National Medical Products Administration announces 4 typical cases of drug violations

2024-09-20

The drug supervision and administration departments at all levels have thoroughly implemented the series of decisions and deployments of the Party Central Committee and the State Council on strengthening drug safety, solidly promoted the consolidation and improvement of drug safety, continuously strengthened drug supervision and administration, severely cracked down on illegal and criminal activities in the drug field, and lawfully investigated and dealt with a number of major cases, effectively safeguarding the health and medication safety of the people. The following are four typical cases of drug violations. 1、 Case of Production and Sales of Fake Drugs by Yuanou Biotechnology Co., Ltd. in Renqiu City, Cangzhou City. In August 2021, the Market Supervision Administration of Renqiu City, Cangzhou City, Hebei Province conducted an on-site inspection of Yuanou Biotechnology Co., Ltd. based on public reports. After investigation, the company produced and sold drugs such as progesterone, Boldenone, and testosterone propionate without obtaining the Drug Production License and Drug Approval Certificate, with a total value of over 1.197 million yuan. In August 2021, the Market Supervision Administration of Renqiu City transferred the case to the public security organs for filing and investigation. In July 2023, the People's Court of Renqiu City, based on relevant laws and regulations such as the Criminal Law of the People's Republic of China and the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Handling Criminal Cases Involving Endangering Drug Safety (revised in 2022), sentenced the legal representative of the enterprise, Tong, and the enterprise supervisors, Wei and Xu, to the crime of producing and selling counterfeit drugs, and sentenced them to fixed-term imprisonment and fines. 2、 Wang and 15 others are involved in a series of cases of unlicensed operation of unapproved imported drugs. In October 2023, the Market Supervision Administration of Jianping County, Chaoyang City, Liaoning Province, conducted an investigation into the case of Wang and 15 others suspected of operating drugs without a license based on clues. After investigation, Wang and 15 other individuals involved in the case purchased and sold unapproved imported drugs without obtaining a Drug Business License, with a total value of 2.2452 million yuan. The above-mentioned behavior of Wang and 15 others violates the provisions of Article 51 (1) and Article 98 (4) of the Drug Administration Law of the People's Republic of China. In January 2024, the Market Supervision Administration of Jianping County imposed a total of 1.1226 million yuan in administrative penalties on Wang and 15 others in accordance with Article 115, Article 124, Paragraph 1, Item 1 and Item 2 of the Drug Administration Law of the People's Republic of China, Article 9, Paragraph 1, Item 1, and Article 14, Paragraph 1, Item 1 and Item 2 of the Administrative Penalty Discretionary Power Application Regulations of the Liaoning Provincial Drug Administration. 3、 Case of illegal procurement of drugs by Li Lin Traditional Chinese Medicine Clinic in Shuozhou City. In November 2023, the Market Supervision Administration of Shuocheng District, Shuozhou City, Shanxi Province conducted an on-site inspection of the Li Lin Traditional Chinese Medicine Clinic based on public reports. After investigation, it was found that the 53 types of traditional Chinese medicine decoction pieces used in the clinic did not have labels indicating the place of origin or other relevant information on the smallest unit packaging, and could not provide the supplier with relevant qualifications and certification materials for drug production and operation enterprises. The above behavior of the clinic violates Article 55 of the Drug Administration Law of the People's Republic of China. In December 2023, the Market Supervision Administration of Shuocheng District imposed administrative penalties on the clinic, including confiscation of drugs involved in the case, confiscation of illegal gains of 29800 yuan, and a fine of 100000 yuan, in accordance with Article 129 of the Drug Administration Law of the People's Republic of China and Article 11 of the Administrative Penalty Discretionary Power Application Rules of Shanxi Provincial Drug Administration. 4、 The case of He and Tan illegally buying and selling drug business licenses. In July 2023, the Market Supervision Administration of Enping City, Jiangmen City, Guangdong Province conducted a daily inspection of Guochun Pharmacy in Shahu Town, Enping City. After investigation, it was found that the operator of the store's "Business License" and the person in charge of the enterprise indicated on the "Drug Business License" are both Tan. After obtaining the drug business license in January 2020, Tan sold the license to the current operator He. The above-mentioned behavior of the parties violates Article 122 of the Drug Administration Law of the People's Republic of China. In March 2024, the Enping Market Supervision Administration imposed an administrative penalty of confiscating illegal gains of 90400 yuan and a fine of 30000 yuan on the party He, in accordance with Article 122 of the Drug Administration Law of the People's Republic of China; Impose an administrative penalty of confiscating illegal gains of 3000 yuan and a fine of 3000 yuan on the party involved, Tan. Compliance Reminder 1: According to the Drug Administration Law of the People's Republic of China, those engaged in drug production and operation activities shall apply for the Drug Production License and Drug Operation License in accordance with the law. It is prohibited to engage in drug production and operation activities without obtaining the Drug Production License and Drug Operation License. It is strictly prohibited for any unit or individual to obtain drug production and operation licenses through illegal means such as forging, altering, renting, lending, or illegally buying or selling licenses. 2、 According to the Drug Administration Law of the People's Republic of China, drug trading enterprises and medical institutions shall purchase drugs from drug marketing authorization holders or enterprises with drug production and operation qualifications. Pharmaceutical trading enterprises and medical institutions shall establish and implement a system of incoming inspection and acceptance when purchasing drugs, and verify the drug qualification certificate and other markings; Those that do not meet the prescribed requirements shall not be purchased, sold, or used. (New Society)

Edit:HAN ZHUOLING    Responsible editor:CAICAI

Source:xinhuanet.com

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