1, without a drug license
2, providing false materials to fraudulently obtain licensing qualifications
3, the use of unreviewed packaging materials or containers in direct contact with the drug sales of such medicines
4, the use of unapproved labels, instructions
5, did not obtain the document of approval of the drug Imported drugs
6, the use of fraudulent means of obtaining drug approval documents imported drugs
7, should be tested without testing that is the sale of drugs
Penalties based on the provisions of the relevant laws of our country to be punished.
Legal basis
"Chinese People's Republic of China*** and the State Drug Administration Law"
Article 115 The production and sale of drugs without obtaining a license for the production of medicines, a license for the operation of medicines, or a license for the preparation of medicinal products for medical institutions shall be ordered to be closed down, and the illegal production and sale of medicines and the illegal proceeds confiscated and imposed illegal Production, sale of drugs (including sold and unsold drugs, the same below) the value of the amount of fifteen times or more than thirty times the amount of the fine; the value of less than 100,000 yuan, calculated as 100,000 yuan.
Article 116 Where a person produces or sells counterfeit medicines, he shall confiscate the illegally produced or sold medicines and the illegal proceeds, order the suspension of production and rectification of business, revoke the document certifying the approval of the medicines, and impose a fine of not less than fifteen times but not more than thirty times the amount of the goods value of the illegally produced or sold medicines; where the amount of the goods value is less than one hundred thousand yuan, the amount shall be calculated at one hundred thousand yuan; where the circumstances are serious, he shall revoke his license for the production of medicines, license to conduct pharmaceutical business, or license to prepare preparations for medical institutions. License or medical institution preparation license, and will not accept the corresponding application within ten years; the holder of the listed drug license is an overseas enterprise, within ten years, prohibit the importation of its medicines.
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 value of the illegally produced or sold medicines; if the value of the illegally produced or wholesaled medicines is less than one hundred thousand yuan, the amount shall be calculated according to one hundred thousand yuan, and if the value of the illegally retailed medicines is less than ten thousand yuan, the amount shall be calculated according to ten thousand yuan; if the circumstances are serious, the person concerned shall be 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 a lifetime. 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.
Article 119 The use of counterfeit or substandard medicines by a unit using medicines shall be punished in accordance with the provisions on the sale of counterfeit medicines and the retail sale of substandard medicines; where the circumstances are serious, the legal representative, the principal person in charge, the supervisory personnel directly responsible for, and other responsible personnel who have a certificate of practice as a healthcare worker shall also have their certificates of practice revoked.
Article 120 If a person who knows or should know that a drug is counterfeit or substandard or is one of the drugs specified in the first paragraph of Article 124, subparagraphs (1) to (5), of this Law, and provides it with storage, transportation and other facilities, shall confiscate all the income from storage and transportation, and shall be fined at not less than one but not more than five times the unlawful income; in case of seriousness of the circumstances, he or she shall also be fined at not less than five but not more than fifteen times the unlawful income; in case the unlawful income is less than fifty thousand yuan, the fine shall be at not less than five but not more than fifteen times. If the income is less than fifty thousand yuan, it shall be calculated at fifty thousand yuan.
Article 121: Decisions on penalties for counterfeit or substandard medicines shall, in accordance with the law, contain the conclusions of the quality inspection by the drug inspection organization.
Article 122 Anyone who forges, alters, rents, lends, or illegally trades in licenses or documents certifying approval of medicines shall have the illegal income confiscated and shall be fined at not less than double and not more than five times the illegal income; if the circumstances are serious, he or she shall also be fined at not less than five and not more than fifteen times the illegal income, and shall have his or her license to manufacture medicines, license to operate medicines, license to formulate preparations for health care institutions, or document certifying approval of medicines revoked. Proof of documents, the legal representative, the main person in charge, directly responsible for the supervisors and other responsible persons, shall be sentenced to a fine of not less than 20,000 yuan and not more than 200,000 yuan, and prohibited from engaging in the production and operation of medicines within ten years, and may be sentenced by the public security organs to detention for not less than five days and not more than fifteen days; the illegal income of less than one hundred thousand yuan, calculated on the basis of one hundred thousand yuan.
Article 123 Where a person provides false certificates, data, information, samples or adopts other means to fraudulently obtain a clinical trial license, drug production license, drug business license, medical institution preparation license or drug registration license, the relevant license shall be revoked, and the corresponding application shall not be accepted within ten years, and a fine of not less than five hundred thousand Yuan and not more than five million Yuan shall be imposed; where the circumstances are serious, the legal representative, The seriousness of the case, the legal representative, the main person in charge, directly responsible for the supervisors and other responsible personnel, a fine of 20,000 yuan or more than 200,000 yuan or less, within ten years prohibited from engaging in the production and operation of pharmaceutical activities, and can be sentenced by the public security organs of the five days or more than fifteen days of detention.