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What are the regulations for administrative penalty decisions in the food and drug system?

Several time limits related to food and drug administrative penalties

1. If an illegal act is found to meet the following conditions, the case shall be filed within 7 working days: 1. There is a clear suspicion of illegal behavior 2. There are objective illegal facts; 3. It falls within the scope of administrative penalties for drug supervision and administration; 4. It falls under the jurisdiction of this department.

2. The administrative agency shall make an administrative penalty decision within three months from the date of filing the case.

3.

The audit shall make a decision on the disposal of items registered and preserved in advance within 7 days. For sealed or detained items, a decision should be made within 7 days on whether to file a case; if inspection is required (within 25 days), a decision on whether to file a case should be made within 15 days from the date of issuance of the inspection report

. If a case has been filed, an "Administrative Handling Notice" should be filled out and sent to the party whose items are sealed or detained. The period of sealing or detaining the items will be extended to the date when the administrative penalty decision is made

or the decision is made to withdraw the case.

4. The party concerned may go to the drug regulatory department to make a statement and review within 3 days after receiving the advance notice of administrative penalty.

5. If the party requests a hearing within 3 days after receiving the hearing notice, the drug regulatory department shall determine the composition of the hearing personnel, the time, place and method of the hearing within 3 days from the date the party requests the hearing. , and serve the "Hearing Notice" to the parties 7 days before the hearing, and announce it to the public 3 days before the hearing.

6.

The "Administrative Penalty Decision" shall be delivered to the parties on the spot after the announcement, and the parties shall sign on the "Delivery Receipt". If the party concerned is not present, the "Administrative Penalty Decision" shall be served to the party within 7 days. The "Administrative Punishment Decision" shall be delivered by the person in charge to the punished unit or individual for signature. The recipient shall indicate the date of receipt on the delivery receipt and sign or seal it. The date of receipt is the date of delivery.

Procedural Provisions for Food and Drug Administrative Penalties

Chapter 1 General Provisions

Article 1 is to regulate the exercise of administrative penalty powers by food and drug regulatory authorities and protect citizens and legal persons. and other organizations’ legitimate rights and interests, in accordance with the Administrative Punishment Law of the People’s Republic of China (hereinafter referred to as the Administrative Punishment Law), the Administrative Enforcement Law of the People’s Republic of China (hereinafter referred to as the Administrative Enforcement Law), the The Food Safety Law of the People's Republic of China, the Drug Administration Law of the People's Republic of China and other relevant laws and regulations formulate these regulations.

Article 2: The food and drug regulatory authorities shall comply with these regulations when imposing administrative penalties on units or individuals that violate laws, regulations, and rules governing food, health foods, drugs, cosmetics, and medical devices.

Article 3 The food and drug regulatory authorities shall implement administrative penalties in accordance with the principles of openness, fairness and impartiality, and ensure that the facts are clear, the evidence is conclusive, the procedures are legal, the application of laws, regulations and rules is accurate and appropriate, and the use of law enforcement documents is standardized .

Article 4: Citizens, legal persons or other organizations shall have the right to state and defend against administrative penalties imposed by the food and drug regulatory authorities; if they are dissatisfied with the administrative penalties, they shall have the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

Article 5: The food and drug regulatory authorities shall establish an administrative penalty supervision system.

The higher-level food and drug regulatory authorities shall supervise the administrative penalties imposed by the lower-level food and drug regulatory authorities. The higher-level food and drug regulatory department shall order the lower-level food and drug regulatory department to make corrections within a time limit for illegal or inappropriate administrative penalty decisions made by the lower-level food and drug regulatory department; if it fails to make corrections within the time limit, it shall be changed or revoked in accordance with the law.

Chapter 2 Jurisdiction

Article 6: Administrative penalties shall be under the jurisdiction of the food and drug supervision and administration department where the violation occurs.

Article 7: County (district) and city (prefecture, state) food and drug regulatory authorities shall have jurisdiction over food and drug administrative penalty cases within their respective administrative regions in accordance with their powers.

The food and drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with their authority, have jurisdiction over major and complex food and drug administrative penalty cases within their respective administrative regions.

The State Food and Drug Administration shall, in accordance with its authority, have jurisdiction over cases where administrative penalties should be implemented by itself, as well as major and complex food and drug administrative penalty cases 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 the actual conditions of the region, stipulate the specific division of labor at the levels within their own administrative regions.

Article 8: Food and drug regulatory authorities at or above the county level may entrust organizations that meet the conditions specified in Article 19 of the Administrative Penalty Law to implement administrative penalties within their legal authority.

The entrusted organization shall make specific administrative actions in the name of the entrusting department within the scope of entrustment. The entrusting department shall guide and supervise the entrusted organization's administrative penalty actions and related administrative law enforcement actions, and bear legal responsibility for the consequences of such actions.

Human health cannot be ignored.