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Medicine Network November 30, in order to strengthen the supervision and management of drug network sales, regulate drug network sales behavior, to ensure the safety of public drug use, the State Drug Administration recently announced the "Drug Network Sales Supervision and Management Measures (Draft for Comments)", for the community to solicit opinions.
draft for comments clearly states that the drug network seller shall be the licensed holder of the drug market (hereinafter referred to as the holder) or the pharmaceutical business enterprise.
chinese medicine beverage tablets produced by the chinese medicine beverage tablets production enterprises shall fulfill the relevant obligations of the holders stipulated in these Measures.
drug network sales shall not exceed the mode of operation of enterprises and the scope of drug business.
who is the holder of a drug network seller, may only sell the drug whose approval number is held.
not obtain the retail qualification of drugs, the drug shall not be sold to individuals.
specially administered drugs, such as vaccines, blood products, narcotic drugs, psychotic drugs, toxic drugs for medical use, radioactive drugs and pharmaceutical-type easily-to-toxic chemicals, shall not be sold through the Internet.
drug retail enterprises that sell drugs through the Internet shall not give prescription drugs and Class A over-the-counter drugs to the public by buying medicines or goods to give medicines.
drug retail enterprises sell prescription drugs over the Internet, they shall ensure that the source of electronic prescriptions is true and reliable, and conduct prescription adjustment examination in accordance with the relevant requirements, and electronically mark the prescriptions used.
drug retail enterprises shall implement the establishment of a drug network sales safety management system, the realization of drug sales process traceability, verifiability, the establishment and implementation of drug quality and safety assurance distribution management system.
if drugs are sold to individuals, an online pharmacy service system shall also be established, equipped with practicing pharmacists to guide rational drug use, and the number of practicing pharmacists shall be appropriate to the scale of operation.
allows drug network sellers to conduct drug network sales through self-built websites, web client applications, third-party platforms or other forms of relying on relevant network service providers to set up their own online stores.
that do not carry out drug network sales should have application software, network security measures and related databases to meet the requirements of business development.
For the obligation of a third-party network platform for drug sales, the draft for comments clearly stipulates that an inspection system shall be established, the published drug information shall be inspected, the trading behavior shall be supervised, the problems found shall be actively stopped, and major issues concerning the quality and safety of drugs shall be reported to the drug supervision and administration department in a timely manner.
shall keep drug display information, transaction records, sales vouchers, evaluation and complaint reporting information.
shall last not less than 3 years and not less than 1 year after the expiration date of the drug.
, the draft also clarifies the supervision and management measures and legal liability of drug network sales.
(Reporter Shen Shao Tie)