Licensed pharmacists and pharmaceutical workers will be severely punished for br

Copyfrom： Release time：2019-07-17 The editor：

       On July 10, the official website of the State Administration of Markets and the State Administration of the People's Republic of China publicly solicited opinions on the "Administrative Measures on Serious Illegal Letters and Faith Lists (Revised Draft for Soliciting Opinions)" (hereinafter referred to as "Draft for Comment").
The "Draft for Comment" pointed out that in accordance with the "four most stringent" requirements, for the food, medicine, special equipment and other areas related to the health and safety of the people, increase the inclusion of the situation and increase the intensity of punishment. Taking into account the particularity of drug supervision and intellectual property management, the "Draft for Comment" stipulates that the drug supervision and intellectual property management departments at or above the provincial level are responsible for the management of serious illegal and untrustworthy lists in their professional fields.
Submitting false clinical trial data will be included in the list
 
       Taking into account the complex and diverse regulatory targets of the market supervision department, the "Draft for Comment" extends the applicable object of the list of serious illegal and untrustworthy letters from "enterprise" to "enterprise, individual industrial and commercial households and other organizations; in accordance with relevant laws and regulations and these regulations, in the main body Natural persons who hold specific positions internally and are directly responsible for violations of law and untrustworthiness; and natural persons who directly participate in market operations. At the same time, the list of “serious and untrustworthy enterprises” was adjusted to “serious list of illegal and untrustworthy letters”.
According to the "four most strict" requirements, the "Draft for Comment" will increase the inclusion of the situation and increase the punishment for food, medicine, special equipment and other fields related to the health and safety of the people. In the part of the program, there are 36 cases in which the responsible department can list the subject into the list of serious violations of the law (see the full text at the end of the article). Among them, specifically for the medical field are:
1. Produce or sell counterfeit drugs, or treat them according to counterfeit drugs; illegally produce and sell special drugs, causing drugs to flow into illegal channels.
2. Drugs, medical devices, and cosmetics companies were ordered to suspend production and suspend business for rectification.
3. Enterprises engaged in the research, production and operation of pharmaceuticals, their legal representatives, directly responsible persons in charge and other directly responsible personnel, submitting false clinical trials or listing permit application materials; fabricating production verification records, changing product batch numbers; submitting False batches issue declaration materials, or use other deceptive means to obtain batch issuance certificates.
 
Disciplinary action for dishonesty includes withdrawal of licensed pharmacist
 
 
        In conjunction with the feedback from the relevant department, the State Food and Drug Administration and the State Intellectual Property Office, the "Draft for Comment" stipulates 10 disciplinary measures, which basically cover the responsibilities of each business line. In order to highlight the effect of credit disciplinary action, the "Draft for Comment" is not repeated for specific disciplinary measures that have been clearly defined by laws and regulations.
At the same time, in order to strengthen the application of serious illegal and untrustworthy lists, the disciplinary measures will be implemented, the market supervision, drug supervision, and intellectual property management departments should embed the information of serious illegal and untrustworthy lists into various business systems, and establish and improve the information of serious illegal and untrustworthy lists. Feedback mechanism to advance the terms of shared sharing.
There are 17 kinds of disciplinary measures for dishonesty in the "Draft for Comment". It is worth noting that it is mentioned that the legal representative or directly responsible person of the enterprise is a licensed pharmacist, and the issuing department revokes its "Practicing Pharmacist Registration Certificate" and acts as personal bad information. Recorded in the National Licensed Pharmacist Registration Management Information System.
 
Perfect inclusion in the removal process
　　
       The "Draft for Comment" has improved the procedures for listing, removing the time limit and removing the list of serious violations of the law:
First, regarding the inclusion procedure, the subject who has been listed in the business anomaly list for 3 years is required to be included in the list of serious violations of the law within 10 working days from the date of expiration, while in other cases, the inclusion is considered. And the object has been expanded, and the complexity of the existing inclusion situation has increased, and verification procedures should be added. Therefore, it is stipulated that “the list of serious violations of the law will be included within 10 working days from the date of verification”.
     Second, regarding the time limit for removal, in line with the "Provisional Regulations on Enterprise Information Disclosure", the main body of the list of serious violations of law and trust that has been listed for three years after the abnormal business directory is still removed after 5 years. Other inclusions, taking into account the actual effect of disciplinary action, coordination with the time of publicity of serious distrust behaviors in other departments, etc., are stipulated to be removed after three years.
     Third, after the inclusion of the situation and the expansion of the object, it is necessary to verify the situation when it is removed. Therefore, the "Draft for Comment" stipulates that the subjects in the list of serious violations of the law must submit a written application and can be removed after verification.
 
       Improve credit repair procedures and standards
 
　　
       For subjects who can actively rectify and eliminate adverse effects, the "Consultation Draft" has added credit repair clauses that stipulate strict repair procedures and standards:
      First, the list of serious violations of law and trust must be completed within one year before applying for credit repair to ensure the seriousness of credit supervision.
Second, the subject of dishonesty must undergo rectification and eliminate the adverse effects before applying for removal.
         The third is to submit relevant certification materials when applying for removal, and after the responsible department conducts inspection and verification, interviews with its legal representative, responsible person, etc., it is approved or decided by the market supervision, drug supervision, and intellectual property management departments at or above the provincial level. Can be repaired.
        Fourth, in order to prevent the malicious use of credit to protect the public interest and the legitimate rights and interests of others, and to ensure the seriousness of the credit repair work, the draft of the consultation also specifically stipulates the cancellation of credit repair.
       Fifth, in order to further deter and discriminate against the illegal and untrustworthy behavior, and to protect the public interest, the draft for comment has specifically stipulated three situations in which credit is not repaired.
 

 
Management of serious illegal and untrustworthy lists
(Revised draft for comment draft)
Chapter I General
　　
Article 1 In order to strengthen the management of serious illegal and untrustworthy lists, strengthen credit supervision, and expand social supervision, these Measures are formulated in accordance with laws and regulations such as the Interim Regulations on Enterprise Information Disclosure.
Article 2 The term "serious and illegal letter-of-trust list management" as mentioned in these Measures refers to the market supervision and administration department at or above the county level. The drug supervision and administration and intellectual property management departments at the provincial level or above (hereinafter referred to as the responsible departments) are listed and removed seriously for serious violations of the law. The list of illegal and untrustworthy letters, the implementation of disciplinary punishment and credit repair, etc., and publicity through the national enterprise credit information publicity system.
Article 3 These Measures are applicable to the following subjects that violate the laws and regulations of market supervision and management (including drug supervision and management, intellectual property management) and have serious circumstances:
(1) Enterprises, individual industrial and commercial households and other organizations;
(2) Natural persons who hold specific positions within the main body and are directly responsible for violations of law and untrustworthiness in accordance with relevant laws and regulations and these Measures;
(3) Natural persons who directly participate in market operations.
Article 4 Including the main body in the list of serious violations of law and trust, it is necessary to comprehensively consider the subjective malice, illegal circumstances, and harmful consequences of the subject. For cases with minor circumstances and no serious harm, they may not be included in the list of serious violations.
Article 5 The State Administration of Market Supervision shall be responsible for guiding and organizing the management of serious illegal and untrustworthy lists throughout the country.
Other responsible departments are responsible for the management of serious illegal and untrustworthy lists in their respective jurisdictions and in this field.
 
Chapter II is included in the procedure
Article 6 If the subject has one of the following circumstances, the responsible department shall list the list of serious violations of the law:
(1) Those who have been listed in the business exception list or the patent agency business anomaly list have not fulfilled their obligations for three years.
(2) Being investigated and dealt with by the responsible department for the relevant illegal acts, and being investigated for criminal responsibility.
(3) Violation of relevant laws and regulations, and the department in charge shall revoke or revoke the administrative license, qualifications and qualifications.
(4) Refusing to implement the administrative punishment and administrative treatment decisions in effect by the responsible department.
(5) In the process of investigating and investigating, accident investigation, and food sampling, the responsible department refuses to cooperate with the investigation, false reports, forgery or vandalism, does not immediately organize rescue, refuses to provide relevant materials, submits false materials, or conceals , destroying, transferring evidence, etc., in violation of the statutory cooperation investigation obligations, and obstructing the responsible department to perform statutory regulatory duties.
(6) Due to the serious consequences caused by unlicensed and unlicensed business practices, the social impact is poor and the administrative department is punished by the responsible department.
(7) The person directly responsible for the market subject who has been deregistered due to the submission of false materials or other fraudulent means to conceal important facts.
(8) Producing, selling, providing, and using products, goods, and services that do not meet the protection of human health and personal and property safety, causing serious harm to human health and property safety, and having a bad social impact, and being punished by the responsible department.
(9) Confirming that there are defects, failing to stop production, sales or import of defective products; refusing to cooperate with the defect investigation; and refusing to recall such repeated recalls and other serious violations of the recall responsibility.
(10) Refusing to perform the "three guarantees" responsibility of the products, the social impact is bad, and the administrative supervision of the market supervision and administration department.
(11) If a major product quality and safety accident occurs, there is an illegal act and the administrative department is punished by the responsible department.
(12) Producing or selling counterfeit drugs and inferior drugs, or dealing with counterfeit drugs and inferior drugs; illegally producing and selling special drugs, resulting in the inflow of drugs into illegal channels.
(13) Drugs, medical devices, and cosmetics companies were ordered to suspend production and suspend business for rectification.
(14) The production or import of unregistered special-purpose cosmetics and the illegal addition of substances that may endanger human health in cosmetics shall be punished by the responsible department.
(15) Enterprises engaged in the research, production and operation of pharmaceuticals, their legal representatives, directly responsible persons in charge and other directly responsible personnel, submitting false clinical trials or listing permission documents; fabricating production verification records and changing product batch numbers Submit a false batch to issue the application materials, or take other deceptive means to obtain the batch issuance certificate.
(16) It was decided to stop accepting the trademark agency business.
(17) If the trademark infringement is subject to 2 administrative penalties within 5 years; if the abnormal patent application is subject to 2 administrative notifications or other serious circumstances within 5 years.
(18) The operator has serious consequences due to unfair competition behavior or the implementation of monopolistic behavior, and the social influence is bad, and is subject to administrative punishment by the market supervision and management department.
(19) Due to direct administrative violations, 3 administrative penalties were imposed within 2 years, or the direct selling illegal acts were serious; organizations planned pyramid schemes; and provided facilitation for pyramid schemes, and received 3 administrative penalties within 2 years.
(20) Using the terms of the format or implementing fraud, coercion, malicious collusion, compulsory trading, etc., endangering national interests, public interests, infringing upon the legitimate rights and interests of consumers, causing serious consequences, adverse social impact, and being subject to administrative punishment by the market supervision and administration department of.
(21) Network transaction operators enhance their business reputation and product reputation for themselves and others by fictitious transactions, removing unfavorable evaluations, instructing others to publish untrue self-interested evaluations, etc., or by placing their own goods with other operators. Commodity is unrealistically contrasted, untrue and unfavorable evaluations of other operators, and other methods of fabricating and distributing false facts damage the commercial reputation and reputation of others, causing serious consequences and adverse social impacts, and are subject to administrative punishment by the market supervision and administration department.
(22) Operators of online trading platforms have lack of management systems and major defects, or abuse of service agreements, trading rules and technologies, or irrational reasons such as trade secrets and information security. The operator's qualification review obligation, the obligation to protect the consumer's safety and security, and the obligation to submit information to the market supervision and management department, or submit the information is not timely, incomplete, untrue, hinder the market supervision and management work, causing serious consequences The social impact is bad.
(23) After the operator has prepaid, the company will close down, close down, or relocate the service place. After being complained, the market supervision and management department will not be able to contact the operator within 60 days, seriously infringing on the legitimate rights and interests of consumers.
(24) The publication of false advertisements has serious consequences and has a bad social impact. It has been administratively punished by the market supervision and administration department.
(25) The cotton operator forged, altered or fraudulently used cotton quality certificates, marks, notarized inspection certificates and notarized inspection marks, causing serious consequences and adverse social impacts, and being subject to administrative punishment by the market supervision and administration department.
(26) If the food business operator is subjected to administrative punishment other than warning three times within one year, or violates food safety laws and regulations, it will cause serious damage to the personal health of the consumer, and the social impact is bad, and the market supervision and administration department shall impose administrative punishment.
(27) Five chain stores in the chain have been administratively punished by the market supervision and administration department within one year.
(28) The use of non-food raw materials, recycled foods or raw materials that exceed the shelf life to produce food, the addition of chemical substances other than food additives to foods and other substances that may endanger human health are subject to administrative punishment by the market supervision and administration department.
(29) The use of meat that has not been quarantined according to the regulations, or the quarantine is unqualified, or the production of food for poultry, livestock, beasts, aquatic animals and animals that are dying of death, poisonous death and unknown cause of death are subject to administrative punishment by the market supervision and administration department. .
(30) The competent personnel and related staff directly responsible for the school canteen cause major food safety accidents due to violation of food safety laws and regulations.
(31) High-risk foods such as infant formula milk powder, infant food supplements, special medical formula foods, etc., are subject to administrative punishment by the market supervision and administration department.
(32) Sales, leasing, delivery, use of special equipment that has been eliminated by the state or has not been licensed for production, and has not been inspected or failed to pass the inspection, causing serious consequences and adverse social impact, and being subject to administrative punishment by the market supervision and administration department.
(33) The measuring instruments manufactured, repaired and sold are unqualified, causing serious consequences and adverse social impacts, and are subject to administrative punishment by the market supervision and administration department.
(34) Inspection, testing and certification institutions and their employees shall conduct inspection, testing, certification, or alteration, reselling, leasing, lending licenses, or issue false inspection reports and certification conclusions without permission or beyond the scope of the license, causing serious Consequences, bad social impact, and administrative punishment by the market supervision and management department.
(35) Products that are included in the compulsory product certification catalogue are not certified, are manufactured, sold, imported or used in other business activities, or obtained compulsory product certification by fraud or bribery. Or complete self-declaration compliance information submission, causing serious consequences, social impact is bad, and is subject to administrative punishment by the market supervision and management department.
(36) Other violations of market supervision and management laws and regulations stipulated by the State Administration of Markets and the circumstances are serious.
Article 7 If the responsible department lists the main body in the list of serious violations of the law, it shall make a decision on inclusion. The relevant information shall be recorded under the name of the main body and shall be publicized through the national enterprise credit information publicity system. The inclusion decision shall include the name/name, the unified social credit code/ID card number, the date of inclusion, the reasons for inclusion, the time limit and means of entitlement relief, and the decision-making body.
Article 8 Where the main body has the situation in item (1) of Article 6 of these Measures, the market supervision and management at the provincial level or above and the intellectual property management department shall pass the national enterprise credit information when the main body is listed in the business anomaly list 3 years ago. The publicity system shall promptly perform its relevant obligations in the form of announcements; if the relevant obligations have not been fulfilled within 3 years, it shall be included in the list of serious violations of the law and untrustworthy within 10 working days from the date of expiration.
Where the main body has other circumstances in Article 6 of these Measures, the responsible department shall include it in the list of serious violations of the law and untrustworthy within 10 working days from the date of verification.
 
Chapter III Removal Procedure
Article 9: Subjects that have been listed in the list of serious violations of the law and fail to comply with the relevant obligations for the three years after the expiration of the list of business exceptions have been listed for 5 years from the date of inclusion, and no further circumstances have occurred in Article 6 You may apply in writing to the responsible department with jurisdiction from the date of expiration. The responsible department shall conduct verification and make a decision to remove within 5 working days from the date of verification.
If the subject of the serious violation of the law is not listed in the other circumstances of Article 6 and has not reoccurred the circumstances listed in the article for three years from the date of inclusion, it may, from the date of expiration, to the responsible department with jurisdiction. Written application for removal. The responsible department shall conduct verification and make a decision to remove within 5 working days from the date of verification.
Article 10 If the responsible department removes the main body from the list of serious violations of the law, it shall make a decision to remove it and publicize it through the national enterprise credit information publicity system. The decision to remove should include the name/name, the unified social credit code/identity number, the date of removal, the reason for the removal, and the decision-making body.
 
Chapter IV Objection, Revocation, Reconsideration, Proceedings
Article 11 If an entity disagrees with a list of serious violations of the law, it may, within 30 days from the date of publication, submit a written application to the responsible department that made the decision and submit relevant supporting materials. The responsible department shall decide within 5 working days. Acceptance. If it is accepted, it shall be verified within 20 working days, and the verification result shall be notified to the applicant in writing; if it is not accepted, the applicant shall be informed in writing of the reasons for the inadmissibility.
If the responsible department finds that there is an error in the list of serious violations of the law by means of verification, it shall correct it within 5 working days from the date of verification.
Article 12 If the circumstances on which the list of serious violations of the law is based are changed and do not meet the conditions for inclusion, the entity may apply to the responsible department with jurisdiction for removal. The responsible department shall make within 5 working days from the date of verification. The decision was revoked and the subject was removed from the list of serious violations.
Article 13 The main body may apply for administrative reconsideration or file an administrative lawsuit for the decision to be included in the list of serious violations of law and trust.
 
Chapter VI Credit Repair
Article 18 If the subject listed on the list of serious violations of law and faith is in the following circumstances, he may apply to remove the list of serious violations of the law:
(1) The subject who has been included in the list of serious violations of the law due to the circumstances of item (1) of Article 6 of these Measures has fulfilled the information disclosure obligation three years before the expiration of the list of business exceptions, but did not apply before the expiration of the list. If it is removed from the list of business exceptions, it may apply to the market supervision and management at the provincial level or above and the intellectual property management department to apply for removal.
(2) The subject who has been included in the list of serious violations of the law due to the circumstances of item (1) of Article 6 of these Measures shall, after being listed in the list of serious violations of the law, be willing to perform the obligation of publicity and be included in the term of one year, Apply to the market supervision and management at the provincial level and above, and apply for removal from the intellectual property management department.
(3) Those who have been included in the list of serious violations of law and trust due to other circumstances in Article 6 of these Measures can actively correct illegal activities and eliminate adverse social influences. After being listed for one year, you can apply to the responsible department for removal.
Article 19 The responsible department shall implement credit repair in accordance with the following procedures:
(1) Application. The untrustworthy entity may submit a credit repair application to the responsible department with jurisdiction, indicating the facts and reasons for applying for credit repair, and attaching relevant certification materials.
(2) Acceptance. After receiving the application for credit repair, the responsible department shall conduct preliminary examination of the application materials, accept the conditions in accordance with the conditions, and issue a notice of acceptance to the applicant; if the conditions are not accepted, the applicant shall be notified of the disapproval and explain reason.
(3) Administrative interviews. The responsible department shall organize the legal representative and responsible person of the untrustworthy entity applying for credit repair to participate in administrative interviews and make credit commitments.
(4) Inspection and verification. The responsible department shall check and verify the relevant situation of the applicant's credit repair.
(5) Objection handling. The responsible department shall decide whether to approve the repair within 5 working days after the inspection and verification. If it is proposed to be approved, the responsible department shall publicize the credit repair decision to the public through the national enterprise credit information publicity system, and the publicity period shall be 15 days.
If there is any objection during the publicity period, the objection shall be verified in time. If it is verified that the objection is not established or there is no objection after the expiration of the publicity period, it shall be subject to market supervision and management, drug supervision and management, and approval or decision of the intellectual property management department to make a decision on granting credit repair. If the objection is established, no credit will be repaired and the applicant will be notified.
(6) Data processing. The responsible department shall implement credit repair within 5 working days from the date of approval of the credit repair decision, and stop the public record of the loss of trust.
Article 20 The responsible department may, through written inspection, on-site inspection and network monitoring, review and verify the facts of the untrustworthy entity's initiative to correct serious violations of law and faith, fulfill relevant obligations and obligations, eliminate adverse effects, and relevant supporting materials.
Article 21 In any of the following circumstances, the responsible department that implements the credit repair shall cancel the decision to grant the repair and restore the subject to the state before the credit repair:
(1) Implementing a repair for a subject that does not meet the credit repair.
(2) The subject conceals the real situation and falsifies during the credit repair process.
(3) The credit repair decision affects the public interest of the society or the significant interests of others. Upon verification, the complaints of the interested parties are true.
Article 22 Unless otherwise stipulated by laws and regulations, credit repair shall not be made in any of the following circumstances:
(1) Serious damage to the national security, public safety, and people's lives, health and property.
(2) After the approved credit is repaired, the untrustworthy entity fails to fulfill its credit commitments and reoccupy serious violations of law and trust, and is included in the list of serious violations of the law.
(3) The subject of dishonesty has entered the liquidation and bankruptcy procedures (except for enterprises that have undergone bankruptcy and reorganization according to the judgment of the court).
Chapter VII Responsibility Investigation
Article 23 If the responsible department fails to perform its duties in accordance with the relevant provisions of these Measures, the responsible department at the higher level shall order it to make corrections; if the circumstances are serious, the responsible persons in charge and other directly responsible personnel shall be dealt with in accordance with relevant regulations.
Chapter VIII Supplementary Provisions
Article 24 The styles of the relevant documents for the management of serious illegal and untrustworthy lists shall be uniformly formulated by the State Administration of Market Supervision.
Article 25 The State Administration of Market Supervision shall be responsible for the interpretation of these Measures.
Article 26 These Measures shall come into force on the day of the month of 2019.