

Fourteenth food and drug supervision and management departments in the investigation and handling of cases, found that illegal acts suspected of a crime, should be in accordance with the requirements of the "administrative law enforcement organs to transfer suspected criminal cases", promptly transferred to the public security organs at the same level.

If the public security organ decides to file a case, the food and drug supervision and administration department shall, within 3 days from the date of receiving the notice of filing a case from the public security organ, hand over the articles involved and other materials related to the case to the public security organ and go through the formalities of making friends; For the items involved in the seizure or detention, the Notice on the Transfer of Sealed or Detained Items shall also be filled out and the parties concerned shall be informed in writing.

Fifteenth food and drug supervision and management departments in handling cases of administrative punishment, food and drug supervision and management departments in other regions need to assist in the investigation and evidence collection, it shall issue a letter of assistance in the investigation. Generally, the assisting department shall complete the relevant work within 15 working days from the date of receiving the letter of assistance in investigation; If it is necessary to postpone the completion, it shall promptly inform the department requesting the investigation.

Article 16 If the administrative license or approval certificate of food and drug should be revoked according to law, it shall be decided by the food and drug supervision and administration department that originally licensed or approved it.

If the food and drug supervision and administration department investigates and deals with illegal cases and should revoke the license or approval certificate according to law, it shall impose administrative punishment according to law within its authority, and submit the obtained evidence and related materials to the food and drug supervision and administration department that originally issued the license and approval, and the original license and approval department shall make an administrative punishment decision on whether to revoke the license or revoke the approval certificate according to law. If it is necessary for China Food and Drug Administration to revoke the approval document, the food and drug administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall report to China Food and Drug Administration for decision.

The original license issuing and examination and approval department shall make the decision of administrative punishment of revoking the license and the approval document according to law, and these provisions shall apply. Seventeenth food and drug supervision and management departments shall promptly investigate and deal with the following matters:

(a) clues found in the supervision and inspection and sampling;

(2) Complaints and reports from citizens, legal persons or other organizations;

(three) assigned by the higher authorities or submitted to the lower authorities for investigation;

(four) transferred by the relevant departments or disclosed by other means or channels.

Those who meet the conditions for filing a case shall file a case within 7 working days.

Eighteenth filing shall meet the following conditions:

(a) there is a clear suspicion of violating the law;

(2) There are illegal facts;

(3) It falls within the scope of administrative punishment of food and drug supervision and administration;

(4) Being under the jurisdiction of this department.

Those who meet the conditions for filing a case shall be reported to the person in charge for approval, and two or more law enforcement officers shall be identified as the case handlers.

Nineteenth investigators in any of the following circumstances, should voluntarily withdraw; The parties also have the right to apply for withdrawal:

(1) Being a party to the case or a close relative of the party;

(2) Having a direct interest in the case;

(3) Having other relations with the parties to the case, which may affect the fair handling of the case.

The withdrawal of the case-handling personnel is decided by the person in charge of the food and drug supervision and administration department, and the withdrawal of the person in charge is decided by the collective research of other responsible persons of the department.

Before the withdrawal decision is made, the person applying for withdrawal shall not stop the investigation and handling of the case without authorization. Twentieth food and drug supervision and management departments to investigate cases, law enforcement personnel shall not be less than 2 people, and shall produce law enforcement certificates.

If evidence is collected and obtained from the parties to a case for the first time, they shall be informed of their right to apply for the withdrawal of the case-handling personnel.

The person under investigation or the relevant personnel shall truthfully answer the inquiry, assist and cooperate with the investigation, and timely provide relevant materials such as bills, vouchers and records that should be kept according to law, and shall not obstruct or interfere with the investigation of the case.

In the process of handling cases involving state secrets, commercial secrets and personal privacy, law enforcement officers shall keep them confidential.

Twenty-first law enforcement officers shall make records when conducting on-site investigations. Records shall indicate the identity, certificate name, certificate number and investigation purpose of law enforcement personnel. Law enforcement officers shall sign the record.

After the transcript is verified to be correct, the respondent shall sign the transcript page by page or press the fingerprint, and indicate his opinion on the authenticity of the transcript. If the record is amended, it shall be signed by the respondent or printed by hand.

Twenty-second investigators should collect evidence related to the case according to law. Evidence includes documentary evidence, physical evidence, audio-visual materials, witness testimony, statements of the parties, inspection reports, expert opinions, investigation transcripts, electronic data, on-site inspection transcripts, etc.

Evidence obtained according to law in the process of investigation or inspection before filing a case can be used as the basis for ascertaining the facts.

Article 23 The evidence obtained shall be original and original. If it is really difficult to retrieve the original and the original, the unit or individual submitting the evidence may sign or affix the official seal on the copy, and indicate that "this copy is provided by ×××".

Article 24 Evidence formed outside the territory of People's Republic of China (PRC) shall state its source, be authenticated by the notary office of the host country, be authenticated by the embassies and consulates of People's Republic of China (PRC) and China in that country, or go through the authentication procedures stipulated in the relevant treaties concluded between People's Republic of China (PRC) and the country where the evidence is located.

The language and characters contained in overseas evidence shall be translated by institutions with translation qualifications or by other Chinese translations with accurate translation.

Evidence formed in People's Republic of China (PRC) Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan Province Province shall be authenticated in accordance with relevant regulations.

Twenty-fifth in the case that the evidence may be lost or difficult to obtain in the future, with the approval of the person in charge, it may be registered and preserved in advance, and a notice of advance registration and preservation of articles shall be issued to the parties. During the period of advance registration and preservation, the parties concerned or relevant personnel shall not damage or transfer the evidence.

Article 26 The food and drug supervision and administration department shall make the following decisions on the evidence registered and preserved in advance within 7 days:

(1) If it is necessary to take evidence preservation measures, it shall be returned after taking evidence preservation measures such as recording, copying, photographing and video recording;

(2) If inspection, testing, quarantine and appraisal are needed, it shall be submitted for inspection, testing, quarantine and appraisal;

(three) if it should be confiscated according to law, make a decision on administrative punishment and confiscate the illegal items;

(4) If it is necessary to seal up or detain, measures of sealing up or detaining shall be taken according to law;

(five) if the illegal facts are not established, or if the illegal facts are established but should not be sealed up, detained or confiscated according to law, the measures for pre-registration and preservation shall be lifted.

If no decision is made within the time limit, the advance registration and preservation shall be revoked.

Article 27 When investigating a case, the food and drug supervision and administration department may, with the approval of the person in charge, take administrative compulsory measures such as seizure and detention according to law, and law enforcement officers shall issue a decision on seizure and detention to the parties concerned.

In case of emergency, if it is necessary to take measures of sealing up or detaining on the spot, law enforcement officers shall report to the person in charge within 24 hours after sealing up or detaining, and go through the approval procedures. If the person in charge thinks that administrative compulsory measures should not be taken, it shall be lifted immediately.

Twenty-eighth food and drug supervision and management departments shall notify the parties to be present when implementing the advance registration and preservation or seizure, and record the relevant measures taken in the on-site inspection record.

Places, facilities or property that have been sealed up or detained shall be sealed in situ or in different places, and the sealed place shall be stamped with the official seal of the department, and the parties shall not unseal it without authorization.

A list of articles registered and preserved in advance or sealed up or detained shall be made and signed or sealed by law enforcement officers, parties concerned or relevant personnel.

Twenty-ninth places, facilities or property that have been sealed up or detained shall be properly kept, and shall not be used, damaged or transferred or disposed of without authorization.

Perishable and deteriorated articles can be disposed of directly according to laws and regulations, or if the parties agree to dispose of them first, they can be disposed of first with the approval of the person in charge of the food and drug supervision and administration department and after taking relevant measures to retain evidence.

Article 30 The time limit for sealing up or detaining shall not exceed 30 days; If the situation is complicated, it may be extended with the approval of the person in charge of the food and drug supervision and administration department, but the extension period shall not exceed 30 days.

After making a decision to extend the time limit for sealing up or detaining, it shall fill in the Notice of Extending the Time Limit for Sealing up or Detaining in time, and inform the parties in writing and explain the reasons.

If it is necessary to inspect, test, quarantine or identify the goods, an inspection (testing, quarantine and identification) notice shall be filled in. The period of sealing up or detaining does not include the period of inspection, testing, quarantine or appraisal.

In accordance with the provisions of Article 28 of the Administrative Enforcement Law, the seizure and detention shall be lifted.

Thirty-first in the process of investigation and evidence collection, law enforcement officers require the parties to sign, seal or confirm in other ways the transcripts or other materials. If the parties refuse to be present, sign, seal or confirm by other means, or the parties cannot be found, two law enforcement officers shall indicate the reasons in the transcripts or other materials, invite the relevant personnel to sign or seal as witnesses, or record by means of audio and video recording.

Article 32 If law enforcement officers need to take samples for inspection when investigating illegal facts, they shall take samples in accordance with relevant regulations. The inspection institution shall conduct inspection in time within the prescribed time limit.

Thirty-third after the investigation of a case, the case undertaker shall write a report on the conclusion of the investigation, except for the summary procedure. The contents of the investigation report include: the basic situation of the parties, the cause of action, illegal facts and evidence, and the investigation process. If administrative punishment is to be given, it shall also include the basis for application and suggestions for punishment.

Article 34 When the food and drug supervision and administration department investigates a case, if there is evidence to prove that there is an illegal act, it shall issue a notice to order it to correct, and order the party concerned to correct the illegal act or within a time limit. Section 1 General Procedures

Article 35 After the undertaker submits the case investigation report, the food and drug supervision and administration department shall organize three or more relevant personnel to discuss the facts, nature, circumstances, social harm, handling procedures and punishment opinions of the illegal act.

The collegial panel shall, according to the facts ascertained, put forward suggestions on punishment, supplementary evidence, re-investigation, dismissal of the case or other handling.

Article 36 Before making a decision on punishment, the food and drug supervision and administration department shall fill in the advance notice of administrative punishment, and inform the parties of the illegal facts, the reasons and basis of punishment, and the rights of statement and defense enjoyed by the parties according to law.

The food and drug supervision and administration department shall fully listen to the statements and defenses of the parties concerned. If the facts, reasons or evidence put forward by the parties are established after examination, they shall be adopted.

The food and drug supervision and administration department shall not aggravate the punishment because of the defense of the parties.

Article 37 The food and drug supervision and administration department shall inform the parties concerned of the right to request a hearing before making a decision on administrative punishment such as ordering to stop production or business, revoking the license, revoking the approval document, imposing a relatively large fine, and confiscating relatively large property. If a party requests a hearing, it shall organize a hearing in accordance with legal procedures.

The standards for large fines shall be implemented in accordance with local regulations, local government regulations and other relevant normative documents.

Article 38 The administrative penalty decision to be made shall be reported to the person in charge of the food and drug supervision and administration department for examination. The person in charge of the food and drug supervision and administration department makes the following decisions according to different situations:

(a) there are illegal acts that should be subject to administrative punishment, and make a decision on administrative punishment according to the seriousness and specific circumstances;

(two) the illegal act is minor, and administrative punishment may not be imposed according to law;

(three) if the illegal facts cannot be established, no administrative punishment shall be given;

(four) if the illegal act constitutes a crime, it shall be transferred to the public security organ.

Thirty-ninth if the circumstances are complicated or major illegal acts are given a heavier administrative punishment, it shall be decided by the person in charge of the food and drug supervision and administration department through collective discussion. The process of collective discussion and decision should be recorded in writing.

The standards for major and complicated cases shall be determined by the food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government according to the actual situation.

Article 40 When making a decision on administrative punishment, the food and drug supervision and administration department shall make a written decision on administrative punishment.

The written decision on administrative punishment shall specify the following items:

(1) The name and address of the party concerned;

(2) Facts and evidence in violation of laws, regulations or rules;

(three) the types and basis of administrative punishment;

(four) the way and time limit for the performance of administrative punishment;

(five) the way and time limit for applying for administrative reconsideration or bringing an administrative lawsuit against the decision on administrative punishment;

(six) the name of the food and drug supervision and administration department that made the decision on administrative punishment and the date of making the decision.

If the decision on administrative punishment involves the confiscation of food, medicine or other related articles, it shall also be accompanied by a confiscation certificate.

The written decision on administrative punishment shall be stamped with the official seal of the food and drug supervision and administration department that made the decision on administrative punishment.

Article 41 Except for articles that should be destroyed according to law, the food and drug supervision and administration department shall, with the approval of the person in charge, deal with the illegal property confiscated according to law in accordance with the provisions of Article 53 of the Administrative Punishment Law. The types and quantities of items to be processed shall be verified and the list shall be filled in.

Section 2 Summary Procedure

Forty-second illegal facts are conclusive and have legal basis, and citizens are given an administrative penalty of less than 50 yuan, or legal persons or other organizations are given a fine of less than 1000 yuan or a warning, and a decision on administrative penalty can be made on the spot.

Article 43 If a law enforcement officer makes a decision on administrative punishment on the spot, he/she shall show his/her law enforcement certificate to the party concerned, and fill in a written decision on administrative punishment with a predetermined format and number and stamped with the official seal of the food and drug supervision and administration department on the spot.

The written decision on administrative punishment on the spot shall be delivered to the parties on the spot, and signed or sealed by the parties.

Forty-fourth administrative punishment decisions made by law enforcement officers on the spot shall be reported to their subordinate departments for the record within 7 working days. Forty-fifth administrative punishment decision shall be delivered to the parties on the spot after the announcement; If the party concerned is not present, the decision on administrative punishment shall be served on the party concerned within 7 days in accordance with the provisions of this chapter.

The written decision on administrative punishment shall be directly sent by the undertaker to the parties for signature. If the person to be served is a citizen, when he is absent, he shall hand in the signature of the adult family member who lives with him; If the addressee is a legal person, its legal representative shall sign for it; If the addressee is any other organization, it shall be signed by the principal responsible person. If the addressee has an agent, he may send it to his agent for signature.

The addressee shall indicate the date of receipt on the receipt and sign or seal it. The date of receipt is the date of delivery.

Article 46 If the addressee or his adult family members who live together are dissatisfied with the written decision on administrative punishment, the addressee may invite the personnel of the relevant grass-roots organizations or units to be present to explain the situation, and indicate the reasons and date of rejection on the service receipt, which shall be signed or sealed by the addressee and witnesses, and the written decision on administrative punishment shall be deemed to have been served.

Article 47 If direct delivery is difficult, the nearest food and drug supervision and administration department may be entrusted to deliver it on its behalf or by mail. If it is delivered by post, the date of receipt indicated on the receipt shall be the date of delivery.

The administrative penalty of revoking the food and drug approval certificate made by China Food and Drug Administration shall be served by the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the party concerned is located.

Article 48 If the addressee's whereabouts are unknown or it cannot be served by other means specified in this Chapter, it may be served by public announcement. 60 days from the date of announcement shall be deemed as delivery.

When the announcement is served, it can be posted at the original residence of the addressee or published in newspapers and television.

When the announcement is delivered, the reasons and process of the announcement shall be stated in the case file. Forty-ninth after the administrative punishment decision is served, the parties shall perform it within the time limit of the punishment decision.

If the parties are in real financial difficulties, they may apply for an extension or payment of the fine by installments, and submit written materials. Upon examination by the case-handling personnel, the time limit and amount of deferred payment or installment payment of the fine shall be determined, and shall be implemented after being reported to the person in charge for approval.

Article 50 If a party refuses to accept the decision on administrative punishment, applies for administrative reconsideration or brings an administrative lawsuit, the execution of administrative punishment shall not be suspended, except that it is decided or ruled to stop execution during the administrative reconsideration or administrative lawsuit.

Article 51 The food and drug supervision and administration departments that make decisions on fines and confiscation of illegal income shall be separated from the institutions that collect fines and confiscate illegal income. In addition to the fines collected on the spot according to regulations, law enforcement officers shall not collect fines and confiscations by themselves.

Fifty-second according to the provisions of the decision on administrative punishment on the spot, in any of the following circumstances, law enforcement officers can collect fines on the spot:

(a) to give 20 yuan a fine according to law;

(two) it is difficult to implement after it is not collected on the spot.

Article 53 In remote, water and inaccessible areas, after the food and drug supervision and administration department and its law enforcement officers have made a punishment decision in accordance with these Provisions, if it is really difficult for the parties to pay the fine to the designated bank, the law enforcement officers may collect the fine on the spot at the request of the parties.

Article 54 Where the food and drug supervision and administration department and its law enforcement officers collect fines on the spot, they shall issue a receipt for fines uniformly issued by the financial departments of provinces, autonomous regions and municipalities directly under the Central Government to the parties concerned.

The fines collected by law enforcement officers on the spot shall be turned over to the food and drug supervision and administration department within 2 days from the date of collecting the fines; The food and drug supervision and administration department shall pay a fine to the designated bank within 2 days.

Article 55 If a party concerned does not apply for administrative reconsideration or bring an administrative lawsuit within the statutory time limit, nor complies with the decision on administrative punishment, the food and drug supervision and administration department shall apply to the people's court for compulsory execution.

Before applying to the people's court for compulsory execution, the food and drug supervision and administration department shall fill in a written reminder of the execution of the administrative penalty decision, urge the parties to perform their obligations in writing, and inform them of the time limit and method of performing their obligations, and the rights of statement and defense they enjoy according to law. If a fine is involved, there should be a clear amount and payment method.

The total amount of fines shall not exceed the original amount of fines.

If the parties make statements and arguments, the food and drug supervision and administration department shall record and review the facts, reasons and evidence put forward by the parties, and make statements and arguments transcripts and statements and arguments review opinions. If the facts, reasons or evidence put forward by the parties are established, the food and drug supervision and administration department shall adopt them.

Within 10 working days after the administrative penalty decision is served, the food and drug supervision and administration department may apply to the people's court for compulsory execution, and fill in the Application Form for Compulsory Execution of Administrative Punishment.

Article 56 After the decision on administrative punishment is fulfilled or executed, the case-handling personnel shall fill in the report on the closing of administrative punishment, sort out and bind the relevant case materials, and file them for preservation. Article 57 The term of these Provisions shall be calculated in hours and days, excluding the starting hours and starting days. The last day of expiration is a holiday, and the first day after the holiday is the expiration date. Except as otherwise provided by laws and regulations.

Article 58 The terms "above", "below" and "within" mentioned in these Provisions all include this number.

Article 59 The food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government may, according to the actual conditions of their respective administrative regions, formulate detailed rules for the implementation of these Provisions.

Sixtieth China Food and Drug Administration is responsible for formulating the model document format applicable to administrative punishment. The food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government may refer to the model document format, formulate the document format applicable to administrative punishment in their respective administrative areas and print it by themselves.

Article 61 These Provisions shall come into force on June 1 day, 2065. On April 28, 2003, the Provisions on the Procedure of Administrative Punishment for Drug Supervision (the former State Food and Drug Administration OrderNo. 1) was abolished at the same time.