I. Administrative Liability for Violation of the Drug Administration Law
Mainly in the following points:
1. If a person produces or operates drugs without obtaining a license to produce or operate drugs or a license to make preparations for a healthcare institution, he or she shall be prohibited from doing so, and shall be confiscated of the drugs and the illegal income and shall be sentenced to a fine of not less than two and not more than five times of the amount of the goods of the drugs he or she produces or sells (sold and to be sold, hereinafter referred to as "the drugs"); a criminal liability shall be investigated according to the law. The following fine; constitutes a crime, shall be investigated for criminal responsibility.
Providing false certificates, documents, information, samples, or other deceptive means to obtain a license to manufacture, operate, or use drugs or other drug approval documents, the license shall be revoked or revocation of the drug approval documents, and the application shall not be accepted within 5 years, and shall be subject to a fine of not less than 10,000 yuan and not more than 30,000 yuan.
Any of the following circumstances, in accordance with the above provisions of the penalty: (1) without approval, set up in the bazaar to sell drugs or in the bazaar to sell drugs beyond the scope of the approved business; (2) individuals set up outpatient clinics, clinics and other health care institutions to provide patients with medicines in excess of the prescribed range and varieties.
2. Production, sale, fake drugs or medical institutions using fake drugs, confiscate the fake drugs and illegal income and dedicated to the production of fake drugs of raw and auxiliary materials, packaging materials, production equipment, and impose illegal production and sale of drugs of the same type of drugs of real drugs more than two times the value of the amount of more than five times the following fine; constitutes a crime, shall be prosecuted according to law criminal responsibility; there is a drug approval documents to be withdrawn, revoke the
The direct supervisors and other persons directly responsible for the production and sale of counterfeit medicines shall be prohibited from engaging in the production and operation of medicines within 10 years; those who know (know or should know) that the medicines are counterfeit and provide them with transportation, storage and other facilitating conditions shall have their illegal income confiscated and be subject to a fine.
In violation of the provisions of Article 13 of the Drug Administration Law, unauthorized commissioning or acceptance of commissioned production of drugs, in accordance with the above provisions shall be punished.
3. Anyone who produces or sells substandard drugs or uses counterfeit drugs in a medical institution shall confiscate the substandard drugs and the illegal income, and shall be fined more than one and less than three times the amount of drugs produced or sold and the amount of drugs to be sold equal to the amount of the value of the same kind of drugs; and, if the circumstances are serious, shall be ordered to stop production, suspend business rectification or revoke the document of approval of the drugs, suspend the Drug Manufacturing License, the Drug Business License or "medical institutions preparation license"; constitutes a crime, shall be investigated for criminal responsibility.
The direct supervisors and other persons directly responsible for the production and sale of substandard medicines shall be prohibited from engaging in the production and operation of medicines for a period of 10 years; and those who provide facilities for the transportation and storage of substandard medicines with the full knowledge of their substandard nature shall have their illegal income confiscated and shall be fined.
The production of traditional Chinese medicine tablets without national drug standards, not in line with the provincial drug supervision and management department of the formulation of concoction norms, in accordance with the above provisions shall be punished.
4. Drug manufacturers, drug companies, drug business enterprises, drug non-clinical safety evaluation organizations, drug clinical trial institutions are not in accordance with the provisions of the implementation of the "Good Manufacturing Practice", "Good Management Practice for Drug Business", the quality of drug non-pro non-clinical research management practices, quality management practices for drug clinical trials, give a warning, and ordered to make corrections within a certain period of time; overdue corrections ordered to stop production, Suspension of rectification, and out of more than 5,000 yuan, 20,000 yuan fine; the circumstances are serious, revocation of the "Drug Manufacturing License", "Drug Business License" and the qualification of drug clinical trial institutions.
One of the following circumstances, in accordance with the above provisions of the heavier penalties: (1) the start of drug production enterprises, drug production enterprises, new drug production plant, new production of dosage forms, in the State Council drug supervision and management department of the time not to pass the "Good Manufacturing Practice" certification, but still production; (2) the start of the drug business enterprises, the State Council drug supervision and management department of the time not to pass the "Good Manufacturing Practice" certification, but still production; (2) the start of the drug business enterprises, in the State Council drug supervision and management department (2) the establishment of drug business enterprises, in the State Council drug supervision and management department within the time not through the "Drug Business Quality Management Standard" certification, but still in production.
Drug filers in the declaration of clinical trials, reporting false development methods, quality standards, pharmacology and toxicology test results and other relevant information and samples, the declaration of clinical trials will not be approved, and the filer shall be warned; the circumstances are serious, the application will not be accepted within three years of the declaration of the clinical trials of the species.
5. Drug manufacturers, drug companies in violation of the provisions of the purchase of drugs from unlicensed units, ordered to correct, confiscate the drugs, and impose a fine of more than two times the value of the illegal purchase of drugs 5 times the amount of money; there is illegal income, confiscate the illegal income; the circumstances of the serious revocation of the "Drug Manufacturing License", "Drug License" or the license to practice in a medical institution.
6. The import of drugs has been granted a certificate of registration of drug imports, not in accordance with the provisions of the port to allow the import of drugs to the location of the drug supervision and management department for the record, shall be warned, and ordered to make corrections within a specified period of time; failure to make corrections, the revocation of imported drugs license.
7. Forgery, alteration, trading, leasing, lending licenses or drug approval documents, confiscate the illegal income, and impose a fine of more than one times the illegal income, three times the fine; the circumstances are serious, and revocation of the seller, lessor, lender of the "Drug Manufacturing License", "Drug Business License," "Medical Institutions Preparations License" or revocation of the approval of drug documents; constitute a crime, shall be investigated for criminal responsibility according to law. of criminal responsibility shall be investigated according to law.
8. If a medical institution sells its prepared preparations on the market, it shall be ordered to rectify the situation, confiscate the illegally sold preparations and impose a fine of not less than one but not more than three times of the value of the illegally sold preparations; and if there is any illegal income, it shall be confiscated.
Where a medical institution uses preparations prepared by other medical institutions without authorization, it shall be punished according to the above provisions.
9. Drug business enterprises in violation of "Drug Administration Law," Article 18, Article 19 of the "Drug Purchase and Sales Records", "sales of drugs required" provisions, shall be ordered to make corrections, and given a warning; the circumstances are serious, the revocation of the "drug business license". License".
10. Drug labeling does not comply with the provisions of the law, in addition to counterfeit drugs, substandard drugs, ordered to correct, given a warning; the circumstances are serious, revoke the approval of the drug documents.
If the packaging, labeling, and instructions of the drugs operated by a drug manufacturer or business enterprise or the preparations prepared by a medical institution violate the provisions of the Drug Administration Law, they shall be punished in accordance with the above provisions.
11. Drug testing organization issued a false test report, constituting a crime, shall be investigated for criminal responsibility; does not constitute a crime, shall order correction, give a warning to the unit and impose a fine of 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 30,000 yuan; there is unlawful income, confiscate the unlawful income; the circumstances are serious, revoke the penalty. Income; the circumstances are serious, the withdrawal of its test qualifications. Drug testing organizations issued false test results, resulting in losses, shall bear the corresponding liability.
12. Violation of "Drug Administration Law" Article 55, Article 56, Article 57 on the management of drug prices, in accordance with the "People's Republic of China *** and the State Price Law" shall be punished.
13. Drug manufacturers, drug business enterprises and medical institutions in the purchase and sale of drugs secretly give, accept kickbacks or other benefits, drug manufacturers, business enterprises or their agents to give the use of drugs to the person in charge of medical institutions, drug purchasers, physicians and other relevant personnel to the property or other benefits, by the administration for industry and commerce shall be sentenced to more than 10,000 yuan of 200,000 yuan of the following Fines, there are illegal income, shall be confiscated; the circumstances are serious, by the administrative department for industry and commerce to revoke the business license of drug manufacturers, drug companies, and notify the drug supervision and management department, the drug supervision and management department to revoke its "Drug Manufacturing License", "Drug Business License"; constitutes a crime; shall be investigated for criminal responsibility.
14. The person in charge of drug production and operation enterprises, procurement personnel and other relevant personnel, in the purchase and sale of drugs to accept other production enterprises, business enterprises or agents to give property or other benefits, shall be punished according to law, confiscate the illegal income; constitutes a crime; be held criminally responsible according to law.
The person in charge of a medical institution, drug purchasing personnel, physicians and other relevant personnel to accept drug production, operation enterprises or their agents to give property or other benefits, the administrative department of health or the unit to be given sanctions, confiscation of the illegal income; on the seriousness of the violation of the practicing physician, by the administrative department of health to revoke its certificate of practice; constitutes a crime, shall be investigated for criminal responsibility.
15. Violation of the "Drug Administration Law" on the management of drug advertising, in accordance with the provisions of China's "Advertising Law" penalties, and by the issuance of advertising approval number of the drug supervision and management department to revoke the advertising approval number, 1 year will not be accepted for approval of advertising of the species; constitutes a crime, shall be investigated for criminal responsibility.
If the drug supervision and management department does not fulfill its duty to review drug advertisements in accordance with the law, and the advertisements approved for publication are false or violate the content of laws and administrative regulations, the directly responsible supervisory personnel and other directly responsible personnel shall be given administrative sanctions; if a crime is constituted, the person in charge shall be held criminally liable in accordance with the law.
16. Drug supervision and management departments in violation of the provisions of the Drug Administration Law, one of the following circumstances, by its higher competent authority or supervisory organs ordered to recover the certificate issued in violation of the law, revoke the drug approval documents, the directly responsible officers and other personnel directly responsible for administrative sanctions; constitutes a crime, be held criminally liable according to law:
(1) on the non-compliance of the Good Manufacturing Practice for Pharmaceuticals", "Good Management Practice for Pharmaceutical Business" of enterprises issued a certificate of authentication in line with the relevant norms, or to obtain a certificate of authentication of the enterprise did not fulfill the duties of tracking and inspection in accordance with the provisions of the enterprise does not meet the conditions of authentication and did not order it to make corrections or revoke its certificate of authentication according to the law;
(2) for the unit does not meet the statutory conditions issued the "Pharmaceutical Manufacturing License, Drug Business License" or "Medical Institution Preparation License";
(3) for the drugs that do not meet the import conditions of the imported drugs issued registration certificate;
(4) for the clinical trials or production conditions do not have the conditions but approved for clinical trials, issued a certificate of a new drug, and issued the approval number of the drug.
17. Drug supervision and management department or its set of drug testing organizations or its determination of institutions specializing in drug testing, involved in the production and management of drugs, the higher authorities or supervisory organs ordered to rectify the illegal income shall be confiscated; the circumstances of the seriousness of the situation, the directly responsible for the supervisor and other personnel directly responsible for the administrative sanctions.
Pharmaceutical supervision and management department or its set up by the drug testing organization or its determination of the agency specializing in drug testing staff involved in drug production and management activities, shall be given administrative sanctions.
18. Drug supervision and management department or its set up, determined by the drug testing organizations, in drug supervision and inspection of illegal collection of inspection fees, the relevant government departments ordered to return, the directly responsible officer in charge and other personnel directly responsible for administrative sanctions. Illegal collection of inspection fees for serious cases of institutions, revoke their inspection qualifications.
19. Has obtained a "Drug Manufacturing License", "Drug License" of the enterprise production, sales of counterfeit drugs, substandard drugs, in addition to investigating the enterprise's legal responsibility, there is dereliction of duty, malpractice of drug supervision and management departments directly responsible for supervisors and other personnel directly responsible for the administrative sanctions according to law; constitutes a crime, shall be investigated for criminal responsibility.
20. Higher drug supervision and management department of the lower drug supervision and management of administrative acts in violation of the Drug Administration Law, ordered to make corrections within a certain period of time; overdue corrections, the right to change or revoke the lower level of the specific administrative act.
21. Drug supervision and management personnel abuse of power, favoritism, negligence, constitutes a crime, shall be investigated for criminal responsibility; does not constitute a crime, shall be given administrative sanctions.
Two, violation of the "Drug Administration Law" civil liability
On the violation of the "Drug Administration Law" civil liability, China's "Drug Administration Law," Article 93 provides that: "drug manufacturers, business enterprises, medical institutions in violation of the provisions of this law, to the user of the drugs caused damage, shall bear the liability for compensation. " Violation of the "Drug Administration Law" civil liability, according to this provision.
Third, the violation of the "Drug Administration Law" of criminal responsibility
Violation of the relevant provisions of the "Drug Administration Law", constituting a crime, in accordance with China's "Criminal Law" of the relevant provisions of the criminal responsibility; the specific provisions of the foregoing description, I will not repeat here.