Criminal litigation involving medicine: on the management of self-made Chinese medicine pills by TCM clinics without approval number according to fake medicine

[Abstract] the defendant Youmou produced and sold traditional Chinese medicine pills in traditional Chinese medicine clinic without obtaining drug production license and preparation license of medical institutions If there is no valid approval number, it shall be treated as fake medicine The defendant Youmou, in violation of the national drug administration laws and regulations, produces and sells fake drugs, which has constituted the crime of producing and selling fake drugs The court shall support the establishment of the charges charged by the public prosecution On September 2, 2019, the court ruled that the defendant Youmou was exempted from criminal punishment for the crime of producing and selling fake drugs The traditional Chinese medicine clinic manages the self-made traditional Chinese medicine pill, without the effective approval number, it will be punished as fake medicine This article explains this through a judicial case 。 The data comes from the criminal judgment of the first instance of Youmou's production and sale of fake drugs (2019) No 599, x0482 （1） Since 2015, the defendant Youmou has produced and sold TCM pills in the TCM clinic of "Tianxue Tongluo powder" operated by him at No 61, XX street, XX City, without obtaining the pharmaceutical production license and the pharmaceutical preparation license of medical institutions, with a total sales of 127944 yuan and a profit of 45473 yuan On May 21, 2018, XX food and Drug Administration seized 5 kinds of traditional Chinese medicine pills on the spot, and issued 3 prescriptions （2） Later, it was confirmed by XX food and drug administration that: the 5 unknown pills prepared by Youmou have usage, dosage, function, indications and ingredients, which conform to the drug characteristics specified in Article 101 of the drug administration law of the people's Republic of China, but without effective approval number According to the provisions of Article 48, paragraph 3, item 2 of the drug administration law of the people's Republic of China, Youmou should According to the fake medicine （3） In 2009, the defendant Youmou opened a TCM clinic in X market of XX city After 2015, he operated "tianxuetongluo powder" TCM clinic in XX street of XX city Tianxuetongluo powder was processed and processed with traditional Chinese medicine after many years of research, and on May 5, 2015, it was rated as the representative inheritor of XX Municipal intangible cultural heritage project (traditional medicine) by XX Municipal Bureau of culture, radio and television The defendant Youmou, in violation of the national drug administration laws and regulations, produces and sells fake drugs, which has constituted the crime of producing and selling fake drugs The court shall support the establishment of the charges charged by the public prosecution On September 2, 2019, the court ruled that the defendant Youmou was exempted from criminal punishment for the crime of producing and selling fake drugs （1） According to the public prosecution organ, the public prosecution organ is the people's Procuratorate of XX City, XX Province The defendant Youmou, the director and doctor of "Tianxue Tongluo San" traditional Chinese medicine clinic in XX city On November 28, 2018, he was granted a guarantor pending trial by XX Municipal Public Security Bureau on suspicion of the crime of producing and selling fake drugs, and filed a public prosecution with the court （2） The defendant argued that the defendant had no objection to the above facts during the trial and pleaded guilty.