Attached: trial method for registration administration of Shanghai medical representative (draft)
Chapter I general provisions
Article 1 (development of purpose)
To play a medical representative in the clinical medicine professional and technical guidance, implement enterprise's main body responsibility, promote medical work on behalf of the specification, the formation of the pharmaceutical industry good professional technical service order, according to the general office of the state council on further reform and improve the pharmaceutical production circulation use policy several opinions do hair [2017] no. 13 (countries) and other relevant provisions, in combination with the actual, formulate the measures.
Article 2 (definition and responsibilities of medical representatives)
The term "medical representative" in this method refers to the professionals who are engaged in drug delivery, communication and feedback on behalf of drug manufacturers.The general agents of import drugs and the professionals engaged in the relevant work of the listed licensee shall be governed by these measures.
A medical representative is responsible for formulating drug (focus on new drugs) academic promotion plan and scheme, drug related message to medical personnel, to assist medical staff rational drug use, collect, feedback and drug clinical use, adverse drug reactions information, etc.
The academic promotion activities of medical representatives in medical institutions shall be carried out in accordance with the relevant reception management regulations of the municipal health and family planning department.
Article 3 (medical representative administration requirements)
Pharmaceutical producing enterprises shall be responsible for the management of medical representative advertised, industry management in accordance with the rules and working requirements and academic, professional and work experience of medical representative condition such as cap, and pharmaceutical representatives signed the formal labor contract, giving a clear mandate, regularly every year to carry out integrity education and business training, medical representatives to ensure that medical representative from behavior comply with relevant regulations.
Chapter ii information registration
Article 5 (registration principle)
The registration of medical representative information shall ensure the authenticity of the registration information in the principle of honesty and trustworthiness.No one may forge, alter, lend or transfer medical representatives to register information.
Article 6 (registration principal)
All medical representatives who work in the medical institutions of this municipality shall be registered and recorded.The registration information of the pharmaceutical representatives in this municipality shall be examined and recorded by the pharmaceutical producing enterprises, and shall be responsible for the authenticity of the registered information.
Article 7 (registration particulars)
Medicine on behalf of the registered items, including a medical representative name, gender, id card number, education level, working years, contact phone number, and name of the pharmaceutical production enterprise, industrial and commercial residence, legal representative name, etc.
Article 8 (registration mode)
Medical representatives are registered on the Internet."Shanghai medical representative registration system" is the only platform for the registration of medical representatives;Once the online information is registered, it will take effect immediately and generate the registration certificate. The enterprise can print the registration voucher on its own.
Article 9 (registration change)
After the enterprise and the medical representative change the authorization to entrust matters or terminate the labor relationship, the company shall log on to the "Shanghai medical representative registration system" to register the change truthfully within 30 working days.
Article 10 (registration cancellation)
The pharmaceutical production enterprise shall be cancelled or revoked, and the medical representative information signed by the pharmaceutical representative shall be automatically invalidated upon the date of cancellation or cancellation of the enterprise.
Article 11 (information disclosure)
The medical representative registers information, except the id number and the contact number, the other can be made public through the website.
Article 12 (registration enquiry)
The medical representative of this city can inquire the medical representative and his company information through "registration system of Shanghai medical representative".
Chapter iii supervision and administration
Article 13 (corporate responsibility)
Pharmaceutical producing enterprises shall strictly implement enterprise's main body responsibility, strengthen the laws and regulations, professional ethics education and medical representatives, business standardization training for violation of laws and the serious breach of medical representative to give serious treatment, and the personal record pushed to "on behalf of Shanghai pharmaceutical registration system".
Article 14 (supervision of commercial bribery)
If a pharmaceutical representative or his company has a commercial bribery act or constitutes a crime, he shall be investigated for criminal responsibility according to law;Those who do not constitute a crime shall be handled according to law by the administrative department for industry and commerce.
A medical representative and its subordinate enterprises in violation of "Shanghai pharmaceutical sales record management regulations on commercial bribery in the field of relevant situation, by the health administrative departments of family planning and drug bidding procurement management department to dispose of according to regulation.
Article 15 (violation of regulations governing the reception of medical institutions)
Medical representatives and its subordinate enterprises exist in violation of the "Shanghai medical institutions reception pharmaceutical production enterprise management provisions about the situation, by the municipal public health family planning department is responsible for disposal in accordance with the rules.
Article 16 (medical representative information verification)
The food and drug administration of the city shall organize the inspection and verification of the authenticity of the registration information of the medical representatives according to the lead and the work of the complaint.Where there is a case of intentionally providing information on the registration of a false medical representative, or without violating the provisions of article 9 of this measure, the registration information shall be classified as a breach of trust.
Article 17 (disposal of adverse records)
Pharmaceutical representatives and its subordinate enterprises exist in the present measures circumstances stipulated in article 14, 15, 16, or the pharmaceutical production enterprise in violation of the laws, regulations and other relevant administrative regulations, by the municipal public health pharmaceutical bidding procurement management department, city family planning branch office written confirmation and other judicial administrative organs of this city has reported to the municipal food drug safety, shall be considered bad record.
For medical representatives with poor records, the registration number shall be cancelled;If there are 5 persons or more in a year, the information of all medical representatives of the enterprise shall be cancelled.
The food and drug administration departments shall timely notify the municipal health and family planning departments and health insurance departments and make public announcements according to the relevant provisions for the cancellation of registration Numbers for the adverse records.Normally, within 2 years from the date of cancellation, the registration will not be registered.
Article 18 (credit management)
The relevant administrative departments of this municipality shall timely push the bad credit records of pharmaceutical representatives and their enterprises to the "Shanghai public credit information service platform" and realize the sharing of credit information.
Article 19 (joint punishment)
This city family planning department, the drug bidding procurement management department of public health, food agency for record and its subordinate enterprises, medical representatives shall notify each other, will be disposal by according to their respective duties, and implementation of joint punishment.
Chapter iv supplementary provisions
Article 20 (social security)
Encourage relevant industry organizations to conduct regular or irregular training for medical representatives, and explore medical representatives' credit classification management system.
Article 21 (registration time limit)
The production enterprises that are stationed in this municipality for medical representatives shall complete the registration of medical representative information within 60 working days from the date of implementation of these measures.
Article 22 (date of implementation)
The measures shall be implemented after 30 days from the date of promulgation, and shall be interpreted by the Shanghai food and drug administration.
The state administration of food and drug administration shall, in accordance with its relevant provisions, propose new regulations for the registration and administration of pharmaceutical representatives.
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