The home page of the website and the home page of the online store must not display prescription drug information. The subject of online drug sales must be a qualified pharmaceutical production and operating enterprise, and the purchase of prescription drugs must be “real-name”… From now on, the “Detailed Rules for the Implementation of Beijing Drug Online Sales Supervision and Management Measures” (hereinafter referred to as the “Details”) was officially implemented. A Beijing Youth Daily reporter learned from the Municipal Food and Drug Administration that the “Detailed Rules” are the country’s first regulatory document for the supervision and management of online drug sales issued by provincial and municipal drug regulatory authorities.
Drugs sold online must have marketing authorization
In recent years, the number of pharmaceutical e-commerce platforms and online pharmacies has continued to increase, new business formats have continued to emerge, and online sales of pharmaceuticals have become increasingly active. Especially during the epidemic, online sales of pharmaceuticals have experienced explosive growth, showing a trend of rapid development. In order to further standardize drug online sales services and strengthen the supervision and management of drug online sales, in accordance with the “Measures for the Supervision and Administration of Drug Online Sales” promulgated by the State Administration of Market and other relevant requirements, combined with the actual development of the capital’s Internet economy, the Beijing Municipal Food and Drug Administration has formulated the “Beijing “Detailed Implementation Rules of the Municipal Drug Online Sales Supervision and Administration Measures”, including a total of 5 chapters and 38 articles.
Online sales of drugs adhere to the principle of “integrated online and offline supervision”, that is, drugs sold online must obtain marketing approval from the drug regulatory department; the main body of online sales of drugs must be drug production and operating enterprises that have obtained corresponding qualifications. In accordance with the principles of consistent online and offline functions and unified business centralized management, establish a regulatory mechanism for unified online and offline deployment, unified supervision, and unified assessment, and promote the standardization, institutionalization, and legalization of drug online sales supervision.
Prescription drug packaging information may not be displayed
The “Details” focus on strengthening the concept of drug quality management, guiding enterprises to establish quality and safety awareness, and requiring enterprises to improve their own quality risk prevention and control capabilities by establishing effective quality management systems to ensure the quality and safety of online drugs. Among them, for pharmaceutical online sales companies, the “Details” stipulate that online quality management requirements and content must be added to the quality management responsibilities of offline entities; for self-built websites, the sales system should also be able to comply with the entire business process management and quality control Requirements: For third-party platforms for drug online transaction services, the “Details” list fourteen basic responsibilities of drug network quality and safety management agencies, and stipulate that the management agency can set up departments including quality control, data management, customer service, operation and maintenance, etc. , perform responsibilities such as drug quality supervision, qualification review of both parties to the transaction, pre-sales, during-sales and after-sales services, and drug network transaction data management to ensure the quality and safety of drugs.
Regarding the supervision of prescription drugs, the “Details” require that information such as prescription drug packaging and labels must not be displayed on the website homepages of drug online retail companies and third-party platforms engaged in the sale of prescription drugs, the homepages of medical and health industry sectors, and the homepages of platform merchant stores. Before the prescription is reviewed by a licensed pharmacist, the prescription drug sales page shall not display or provide drug instructions, and shall not contain information such as functional indications, indications, usage and dosage. In addition, drug online sales companies that sell prescription drugs to individuals through the Internet should sign an agreement with an electronic prescription provider to ensure that the source of the prescription is authentic and reliable. Drug online retail companies and third-party platforms engaged in the sale of prescription drugs should implement real-name management of drug purchaser information.
Drug sales in violation of regulations will face suspension of trading
During the inspection, the drug regulatory department finds that the relevant quality management systems established by drug online sales companies and third-party platforms do not meet the drug quality management requirements, the website or network client application does not meet the system functional requirements for ensuring drug safety, and the drug network If a sales enterprise fails to release drug information in accordance with the requirements of the “Measures for the Supervision and Administration of Drug Online Sales” and the “Detailed Rules” and there are safety hazards, or other situations where safety hazards exist, the drug regulatory department may order the suspension of online sales or the suspension of relevant network provision in accordance with its duties. Transaction Services.