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    Home > Medical News > Medical World News > There's a big wave of clauses coming. Don't touch 20 red lines in drugstores

    There's a big wave of clauses coming. Don't touch 20 red lines in drugstores

    • Last Update: 2019-12-16
    • Source: Internet
    • Author: User
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    Source: sepiland - pharmacy Manager ▍ editor: yuanashley A wave of terms came The drugstore checked itself There are 20 red lines in operation Please don't touch them According to the new version of the drug administration law, pharmacies will face more severe penalties for violations of the law Please do not touch the following 20 red lines 1 Trading drugs without a drug trading license According to Article 115 of the drug administration law Where a drug is produced or sold without a drug production license, drug trade license or pharmaceutical preparation license of a medical institution, it shall be ordered to close down, the drugs illegally produced or sold and the illegal income shall be confiscated, and a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced or sold (including the sold and unsold drugs, the same below) shall be imposed; if the value of the goods is less than 100000 yuan If it's $100000, it's $100000 2 Sale of fake and inferior drugs According to Article 116 of the drug administration law Where counterfeit drugs are produced or sold, the illegally produced or sold drugs and their illegal income shall be confiscated, the production and business suspension shall be ordered for rectification, the drug approval documents shall be revoked, and a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced or sold shall be imposed; if the value of the drugs is less than 100000 yuan, it shall be calculated as 100000 yuan; if the circumstances are serious, the drug production license and drug trading license shall be revoked No corresponding application shall be accepted for a permit or preparation permit of a medical institution within ten years; if the holder of a drug listing permit is an overseas enterprise, the import of the drug shall be prohibited within ten years Article 117 where inferior drugs are produced or sold, the drugs illegally produced or sold and the illegal gains therefrom shall be confiscated, and a fine of not less than 10 times but not more than 20 times the value of the drugs illegally produced or sold shall be imposed; if the value of the drugs illegally produced or sold is less than 100000 yuan, it shall be calculated as 100000 yuan; if the value of the drugs illegally sold is less than 10000 yuan, it shall be calculated as 10000 yuan; If the circumstances are serious, it shall be ordered to suspend production or business for rectification or even to revoke the drug approval certificate, the drug production license, the drug trade license or the preparation license of the medical institution If the Chinese herbal pieces produced or sold do not meet the drug standards and do not affect the safety and effectiveness, they shall be ordered to make corrections within a time limit and given a warning; they may be fined not less than 100000 yuan but not more than 500000 yuan Article 118 where a person who produces or sells fake drugs or inferior drugs is serious, the legal representative, the principal person in charge, the person in charge who is directly responsible for the case and other persons responsible for the case shall be confiscated of the income earned from his own unit during the period of the illegal act, and a fine of not less than 30% but not more than three times the income earned shall be imposed The production and marketing of drugs shall be prohibited for life, And may be detained by the public security organ for not less than five days but not more than 15 days The raw materials, auxiliary materials, packaging materials and production equipment specially used by the producers for the production of fake and substandard drugs shall be confiscated 3 Knowing that fake and inferior drugs are provided for storage and transportation If, according to Article 120, one knows or ought to know that a drug belongs to a counterfeit drug, a substandard drug, or a drug specified in Items 1 to 5 of the first paragraph of Article 124 of this law, and provides convenient conditions for its storage and transportation, all the storage and transportation income shall be confiscated, and a fine of not less than one time but not more than five times the illegal income shall be concurrently imposed; if the circumstances are serious, the illegal income shall be not less than five times but not more than 15 times the illegal income If the illegal income is less than 50000 yuan, it shall be calculated as 50000 yuan 4 Forging, altering, leasing, lending, trading licenses or approval documents Article 122 Whoever forges, alters, rents, lends or illegally trades in a license or a drug approval certificate shall have his illegal income confiscated and be concurrently fined not less than one time but not more than five times his illegal income; if the circumstances are serious, he shall also be fined not less than five times but not more than fifteen times his illegal income, and his drug production license, drug trading license or drug preparation license of a medical institution shall be revoked The legal representative, the main person in charge, the person in charge directly responsible and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan for the certificate or drug approval certificate, and shall be prohibited from engaging in drug production and marketing activities within 10 years, and may be detained by the public security organ for not less than five days but not more than 15 days; if the illegal income is less than 100000 yuan, it shall be calculated as 100000 yuan 5 Providing false information to obtain permission According to Article 123, those who provide false certificates, data, materials, samples or take other means to defraud clinical trial license, drug production license, drug trade license, preparation license of medical institutions or drug registration and other licenses shall cancel the relevant licenses, and shall not accept the corresponding applications within 10 years, and shall be fined not less than 500000 yuan but not more than 5000000 yuan; the circumstances are serious The legal representative, the principal person in charge, the person in charge directly in charge and other persons in charge shall be fined not less than 20000 yuan but not more than 200000 yuan, shall be prohibited from engaging in drug production and marketing activities within ten years, and may be detained by the public security organ for not less than five days but not more than 15 days 6 Sales of three types of drugs Article 124 Whoever, in violation of the provisions of this law, commits one of the following acts, confiscates the drugs illegally produced, imported or sold, as well as the raw materials, auxiliary materials, packaging materials and production equipment specially used for the illegal production, orders it to suspend production or business for rectification, and also imposes a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced, imported or sold; the value of the goods If the amount is less than 100000 yuan, it shall be calculated as 100000 yuan; if the circumstances are serious, the drug approval certificate shall be revoked until the drug production license, drug trade license or preparation license of medical institutions are revoked, and the income obtained from the unit during the period of the illegal act shall be confiscated to the legal representative, the main person in charge, the directly responsible person in charge and other responsible persons A fine of not less than 30% but not more than three times the income shall be prohibited from engaging in drug production and marketing activities for ten years or even for life, and a detention of not less than five days but not more than 15 days may be imposed by the public security organ: (1) Producing and importing drugs without obtaining the drug approval certificate; (2) Use the drug approval documents obtained by deception to produce and import drugs; (3) Use APIs without review and approval to produce drugs; (4) Selling drugs that should be tested but not tested; (5) To produce and sell drugs prohibited by the drug regulatory department under the State Council; (6) Make up production and inspection records; (7) Major changes are made in the process of drug production without approval Whoever sells the drugs specified in Items 1 to 3 of the preceding paragraph, or a drug using unit uses the drugs specified in Items 1 to 5 of the preceding paragraph, shall be punished in accordance with the provisions of the preceding paragraph; if the circumstances are serious, and the legal representative, the main person in charge, the person in charge directly responsible and other persons in charge of the drug using unit have the practice certificate of medical and health personnel, the practice certificate shall also be revoked If a small amount of drugs that have been legally listed abroad are imported without approval, if the circumstances are relatively minor, the punishment may be mitigated or exempted according to law 7 Imported drugs without approval The sale of drugs imported without approval shall also be punished in accordance with Article 124 8 Sale of unapproved drugs Article 125 Whoever, in violation of the provisions of this law, commits one of the following acts shall be confiscated the drugs illegally produced or sold, the illegal gains, the packaging materials and containers, be ordered to stop production and business for rectification, and be fined not less than 500000 yuan but not more than 5000000 yuan; if the circumstances are serious, the drug approval certificate, the drug production license and the drug trading license shall be revoked, and the legal representative shall be revoked The person in charge, the person in charge directly in charge and other persons in charge shall be fined not less than 20000 yuan but not more than 200000 yuan, and shall be prohibited from engaging in drug production and marketing activities for ten years or even for life: (1) Conducting clinical trials of drugs without approval; (2) Use unapproved packaging materials or containers in direct contact with drugs to produce drugs or sell such drugs; (3) Use unapproved labels and instructions 9 Violation of the quality management regulations for drug distribution Article 126 except as otherwise provided in this law, the holders of drug listing licenses, drug manufacturing enterprises, drug trading enterprises, non clinical safety evaluation and research institutions and clinical trial institutions of drugs, etc fail to abide by the norms of drug production quality control, drug trade quality control, non clinical research quality control and clinical trial quality Those with standardized management shall be ordered to make corrections within a time limit and given a warning; those who fail to make corrections within the time limit shall be fined not less than 100000 yuan but not more than 500000 yuan; If the circumstances are serious, a fine of not less than 500000 yuan but not more than 2 million yuan shall be imposed, the company shall be ordered to suspend production and business for rectification, or even revoke the drug approval documents, drug production licenses, drug trading licenses, etc., and the drug non clinical safety evaluation and research institutions and drug clinical trial institutions shall not carry out drug non clinical safety evaluation and drug clinical trials within five years, and the legal representative shall The person in charge, the main person in charge, the person in charge directly in charge and other persons in charge shall confiscate the income obtained from the unit during the period of the illegal act and impose a fine of not less than 10% but not more than 50% of the income obtained, and shall be prohibited from engaging in drug production and marketing for ten years or even for life 10 Fail to establish traceability system as required Article 127 Whoever, in violation of the provisions of this law, commits one of the following acts shall be ordered to make corrections within a time limit and given a warning; if he fails to make corrections within the time limit, he shall be fined not less than 100000 yuan but not more than 500000 yuan: (1) The bioequivalence test has not been filed; (2) During the clinical trial of drugs, if safety problems or other risks are found, the clinical trial sponsor fails to timely adjust the clinical trial scheme, suspend or terminate the clinical trial, or fails to report to the drug regulatory department under the State Council; (3) Failing to establish and implement drug traceability system as required; (4) Failing to submit the annual report as required; (5) Failing to file or report changes in the pharmaceutical production process in accordance with regulations; (6) No post marketing risk management plan has been formulated; (7) Failure to carry out post marketing research or post marketing evaluation in accordance with regulations 11 Purchase drugs from illegal channels Article 129 If, in violation of the provisions of this law, the holder of the drug listing license, the drug producing enterprise, the drug handling enterprise or the medical institution fails to purchase drugs from the holder of the drug listing license or the enterprise with the qualification of drug production or marketing, it shall be ordered to make corrections, the illegally purchased drugs and the illegal income shall be confiscated, and the value of the illegally purchased drugs shall be more than two times and more than ten times the value of the illegally purchased drugs If the case is serious, a fine of not less than 10 times but not more than 30 times the value of the goods shall be imposed, and the drug approval certificate, drug production license, drug trade license or medical institution practice license shall be revoked; if the value of the goods is less than 50000 yuan, it shall be calculated as 50000 yuan 12 Irregular purchase and sale According to Article 130, if a pharmaceutical trading enterprise, in violation of the provisions of this law, fails to record the purchase and sale of pharmaceuticals in accordance with the provisions, fails to correctly explain the usage and dosage of the retail pharmaceuticals, or fails to dispense prescriptions in accordance with the provisions, it shall be ordered to make corrections and be given a warning; if the circumstances are serious, its pharmaceutical trading license shall be revoked 13 The third-party platform of the drug network has not been stopped According to Article 131, in violation of the provisions of this law, the third-party platform provider of drug online trading fails to perform the qualification review, report and stop providing
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