Type of Punishment: Confiscation of illegally produced or sold drugs and illegal proceeds, and fines
Legal Basis:
Article 73 of the Chinese People's Republic of China's Law of the People's Republic of China on the Administration of Pharmaceuticals "Anyone who produces or operates drugs without obtaining a Drug Manufacturing License, a Drug Operation License or a Medical Institution Preparation License shall be banned according to law, the illegally produced or sold drugs and the illegal income shall be confiscated, and a fine of not less than two times and not more than five times the amount of the goods value of the illegally produced or sold drugs (including both sold and unsold drugs, the same hereinafter) shall be imposed; Constitutes a crime, shall be investigated for criminal responsibility according to law."
Second, the production and sale of counterfeit medicines
Type of punishment: confiscation of illegal production and sale of drugs and illegal income, fines, revocation of the approval certificate, ordered to stop production, suspension and rectification, revocation of licenses, and prohibited from practicing medicine for ten years
Legal basis:
Article 74 of the Chinese People's Republic of China Drug Administration Law "Anyone who produces or sells counterfeit drugs shall confiscate the illegally produced or sold drugs and the illegal income, and shall be fined at not less than two times and not more than five times the amount of the value of the illegally produced or sold drugs; if there is a document certifying the approval of the drugs, it shall be revoked, and ordered to stop production or business rectification; if the circumstances are serious, the "Drug Production License", "Drug Business License", or "Preparation License for Medical Institutions" shall be suspended; if a crime is constituted, the license shall be suspended within ten years. License"; constitutes a crime, shall be investigated for criminal responsibility."
Article 76: "Enterprises or other units engaging in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not allow their directly responsible supervisors and other directly responsible persons to engage in the production and operation of medicines within ten years.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively for the production of counterfeit or substandard drugs by the producer shall be confiscated."
Third, the production and sale of substandard drugs
Type of punishment: confiscation of illegal production and sale of drugs and illegal income, fines, revocation of the approval certificate, ordering, suspension of production, shutdown and rectification, revocation of licenses, and prohibited from engaging in the practice of the profession for ten years
Legal basis:
Article 75 of the Chinese People's Republic of China **** and the State Drug Control Law "Whoever produces or sells substandard drugs shall confiscate the illegally produced or sold drugs and the illegal income, and shall be fined not less than double and not more than triple the amount of the value of the illegally produced or sold drugs; if the circumstances are serious, he shall be ordered to stop production, suspend business and rectify the situation, or revoke the document of approval of the drugs, or revoke the "Drug Manufacturing License", the "Drug Business License", or the "Preparation License for Medical Institutions"; Constitutes a crime, shall be investigated for criminal responsibility according to law."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not allow their directly responsible supervisors and other directly responsible persons to engage in the production and operation of medicines within ten years.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively for the production of counterfeit and substandard drugs by the producer shall be confiscated."
Fourth, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs as other drugs, or other drugs as the above drugs
Type of punishment: confiscation of illegal production, sale of drugs and illegal income, fines, revocation of the approval of the certification documents, ordered to stop production, suspension and reorganization of the business, revocation of the license, within ten years, shall be prohibited from engaging in the practice of the profession
Legal basis
l. Article 74 of the Drug Administration Law of the People's Republic of China: "If a person produces or sells counterfeit drugs, he shall confiscate the illegally produced or sold drugs and the illegal proceeds, and shall be fined at not less than two times and not more than five times the amount of the goods value of the illegally produced or sold drugs; if there is a document certifying the approval of a drug, it shall be revoked, and he shall be ordered to stop the production or suspend the business for reorganization; in case of a serious case. Revocation of the Drug Production License, Drug Operation License or Medical Institution Preparation License; constitutes a crime, shall be investigated for criminal responsibility."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not allow their directly responsible supervisors and other directly responsible persons to engage in the production and operation of medicines within ten years.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated."
2. Article 79 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and the People's Republic of China "In case of violation of the provisions of the Drug Administration Law and these Regulations, any one of the following acts shall be punished more severely by the drug supervision and administration department within the range of punishment stipulated by the Drug Administration Law and the Regulations:
(1) Counterfeiting anesthesia drugs, psychotropic drugs, medical toxic drugs, and radioactive drugs for the production of counterfeit or substandard drugs shall be confiscated. (a) Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs as other drugs, or other drugs as the above drugs;"
V. Production and sale of counterfeit or substandard drugs mainly for use by pregnant women, infants and children
Types of penalties: confiscation of illegally produced or sold drugs and illegal income, fines, revocation of the approval of the documents, and ordering the production to be suspended, shut down and reorganized. Suspension of production, suspension of rectification, revocation of licenses, prohibited from practicing for ten years
Legal basis:
1, "People's Republic of China *** and the State Drug Administration Law," Article 74, "the production and sale of counterfeit medicines, confiscation of illegal production and sale of medicines and the illegal income, and impose a fine of not less than twice and not more than five times the amount of the goods of the illegal production and sale of medicines; If there is a document certifying the approval of the drug, it shall be revoked, and ordered to stop production or business rectification; if the circumstances are serious, the Drug Manufacturing License, Drug Business License, or Medical Institution Preparation License shall be revoked; if a crime is constituted, criminal responsibility shall be investigated in accordance with the law."
Article 75: "Anyone who produces or sells substandard medicines shall confiscate the illegally produced or sold medicines and the illegal income, and shall be fined at not less than double and not more than triple the value of the illegally produced or sold medicines; if the circumstances are serious, he shall be ordered to cease production, suspend business and carry out rectification, or to revoke the documents certifying the approval of medicines, or to revoke the Medicines Manufacturing License, Medicines Business License or Preparation License for Medical Institutions; if a crime is constituted, criminal responsibility shall be investigated according to law."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not be allowed to engage in the production and operation of medicines within ten years for the persons directly in charge and other persons directly responsible.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated."
2. Article 79 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and of the State of China: "Anyone who violates the provisions of the Drug Administration Law and these Regulations and commits any of the following acts shall be punished more severely by the drug supervision and administration department within the range of punishment stipulated in the Drug Administration Law and these Regulations:
(2) Production and sale of counterfeit medicines which are mainly for use by mothers, infants, young children and children as the main object of use of fake drugs, substandard drugs;"
VI. Production and sale of biological products, blood products are fake drugs, substandard drugs
Types of punishment: confiscation of illegal production, sale of drugs and illegal income, fines, revocation of the approval of the documents, ordering the suspension of production, shutdown, consolidation, revocation of licenses, a ban of ten years to practise
Legal basis:
1, "People's Republic of China *** and the State Drug Administration Law," Article 74 "the production and sale of counterfeit drugs, confiscate the illegal production and sale of drugs and illegal income, and impose the illegal production and sale of drugs of the value of the amount of more than two times the amount of five times the following fines; have the approval of the drug certification documents shall be revoked, and ordered to stop production, suspension and reorganization; if the circumstances are serious, revocation of the "Drug Production License", "Drug Business License" or "Medical Institutions Preparation License"; constitutes a crime, be investigated for criminal responsibility according to law."
Article 75: "Anyone who produces or sells substandard drugs shall confiscate the illegally produced or sold drugs and the illegal income, and shall be fined not less than double and not more than triple the amount of the value of the illegally produced or sold drugs; if the circumstances are serious, he shall be ordered to stop production, suspend business and rectify the situation, or revoke the approval documents of the drugs, suspend the Drug Manufacturing License, the Drug Operation License or the Preparation License for Medical Institutions; if a crime is constituted, criminal responsibility shall be investigated according to law."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not be allowed to engage in the production and operation of medicines within ten years for the persons directly in charge and other persons directly responsible.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated."
2. Article 79 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and of the State of China "In case of violation of the provisions of the Drug Administration Law and these Regulations, any one of the following acts shall be punished more severely by the drug supervision and administration department within the range of punishment provided for in the Drug Administration Law and the Regulations:
(3) Biological products produced or sold, blood products are counterfeit drugs, substandard drugs;"
Seven, the production, sale, use of counterfeit drugs, substandard drugs, resulting in the consequences of injury to persons
Types of penalties: confiscation of illegal production, sale of drugs and illegal income, fines, revocation of the approval of the certification documents, ordered to stop production, suspension of rectification, revocation of licenses, and banned from practicing for ten years
Legal basis:
1. Article 74 of the Drug Administration Law of the People's Republic of China "If a person produces or sells a counterfeit drug, he shall confiscate the illegal production or sale of the drug and the illegal proceeds, and shall also be fined at not less than two times and not more than five times the amount of the goods value of the illegal production or sale of the drug; if there is any drug approval document, it shall be withdrawn, and ordered to stop the production or suspend the business for a period of rectification; If the circumstances are serious, revoke the "Drug Production License", "Drug Business License" or "Preparation License for Medical Institutions"; constitutes a crime, shall be investigated for criminal responsibility."
Article 75: "Anyone who produces or sells substandard drugs shall confiscate the illegally produced or sold drugs and the illegal proceeds, and shall be fined not less than double and not more than triple the amount of the value of the illegally produced or sold drugs; if the circumstances are serious, he shall be ordered to stop production, suspend business and carry out rectification, or revoke the approval documents of the drugs, suspend the Drug Manufacturing License, the Drug Operation License or the Preparation License for Medical Institutions; if a crime is constituted, criminal responsibility shall be investigated according to law."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not allow their directly responsible supervisors and other directly responsible persons to engage in the production and operation of medicines within ten years.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer to produce counterfeit or substandard drugs shall be confiscated."
2. Article 79 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and of the State of China: "Anyone who violates the provisions of the Drug Administration Law and these Regulations, and commits any of the following acts, shall be punished more severely by the drug supervision and administration department within the range of punishment provided for in the Drug Administration Law and the Regulations:
(4) Produces, sells, or uses counterfeit drugs or substandard drugs
Eight, the production, sale, use of counterfeit drugs, substandard drugs, after treatment, repeat offenders
Type of punishment: confiscation of illegal production, sale of drugs and illegal income, fines, revocation of the approval of the certification documents, ordered to stop production, suspension of rectification, revocation of licenses, a ban of ten years to practise
Legal basis
1. Article 74 of the Drug Administration Law of the People's Republic of China: "If a person produces or sells counterfeit drugs, he shall confiscate the illegally produced or sold drugs and the illegal proceeds, and shall be fined at not less than two times and not more than five times the amount of the goods value of the illegally produced or sold drugs; if there is a document certifying the approval of a drug, it shall be revoked, and he shall be ordered to stop the production or suspend the business for reorganization; in case of a serious case. Revocation of the "Drug Production License", "Drug Business License" or "Medical Institution Preparation License"; constitutes a crime, shall be investigated for criminal responsibility."
Article 75: "Anyone who produces or sells substandard drugs shall confiscate the illegally produced or sold drugs and the illegal income, and shall be fined at not less than double and not more than triple the amount of the value of the illegally produced or sold drugs; if the circumstances are serious, he shall be ordered to stop production, suspend business and carry out rectification, or revoke the approval documents of the drugs, suspend the Drug Manufacturing License, the Drug Operation License or the Preparation License for Medical Institutions"; constitutes a crime, shall be investigated for criminal responsibility."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not allow their directly responsible supervisors and other directly responsible persons to engage in the production and operation of medicines within ten years.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated."
2. Article 79 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and of the State of China: "Anyone who violates the provisions of the Drug Administration Law and these Regulations and commits any of the following acts shall be punished more severely by the drug supervision and administration department within the range of punishment stipulated in the Drug Administration Law and the Regulations:
(5) Producing, selling, or using counterfeit or substandard medicines Prohibited from practicing within ten years
Legal basis:
1, "People's Republic of China *** and the State Drug Administration Law," Article 74, "the production and sale of counterfeit drugs, confiscate the illegal production and sale of drugs and illegal income, and impose a fine of not less than twice and not more than five times the amount of the value of illegally produced and sold drugs; there is a proof of approval of the document to be revoked and ordered to stop production, suspend business rectification; the circumstances are serious, revocation of the "Drug Manufacturing License", "Drug Business License" or "Preparation License for Medical Institutions"; constitutes a crime, shall be investigated for criminal responsibility."
Article 75: "Anyone who produces or sells substandard drugs shall confiscate the illegally produced or sold drugs and the illegal proceeds, and shall be fined not less than double and not more than triple the amount of the value of the illegally produced or sold drugs; if the circumstances are serious, he shall be ordered to stop production, suspend business and rectify the situation, or revoke the approval documents of the drugs, revoke the Drug Manufacturing License, the Drug Business License or the Preparation License for Medical Institutions"; constitutes a crime, shall be investigated for criminal responsibility."
Article 76: "Enterprises or other units engaged in the production and sale of counterfeit medicines and the production and sale of substandard medicines under serious circumstances shall not allow their directly responsible supervisors and other directly responsible persons to engage in the production and operation of medicines within ten years.
The raw and auxiliary materials, packaging materials, and production equipment used exclusively by the producer for the production of counterfeit or substandard drugs shall be confiscated."
2. Article 79 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and the State of China, "Anyone who violates the provisions of the ((Drug Administration Law) and these Regulations and commits any of the following acts shall be punished more severely by the drug supervision and administration department within the range of penalties stipulated in the Drug Administration Law and the Regulations:
(6) refusing or evading supervision and inspection, or Falsification, destruction, concealment of relevant evidence and materials, or unauthorized use of seized or impounded items."
X. Medical institutions using counterfeit drugs, substandard drugs
Type of punishment: confiscation of illegal production, sale of drugs and illegal income, fines, revocation of the approval of the documents, ordered to stop production, suspension of rectification, revocation of licenses, a ten-year ban on the practice of
Legal basis:
1, "Chinese People's Republic of China * * * and the State Drug Administration Law," Article 74 "The production and sale of counterfeit drugs, confiscate the illegal production and sale of drugs and illegal income, and impose illegal production and sale of drugs more than two times the amount of the value of goods less than five times the fine; have the drug approval documents shall be revoked, and ordered to stop production, suspension and reorganization; the circumstances are serious, the revocation of the "Drug Manufacturing License", "Drug Business License" or "Medical Institutions Formulation License"; constitutes a crime, shall be investigated for criminal responsibility."
Article 75: "Anyone who produces or sells substandard drugs shall confiscate the illegally produced or sold drugs and the illegal income, and shall be fined at not less than double and not more than triple the amount of the value of the illegally produced or sold drugs; if the circumstances are serious, he shall be ordered to stop production, suspend business and carry out rectification, or revoke the approval documents of the drugs, suspend the Drug Manufacturing License, the Drug Operation License or the Preparation License for Medical Institutions; constitutes a crime, shall be investigated for criminal responsibility."
2, "Chinese People's **** and the State Drug Administration Law Enforcement Regulations" Article 68 "medical institutions using counterfeit drugs, substandard drugs, in accordance with the provisions of Article 74, Article 75 of the Drug Administration Law shall be punished." should know that belongs to the fake and shoddy drugs and provide them with transportation, storage, warehousing and other facilities, confiscate all the transportation, storage, warehousing receipts, and impose illegal receipts of more than fifty percent of the fine of not less than three times; constitutes a crime, shall be investigated for criminal responsibility."
XII, drug manufacturers, business enterprises, drug non-clinical safety evaluation of research institutions, drug clinical trial institutions in accordance with the provisions of the implementation of the "Good Manufacturing Practice", "Good Management Practice for Drug Administration", "Good Quality Management Practice for Drug Operation", "Good Manufacturing Practice for Drug Non-Clinical Research", "Good Quality Management Practice for Drug Clinical Trials"
Types of penalties: warnings, ordered to stop production, suspension and reorganization, Fines, revocation of licenses and qualifications
Legal basis:
Article 79 of the Drug Administration Law of the People's Republic of China "Drug manufacturers, business enterprises, drug non-clinical safety evaluation research institutes, drug clinical trial institutes fail to implement the "Good Manufacturing Practice for Drug Production", "Good Management Practice for Drug Business", "Good Management Practice for Drug Non-Clinical Research", "Good Management Practice for Drug Non-Clinical Research", "Good Management Practice for Drug Non-Clinical Research", "Good Management Practice for Drug Non-Clinical Research", and "Good Management Practice for Drug Clinical Trials", in accordance with the regulations. Specification for the Quality Management of Drug Manufacturing, the Specification for the Quality Management of Drug Non-clinical Research, and the Specification for the Quality Management of Drug Clinical Trials, shall be given a warning and ordered to make corrections within a certain period of time; if no corrections are made after the expiration of this period, they shall be ordered to stop production and business rectification, and shall be imposed a fine of not less than 5,000 yuan and not more than 20,000 yuan; if the circumstances are serious, they shall be subject to the revocation of their "Drug Manufacturing License," "Drug Business License," and qualifications for drug clinical trial institutions."
Thirteen, drug manufacturers, business enterprises or medical institutions from the lack of "Drug Manufacturing License", "Drug Business License" enterprises to purchase drugs
Types of penalties: confiscation of illegal purchase of drugs, confiscation of illegal income, fines, revocation of licenses
Legal basis:
"Chinese People's **** and the State Law on Drug Administration" Article 8 Article 10 "If a pharmaceutical manufacturer, business enterprise or medical institution violates the provisions of Article 34 of this Law by purchasing drugs from an enterprise that does not have a Drug Manufacturing License or a Drug Business License, it shall be ordered to rectify the situation, confiscate the illegally purchased drugs, and impose a fine of not less than two but not more than five times the amount of the value of the illegally purchased drugs; if there is any illegal income, the illegal income shall be confiscated; If the circumstances are serious, revocation of the Drug Manufacturing License, Drug Operation License, or the license to practice in medical institutions."
XIV, the import of drugs have been issued a certificate of registration of drug imports, not in accordance with the provisions of the port of entry to allow the import of drugs to the seat of the drug supervision and management department of the registration record
Punishment: warning, revocation of the certificate of registration
Legal basis:
The Chinese People's Republic of China and the State Drug Administration Law, Article 81 "The import of drugs that have been granted a certificate of registration for import of drugs, not in accordance with these regulations to allow the import of drugs to the port of the location of the drug supervision and management department to register for the record, be given a warning and ordered to make corrections within a specified period of time; overdue correction, revocation of the certificate of registration of the imported drugs."
Fifteen, forgery, alteration, trading, leasing, lending of licenses or drug approval documents
Types of punishment: confiscation of illegal income, fines, suspension of licenses, revocation of the approval documents
Legal basis:
"Chinese People's Republic of China *** and the State Drug Administration Law," Article 82, "forgery, Anyone who forges, alters, buys, sells, rents, or lends a license or drug approval certification document shall have the illegal income confiscated and shall be fined at not less than double and not more than triple the illegal income; if there is no illegal income, he shall be fined at not less than 20,000 yuan and not more than 100,000 yuan; if the circumstances are serious, he shall also revoke the Drug Production License, Drug Operation License, and Drug Preparation Permit for Healthcare Institutions of the seller, lessor, and lender, or withdraw the Drug approval documents; constitutes a crime, shall be investigated for criminal responsibility."
Sixteen, provide false proof, document information samples or take other deceptive means to obtain the "Drug Manufacturing License", "Drug Business License", "Preparation License for Medical Institutions" or drug approval certification documents
Type of punishment: revocation of license, revocation of the approval of the certification documents, fines
Legal basis. People's Republic of China **** and the State Drug Administration Law" Article 83 "violation of the provisions of this law, provide false proofs, documents and information samples or take other deceptive means to obtain the "Drug Manufacturing License", "Drug Business License", "Preparation License for Medical Institutions" or the drug approval documents, revocation of the "Drug Manufacturing License", "Drug Business License , the Preparation License for Medical Institutions or revocation of the document certifying the approval of medicines, not to accept their applications within five years, and impose a fine of not less than 10,000 yuan and not more than 30,000 yuan."
XVII, medical institutions will be formulated in the market sales of preparations
Type of punishment: confiscation of illegal sales of preparations, confiscation of illegal income, fines
Legal basis:
"People's Republic of China *** and the State Drug Administration Law", Article 84, "medical institutions will be formulated in the market sales of preparations, shall be ordered to make corrections, confiscate the illegal income. It shall be ordered to make corrections, confiscate the illegally sold preparations, and impose a fine of not less than double and not more than three times the amount of the value of the illegally sold preparations; if there is any illegal income, the illegal income shall be confiscated."
18, the drug business enterprises purchase and sale of drugs incomplete or untrue records
Type of punishment: warning, revocation of licenses
Legal basis:
"Chinese People's Republic of China *** and the State Drug Administration Law," Article 18, "drug business enterprises purchase and sale of medicines, there must be a true and complete record of purchase and sale. Purchase and sale records must indicate the generic name of the drug, dosage form, specifications, batch number, expiration date, manufacturer, purchase (sale) unit, purchase (sale) quantity, purchase (sale) price, purchase (sale) date and the State Council drug supervision and management department of the other contents of the provisions of the drug."
Article 85 "Drug business enterprises in violation of the provisions of Article 18 and Article 19 of this Law, shall be ordered to make corrections, and given a warning; if the circumstances are serious, the revocation of the Drug Business License."
XIX, the drug business enterprises do not comply with the provisions of the law to sell drugs
Type of punishment: warning, revocation of the license
Legal basis:
The Chinese People's Republic of China *** and the State Drug Administration Law, Article 19 "Drug business enterprises selling drugs must be accurate and correctly explain the usage, dosage and precautions; dispense prescriptions and notes. and precautions; dispensing prescriptions must be checked, the drugs listed in the prescription shall not be changed without authorization or substitution. There are contraindications or excessive dosage of the prescription, should be refused to deploy; if necessary, by the prescribing physician to correct or re-signature, can be deployed.
Drug companies selling Chinese herbal medicines must be labeled with the place of origin."
Article 85 "Drug business enterprises in violation of the provisions of Article 18 and Article 19 of this Law, shall be ordered to make corrections and given a warning; if the circumstances are serious, the revocation of the Drug Business License."
XX, drug labeling does not comply with the provisions of the law
Type of punishment: warning, revocation of the approval of documents
Legal basis:
1, "People's Republic of China *** and the State Drug Administration Law," Article 54, "Drug packaging must be printed in accordance with the provisions of the labeling or labeling and accompanied by instructions. Label or instructions must indicate the generic name of the drug, ingredients, specifications, manufacturer, approval number, product batch number, date of manufacture, expiration date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions.
The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals, medicines for external use, and over-the-counter medicines must bear the prescribed symbols."
Article 86 "Where the labeling of a drug does not conform to the provisions of Article 54 of this Law, except for those which shall be dealt with in accordance with the law as counterfeit or substandard drugs, it shall be ordered to make corrections and be given a warning; if the circumstances are serious, the approval certification document of the drug shall be revoked."
2, "Drug Instructions and Labeling Regulations" Article 30 "Drug instructions and labeling does not comply with the provisions of this regulation, in accordance with the "Chinese People's *** and the State Drug Administration Law" of the relevant provisions of the punishment."
Twenty-one, the drug testing organization issued a false test report
Type of punishment: warning, fines, confiscation of illegal income, revocation of qualifications
Legal basis:
"Chinese People's Republic of China **** and the State Drug Administration Law" Article 87 "drug testing organization issued a false test report, constituting a crime. Criminal liability shall be investigated according to law; does not constitute a crime, shall order rectification, give a warning to the unit and impose a fine of more than 30,000 yuan 50,000 yuan; directly responsible for the competent person and other personnel directly responsible for the law shall be given a demotion, dismissal, dismissal, and impose a fine of less than 30,000 yuan; there is illegal income, confiscation of the illegal income; if the circumstances are serious, the revocation of its inspection qualifications. Drug testing organizations issued by the test results are not true, resulting in losses, shall bear the corresponding liability."
Twenty-two, the opening of pharmaceutical production enterprises, pharmaceutical production enterprises, new drug production plant, new production of dosage forms, in the State Council drug supervision and management department of the specified time did not pass the "Good Manufacturing Practice" certification, but still carry out the production of drugs
Type of punishment: warning, ordered to stop production, suspension, fines, revocation of licenses and qualifications
Legal basis:
1, "Chinese People's *** and the State Drug Administration Law" Article 79 "drug manufacturers, business enterprises, drug non-clinical safety evaluation of research institutions, drug clinical trial institutions in accordance with the provisions of the implementation of the "Good Manufacturing Practice," the "Good Management Practice for Drug Business," the quality of non-clinical studies of drugs, the quality of clinical trials, the implementation of norms , the quality management standard for drug clinical trials, shall be given a warning and ordered to make corrections within a certain period of time; if they fail to make corrections after the expiration of the period of time, they shall be ordered to suspend production and business rectification, and shall be fined not less than 5,000 yuan and not more than 20,000 yuan; if the circumstances are serious, they shall be revoked their Drug Production License, Drug Operation License, and qualifications of drug clinical trial institutions."
2. Article 63 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China*** and the People's Republic of China "If a drug manufacturer or drug business enterprise has any of the following circumstances, it shall be punished by the drug supervision and management department in accordance with the provisions of Article 79 of the Drug Administration Law:
(1) Starting up a drug manufacturing enterprise or a drug manufacturing enterprise that builds a new drug Production plant, new production of dosage forms, in the State Council drug supervision and management department within the time specified by the "Good Manufacturing Practice" certification, still carry out the production of drugs; "
Twenty-three, the opening of drug business enterprises, in the State Council drug supervision and management department within the time specified by the "Good Manufacturing Practice" certification, still carry out the drug business Drug business
Types of punishment: warning, ordered to stop production, suspension and rectification, fines, revocation of licenses and qualifications
Legal basis:
1, "People's Republic of China *** and the State Drug Administration Law", Article 79 "Drug production enterprises, business enterprises, drug non-clinical safety evaluation of research institutes, drug clinical trials Business License" and the qualification of drug clinical trial institutions."
2, "People's Republic of China *** and the State Drug Administration Law Enforcement Regulations," Article 63 "drug manufacturers, drug business enterprises in one of the following circumstances, by the drug supervision and management department in accordance with the provisions of Article 79 of the Drug Administration Law shall be punished:
(2) the start-up of drug business enterprises in the State Council drug supervision and management department of the failure to pass the "Drug Administration Law" within the time prescribed by the drug administration department of the State Council. (B) the start of drug business enterprises, in the State Council Drug Administration within the time specified by the department did not pass the "Drug Business Quality Management Standard" certification, but still carry out drug business."
Twenty-four, unauthorized commissioning or acceptance of commissioned production of drugs
Type of punishment: confiscation of illegal production, sale of drugs and illegal income, fines, revocation of the approval of the documents, ordered to stop production, suspension, suspension of rectification, revocation of the license, within ten years of the ban on the practice of
Legal basis:
1. Article 13 "approved by the drug supervision and management department of the State Council or the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government authorized by the State Council drug supervision and management department, drug manufacturers can accept entrusted production of drugs."
Article 74: "Anyone who produces or sells counterfeit medicines shall confiscate the illegally produced or sold medicines and the illegal income, and shall be fined not less than two times and not more than five times the amount of the value of the illegally produced or sold medicines; if there is a document certifying the approval of the medicines, the document shall be revoked, and shall be ordered to stop production or suspend business for rectification; and in case of seriousness of the case, the Drug Manufacturing License, the Drug Operation License or the Preparation for Medical Institutions License shall be revoked. License" or "Medical Institution Preparation License"; constitutes a crime, shall be investigated for criminal responsibility."
2, "the Chinese people *** and the State Drug Administration Law Enforcement Regulations" Article 64 "violation of the provisions of Article 13 of the Drug Administration Law, unauthorized commissioning or acceptance of commissioned production of drugs, the commissioning party and the commissioned party are in accordance with the provisions of Article 74 of the Drug Administration Law shall be punished."
Twenty-five, without authorization, set up in urban and rural markets and trade markets to sell drugs or set up in urban and rural markets and trade markets to sell drugs in excess of the approved scope of drugs
Type of punishment: confiscation of illegal production, sale of drugs and illegal income, fines
Legal basis:
1, "The Chinese People's Republic of China *** and the State Drug Administration Law" Article 73 ", the commissioning party and the commissioning party shall be punished in accordance with the provisions of Article 74 of the "Drug Administration Law". Administration Law, Article 73 "If a person fails to obtain a Drug Manufacturing License, a Drug Operation License or a Medical Institution Preparation License to produce or operate drugs, he shall be banned according to law, the illegally produced or sold drugs and the illegal income shall be confiscated, and a fine of not less than two times and not more than five times the amount of the value of the illegally produced or sold drugs shall be imposed on the person concerned; and if a crime is constituted, it shall be investigated for criminal responsibility in accordance with law. Criminal responsibility shall be investigated according to law."
2, "People's Republic of China *** and the State Drug Administration Law Enforcement Regulations" Article 65 "without authorization, unauthorized in the urban and rural market trade market set up sales of drugs or in the urban and rural market trade market set up sales of drugs in excess of the approved scope of the drugs, in accordance with the provisions of Article 73 of the Drug Administration Law shall be punished. "
Twenty-six, without approval, the medical institutions to use other medical institutions prepared preparations
Types of punishment: confiscation of illegally purchased drugs, confiscation of the illegal income, fines, revocation of licenses
Legal basis:
1, "People's Republic of China *** and the State Law on Drug Administration", Article 80 "drug Manufacturing enterprises, business enterprises or medical institutions in violation of the provisions of Article 34 of this Law, from no "Drug Manufacturing License", "Drug Business License" of the enterprise purchase of drugs, shall order rectification, confiscate the illegal purchase of drugs, and impose a fine of more than two times the amount of the value of the illegal purchase of drugs not exceeding five times the amount of the goods; there is illegal income, confiscate the illegal income; the circumstances are serious, revocation of the "Drug Manufacturing License", "Drug Business License" or medical institution license. Drug Business License" or the license to practice in medical institutions."
2, "People's Republic of China *** and the State Drug Administration Law Enforcement Regulations," Article 66 "without authorization, the medical institutions without authorization to use other medical institutions formulated preparations, in accordance with the provisions of Article 80 of the Drug Administration Law shall be punished."