The left side of the drug packaging clearly states that the incomplete anti-counterfeiting marks and product serial numbers on the drug packaging are fake drugs. Law enforcement officers seized the unsold drugs on the spot. After investigation, it was found that the drugs in Pharmacy A were purchased from the manufacturer's salesperson, who "smuggled them" from Pharmacy B in other provinces. When the manufacturer sells drugs, each province has a fixed product serial number. In order to achieve the purpose of selling in this province, the salesperson took out the product serial number and telephone anti-counterfeiting mark on the outer packaging of the drug, and then sold the drug to A Pharmacy, and issued a sales invoice for Pharmacy B. Law enforcement officials are divided on how to deal with the behavior of Pharmacy A in selling "cut-out" drugs: Some people believe that Pharmacy A should be punished as selling counterfeit drugs because the manufacturer has clearly indicated that the product serial number and anti-counterfeiting label are missing or incomplete. Counterfeit drugs; some people think that they should be punished as substandard drugs, which violates the provisions of Article 49, paragraph 3, item (6) of the Drug Administration Law; some people think that they should be punished as drugs purchased from illegal channels, because The invoice was issued by Pharmacy B, which is not qualified to wholesale medicines. Analysis: There are three illegal acts in this case, and different illegal entities should be punished separately. Irregular packaging First of all, it should be clear that the drugs that were “cut out” in this case should not be considered fake or inferior drugs. According to my country's current drug management laws and regulations, if a drug is illegally packaged and regarded as a counterfeit or inferior drug, there are only two situations: first, if the indicated indications or functions are beyond the prescribed scope, it will be treated as a counterfeit drug; if the indication is not If the validity period is changed or the validity period is changed, or if the production batch number is not indicated or the production batch number is changed, it will be treated as an inferior drug. In other words, the regulation adjusts the three contents of drug packaging: indications (functions and indications), validity period and production batch number. It does not stipulate that non-standard product serial numbers and telephone anti-counterfeiting inquiry marks on the outer packaging of drugs should be labeled as fake or inferior drugs. Medicine discussion. Therefore, the drug regulatory department should follow the principle of "legal penalties" and strictly characterize and handle cases in accordance with legal provisions, instead of simply identifying them as fake or inferior drugs based on the prompt text on the left side of the drug packaging. At the same time, it should also be noted that the packaging of this batch of "cut out" drugs was not standardized and did not comply with relevant regulations. Article 6 of the "Regulations on the Administration of Drug Instructions and Labels" stipulates: "The text in drug instructions and labels should be clear and easy to read, and the labels should be clear and eye-catching. There should be no signs of falling off or weak pasting, and they should not be pasted, cut, or altered. "In this case, the product serial number and telephone anti-counterfeiting inquiry mark of this batch of drugs were artificially scratched off, which should be considered as unclear labeling and drug packaging that did not meet the standards. In accordance with Article 86 of the "Drug Administration Law", the drug regulatory department with jurisdiction will impose a penalty of "ordering corrections and giving warnings" to the manufacturer of this batch of drugs, and instruct the manufacturer to properly handle this batch of drugs with irregular packaging. As for the salesperson's "picking" behavior, it is an internal management issue of the manufacturer. The drug regulatory department should not interfere too much and should be handled by the manufacturer. Pharmacies are not allowed to change their business methods without authorization. my country implements a legal licensing system for pharmaceutical operations. The "Drug Administration Law" and related laws and regulations divide pharmaceutical operating enterprises into wholesale enterprises and retail enterprises according to different operating methods, and stipulate respectively wholesale enterprises and retail enterprises. The approval authority, subjects, procedures and review requirements for enterprises to apply for licenses are also clarified. At the same time, the license sales objects of the two are also clarified. Although pharmaceutical wholesale and retail enterprises both receive "Pharmaceutical Business Licenses", their operating capabilities and operating methods are different. Therefore, Article 17 of the "Measures for the Supervision and Administration of Drug Circulation" stipulates: Drug operating companies shall not change their business methods without the approval of the drug regulatory department. Pharmaceutical trading enterprises shall operate pharmaceuticals in accordance with the business scope permitted by the "Drug Trading License". Article 32 stipulates: If a pharmaceutical trading enterprise violates the provisions of Article 17 of these Measures, in accordance with the provisions of Article 73 of the "Drug Administration Law", the illegally sold drugs and illegal income will be confiscated, and a fine of not less than twice the value of the illegally sold drugs and five times the fine.
In this case, Pharmacy B, as a retail enterprise, sold drugs to Pharmacy A without approval, issued sales invoices, and engaged in drug wholesale business without authorization. It has violated the above regulations and should be dealt with by the drug regulatory department according to the illegal act of operating drugs without a license. . Pharmacy A constitutes the purchase of drugs from illegal channels. Pharmacy A constitutes the illegal act of purchasing drugs from illegal channels. Article 34 of the "Drug Administration Law" stipulates: Drug manufacturing enterprises, drug operating enterprises, and medical institutions must purchase drugs from enterprises with drug production and operation qualifications.