China-Singapore Jingwei, July 7th. According to the website of the State Food and Drug Administration, since the beginning of this year, the State Food and Drug Administration has organized and carried out special drug safety rectification actions across the country with the main line of strictly investigating illegal activities and strictly controlling risks.The local drug regulatory authorities continued to strengthen supervision and law enforcement, severely cracked down on illegal acts that endangered drug safety, and investigated and dealt with a number of violations of laws and regulations.
The second batch of typical cases of drug safety special rectification are announced as follows:
1. The case of Xiamen Kailelin Trading Co., Ltd. selling drugs without a license on the Internet without obtaining drug approval documents
[Introduction to the case] In September 2020, the Xiamen Municipal Market Supervision and Administration Bureau of Fujian Province conducted a cause-based inspection of Xiamen Kailelin Trading Co., Ltd. based on the clues reported by the masses and found that the company did not obtain the "Drug Business License" and passed Taobao. The platform-registered online store "Kailelin" sold "Yituosan Injection" brought in from abroad without obtaining a drug approval certificate. The value of the drugs involved was 34,100 yuan.The above-mentioned behavior of the company violated the provisions of Article 51, paragraph 1, and Article 98, paragraph 4 of the Drug Administration Law.In February 2022, the Xiamen Municipal Market Supervision and Administration Bureau, in accordance with Article 124, Paragraph 1, Item 1 of the Drug Administration Law, Article 12 of the Regulations of Xiamen Municipality on Standardizing the Discretionary Power of Administrative Punishment and the Xiamen Municipal According to Article 14, paragraph 1, of the Rules for the Application of Administrative Penalty Discretionary Power of the Market Supervision Administration, the company shall be subject to administrative penalties of confiscation of illegally operating drugs, confiscation of illegal gains of RMB 29,450, and a fine of RMB 1.5 million.
[Typical significance] In recent years, some criminals have taken advantage of online stores, circles of friends, and express delivery services to purchase drugs from overseas and illegally sell drugs for profit, involving a wide range of regions and more concealed illegal means.In this case, the party brought unapproved drugs into the country from abroad, and the safety and effectiveness of the drugs could not be guaranteed.This case is a typical case of investigating and dealing with overseas purchasing and selling of medicines, and has a positive demonstration role in effectively curbing similar illegal acts.
2. The case of Jiajiang Jinyi Medical Beauty Clinic Management Co., Ltd. Orange Medical Beauty Clinic Branch suspected of using unregistered drugs, medical devices and expired cosmetics
[Introduction to the case] In February 2022, the Jiajiang County Market Supervision and Administration Bureau of Leshan City, Sichuan Province found in its daily inspection that the orange medical and beauty clinic branch of Jiajiang County Jinyi Medical Beauty Clinic Management Co., Ltd. used the logo as NABOTA injection A Botulinum toxin and other drugs that have not obtained drug approval documents, unregistered medical devices such as NCTF hyaluronic acid, and expired cosmetics Baisuyanheng Skin Refining and Acne Clearing Cream, the value of the products involved is 3,130 yuan.The above behavior of the company violated the first paragraph of Article 24 of the Drug Administration Law, Article 55 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), and Article 39 of the Regulations on the Supervision and Administration of Cosmetics Article regulations.In March 2022, Jiajiang County Market Supervision and Administration Bureau, in accordance with the second paragraph of Article 124 of the Drug Administration Law, and the third article of Article 86 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council) Item 5, Article 60 Item 5 of the Regulations on Supervision and Administration of Cosmetics and Article 32 Item 5 of the Administrative Penalty Law, the company shall be confiscated of unregistered drugs, medical devices and expired cosmetics, and a fine An administrative penalty of 500,000 yuan.
[Typical meaning] The medical beauty industry has high profits and large market demand.In this case, some illegal operators took advantage of the public's love for beauty, lack of relevant professional knowledge and lack of awareness of prevention, and used drugs without drug approval documents, unregistered medical devices and expired cosmetics, violating relevant laws. regulations, which pose potential risks to public health.The investigation and handling of such cases fully reflects the determination of the regulatory authorities to focus on cracking down on, resolutely punish, and never tolerate violations of laws and regulations in the industry according to their duties, and effectively safeguard the legitimate rights and interests of consumers.
3. The case of dealing in drugs without obtaining a drug business license by Guoyun Medicinal Materials Management Department, Jingyang District, Deyang City
[Introduction to the case] In November 2021, the Market Supervision and Administration Bureau of Jingyang District, Deyang City, Sichuan Province supervised and inspected the Guoyun Medicinal Materials Business Department of Jingyang District, Deyang City, and found that the business department did not obtain the "Drug Business License" to sell tortoise shell glue , deer antler glue and other drugs, and can not provide the above-mentioned drug sources, purchase certificates and product qualification certificates, the value of the drugs involved in the case is 9769.29 yuan.The above-mentioned behavior of the operation department violated the provisions of Article 51, Paragraph 1 of the Drug Administration Law.In March 2022, the Market Supervision and Administration Bureau of Jingyang District, Deyang City imposed an administrative penalty of confiscation of illegally operating drugs and a fine of 1.5 million yuan to the operation department in accordance with Article 115 of the Drug Administration Law.
[Typical significance] In recent years, some unscrupulous operators have illegally sold Chinese herbal decoction pieces and proprietary Chinese medicines that should be licensed for drug distribution.In this case, the parties did not obtain a drug business license to sell Chinese herbal decoction pieces and proprietary Chinese medicines, which seriously hindered the order of drug administration.Due to the inability to trace the source, the product quality cannot be guaranteed, which brings hidden dangers to the safety of medicines for the masses.The regulatory authorities have provided a model for cracking down on such illegal acts by accurately characterizing the products involved, scientifically and reasonably determining the value of the goods and punishing them in accordance with the law, which is conducive to further regulating the traditional Chinese medicine market and promoting the healthy development of the industry.
4. The case of Shenzhen Dream Circle Technology Co., Ltd.'s production and operation of the second-class medical device "deafness and tinnitus light wave instrument" that has not obtained the medical device registration certificate
[Introduction to the case] In November 2021, the Guangdong Provincial Food and Drug Administration received a clue that Shenzhen Dream Circle Technology Co., Ltd. was suspected of illegally producing and selling "deafness and tinnitus light wave instrument" online, and immediately organized the Shenzhen Municipal Market Supervision and Administration Bureau to carry out an investigation.After investigation, from March to June 2020, the parties purchased the main board, shell, and packaging from the online platform, and produced and operated 46 second-class medical devices "deafness and tinnitus light wave instrument" without a medical device registration certificate without permission. And through the network platform for sales, the value of the amount of 3887 yuan.The behavior of the parties involved in the production and operation of Class II medical devices that have not obtained a medical device registration certificate violates the first paragraph of Article 11 and the first paragraph of Article 22 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council). provisions.On February 23, 2022, the Shenzhen Municipal Market Supervision and Administration Bureau ordered the parties to correct their illegal acts in accordance with the provisions of Article 63, Paragraph 1, Item 1 and Item 2 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council). , 3,887 yuan of illegal income was confiscated and a fine of 50,000 yuan was imposed.
[Typical significance] The products involved in this case are medical devices commonly used by the elderly.With the accelerated development of the aging population, the market demand for such products is large.Taking advantage of the characteristics of the elderly who pay attention to health, eagerness to seek medical treatment, and weak awareness of self-prevention, the company purchases parts and assembles them by themselves and sells them through online platforms without obtaining a medical device production license. The products have great safety risks. hidden danger.The investigation and punishment of such cases of unlicensed production and online sales of medical devices has purified the online sales environment of medical devices and ensured the safety of the people, especially the elderly.The case also reminds consumers to obtain relevant tickets when purchasing medical device products to protect their legitimate rights and interests.
5. The case of Henan Huanan Medical Device Trading Co., Ltd. engaging in business activities of Class III medical devices without permission and setting up a warehouse for Class II medical devices without authorization
[Introduction to the case] On January 5, 2021, the Market Supervision and Administration Bureau of Jingyang District, Deyang City, Sichuan Province seized a large number of second-class, third-class class of medical devices.After investigation, the value of the second-class medical devices such as disposable suction connecting tubes involved in the case was 608,022.3 yuan.The parties also engaged in the business activities of Class III medical devices such as disposable heparin caps and disposable anesthesia puncture bags without permission, with a value of 60,196 yuan and illegal gains of 60,196 yuan.
The party's unauthorized establishment of warehouses violated the provisions of Article 17, paragraph 2, and Article 23 of the "Measures for the Supervision and Administration of Medical Device Operation" (former order No. 8 of the State Food and Drug Administration). Supervision and Administration Measures (former CFDA Order No. 8), Article 54, Item 2, imposes a fine of 25,000 yuan.The behavior of the parties involved in the business activities of Class III medical devices without permission violates the provisions of paragraph 1 of Article 31 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 680 of the State Council). According to the Regulations on the Supervision and Administration of Medical Devices ( The State Council Order No. 680) stipulates that 60,196 yuan of illegal gains will be confiscated and a fine of 601,960 yuan 10 times the value of the goods will be imposed.To sum up, on April 2, 2022, Jingyang District Market Supervision and Administration Bureau ordered the parties to correct their illegal acts, and imposed administrative penalties of confiscation of illegal gains of 60,196 yuan and a fine of 626,960 yuan.
[Typical significance] In order to ensure the safety and effectiveness of medical devices, and to protect human health and life safety, the state implements licensing management for the operation of Class III medical devices.The illegal act of setting up warehouses across provinces and different places without authorization, especially in residential quarters, is extremely concealed. The same salesperson acts as an agent for the sales business of multiple medical device business enterprises, and it is more difficult to investigate their unlicensed business practices.This case is a major medical device illegal operation case that law enforcement officers inquired about the logistics of a hospital's medical device quality sampling and found that the procurement and delivery time were abnormal, and then analyzed, visited and investigated.By analyzing and sorting out a large number of bills and transaction clues, the illegal acts of the parties were verified.The investigation and punishment of this case has effectively cracked down and deterred the illegal and illegal behaviors of medical device business in the administrative regions of different provinces and cities, and made it difficult to escape the illegal and illegal behaviors that evade supervision between different provinces and cities. The strictest" requirements, the firm determination to crack down on illegal business practices in the field of medical devices and ensure the safety of the people's use of medical devices.
6. The case of Meng Mouqin engaging in the production of Class II medical devices without permission
[Introduction to the case] On December 28, 2021, the Xinji City Market Supervision and Administration Bureau of Hebei Province inspected Meng Mouqin's house at No. 4 Chiluli, Shulu Street, Xinji City, and found that the party was suspected of engaging in dentures without permission. Production Activities.After investigation, the value of the goods involved was 540 yuan, and the illegal income was 540 yuan.The behavior of the parties involved in the production of Class II medical devices without permission violated the first paragraph of Article 32 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council).On January 25, 2022, the Xinji Market Supervision and Administration Bureau ordered the parties to correct their illegal acts and imposed confiscation in accordance with the provisions of Article 81, Paragraph 1, Item 2 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council). Administrative penalties of 540 yuan for illegal gains and a fine of 100,000 yuan.
[Typical significance] According to the first paragraph of Article 32 of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council), those engaged in the production of Class II and Class III medical devices shall report to the province, autonomous region, or municipality directly under the Central Government where they are located. The drug regulatory department of the people's government applies for a production license and submits the relevant materials that meet the conditions stipulated in these regulations and the registration certificate of the medical device produced.With the increasing demand for dentures by consumers, the denture market is booming.Aiming at this business opportunity, some illegal businesses use simple production platforms and simple production processes to carry out concealed production without obtaining the "Medical Device Production License", evading supervision, and burying great hidden dangers to the health of users.The regulatory authorities quickly investigate and deal with such cases, and warn businesses that they should implement their main responsibilities and carry out production and business activities in accordance with laws and regulations.This case also reminds consumers to keep their eyes open when purchasing dentures and choose medical institutions with relevant qualifications.
7. "2.23" case of Yuan Mou and others producing and selling cosmetics with illegally added prohibited raw materials
[Introduction to the case] At the end of 2020, the Market Supervision and Administration Bureau of Xinyi City, Jiangsu Province received reports from the masses that the cosmetics such as "Old Traditional Chinese Medicine Freckle Cream" sold by the "Meishuer Cosmetics" online store may have quality and safety problems.The Xinyi City Market Supervision and Administration Bureau of Jiangsu Province immediately organized an investigation and found that the above-mentioned cosmetics contained hormones such as dexamethasone and triamcinolone acetonide acetate, which were prohibited by laws and regulations, and the heavy metal mercury content was seriously exceeding the standard.According to Articles 59 and 60 of the "Regulations on the Supervision and Administration of Cosmetics", the Xinyi City Market Supervision Bureau of Jiangsu Province has determined that the above-mentioned illegal acts are suspected of constituting a crime, and will transfer the case to the public security organs according to law, and jointly with the public security organs. Investigate in depth.Up to now, the case has destroyed 7 cosmetics production and sales dens, and seized 1,500 kilograms of illegally added cosmetic raw materials and more than 1,000 boxes of finished products. The value of the goods in this case amounted to more than 35 million yuan.In March 2022, the Xinyi City People's Procuratorate prosecuted Yuan Mou and 14 others to the Xinyi City People's Court for the crime of producing and selling fake and shoddy products, and the case is under further trial.
[Typical significance] According to the third item of Article 59 of the "Regulations on the Supervision and Administration of Cosmetics", no raw materials that are prohibited for use in cosmetic production shall be used to produce cosmetics, and no substances that may endanger human health shall be added to cosmetics.The parties in this case added hormones such as dexamethasone and triamcinolone acetonide acetate and heavy metal mercury in the cosmetic production process, in order to achieve obvious effects in the short term after consumers use it.However, the long-term use of cosmetics with illegally added hormones, antibiotics and heavy metals will cause great harm to human health.In this case, the drug supervision and administration department and the public security organs worked together to crack down on the whole chain from the online sales end to the offline cosmetics and raw material production end, and effectively safeguarded the safety of public makeup.
8. The case of Guangzhou Saiin Cosmetics Co., Ltd. producing cosmetics that did not meet the technical requirements stated in the cosmetics filing materials
[Introduction to the case] In August 2021, the drug supervision and management department monitored and found that some consumers had cosmetic adverse reactions due to the use of the "TOURAN Pure Beauty Set" cosmetics produced by Guangzhou Saiin Cosmetics Co., Ltd.The Guangdong Provincial Drug Administration immediately organized risk control measures against the companies involved and related cosmetics, and carried out in-depth investigations.After investigation, the company's "TOURAN Pure Beauty Set" produced in May 2021 contains two cosmetics with the label names "Transparent Skin Serum" and "Peptide Repair Essence". Undocumented and unlabeled ingredient "salicylic acid".The company's behavior of producing cosmetics that did not meet the technical requirements stated in the cosmetics filing materials violated the provisions of paragraph 2 of Article 29 of the "Regulations on the Supervision and Administration of Cosmetics".In view of the fact that the product involved in the case caused consumers to have adverse reactions to cosmetics, and the company deliberately evaded the investigation by providing false certification materials during the investigation process, and the circumstances of the violation were serious, according to the second item of Article 60 of the "Regulations on the Supervision and Administration of Cosmetics", Guangdong Province Pharmaceuticals The Supervision and Administration Bureau imposed an administrative penalty of 40,000 yuan on the company, and imposed an administrative penalty on its legal representative, Xing Tengze, prohibiting the production and operation of cosmetics within 10 years, and canceled the company's "Cosmetics Production License" according to law (during the handling of the case). , the company's cosmetics production license has not been renewed).
[Typical significance] "Regulations on the Supervision and Administration of Cosmetics" stipulates that ordinary cosmetics should be filed as required before they are listed or imported, and ordinary cosmetics that have been filed shall not change the product formula at will.The drug supervision and administration department shall supervise and inspect the filing materials and products of cosmetics in accordance with the law. Cosmetics filing persons and entrusted manufacturing enterprises shall produce ordinary cosmetics in accordance with the technical requirements stated in the filing materials of cosmetics.In this case, the party involved added the ingredient "salicylic acid" that was not specified in the product filing materials and the label during the production of cosmetics, and provided false certification materials during the investigation process. The Regulations provide for severe penalties in accordance with the law.The drug supervision and administration department used methods such as back-tracking from the business link and cross-regional investigation and linkage to find out the illegal facts of the parties in accordance with the law. While punishing the parties in accordance with the law, the legal representatives of the parties were punished by prohibiting their employment, which effectively deterred the illegal molecular.(Sino-Singapore Jingwei APP)
(Editor in charge: Cai Qing)
