Article 1 In order to regulate the sale of drugs on the Internet and the service activities of the drug network trading platform, to protect the safety of public medication, according to the "People's Republic of China *** and the State Drug Administration Law" (hereinafter referred to as the Drug Administration Law) and other laws and administrative regulations, the formulation of these measures.
Second, in the Chinese People's *** and the State engaged in the sale of drugs on the Internet, the provision of drug network trading platform services and its supervision and management, shall comply with these measures.
Article 3 The State Drug Administration is in charge of the supervision and management of the national drug network sales.
Provincial drug supervision and management departments are responsible for the supervision and management of the sale of pharmaceutical products network within the administrative region, is responsible for the supervision and management of the third-party platform for drug network trading, as well as drug listing license holders, pharmaceutical wholesale enterprises through the network sales of pharmaceutical activities.
The municipal and county-level departments responsible for drug supervision and management (hereinafter referred to as the drug supervision and management department) are responsible for the supervision and management of the sale of drugs on the Internet within the administrative area, and are responsible for the supervision and management of the activities of drug retailers selling drugs through the Internet.
Article 4 Engaged in the sale of drugs on the Internet, providing drug network trading platform services, shall comply with drug laws, regulations, rules, standards and norms, in accordance with the law and good faith, to protect the quality and safety of drugs.
Article 5 engaged in the sale of drugs on the Internet, providing pharmaceutical network trading platform services, shall take effective measures to ensure that the whole process of transaction information is true, accurate, complete and traceable, and comply with the relevant provisions of the national personal information protection.
Article 6 The drug supervision and management departments shall strengthen collaboration with relevant departments, give full play to the role of industry organizations and other institutions to promote the construction of credit system, and promote social **** governance.
Chapter II Management of network sales of drugs
Article 7 Engaged in the sale of drugs on the network, shall be the holder of a listed drug license or drug business enterprises with the ability to ensure the safety of drugs sold on the network.
Chinese medicinal herbs manufacturers to sell their production of Chinese medicinal herbs, shall fulfill the relevant obligations of the holder of the listed drug license.
Article VIII of the drug network sales enterprises shall operate in accordance with the approved mode of operation and business scope. Drug network sales enterprises for the drug listing license holder, can only sell their drugs to obtain a certificate of drug registration. Those that have not obtained the qualification of drug retailing shall not sell drugs to individuals.
Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs and other chemicals under special management of the State shall not be sold on the network, the specific directory formulated by the State Drug Administration organization.
Pharmaceutical network retailers shall not violate the provisions of the purchase of medicines to give drugs, buy goods to give drugs to individuals in the form of prescription drugs, Class A non-prescription drugs.
Article 9 The sale of prescription drugs to individuals through the network shall ensure that the source of the prescription is true and reliable, and the implementation of real-name system.
The drug network retail enterprises shall sign an agreement with the electronic prescription provider, and strictly in accordance with the relevant provisions of the prescription review and allocation, the electronic prescription has been used to mark, to avoid the repeated use of prescriptions.
The third-party platform to undertake e-prescription, should be verified on the situation of the e-prescription provider, and signed an agreement.
Pharmaceutical network retailers to receive prescriptions for paper prescription photocopy version, should take effective measures to avoid reuse of prescriptions.
Article 10 of the drug network sales enterprises shall establish and implement the quality and safety management of drugs, risk control, drug traceability, storage and distribution management, adverse reaction reports, complaints and reports handling system.
Pharmaceutical network retail enterprises shall also establish online pharmacy service system, by the pharmacist or other pharmacy technicians qualified according to law to carry out prescription review and allocation, guidance on the rational use of drugs and other work. Qualified pharmacists or other pharmacy technicians according to law should be appropriate to the scale of operation.
Article XI of the pharmaceutical network sales enterprises shall report to the drug supervision and management department of the enterprise name, website name, application name, IP address, domain name, drug production license or drug license and other information. Changes in information shall be reported within 10 working days.
Pharmaceutical network sales enterprises for drug marketing license holders or drug wholesalers, should be reported to the provincial drug supervision and management departments. Drug network sales enterprises for drug retailers, should be reported to the municipal and county-level drug supervision and management departments.
Article XII of the drug network sales enterprises should be in the website home page or the main page of the business activities of the prominent position, and continue to publicize its drug production or business license information. Pharmaceutical network retail enterprises shall also display the pharmacist or other pharmacy technician qualified in accordance with the law, and other information. Changes in the above information shall be updated within 10 working days.
Article XIII of the drug network sales enterprises to display drug-related information should be true, accurate and legal.
Enterprises engaged in the sale of prescription drugs in the pharmaceutical network retail enterprises, should be displayed prominently on each page of the display of drugs, "prescription drugs must be purchased and used under the guidance of a pharmacist with a prescription," and other risk warning information. Before the sale of prescription drugs, consumers should be fully informed of the relevant risk warning information, and by the consumer to confirm knowledge.
Pharmaceutical online retailers should distinguish between prescription drugs and non-prescription drugs on display, and in the relevant web pages prominently display prescription drugs, non-prescription drugs.
Pharmaceutical online retailers shall not directly and publicly display prescription drug packaging, labeling, and other information on the main page of the sale of prescription drugs and on the front page. Before passing the prescription audit, shall not display instructions and other information, shall not provide services related to the purchase of prescription drugs.
Article 14 of the drug network retail enterprises shall be responsible for the quality and safety of drug distribution. Distribution of drugs, should be based on the number of drugs, transport distance, transport time, temperature and humidity requirements, choose the appropriate means of transportation and facilities and equipment, distribution of drugs should be placed in an independent space and clearly marked to ensure compliance with the requirements of the whole process can be traced.
Pharmaceutical network retailers entrusted distribution, the quality management system of the commissioned enterprise should be audited, and signed a quality agreement with the commissioned enterprise, agreed to the responsibility for the quality of medicines, operating procedures, and other content, and supervision of the commissioned party.
The specific distribution requirements for the retail of pharmaceutical products network by the State Drug Administration to develop separately.
Article XV of the sale of drugs to individuals, should be issued in accordance with the provisions of the sales voucher. Sales vouchers can be issued in electronic form, the smallest sales unit of drugs sales records should be clearly retained to ensure traceability.
Pharmaceutical network sales enterprises should be completely preserved supplier qualification documents, electronic transactions and other records. Sales of prescription drugs, pharmaceutical network retail enterprises should also save prescriptions, online pharmacy services and other records. The relevant records are kept for a period of not less than five years, and not less than one year after the expiration of the validity of the drug.
Article XVI of the pharmaceutical network sales enterprises on the existence of quality problems or safety hazards of drugs, should be taken according to law, the corresponding risk control measures, and in a timely manner in the home page of the website or the main page of business activities to disclose the appropriate information.