Illegal act 1: No drug production license.
Illegal act 2: unlicensed operation
Punishment: Those who produce and sell drugs without obtaining the Pharmaceutical Production License, Pharmaceutical Trading License or Pharmaceutical Preparation License for Medical Institutions shall be ordered to close down, the illegally produced and sold drugs and illegal income shall be confiscated, and the illegally produced and sold drugs (including sold and unsold drugs, the same below) shall be fined between fifteen times and thirty times; If the value of the goods is less than100000 yuan, it shall be calculated as100000 yuan.
(2)
Illegal act 3: providing false materials to defraud the license qualification.
Punishment: providing false certificates, data, materials, samples or taking other means to defraud the clinical trial license, drug production license, drug business license, drug preparation license or drug registration license of medical institutions;
Revoke the relevant license, refuse to accept the corresponding application within ten years, and impose a fine of not less than 500,000 yuan but not more than 5 million yuan; If the circumstances are serious, the legal representative, principal responsible person, directly responsible person in charge and other responsible persons shall be fined between 20,000 yuan and 200,000 yuan, and drug production and marketing activities shall be prohibited within ten years, and may be detained by public security organs for more than five days and less than fifteen days.
(3)
Illegal act 4: conducting clinical trials of drugs without approval.
Illegal act 5: using unapproved packaging materials or containers that directly contact drugs to produce or sell drugs.
Illegal act 6: using unapproved labels and instructions.
Punishment: confiscation of illegally produced and sold drugs, illegal income, packaging materials and containers, order to stop production and business for rectification, and impose a fine of more than 500,000 yuan and less than 5 million yuan; If the circumstances are serious, the drug approval certificate, drug production license and drug trading license shall be revoked, and the legal representative, principal responsible person, directly responsible person in charge and other responsible persons shall be fined between 20,000 yuan and 200,000 yuan, and it is forbidden to engage in drug production and trading activities for more than ten years to life.
(4)
Illegal act 7: producing or importing drugs without obtaining the drug approval number.
Illegal act 8: using the fraudulent drug approval number to produce or import drugs.
Illegal act 9: using raw materials that have not been examined and approved to produce drugs.
Illegal act 10: selling drugs without inspection.
Illegal act 1 1: producing and selling drugs that are prohibited from being sold by the drug supervision and administration department of the State Council.
Illegal act 12: forging production and inspection records.
Illegal act 13: making major changes to the pharmaceutical production process without approval.
Punishment:
1. Confiscate the illegally produced, imported and sold drugs and illegal income, as well as raw materials, auxiliary materials, packaging materials and production equipment specially used for illegal production, order them to stop production and business for rectification, and impose a fine of not less than 5 times but not more than 30 times the value of illegally produced, imported and sold drugs/kloc-0; If the value of the goods is less than100000 yuan, it shall be calculated as100000 yuan;
2. If the circumstances are serious, the drug approval certificate shall be revoked until the Drug Production License, Drug Business License or Pharmaceutical Preparation License of Medical Institution is revoked. The legal representative, principal responsible person, directly responsible person in charge and other responsible persons shall be confiscated of the income obtained by the unit during the illegal act, and shall be fined at least 30% but not more than three times of the income obtained. It is forbidden to engage in pharmaceutical production and business activities for ten years to life, and may be detained by the public security organ for more than five days but not more than fifteen days.
3. Drug addicts who use 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, if the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel of the drug-using unit hold the Practice Certificate for Medical and Health Personnel, their practice certificate shall also be revoked.
(5)
Illegal act 14: producing and selling counterfeit and inferior drugs.
#3p4#, punitive damages
If counterfeit drugs or inferior drugs are produced or are still sold and used knowing that they are counterfeit drugs or inferior drugs, the victim or his close relatives may demand compensation of ten times the price or three times the loss in addition to compensation; If the additional compensation amount is less than 1000 yuan, it is 1000 yuan.
2. Punishment:
General situation: confiscate the illegally produced and sold drugs and illegal income, order to stop production and business for rectification, revoke the drug approval certificate, and impose a fine of more than 15 and less than 30 times the value of illegally produced and sold drugs; If the value of the goods is less than100000 yuan, it shall be calculated as100000 yuan; If the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical Trading License or Pharmaceutical Preparation License of Medical Institution shall be revoked, and the corresponding application shall not be accepted within ten years; If the holder of the drug marketing license is an overseas enterprise, it is forbidden to import drugs within ten years.
If the circumstances are serious: in addition to the above-mentioned general punishment, it also includes: revoking the drug production license, drug business license or preparation license of medical institutions, and rejecting their corresponding applications within ten years; If the holder of the drug marketing license is an overseas enterprise, it is forbidden to import drugs within ten years.
The legal representative, principal responsible person, directly responsible person in charge and other responsible personnel shall be confiscated, and the income of the unit during the illegal act shall be fined more than 30% and less than 3 times, and the drug production and business activities shall be banned for life, and may be detained by the public security organ for more than 5 days 15 days.
(6)
Illegal act 15: providing storage or transportation for illegal drugs.
Punishment: Whoever knowingly or should have known that it is a prohibited drug and provided it with convenient conditions such as storage and transportation, all the storage and transportation income shall be confiscated, and a fine of more than 5 times the illegal income/kloc-0 shall be imposed; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal income shall be imposed; If the illegal income is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
Illegal drugs include the following:
(1) Fake and shoddy drugs
(1) Producing or importing drugs without obtaining the drug approval certificate;
(2) Using the fraudulently obtained drug approval certificate to produce or import drugs;
(3) using raw materials that have not been examined and approved to produce drugs;
(4) selling drugs that have not been tested;
(5) Drugs whose production and sale are prohibited by the drug supervision and administration department of the State Council;
(7)
Illegal act 16: forging, altering, leasing, lending, illegally buying or selling licenses or drug approval numbers.
Punishment:
1, confiscate the illegal income, and impose a fine of more than 5 times the illegal income 1;
2. If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal income shall be imposed, the Pharmaceutical Production License, Pharmaceutical Trading License, Pharmaceutical Preparation License of Medical Institution or Pharmaceutical Approval Certificate shall be revoked, and the legal representative, principal responsible person, directly responsible person in charge and other responsible persons shall be fined not less than 20,000 yuan but not more than 200,000 yuan, and pharmaceutical production and marketing activities shall be prohibited within ten years, and the public security organ may detain them for not less than five days but not more than fifteen days. If the illegal income is less than one hundred thousand yuan, it shall be calculated as one hundred thousand yuan.
(8)
Illegal act 17: purchasing drugs from enterprises that are not qualified for drug production and operation.
Punishment: order correction, confiscate the illegally purchased drugs and illegal income, and impose a fine of more than two times and less than ten times the value of illegally purchased drugs; If the circumstances are serious, a fine of more than 0/0 and less than 30 times of the value of the goods shall be imposed, and the drug approval certificate, drug production license, drug business license or medical institution practice license shall be revoked; If the value of the goods is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
Illegal act 18: giving kickbacks and other illegitimate interests.
Punishment: confiscate the illegal income and impose a fine of more than 300,000 yuan and less than 3 million yuan; If the circumstances are serious, the business licenses of drug marketing license holders, drug production enterprises and drug trading enterprises shall be revoked, and the drug approval documents, drug production licenses and drug trading licenses shall be revoked by the drug supervision and administration department.
Violation 19: Bribery of State functionaries.
Punishment: If a drug marketing license holder, a drug production enterprise or a drug trading enterprise offers bribes to state functionaries in drug research, production and sales, its legal representative, principal responsible person, directly responsible person in charge and other responsible persons are prohibited from engaging in drug production and sales activities for life.