Prescription drug network is released, and the new rules are implemented in December

In the three editions of the three editions of the "Drug Online Sales Supervision and Administration Measures (Draft for Opinions)" announced in 2017, 2018, and 2020, and the submission draft circulated on the Internet in 2021, after 5 years, the "Measures for the Supervision and Administration of Drug Network Sales Sales Supervision and Management "The boots are officially landed.

On September 1, the State Administration of Market Supervision and Administration issued the "Measures for the Supervision and Administration of Drug Network Sales" (Order 58th of the State Administration of Market Supervision and Administration). It will be implemented from December 1, 2022. A total of 6 chapters and 42 articles are implemented. The network sales management, platform responsibility performance, supervision and inspection measures and legal responsibilities have been provided.

Compared with the online delivery review circulating on the Internet last year, the content of the formal draft is simpler, the responsibilities are clear, and the interpretation is simple. The total terms have been streamlined from 52 to 42.

Among them, Chapter 4 Drug Supervision and Administration has the most deletion of supervision and management clauses, from 11 cuts to 6.

Overall, the core content of the official document that was officially introduced this time was basically the same as the submission of review, and followed the principle of "online and offline" of the online drug management supervision. Prescription authenticity and other provisions are stricter and specific.

For the first time, it is proposed to distinguish the display of prescription drugs from the online sales and over -the -counter drugs

The "network -saving prescription medicine" policy that the society is most concerned about, this document is in the form of laws and regulations, and once again affirmed the legitimacy of online sales prescription drugs. Through the form of orderly release, it officially responded to the social and industry -to -pharmaceutical e -commerce and pairs Wide demand for online sales prescription drugs.

This also marks that the country's network sales of prescription drugs are officially liberalized.

The prescription drugs and non -prescription drugs in the physical pharmacy need to be placed in separate cabinets, and the prescription medicine should be placed in the cabinet and does not open the shelf for sale. This is to ensure the safety and effectiveness of the people. The formal draft follows the same standards of online and offline, considers the safety risks of medication and online consistency management requirements, clearly implements real -name systems for prescription drug network sales, and conducts prescription review and deployment in accordance with regulations.

At the same time, before the sales of prescription drugs, consumers should fully inform consumers to fully inform the relevant risk warning information and confirm their knowledge by consumers, and effectively prevent the safety risk of medication.

Online sales prescription drug process will be more standardized for prescription drug information display and acquisition will be limited

Previously, "prescription drug information can be displayed," prescription drug information can display universal names, product names, dosage forms, specifications, holders and price information, etc. "But the formal draft deletes this expression.

The formal draft clearly states that pharmaceutical network retail companies shall not directly display information such as prescription drug packaging and labels on the homepage and homepage of pharmaceutical network retail companies. Before the prescription review, no information such as the manual shall be displayed, and the relevant services of the prescription medicine purchase shall not be provided. This is intended to emphasize the management requirements of "first medicine" and prescription review.

In this regard, it echoed the "Regulations on the Implementation of the Pharmaceutical Management Law of the People's Republic of China in May 2022" (revised draft solicitation draft), and the latter also stipulated that if pharmaceutical retail enterprises through online sales prescriptions should ensure that the source of prescription sources should be true It is reliable and after review. For those who have not passed the prescription, the packaging, labels, and manuals of the prescription medicine shall not directly display the prescription medicine.

Picture source Pexels.

Responsibility for compact pharmaceutical network sales platform

Clarify that third -party platforms should set up drug quality and safety management institutions, equipped with pharmacy and technical personnel, and establish and implement drug quality and safety, pharmaceutical information display, prescription review, prescription drug real -name purchase, drug distribution, transaction record preservation, adverse reaction report, complaint report processing, etc. Management system and record in accordance with regulations.

At the same time, the platform is required to sign an agreement with the drug network sales enterprise to clarify the responsibility of drug quality and safety between the two parties. It stipulates that the platform shall perform the obligations and reports of the stop service and report of the suspension of the audit, inspection and monitoring, and the discovery of serious violations. Emergency treatment and coordination obligations in supervision and inspection.

New penalties and higher fines are added.

Compared with the comments draft or submitting review, the amount of 1,000 yuan, 20,000, and 30,000 is low, and the amount of fines in the formal draft is 10,000, up to 200,000.

Among them, the new penalties include the provisions of violating the scope of network sales. Drugs that are specially managed through online sales countries are imposed on a fine of 50,000 yuan and more than 100,000 yuan. fine. In addition, the amount of fine is higher. For example, if a third -party platform undertakes the electronic prescription and does not verify and sign an agreement on the situation of the electronic prescription, it will be fined 50,000 yuan and more than 100,000 yuan; if it causes the consequences of harm, it will be 100,000 yuan and 200,000 yuan. The following fines.

The scope of the drug forbidden to sell the drugs is consistent with the opinion draft

Earlier, on the basis of the online ban on online banned drugs such as vaccines, blood products, and poisonous release, the newly added list of banned sale "protein assimilation preparations, termination of pregnancy drugs, compound preparations with special drugs, injections, infusion agents, infusion agents, infusion agents, infusion agents Wait for other drugs with high risk of medication to retail through the Internet. "

The formal draft deletes this expansion catalog, which is consistent with the opinion draft.

Except for 8 types of drugs such as vaccines, blood products, and essence medicines stipulated in the State Drug Administration Law cannot be sold through online sales, the "Administrative Measures" does not limit other types of drugs for online sale, including national shortage drugs.

This actually affirms the ability of the Internet platform in terms of regulating surplus and ensuring supply.

Implement the "four strictest" requirements to strengthen the supervision measures of supervision departments at all levels to clarify the duties of the drug supervision and management departments at all levels in the duties of the drug network sales supervision and the jurisdiction of the investigation and punishment of illegal acts. The discovered illegal acts were investigated and disposed of in accordance with the law.

To strengthen the control of drug safety risks, if there is a hidden safety hazard in the evidence, it is clear that the drug regulatory authorities can adopt advice, interviews, rectification within a time limit, and suspending production, sales, use, and imports. In addition, the "Measures" also clarified the corresponding legal liability for the illegal act of drug network sales. Generally speaking, the formal draft first increased the entry threshold.

The conditions and obligations of online sales prescription drugs have been greatly improved, and supervision is more comprehensive and detailed, such as the requirements of pharmaceutical traceability, electronic prescription verification requirements, data confidentiality requirements, and drug distribution requirements. Enterprises or physical pharmacies are difficult to participate in the game. Second, supervision is more strict. The core of strict supervision still depends on the penalty terms. The penalty of this formal draft is improved than before. Compared with the current offline supervision, it highlights the principle of consistent online and offline.

For head companies involving the drug retail market, whether it is an Internet company or a physical pharmacy enterprise, it is generally good; for companies with weak strength, it is generally easy. The hard work of policy makers is fully understandable. For example, a single store can make business nationwide through online sales prescription drugs. It is clear that everyone is unwilling to see.

The new rules are inseparable from the continuous exploration and promotion of the industry.

As early as 2017, the "Administrative Measures" began to solicit opinions, during which it witnessed the heyday of the Internet industry, and also experienced the valuable value of online medical services under the test of epidemic.

It can be said that without the exploration of a large number of enterprises, these operations are difficult to legalize through legal forms as soon as possible.

Today, in the face of the external doubts, the introduction of drug network sales regulations has given the industry a peace of mind.

In fact, through standardized operations, the model of drug network sales has gradually been accepted by the public, which can generate great social value.

For example, it has exerted important social protection value value in terms of helping the patient's normalization prevention and control, providing drugs and supplies of epidemic prevention.

The Measures for the Supervision and Administration of Drug Networks will be officially implemented on December 1, 2022. In the previous three months, major enterprises must complete the adjustment as required.

In the future, the irregular behavior of the Internet medical industry will be completely cured, and companies focusing on service quality will have the opportunity to further expand the market.

Source: General Market Supervision Administration, Yaowen Kangze

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