In accordance with the "Drug Administration Law of the People's Republic of China", "Measures for the Supervision and Administration of Drug Online Sales", and "Measures for the Administration of Drug Inspection (Trial)", the State Food and Drug Administration organized and formulated the "Guidelines for the Inspection of Third-Party Platforms for Drug Online Trading (Trial)" (hereinafter referred to as the Inspection Guidelines) to strengthen the supervision of the online drug business process, ensure that there are no blind spots in supervision, and implement the digital supervision requirements and guidance of the "network management network".A third-party platform for online drug tradingStrengthen its own compliance management, implement the main responsibilities of the platform, maintain the order of fair competition in the market, and promote the high-quality development of drug circulation.
1.Qualification information publicity capability (platform & merchant).
1.1. Platform Qualification and Display.
If a third-party platform for drug online trading provides drug online retail platform services, it shall obtain the "Internet Drug Information Service Qualification Certificate" and the "Drug Online Trading Service Third-party Platform Filing Certificate" in accordance with the law, and there are no other **, applications, applets or other network carriers that have not been filed to carry out third-party platform activities. And in a prominent position on its homepage or the main page of business activities, continue to publicize information such as business licenses, relevant administrative licenses or filings, and complaint and reporting methods, or links to the above information. Where there is a change in the relevant information, the update and announcement shall be completed within 10 working days.
1.2 Merchant Qualifications and Display.
The platform should set up a section to display the merchant's qualification certificate. It is used to directly or indirectly (through link identification) to continuously publicize the business license of the settled business, the drug business license, and the registration certificate of the licensed pharmacist. Where there is a change in the relevant information, the update and publicity shall be completed within 10 working days, and the platform quality personnel shall be notified for review.
2.Quality compliance control capabilities (merchants & products).
2.1 Merchant Management Requirements (Three Phases).
2.1.1. Pre-occupancy review.
The third-party platform for online drug trading shall, in accordance with the law, verify and register the business license, personal identity, address, ** and other subject qualifications or information submitted by the operator who applies for entry to the platform for the first time, establish a registration file, and verify and update it at least once every six months. In general, the following should be verified:
1) Whether a natural person business operator who has not obtained a business license meets the requirements of the "E-Commerce Law of the People's Republic of China" for exemption from entity registration;
2) Whether the entity information on the business licenses and relevant permits and qualification certificates provided by the business operators on the platform is consistent, and whether there are circumstances such as forgery, alteration, fraudulent use, or expiration;
3) Whether the operators on the platform engage in business activities in accordance with the main business format, business scope, and approved business mode specified in the relevant license qualification certificates, such as the TOC platform, where the merchant's drug certificate business mode can only be retail, and the TOB platform, where the merchant's drug license business mode can only be wholesale. Drug marketing authorization holders, manufacturers, merchants whose drug licenses have not been renewed when their drug licenses expire, or whose drug licenses have been revoked do not meet the entry conditions;
4) The drug business license and quality and safety assurance ability of the drug operators on the platform shall be verified if the business mode is retail. If necessary, the business personnel can be requested to verify on site. Businesses engaged in drug retail activities dealing in prescription drugs and Class A non-prescription drugs shall be equipped with pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law and are suitable for the scope and variety of business; If there is a business premises, equipment, display, storage facilities and a sanitary environment suitable for the drugs it operates, and it engages in drug retail activities in supermarkets and other places, it shall have an independent business area; There is a quality management organization or personnel suitable for the drugs it handles; **The quality management system of drug quality, the information management system that meets the requirements of quality management and traceability, and the requirements of drug management quality management standards.
2.1.2. Compliance control between tenants.
Conduct dynamic monitoring of on-platform business operators, prompt on-platform business operators to promptly change information such as licenses and personal identities, and promptly remind on-platform business operators that no longer meet the requirements for exemption from market entity registration to handle market entity registration in accordance with law, and shall review the change information submitted by business operators on the platform within 7 working days, and complete the update and publicity. The agreement signed between the platform and the settled merchants, check whether the relevant clauses of drug quality and safety responsibility in the agreement clarify the subject of quality and safety responsibility, the performance of the quality and safety assurance mechanism, etc., and conduct regular assessments.
Regularly check whether the merchants settled in the platform have the behavior of operating drugs beyond the scope and in the way: 1Focus on whether the B2C platform has directly sold drugs to consumers by drug marketing authorization holders (including traditional Chinese medicine decoction piece manufacturers), wholesale enterprises, and chain headquarters who have not obtained a drug retail business license. Spot check whether the merchants settled on the platform have donated prescription drugs and Class A non-prescription drugs to individuals by buying drugs and giving away drugs, buying goods and giving away drugs, etc. When a merchant has serious violations, it shall promptly stop the services of the online trading platform, remove or close the store of the violating merchants, stop the display of drug-related information in a timely manner, and have records such as deletion and blocking of the illegal information. Whether the merchants who violate the appeal are punished in accordance with the rules of the platform, and whether the circumstances are serious to the regulatory department where the violating entity is located to report the process, channels and records of the platform's reporting of the illegal activities of the merchants to the local drug regulatory department.
2.1.3. Compliance cleanup after delisting.
After the merchant goes offline, the product goes offline in time. After-sales service should be properly handled (the after-sales service of the drug that has been sold within three months should be in place). Goods and services information, transaction information, and related records shall be kept for a period of not less than 5 years, and shall not be less than 1 year after the expiration of the validity period of the drug.
2.2 Drug administration requirements (answer three questions).
2.2.1 Can the merchant sell the drug?
The Measures for the Supervision and Administration of the Quality of Drug Operation and Use clearly states that drug trading enterprises shall not operate vaccines, preparations of medical institutions, traditional Chinese medicine formula granules and other drugs prohibited by the state. Pharmaceutical retail enterprises shall not sell first-class drugs, Class I psychotropic drugs, radioactive drugs, pharmaceutical precursor chemicals, anabolic preparations, peptide hormones (except insulin), pregnancy termination drugs and other drugs prohibited by the state from retail. According to the business scope on the merchant's drug certificate, it is judged that the merchant furniture does not have the business qualification of the product: for example, if a merchant wants to sell insulin online, it must approve whether the merchant has the qualification to operate refrigerated drugs, and whether the drug certificate clearly includes the scope of biological products (including refrigeration).
2.2.2 Can the drug be sold online?
It is necessary to determine whether the goods released by the merchant are drugs in the "Drug Online Sales Prohibition List" issued by the State Drug Administration, and if so, they cannot be sold online. If the drug registration certificate is revoked or cancelled in accordance with the law, the information of the relevant drug shall not be displayed.
2.2.3 How to display the drug online?
Third-party platform operators for online trading shall establish and improve drug release specifications, ensure compliance with the provisions of Article 9 of the Measures for the Administration of Internet Drug Information Services and Articles 16 and 19 of the Advertising Law, strengthen the pre-launch review of drugs in accordance with the law, and the advertised functional indications, indications, and dosage shall not exceed the approved content of the drug instructions. Urge businesses to release drug qualification information comprehensively, truthfully, accurately, and in a timely manner in accordance with the law, and the platform needs to provide necessary technical support for information disclosure.
Merchants distinguish prescription drugs from over-the-counter drugs according to the attributes of drugs, and prominently mark prescription drugs and over-the-counter drugs on relevant web pages. Under each prescription drug display page, risk warning information such as "prescription drugs must be purchased and used under the guidance of a pharmacist with a prescription" are highlighted. Platforms must not display information such as prescription drug packaging and labels on the homepage of the drug online sales platform, the homepage of the pharmaceutical and health industry sector, or the homepage of the stores of operators on the platform. Before reaching the sale of prescription drugs, consumers shall be fully informed of the relevant risk warning information, and consumers shall confirm their knowledge, so as to protect consumers' right to know about the services purchased, and the platform shall fulfill its obligation to inform the risks. Before passing the prescription review, the drug instructions shall not be displayed or provided, and the page shall not contain information such as functional indications, indications, usage and dosage, and shall not induce the purchase of drugs.
3.In-platform prescription drug sales (regulatory top priority).
3.1 Before prescription is issued.
The agreement between the platform and the e-prescription provider. (Review the qualifications of prescription providers: the qualifications of medical institutions and prescription issuers who have obtained corresponding qualifications on the national supervision platform: the doctor's scope of practice is consistent with the scope of diagnosis and treatment of the hospital, the practice period meets 3 years, and the record is filed in the hospital according to law, and the supervision platform can be checked, and the prescription format, color, and content contained in it comply with the relevant provisions of the health department).
3.2 Prescription review.
The prescription drug purchase process on the platform is in line with the prescription before the drug, and the prescription shall not be paid before it is reviewed, and the platform reviewer shall have the qualification of the prescription. Spot check the prescription retention records, check whether the prescription** is authentic and reliable, and whether there is a real-name system. There is a risk warning mechanism for multiple purchases of specific drugs by the same account or the same mobile phone number to prevent illegal elements from maliciously purchasing drugs. Establish relevant measures to avoid prescription reuse, and have inspection records of prescription reuse by merchants.
3.3 After prescription review.
Merchants can trace the prescription issuance according to the sales records of prescription drugs, check whether there is a situation of dispensing and selling prescription drugs without a prescription, compare the content of the prescription and the sales records, check whether the varieties and quantities of drugs are consistent, conduct inventory in a timely manner, and beware of wrong, missing and multiple issuances.
The content of this article represents personal views and is for reference only, due to the different regulatory policies in various places, please consult the local drug regulatory department and implement it according to its opinions.