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    Home > Medical News > Latest Medical News > The administrative measures for the record keeping of medical representatives were solicited for opinions for the second time, and there were significant changes in these contents

    The administrative measures for the record keeping of medical representatives were solicited for opinions for the second time, and there were significant changes in these contents

    • Last Update: 2020-06-19
    • Source: Internet
    • Author: User
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    < br / >< br / > < br / > < br / > < br / >< br / > < br / > < br / > < br / > < br / > < br / > the draft measures highlights the self-management requirements of drug marketing license holders, further implements the main responsibility of drug marketing license holders, and requires them to set the professional qualification and employment requirements of pharmaceutical representatives, so as to ensure that the employed and authorized medical representatives can meet the requirements of post ability and comply with the relevant regulations on employment< br / > < br / >The draft of the measures prohibits pharmaceutical representatives from undertaking drug sales tasks and proposes two prohibitive clauses related to the sales tasks of pharmaceutical representativesThat is, it is prohibited to "assign drug sales tasks to drug representatives and require them to collect and process purchase and sale bills" and "drug representatives shall undertake drug sales tasks and collect and process purchase and sale bills"Article 13 of < br / > < br / > < br / > < br / / > stipulates that the holders of drug marketing license shall not have the following circumstances: < br / > < br / > < br / > < br / > (I) encourage and imply the drug representatives to engage in illegal behaviors; < br / > < br / > < br / > < br / > (II) assign drug sales tasks to the drug representatives, Require medical representatives to collect and process purchase and sale bills; < br / > < br / > < br / > < br / > (3) require medical representatives or other personnel to count the number of prescriptions issued by individual doctors; < br / > < br / > < br / > < br / > (4) deliberately provide other false information in the filingArticle 14 of < br / > < br / > < br / > < br / / > stipulates that medical representatives shall not have the following situations: < br / > < br / > < br / > < br / > (1) carry out academic promotion and other activities without the consent of medical institutions; < br / > < br / > < br / > < br / > (2) undertake drug sales tasks, Collect and process purchase and sale bills; < br / > < br / > < br / > < br / > (3) participate in statistics of the number of drug prescriptions issued by individual doctors; < br / > < br / > < br / > < br / > (4) directly provide donation and sponsorship to internal departments and individuals of medical institutions; < br / > < br / > < br / > < br / > (5) mislead doctors to use drugs, exaggerate or mislead efficacy, and conceal known adverse reactions of drugs, Or conceal the adverse drug reaction information fed back by doctors< br / > < br / >, The contents of the work listed are as follows: first, to formulate plans and plans for the promotion of pharmaceutical products; second, to transmit information about pharmaceutical products to medical personnel; third, to assist medical personnel in the rational use of drugs; fourth, to collect and feed back the clinical use of drugs< br / > < br / >, It can also carry out academic promotion and other activities in five forms: face to face communication with medical personnel in medical institutions; holding academic conferences and lectures; providing academic materials; communicating through Internet or conference call; other forms agreed by medical institutionsIn the interview of < br / > < br / > < br / > < br / / /, the reporter of medical economic news also learned that there has been a debate in the industry on the qualification of medical representativesIt is suggested that, from the perspective of reality, in the less developed and remote areas, setting academic qualifications will lead to the insufficient number of medical representatives, unable to meet the needs of providing academic and product support for doctors< br / > < br / >, Ensure that the medical representative can meet the competency requirements of the post and meet the relevant regulations of the practice< br / > < br / >The holder of a drug listing license may entrust a social institution to carry out the training and be responsible for the authenticity of the training records< br / > < br / > < br / > < br / > further simplify the filing process < br / > < br / > < br / > < br / > in order to further implement the requirements of the CPC Central Committee and the State Council for deepening the reform of release and management services, the draft of measures further simplifies the content that drug listing license holders need to file and publicizeThe < br / > < br / > < br / > < br / > method draft indicates that the filing platform of pharmaceutical representatives can record, check and verify the information of pharmaceutical representatives, publicize the dishonesty and illegal information of pharmaceutical listing license holders or pharmaceutical representatives, publish notices, policies and regulations, and provide public queriesthe Registration Platform for pharmaceutical representatives is constructed and maintained by the China Pharmaceutical Association entrusted by the State Drug AdministrationRelevant person in charge pointed out: "in case of any change in the filing information of the medical representative, the holder of the drug listing license shall complete the change of the filing information within 30 working days, and simultaneously change the information publicized on the website." < br / > < br / >When the holder of the drug listing license is revoked, revoked or cancelled of the drug production license, he / she shall cancel the information of his / her registered medical representative within 30 working days after the administrative organ makes an administrative penalty or administrative decision< br / > < br / >Only with the consent of the medical institution can they carry out academic promotion and other activities with their medical staff" < br / > < br / >The opinions on filing qualification were adopted, and it was agreed that the filing management method only records the medical representatives, does not involve the examination of personnel qualification, and the statement of canceling the filing qualification was deletedAt the same time, the responsibility of rectifying and standardizing the violation of the prohibition shall be implemented to the drug listing license holder, who shall be required to strictly perform the management responsibility of the drug representative, so as to ensure that the medical representative hired and authorized by him continues to meet the employment requirements< br / > < br / >, Conduct investigation and handling in accordance with the drug administration law of the people's Republic of China, the Anti Unfair Competition Law of the people's Republic of China and other relevant laws and regulations" < br / > < br / > < br / > < br / > Article 142 of the law of the people's Republic of China on the administration of drugs < br / > stipulates that drug marketing license holders, drug production < br / > enterprises < br / > drug trading enterprises or medical institutions give, receive kickbacks or other improper interests in the purchase and sale of drugs, If the holder of the drug listing license, the drug manufacturing enterprise, the drug trading enterprise or the < br / > agent gives money, property or other improper benefits to the person in charge of the medical institution using the drug, the drug purchaser, the doctor, the pharmacist and other relevant personnel, the market supervision and management department shall confiscate the illegal income and impose a fine of not less than 300000 yuan but not more than 3 million yuan; if the circumstances are serious, The business license of the holder of the drug listing license, the drug manufacturing enterprise and the drug trading enterprise shall be revoked, and the drug approval certificate, the drug production license and the drug trading license shall be revoked by the drug regulatory departmentWhere the holder of the drug listing license, the drug manufacturing enterprise or the drug trading enterprise bribes the State functionaries in the process of drug development, production and trading, the legal representative, the principal person in charge, the person in charge directly in charge and other persons in charge shall be prohibited from engaging in drug production and trading activities for lifeArticle 142 of < br / > < br / > < br / > < br / / > stipulates that if the holder of the drug listing license, the person in charge of the drug manufacturing enterprise, the drug trading enterprise, the purchaser and other relevant personnel accept the property or other improper interests from the holder of the drug listing license, the drug manufacturing enterprise, the drug trading enterprise or the agent in the purchase and sale of drugs, the illegal income shall be confiscated, Punishment shall be given according to law; if the circumstances are serious, it shall be forbidden to engage in drug production and marketing activities within five yearsIf the person in charge of a medical institution, drug purchaser, doctor, pharmacist and other relevant personnel accept the property or other improper interests from the holder of the drug listing license, drug manufacturing enterprise, drug trading enterprise or agent, they shall be punished by the competent department of health or this unit, and their illegal income shall be confiscated; if the circumstances are serious, their practice certificate shall be revoked< br / > < br / >, The measures are formulated in accordance with the opinions of the general office of the CPC Central Committee and the general office of the State Council on deepening the reform of the review and approval system to encourage the innovation of drugs < br / > medical devices < br / > and the opinions of the general office of the State Council on further reform and improvement of the policies for the production, circulation and use of drugs (GBF [2017] No13)< br / > < br / > < br / > < br / > < br / > < br / > < br / > Article 3 < br / > medical representatives can carry out academic promotion and other activities in the following forms: < br / > < br / > < br / > (1) communicate with medical staff face to face in medical institutions; < br / > < br / > < br / > < br / > (2) hold academic conferences and lectures; < br / > < br / > < br / > < br / > (3) provide academic materials; < br / > < br / > < br / > < br / > (4) communicate through Internet or conference call< Br / > < br / > < br / > < br / > < br / > < br / > < br / > < br / > training subjects should include laws and regulations, professional ethics education, medical and pharmaceutical professional knowledge, product related knowledge, etc < br / > < br / >
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