The latest penalty standard: pharmacies involved in 5 cases from heavy punishment.

After the implementation of the new Drug Administration Law, administrative penalty discretion standards have been introduced in various places in response to the law.
11, the Chongqing Municipal Drug Administration issued the "Chongqing Municipal Drug Administration Administrative Penalty Discretionary Application Rules (Trial)" (hereinafter referred to as the "Rules").
the Rules have formulated new rules on the correct performance of regulatory duties for medicines (including medicines, medical devices, cosmetics, the same as between companies) and for ensuring the correct exercise of administrative penalty discretion.
the Rules, the administrative penalty is divided into five levels: non-punishment, mitigation of punishment, light punishment, general punishment and severe punishment.
, except in other cases where the provisions are not granted, are reduced, lightly or severely punished, the general administrative penalty shall apply.
retail pharmacies, these red lines do not touch the need to note that in the administrative penalties referred to in the Rules, there is also talk of penalties for drug retailers.
so, how exactly? How to punish? First of all, it should be reminded that, in accordance with the Rules, retail pharmacies shall be punished in accordance with the "serious circumstances" prescribed by the relevant laws, regulations and regulations: 1. If the operating enterprise discovers that the product it sells is in danger of safety, it may cause harm to human health and life safety, does not immediately stop selling the product, does not notify the production enterprise or supplier, and does not report to the supervisory and regulatory authorities, causing serious consequences; 2, refuse, evade supervision and inspection, or forge, destroy, conceal the relevant evidence materials, or unauthorized use of seized or seized articles, resulting in the product difficult to recover, harm difficult to eliminate or cause serious consequences; 3, the operating enterprise has not established or failed to implement the inspection and acceptance system of in-stock purchase, or the sale of products that have been publicly discontinued, resulting in serious consequences;
Secondly, if a pharmaceutical business enterprise has the following circumstances, it shall be regarded as "sufficient evidence" in accordance with Article 75 of the Regulations on the Implementation of the Drug Administration Law, according to which the counterfeit drugs, inferior drugs and illegal proceeds sold or used by it shall be confiscated, but other administrative penalties may be waived.
1, the purchase channel is legal, and can provide real and legal drug production or business license, business license, power of attorney, sales bills and other proof; 2, drug purchase (sale) records, storage inspection and acceptance records are true and complete; 3, drug storage, storage and maintenance has not violated the relevant provisions and has a true and complete record.
If a Chinese medicine tablet sold by a pharmaceutical business enterprise does not meet the drug standards, but is determined by an expert to have no effect on safety or effectiveness, it shall be ordered to make corrections within a time limit and given a warning, in accordance with the provisions of Article 117, paragraph 2, of the Drug Administration Law, and may be exempted from a fine.
These circumstances may not be punished In addition, in accordance with the Rules, in the implementation of administrative penalties, the following factors should be taken into account, mainly related to the risk of the products involved, the consequences of the violation, the degree of subjective intent of the illegal act, the seriousness of the nature of the violation, the frequency and continuity of the violation, the degree of social impact of the violation and other factors affecting the discretion of the punishment.
If the parties have one of the following circumstances, they shall not be punished according to law: 1, voluntarily suspend the illegal act without causing harmful consequences; 2. If the illegal act is minor and promptly corrected, and no harmful consequences are caused; 3, a person under the age of fourteen has committed an illegal act; 4, a mentally ill person who has committed an illegal act when he is unable to recognize or control his own behavior; 5, unless otherwise provided by law, the illegal act has not been discovered within two years;
if the illegal act of the party concerned has any of the following circumstances, the administrative punishment shall be reduced or reduced according to law: 1. If a person who has reached the age of fourteen or under the age of eighteen has committed an illegal act; 3, the active suspension of illegal acts, the harmful consequences are minor; 4, the initiative to report and truthfully state the illegal acts; 5, the parties to expose major violations of the law or provide key clues or evidence of other major illegal acts not yet in the possession of the case handling organ, and after investigation and certification, or cooperate with the drug regulatory authorities to investigate and punish illegal acts have other meritority; 6, coerced by others to commit illegal acts; 7, the property involved in the case or less illegal gains; 8, other laws should be light or reduced administrative punishment.
the violation of the law by the parties concerned, administrative penalties may be reduced or reduced according to law: 1. The illegal act is minor and the social harm is less; 2, lured by others to commit illegal acts; 3, play a secondary or auxiliary role in the common illegal act; 4, the parties have sufficient evidence that there is no subjective intent or gross negligence; 5, the parties due to disability or major illness and other reasons of life is really difficult; 6, actively cooperate with the drug regulatory authorities to investigate, truthfully state the facts of the violation and take the initiative to provide evidence materials; 7, other laws may be light or mitigating administrative punishment.
any of the following circumstances, the penalty shall be imposed in accordance with the law from a heavy administrative penalty: 1. If the illegal act continues for more than six months or has been punished in addition to the revocation of the license three times in a row for 12 consecutive months; 2, subjective intentional or gross negligence; 3, coercion, inducement, instigation of others to break the law and actually occur illegal acts; 4, obstruction, refusal, evasion of supervision and inspection, or forge, destroy, conceal the relevant evidence materials, or unauthorized use of seized, seized articles (places); 5, the complaint against the whistleblower, witnesses, witnesses and other relevant personnel to retaliate; 6, illegal persons refused to take corrective action, active recall and other measures, causing serious harm consequences; 7, ordered to stop, ordered to correct the illegal act, continue to carry out illegal acts; 8, the risk of the products involved is high; 9, the production and sale of counterfeit drugs, inferior drugs, or non-standard medical equipment, cosmetics, after treatment, re-offender; 10, causing major social harm consequences or serious harm to human health; 11, natural disasters, accidents, disasters, During the period of an emergency such as a public health event or a social security incident, the production or sale of a drug used to respond to an emergency is a counterfeit drug, a inferior drug, or the production or sale of medical devices used to respond to an emergency does not meet the standards;
attached: the "high-risk products" called by the rules include the following products 1, the drugs involved belong to narcotic drugs, psychotic drugs, blood products, biological products, toxic drugs for medical use, injectable drugs, radioactive drugs or compound preparations containing special drugs and other drugs; 2. The drugs involved illegally add Western pharmaceutical ingredients, prohibited substances, or are manufactured using non-drug raw materials; 3. The medical devices involved belong to the products listed in the catalogue of medical devices under the state's key supervision, or belong to the high-risk medical device varieties identified by the state; 4, the cosmetics involved in the case add prohibited substances or the addition of restricted substances; 5, the main users of the products involved are pregnant women, infants, children or other specific groups of people; 6, other products that can be judged to be high risk.
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