Whoever produces or sells counterfeit drugs shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention and shall also be fined; Whoever causes serious harm to human health or has other serious circumstances shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years and fined; Whoever causes death or has other particularly serious circumstances shall be sentenced to fixed-term imprisonment of not less than 10 years, life imprisonment or death, and shall also be fined or confiscated.
If a unit commits the crime of producing and selling counterfeit drugs, it shall be fined, and the directly responsible person in charge and other directly responsible personnel shall be punished according to the statutory punishment for the crime of producing and selling counterfeit drugs.
According to Article 116 of the Drug Administration Law of People's Republic of China (PRC), the illegally produced and sold drugs and illegal income are confiscated, ordered to stop production and business for rectification, the drug approval certificate is revoked, and a fine of more than 15 and less than 30 times the value of illegally produced and sold drugs is imposed; 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.
Article 117 stipulates that: those who produce and sell inferior drugs shall have their illegally produced and sold drugs and illegal income confiscated, and shall be fined at least ten times but not more than twenty times the value of the illegally produced and sold drugs; If the value of illegally produced and wholesale drugs is less than100000 yuan, it shall be calculated as100000 yuan; If the value of illegal retail drugs is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan; If the circumstances are serious, it shall be ordered to suspend production and business for rectification, until the Drug Approval Certificate, Drug Production License, Drug Business License or Pharmaceutical Preparation License of Medical Institutions are revoked.
If the production and sale of Chinese herbal pieces 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 be given a warning; A fine of not less than 100,000 yuan but not more than 500,000 yuan may also be imposed.
Article 118 stipulates that if the circumstances are serious, the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be confiscated, and a fine of more than 30% but less than three times the income obtained during the illegal act shall be imposed, and the drug production and marketing activities shall be banned for life, and the public security organ may detain them for more than five days and less than fifteen days.
The raw materials, auxiliary materials, packaging materials and production equipment specially used by producers to produce counterfeit and inferior drugs shall be confiscated.
Definition of counterfeit drugs:
Fake drugs refer to drugs whose ingredients do not meet the national drug standards, and whose indications or functional indications are beyond the prescribed scope.
legal ground
Article 1 16 of the Drug Administration Law of People's Republic of China (PRC).
Those who produce and sell counterfeit drugs shall have their illegally produced and sold drugs and illegal income confiscated, be ordered to stop production and business for rectification, have their drug approval certificates revoked, and be imposed a fine of more than 15 times 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.
Article 117 Whoever produces or sells inferior drugs shall have his illegally produced and sold drugs and illegal income confiscated, and shall be fined at least ten times but not more than twenty times the value of the illegally produced and sold drugs; If the value of illegally produced and wholesale drugs is less than100000 yuan, it shall be calculated as100000 yuan; If the value of illegal retail drugs is less than 1 10,000 yuan, it shall be calculated as 1 10,000 yuan; If the circumstances are serious, it shall be ordered to suspend production and business for rectification, until the Drug Approval Certificate, Drug Production License, Drug Business License or Pharmaceutical Preparation License of Medical Institutions are revoked.
If the production and sale of Chinese herbal pieces 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 be given a warning; A fine of not less than 100,000 yuan but not more than 500,000 yuan may also be imposed.
Article 118 If the circumstances are serious, the legal representative, principal responsible person, directly responsible person in charge and other responsible persons who produce and sell counterfeit drugs shall be confiscated, and a fine of not less than 30% but not more than 300% of the income obtained from illegal acts shall be imposed, and drug production and business activities shall be banned for life, and the public security organ may detain them for not less than five days but not more than fifteen days.
The raw materials, auxiliary materials, packaging materials and production equipment specially used by producers to produce counterfeit and inferior drugs shall be confiscated.