Drug distribution: Is this drug wholesale company punished?
Topic of reason
During the daily inspection, a drug regulatory bureau found that a pharmaceutical wholesale company A in the jurisdiction purchased seven kinds of drugs directly from five manufacturers, with a value of 10,000 yuan. Due to doubts about the problem with the purchase and sale list, the bureau issued a letter of investigation to the local pharmaceutical regulatory bureau. The reply was that the five manufacturers had not opened such a list. The case was then characterized as illegal purchase of medicines.
After further investigation, it was found that Company A claimed that when purchasing medicines, it did carefully review the production licenses, GMP certificates and other relevant materials, and also inquired about the drug information online, only to confirm that the drugs are not counterfeit drugs. The purchaser is assured, and the salesman is indeed the commissioned salesperson of the manufacturer. It turned out that the salesman privately engraved the official seal of several manufacturers, and then forged the purchase list, privately sold the drug to company A in the name of the manufacturer.
Therefore, Company A believes that it has fulfilled its auditing obligations when purchasing medicines. It is not aware of the fact that the salesperson has privately engraved the official seal. It is difficult to accept the authenticity of illegal drug purchases, and some staff inside the SFDA believe that Company A has no direct responsibility and recommends not penalizing Company A. (User yangyupi)
Arguments
Discretion or discretion
It should be punished, but the provisions of Article 27 of the Administrative Punishment Law may be applied, and discretionary or exempt from punishment. The focus should be on investigating the salesman’s unlicensed business practices and the crime of forging corporate seals.
Some people may think that according to the provisions of Article 5 of the Regulations on the Administration of Drug Circulation, the salesperson does not constitute a drug-free operation because the manufacturer is responsible for the sales of the drug by his salesperson in the name of the enterprise. If the logic is established, then why do wholesale companies constitute the purchase of drugs from illegal sources in administrative law? Therefore, the so-called "legal responsibility" in Article 5 of the Measures for the Administration of Drug Circulation Supervision refers to civil liability. (Netizen law and chess)
Company A has tax evasion and tax evasion
Does a company need to promo tax invoices for purchasing drugs? It is recommended that the drug supervision department and the local tax department look at it. Perhaps the company’s illegal activities of tax evasion and tax evasion are also unknown.
Can the company not use the fax or other means to communicate with the other party? In a modern society where communication tools are so developed, unless it can be fraudulent, A company will not be incompatible with each other. (User tongxiouf)
Not fully fulfilling the obligation to review
I feel that Company A has not fully reviewed the qualifications of the salesperson and several companies, and cannot completely rule out its responsibilities. (User Tan Yuchong)
From the point of view that the salesperson also sells drugs to five manufacturers at the same time, the company did not perform its duties when reviewing. Article 9 of the Measures for the Administration of Drug Circulation: "Pharmaceutical production enterprises can only sell drugs produced by the enterprise, and may not sell drugs that are entrusted by the enterprise or produced by others." (User jingling)
Review
Why not punish
The GSP requires a review of legality, not a completeness of the data or a formal review. The company apparently did not operate in accordance with the requirements of the GSP.
Looking closely at this case, it is inevitable to ask such questions as to whether these drugs are delivered to the door by the salesman; who is paying the goods for these drugs; whether the goods are shipped with the counterparts; is it possible for a salesperson to be 5 at the same time? The sales agent of the pharmaceutical company.
According to this series of questions, it is not difficult to see that A company has not fulfilled its obligation to review.
The Drug Administration Law requires companies to purchase drugs from legal sources. To put it bluntly, the result is not the process. If the company believes that its audit work cannot guarantee the legitimacy of the supply channel, it should purchase the drug itself instead of waiting for someone else to deliver it to the door. Therefore, it is not easy to assume that the company has reviewed the information from the appearance of the matter, and the key is whether the company's audited information and related work can ensure that the drug is purchased from legal sources.
Even if the drug inspection agency determines that the drugs are in compliance with the drug standards after inspection, it is not completely certain that these drugs are produced by legal channels. From the case, we can see that the company simply identified the information on the Internet. The authenticity of the drug. From this it may be concluded that the company has not verified the sales of the manufacturer and the authenticity of the drug.
What would be the result if the company was not punished?
With such a "amulet", the company can buy medicines directly from these so-called salesmen in the future, and for the authenticity of these drugs, the company can just check it online. In this case, counterfeit and inferior drugs will flood into the circulation field. Even if it is discovered, the company can be exempted from punishment for the reasons of “reviewing the information and verifying the truth on the Internetâ€. The company's responsibility is to waive, how can the safety of the people's medication be guaranteed? (解文耀)
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