Announcement of the State Food and Drug Administration on the punishment of illegal production and sale of Ginkgo biloba extract and preparations

Notice of the State Food and Drug Administration on punishment of illegal production and sale of Ginkgo biloba extract and preparations (2015 No 219) November 5, 2015 Since May 2015, the State Food and drug administration has organized and carried out special treatment actions for Ginkgo biloba drugs, and has informed the society of illegal addition, production record making and other illegal acts of some ginkgo biloba extract and preparation enterprises After soliciting opinions from relevant departments, the punishment opinions on illegal production and sales of Ginkgo biloba extract and preparations are announced as follows: 1 Punishment principle For the Ginkgo biloba extract and preparation enterprises that illegally produce and sell fake or substandard drugs, according to Article 73 and 74 of the drug administration law of the people's Republic of China (hereinafter referred to as the drug administration law) and the regulations for the implementation of the drug administration law of the people's Republic of China, as well as the criminal law of the people's Republic of China and the customs of the Supreme People's court and the Supreme People's Procuratorate In dealing with criminal cases of endangering drug safety, the relevant provisions of the interpretation of applicable laws shall be punished (1) the violation of drug standards, adulteration, process change and other illegal acts by Ginkgo biloba extract production enterprises are the source of the production of fake drugs and substandard drugs by Ginkgo biloba preparation enterprises, which have obvious subjective intention and impose severe punishment on Ginkgo biloba extract production enterprises and relevant responsible personnel according to law; those suspected of crimes shall be transferred to public security organs for criminal responsibility according to law (2) where a pharmaceutical production and marketing enterprise knows that Ginkgo biloba extract is still used or sold as illegal products, resulting in the determination of the Ginkgo biloba preparation as fake or substandard, it shall impose severe punishment on the pharmaceutical production and marketing enterprise and the relevant responsible personnel according to law; if it is suspected of a crime, it shall be transferred to the public security organ for criminal responsibility according to law (3) those who refuse or evade supervision and inspection, or forge records, forge samples, destroy or conceal relevant evidential materials shall be given a heavier punishment according to law (4) those who refuse to fulfill the recall obligation and fail to take effective measures to recall illegal drugs in an all-round way as required, resulting in the continued sale and use of illegal drugs, shall be investigated and punished in accordance with the special provisions of the State Council on strengthening the supervision and administration of food and other products safety (5) in accordance with the requirements of the relevant circular issued by the State Food and drug administration, take measures such as self inspection, report, self inspection, stop production and operation, recall of illegal drugs in a timely manner, and take the initiative to eliminate or mitigate the consequences of the harm caused by the illegal act, and in accordance with the provisions of the administrative penalty law of the people's Republic of China, give a lighter or mitigated administrative penalty 2 Product quality (1) according to the supplementary test method of Sophoricoside inspection item (approval No.: 2015007), the Ginkgo biloba extract and preparation with positive Sophoricoside were detected According to the provisions of paragraph 2 (1) of Article 48 of the drug administration law, the product was identified as fake drug (II) according to the supplementary inspection method for free quercetin, kaempferol and isorhamnetin inspection items (approval document No.: 2015001-2015006), Ginkgo biloba extract and preparations that do not meet the requirements for free quercetin, kaempferol and isorhamnetin inspection items shall be punished as inferior drugs according to the provisions of item (6), paragraph 3, Article 49 of the drug administration law 3 Specific punishment (1) for the production and sale of fake drugs and substandard drugs by the Ginkgo biloba extract production enterprises, the products and illegal income illegally produced and sold shall be confiscated and the drug production license shall be revoked in accordance with the provisions of Article 73 and article 74 of the drug administration law; the legal representative, the person in charge of the enterprise, the person in charge of quality and production of the enterprise shall be revoked Among the persons in charge and other relevant persons, if the persons in charge and other persons who are directly responsible are suspected of committing a crime, they shall be transferred to the public security organ for criminal responsibility according to law (2) for the production and sale of fake drugs by ginkgo leaf preparation enterprises, according to the provisions of Article 73 of the drug administration law, the illegal drugs and illegal income shall be confiscated, and a fine of more than two times but less than five times the value of the illegally produced and sold drugs shall be imposed, and the approval documents of ginkgo leaf drugs shall be revoked; the adulterated extract prepared by itself or the adulterated extract shall be used, or the adulterated extract shall be withdrawn If the product is still purchased or used, or the product is still purchased or used knowing that it is unable to produce qualified extract according to the fair market cost and price, and there are serious circumstances such as refusing, evading supervision and inspection or forging records, forging samples, destroying or concealing relevant evidence materials, the pharmaceutical production license shall be revoked; the legal representative and the person in charge of the enterprise shall be revoked The person in charge of quality, the person in charge of production and other relevant personnel, the person in charge with direct responsibility and other personnel suspected of committing a crime, shall be transferred to the public security organ for criminal responsibility according to law (3) for the production and sale of inferior drugs by Ginkgo biloba preparation enterprises, according to the provisions of Article 74 of the drug administration law, the illegal drugs and illegal income shall be confiscated, and a fine of more than one time but less than three times the value of the illegally produced and sold drugs shall be imposed; the circumstances of refusing or evading supervision and inspection, or forging records, forging samples, destroying or concealing relevant evidence and materials shall be given priority The approval documents of Ginkgo biloba are revoked (IV) in accordance with the requirements of the circular on illegal production and sale of Ginkgo biloba drugs by Guilin Xingda Pharmaceutical Co., Ltd and other enterprises (No 15 in 2015) and the circular on illegal sale of Ginkgo biloba drugs by Ningbo Lihua Pharmaceutical Co., Ltd and relevant corporate governance (No 17 in 2015) issued by the State Food and drug administration, Ginkgo biloba preparation manufacturers actively report illegal acts , completed the drug recall before June 3, 2015; or actively reported the non conformity of self inspection on June 30, 2015 in accordance with the requirements of the Circular of the State Food and Drug Administration on the inspection of Ginkgo biloba extract and Ginkgo biloba drugs (No 20, 2015) and the Circular of 90 Ginkgo biloba extract and Ginkgo biloba drug manufacturers (No 24, 2015) If the recall has been completed a few days ago, and there is no serious circumstance, the administrative penalty shall be given a lighter or mitigated, and the drug approval certificate or the drug production license may not be revoked If the Ginkgo biloba extract production enterprise and the Ginkgo biloba preparation production enterprise know that the extract they purchased or used is to change the process or adulterate the production, or they know that they cannot produce qualified extract at the fair market cost and price and still purchase or use the Ginkgo biloba preparation, they have subjective intention and shall not be given a lighter or mitigated administrative penalty in principle (5) if the pharmaceutical production and trading enterprises fail to fulfill the recall obligations as stipulated in Article 9 of the special provisions of the State Council on strengthening the supervision and administration of food and other products safety, such as actively reporting to the regulatory authorities, announcing the sales flow of illegal drugs to the public, or the recall is incomplete, resulting in the continued sale of illegal drugs, they shall be punished according to the special provisions (6) the legal representative, the person in charge of the enterprise, the person in charge of the quality, the person in charge of the production and other persons who are directly responsible for the production and sale of fake drugs and the serious circumstances of the production and sale of substandard drugs shall, in accordance with the provisions of Article 75 of the drug administration law, be punished for not engaging in the production and trade of drugs within ten years (7) in principle, the amount of illegal income and value of goods from the illegal production and sale of drugs shall be calculated from January 1, 2015 If there is evidence to prove that the previously produced drugs are fake drugs or substandard drugs, the amount of illegal income and value of goods shall be included in accordance with the law; if there is evidence to prove that the products produced after January 1, 2015 are qualified drugs, the amount shall be deducted according to the law It is hereby announced Food and Drug Administration November 5, 2015