The Measures for the Administration of the Recordation of Medical Representatives officially issued a ban on 7 acts

Medicine Network October 9th, September 30th, the State Health Insurance Administration issued a notice on the management measures for the record of pharmaceutical representatives (trial): "Management Measures" once again stressed that pharmaceutical representatives are on behalf of drug listing license holders in the People's Republic of China to engage in drug information transmission, communication, feedback professionals, not sales staff.
The Administrative Measures prohibit pharmaceutical representatives from taking on the task of drug sales, and propose that pharmaceutical representatives shall not carry out academic promotion activities without the record; (2) carry out academic promotion activities without the consent of medical institutions; (3) undertake the task of drug sales, carry out sales activities such as collection and disposal of bills, and (4) participate in Counting the number of drug prescriptions issued by individual doctors; (5) providing donations directly to departments and individuals in medical institutions; (6) misleading doctors about the use of drugs, exaggerating or misleading the efficacy, concealing information about known adverse reactions to drugs or concealing information on adverse reactions feedback from doctors; and (7) other interventions or acts affecting clinically reasonable drug use.
Attached: Measures for the Record Management of Pharmaceutical Representatives (Trial) Article 1 These Measures are formulated in accordance with the General Office of the General Office of the Central Committee of the Communist Party of China (CPC) on deepening the reform of the review and approval system to encourage innovation in pharmaceutical medical devices and the General Office of the State Council on further reforming and improving the policy on the production and circulation of pharmaceutical products.
2 The term "pharmaceutical representative" as used in these Measures refers to a professional who, on behalf of the licensed holder of a drug market, is engaged in the transmission, communication and feedback of drug information within the territory of the People's Republic of China.
The main tasks of the pharmaceutical representative are: (1) to formulate plans and programs for the promotion of pharmaceutical products; (2) to transmit relevant information on pharmaceutical products to medical personnel; (3) to assist medical personnel in the rational use of pharmaceutical products of the enterprise; and (4) to collect and feedback information on the clinical use of medicines and hospital needs.
article 3 Pharmaceutical representatives may carry out academic promotion and other activities in the following forms: (1) to communicate with medical personnel and pharmaceutical personnel in person in medical institutions; (2) to hold academic conferences and lectures; (3) to provide academic materials; (4) to communicate through the Internet or teleconsescing; and (5) to other forms agreed upon by medical institutions.
Article 4 The holder of a drug listing license shall be responsible for the record-keeping and management of the pharmaceutical representative, and if the drug listing license holder is an overseas enterprise, the designated domestic agent shall perform the corresponding duties.
Article 5 Drug market license holders shall sign labor contracts or authorizations with pharmaceutical representatives and file information on pharmaceutical representatives on the filing platform designated by the State Drug Administration.
drug listing license holders shall, in accordance with the provisions of these Measures, promptly maintain the record information of pharmaceutical representatives and enter, change, confirm or delete the information of their pharmaceutical representatives as required.
Article 6 The filing platform may check and check the information of the pharmaceutical representative for the record, publicize the breach of trust and related illegal and illegal information of the drug listing license holder or the pharmaceutical representative, and issue relevant work notice announcements, policies and regulations.
the State Drug Administration commissioned the construction and maintenance of the Chinese Pharmaceutical Society.
Article 7 Drug listing license holders shall submit the following filing information on the filing platform: (1) the name of the drug listing license holder, the unified social credit code; (2) the name, gender and photograph of the pharmaceutical representative; (3) the type and number of identity documents, the major studied, Education; (4) the start and end dates of labor contracts or authorizations; (5) the types of drugs and therapeutic fields that the pharmaceutical representative is responsible for promoting; (6) the statement of the drug listing license holder on the authenticity of his filing information; and after the filing information is submitted, the filing platform automatically generates the pharmaceutical representative's filing number.
Article 8 Drug Listing License Holders shall publish on the Company's website the information of the pharmaceutical representatives employed or authorized.
if the Company does not have a website, it shall be published on the website of the relevant trade association.
The drug market license holder shall make public the following information: (1) the pharmaceutical representative's record number; (2) the name of the drug listing license holder, the unified social credit code; (3) the name, gender and photo of the pharmaceutical representative; (4) the drug category and therapeutic field promoted by the pharmaceutical representative; and (5) the start and end date of the labor contract or power of authorization.
the information on the record of a pharmaceutical representative is changed, the holder of the drug listing license shall complete the change of the filing information within 30 working days and simultaneously change the information published on the website.
the license holder of an overseas drug market changes the domestic agent, the newly designated domestic agent shall reconfirm the information of the pharmaceutical representative filed in his name.
pharmaceutical representatives who no longer engage in relevant work or cease to be authorized, the drug market license holder shall delete their filing information within 30 working days.
article 10 If the drug listing license holder is revoked, revoked or cancelled the drug approval document or the Drug Production License, the drug listing license holder shall delete the information of the pharmaceutical representative for his record within 30 working days after the administrative organ has made an administrative penalty or administrative decision.
11 Pharmaceutical representatives shall abide by the relevant provisions of the health department and obtain the consent of medical institutions in carrying out academic promotion and other activities in medical institutions.
Article 12 Drug listing license holders shall not have the following circumstances: (1) fail to file the information of the pharmaceutical representative in accordance with the provisions, not change or delete the record information in a timely manner; (2) encourage or imply that the pharmaceutical representative is engaged in illegal and illegal acts; (3) assign the drug sales task to the pharmaceutical representative, request the pharmaceutical representative to carry out such sales acts as collecting money and handling the purchase and sale bills; (4) request the pharmaceutical representative or other personnel to count the number of prescriptions for medicines issued by individual doctors; and (5) provide false information in the record.
Article 13 Pharmaceutical representatives shall not have the following circumstances: (1) carrying out academic promotion and other activities without the record; (2) carrying out academic promotion activities without the consent of medical institutions; (3) taking on the task of drug sales, carrying out sales activities such as collecting funds and handling purchase and sale bills; and (4) participating in the issuance of individual statistical doctors the number of prescriptions for drugs; (5) providing donations, grants and sponsorships directly to departments and individuals in medical institutions; (6) misleading doctors about the use of drugs, exaggerating or misleading the efficacy, concealing information about known adverse reactions to drugs or concealing information on adverse reactions to doctor feedback; and (7) other interventions or acts affecting clinically reasonable drug use.
drug market license holders shall strictly perform their administrative responsibilities to the pharmaceutical representatives employed or authorized, and it is strictly prohibited for pharmaceutical representatives to exist in such cases.
For pharmaceutical representatives who have the above-mentioned situations, the drug market license holder shall promptly correct them, and if the circumstances are serious, they shall suspend the authorization to carry out academic promotion and other activities, and train them in posts, and reconfirm the authorization after passing the examination. article
If a drug market license holder or a pharmaceutical representative gives property or other improper benefits to the persons concerned who use his medicine, he shall be investigated and dealt with 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.
Article 15 A medical institution may not allow an unfile person to carry out academic promotion and other related activities against medical personnel or pharmaceutical personnel of the medical institution;
article 16 Social institutions such as trade (learning) associations shall actively play the role of industry supervision and self-discipline, and encourage social institutions such as trade (learning) associations to formulate industry norms and codes of conduct in accordance with these Measures, and establish supervision mechanisms, credit rating management mechanisms and joint reward and punishment measures.
Article 17 These Measures shall come into effect on December 1, 2020.
: Medical Representative Filing Information Form (Style)