In order to strengthen the supervision and management of drug online sales, regulate drug online sales behavior, and ensure the safety of drug use by the public, the State Drug Administration recently announced the "Measures for the Supervision and Management of Drug Online Sales (Draft for Solicitation of Comments)" to solicit opinions from the society.
The draft for solicitation of comments clarified that the drug online seller should be the drug marketing authorization holder (hereinafter referred to as the holder) or a drug trading enterprise. A Chinese herbal medicine production enterprise that sells Chinese herbal medicines produced by it shall fulfill the relevant obligations of the holders stipulated in these Measures.
Pharmaceutical online sales shall not exceed the business method of the enterprise and the scope of drug business. If a drug network seller is the holder, he can only sell drugs with the approval number. Those who have not obtained the qualification for drug retailing shall not sell drugs to individuals. Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special administration by the state shall not be sold online. Pharmaceutical retail companies sell drugs through the Internet, and may not give prescription drugs and Class A non-prescription drugs to the public in the form of buying drugs as gifts, or buying commodities as gifts. Pharmaceutical retail companies that sell prescription drugs through the Internet shall ensure that the source of electronic prescriptions is true and reliable, conduct prescription adjustment reviews in accordance with relevant requirements, and electronically mark used prescriptions.
Pharmaceutical retail companies should implement the establishment of a drug network sales safety management system, realize the traceability and verification of the entire drug sales process, and establish and implement a distribution management system to ensure drug quality and safety. If selling drugs to individuals, an online pharmacy service system should also be established, with licensed pharmacists to guide the rational use of drugs; the number of licensed pharmacists should be commensurate with the scale of business, etc.
Allow drug network sellers to conduct drug network sales through self-built websites, network client applications, third-party platforms, or in other forms relying on relevant network service providers to build their own online stores. Enterprises that carry out online drug sales should have application software, network security measures and related databases that meet the requirements for business development.
Regarding the obligation of third-party online platforms to carry out drug sales, the draft for comments clearly stipulates that an inspection system should be established to inspect published drug information, supervise transactions, and proactively stop problems found, which involve major drug quality and safety issues. Report the problem to the drug supervision and administration department in a timely manner. The platform shall keep drug display information, transaction records, sales vouchers, evaluation and complaint and report information. The shelf life should be no less than 3 years, and no less than 1 year after the expiration date of the drug.
In addition, the draft for comments also clarifies the supervision and management measures and legal responsibilities of drug online sales.
Source: Chemical Network
