Production and sale of counterfeit medicines shall be punished by fixed-term imprisonment of less than three years or detention, and a fine; if it causes serious harm to human health or has other serious circumstances, it shall be punished by fixed-term imprisonment of not less than three years and not more than ten years, and a fine; if it causes a person's death or has other particularly serious circumstances, it shall be punished by fixed-term imprisonment of more than ten years, life imprisonment, or death penalty, and a fine or confiscation of property.
If a unit commits the crime of producing or selling counterfeit medicines, the unit shall be sentenced to a fine, and its directly responsible supervisors and other directly responsible persons shall be punished according to the statutory penalties for individuals who commit the crime of producing or selling counterfeit medicines.
According to Article 116 of the Drug Administration Law of the People's Republic of China, if a person produces or sells counterfeit drugs, he or she shall confiscate the drugs illegally produced or sold and the illegal proceeds, order the suspension of production and reorganization of the business, suspend the approval documents of the drugs, and impose a fine of fifteen times or more than thirty times the amount of the value of the illegally produced or sold drugs; if the amount of the value of the goods is less than one hundred thousand yuan, the amount shall be calculated according to one hundred thousand yuan; If the circumstances are serious, revoke the drug production license, drug business license or preparation license for medical institutions, and will not accept the corresponding application within ten years; if the holder of the listed drug license is an overseas enterprise, prohibit the import of its medicines within ten years.
Article 117 stipulates that anyone who produces or sells substandard medicines shall confiscate the illegally produced or sold medicines and the illegal income, and shall be fined at least ten times and not more than twenty times the value of the illegally produced or sold medicines; if the value of illegally produced or wholesaled medicines is less than one hundred thousand yuan, it shall be calculated according to one hundred thousand yuan; if the value of illegally retailed medicines is less than one ten thousand yuan, it shall be calculated according to one ten thousand yuan; and in case the circumstances are serious, the enterprise shall be ordered to suspend production and business. The seriousness of the case, ordered to suspend production and rectification until the revocation of drug approval documents, drug production licenses, drug business licenses or preparation licenses for medical institutions.
The production and sale of traditional Chinese medicine tablets do not comply with the drug standards, but does not yet affect the safety and effectiveness, shall be ordered to make corrections within a certain period of time, and shall be given a warning; may be imposed a fine of not less than 100,000 yuan and not more than 500,000 yuan.
Article 118 stipulates that if a person produces or sells counterfeit medicines, or produces or sells substandard medicines and the circumstances are serious, the legal representative, the principal person in charge, the supervisors directly in charge and other responsible persons shall confiscate the income derived from the unit during the period in which the illegal act took place and shall be sentenced to a fine of not less than thirty percent and not more than three times the amount of the income derived, and he or she shall be prohibited from engaging in the production and management of medicines for life, and may be sentenced by the public security organs to be sentenced to five days to fifteen days of detention.
Raw materials, auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated.
Definition of Fake Drugs:
Fake drugs are drugs whose ingredients do not conform to the ingredients specified in the national drug standards, drugs that are passed off as drugs or other kinds of drugs, deteriorated drugs, and drugs whose labeled indications or functions are beyond the prescribed scope.
Legal basis
Article 116 of the Drug Administration Law of the People's Republic of China
Anyone who produces or sells counterfeit drugs shall confiscate the illegally produced or sold drugs and the illegal proceeds, and shall be ordered to suspend production and rectify the situation, and shall be revoked of the document certifying the approval of the drugs and shall be sentenced to a fine of fifteen to thirty times of the amount of the value of the illegally produced or sold drugs. The amount of the value of the goods is less than 100,000 yuan, calculated in accordance with 100,000 yuan; the circumstances are serious, the drug production license, drug business license or medical institutions preparation license shall be revoked, and the corresponding application shall not be accepted for ten years; the holder of the listed drug license is an overseas enterprise, the importation of drugs shall be prohibited within ten years.
Article 117 Anyone who produces or sells substandard medicines shall confiscate the illegally produced or sold medicines and the illegal income, and shall be fined not less than ten times and not more than twenty times the amount of the value of the illegally produced or sold medicines; if the amount of the value of the illegally produced or wholesaled medicines is less than one hundred thousand yuan, the amount shall be calculated as one hundred thousand yuan, and if the amount of the value of the illegally retailed medicines is less than ten thousand yuan, the amount shall be calculated as ten thousand yuan; if the circumstances are serious. Ordered to suspend production and rectification until the revocation of drug approval documents, drug production license, drug business license or medical institutions preparation license.
The production and sale of traditional Chinese medicine tablets do not comply with the drug standards, but does not yet affect the safety and effectiveness, shall be ordered to make corrections within a certain period of time, and shall be given a warning; it may be imposed a fine of not less than 100,000 yuan and not more than 500,000 yuan.
Article 118 If a person produces or sells counterfeit medicines, or produces or sells substandard medicines under serious circumstances, the legal representative, the principal person in charge, the directly responsible person in charge and other responsible persons shall be confiscated the income gained from the organization during the period of the illegal act and shall be sentenced to a fine of not less than thirty percent and not more than three times the amount of the income gained, and he or she shall be prohibited from engaging in the production and management of medicines for life and may be sentenced by the public security organs to be sentenced to five days to fifteen days of detention.
Raw materials, auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated.