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

The Measures emphasize once again that pharmaceutical representatives are professionals, not sales personnel, who are engaged in drug information transmission, communication and feedback within the territory of the People's Republic of China on behalf of drug listing license holders.
Measures prohibit pharmaceutical representatives from taking on the task of drug sales, and suggest that pharmaceutical representatives shall not have the following circumstances: (1) carrying out academic promotion and other activities without filing; (2) carrying out academic promotion and other 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; (4) participating in the counting of the number of drug prescriptions issued by individual doctors; (5) providing donations and subsidies directly to departments and individuals within medical institutions; (6) misleading doctors about the use of drugs, exaggerating or misleading the efficacy, concealing information on known adverse reactions of drugs or concealing adverse reactions from doctors;
Attached: Measures for the Record Management of Pharmaceutical Representatives (Trial) Article 1 These Measures are formulated in accordance with the General Office of the Central Committee of the Communist Party of China issued the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices and the General Office of the State Council on Further Reforming and Perfecting the Policy on the Production and Circulation of Pharmaceuticals.
2 The term "pharmaceutical representative" as used in these Measures refers to professionals who, on behalf of the licensed holders of drug listings, engage in drug information transmission, communication and feedback 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 pharmaceutical products and hospital needs.
Article 3 Medical 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 communicate in other forms agreed by medical institutions.
Article 4 The drug listing license holder 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 verify the information of the pharmaceutical representative for the record, make public the information of the breach of trust and related illegality and violation of the law of the drug market license holder or the pharmaceutical representative, and issue the 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 and the unified social credit code; (2) the name, sex and photograph of the pharmaceutical representative; (3) the type and number of identity documents, the profession and education studied; (4) the starting and ending date of the labor contract or authorization; (5) the drug category and therapeutic field promoted by the pharmaceutical representative; (6) the statement of the drug listing license holder on the authenticity of the information for the record; 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 that the pharmaceutical representative is responsible for promoting; (5) the start and end date of the labor contract or power of authorization.
9 if there is a change in the filing information of a pharmaceutical 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 published on the website.
change the domestic agent by the licensed holder of the overseas drug market, 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 certificate 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.
Article 11 Medical 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, require the pharmaceutical representative to carry out such sales acts as collecting money and handling the purchase and sale bills; (4) require the pharmaceutical representative or other personnel to count the number of drug prescriptions issued by the individual doctor;
Article 13 Pharmaceutical representatives shall not have the following circumstances: (1) carrying out academic promotion and other activities without filing; (2) carrying out academic promotion and other 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; (4) participating in the counting of the number of drug prescriptions issued by individual doctors; (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 on known adverse reactions of drugs or concealing adverse reaction information from doctors;
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 14 Where 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 relevant laws and regulations such as the Drug Administration Law of the People's Republic of China and the Anti-Unfair Competition Law of the People's Republic of China.
Article 15 A medical institution may not allow a person who has not filed a record 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)