Article 45 violation of the provisions of these measures, the relevant laws and regulations have been punished and sanctioned provisions, from its provisions. Article 46 of the food and drug supervision and management and other departments and their staff have one of the following behaviors, by the competent authority in accordance with the management authority, the directly responsible officer in charge and other personnel directly responsible for administrative sanctions:
(a) not in accordance with the provisions of Article 37, Article 38 of these Measures to implement the supervision and inspection and random inspection;
(b) not in accordance with Article 39 of these Measures Provisions to the community to publish the results of quality sampling and testing of drugs and medical devices used in medical institutions;
(3) not in accordance with the provisions of Article 43 of these Measures to publish and handle complaints and reports;
(4) not in accordance with the provisions of Article 44 of these Measures to investigate and handle, referral, as well as the supervision and management of medical advertisements for a comprehensive assessment;
(5) there are other favoritism, neglect of duty, abuse of power.
Article 47 of the medical institutions in one of the following circumstances, by the food and drug supervision and management department at or above the county level shall order rectification within a certain period of time; overdue rectification, may be fined not less than 1,000 yuan to 10,000 yuan:
(a) not in accordance with the provisions of Article 7 of these Measures on the purchase of medicines, medical equipment inspection;
(b) not in accordance with the provisions of Article 8 of these Measures, Article 9 of the purchase of drugs, medical equipment to make acceptance records;
(3) not in accordance with the provisions of this approach to storage, maintenance of drugs, medical equipment;
(4) not in accordance with the provisions of Article 25, Article 26 of this approach to establish and implement the management system for the safe use of medical equipment, equipment, the use of personnel induction training system and maintenance and safety testing system;< /p>
(E) not in accordance with the provisions of Article 27 of the implantable medical device registration.
Article 48 of the medical institutions have one of the following circumstances, by the health administrative department at or above the county level ordered to make corrections within a specified period of time; overdue corrections may be fined more than 1,000 yuan to 10,000 yuan:
(a) violation of the provisions of Article 16, Article 17 of this approach to the use of medicines and medical devices;
(b) not in accordance with the provisions of this method of prescribing, auditing, Dispensing of prescriptions and medicines;
(3) Failure to provide price lists to patients in accordance with the provisions of Article 34 of these Measures, or failure to respond in a timely manner to the inquiries of patients.
Article 49 of the hospital-type medical institutions in accordance with the provisions of Article 29 and Article 30 of these Measures, the establishment and implementation of drugs, medical equipment abnormal use of the control system and prescription assessment system, by the health administrative department at or above the county level and ordered to make corrections within a certain period of time; overdue corrections may be fined more than 3,000 yuan and less than 30,000 yuan.
Article 50 of the medical institutions in violation of the provisions of the first paragraph of Article 33 of these Measures, continue to use unqualified drugs and medical devices, by the food and drug supervision and management department in accordance with the provisions of the relevant state laws and regulations to be dealt with; continue to use the quality of the drugs and medical devices suspected, by the food and drug supervision and management department shall order to stop the use of the food and drug supervision and management department, according to the circumstances of the more than 20,000 yuan of the 50,000 yuan fine below. fine.
Medical institutions in violation of the provisions of paragraph 2 of Article 33 of these Measures, the unqualified or doubtful quality of drugs and medical devices to return or exchange their own, by the food and drug supervision and management department ordered to recover within a certain period of time, and may impose a fine of 5,000 yuan or more than 50,000 yuan.
Article 51 of the medical institutions and their relevant personnel in violation of the provisions of Article 41 of these Measures, accept kickbacks or other benefits, in accordance with the "People's Republic of China *** and the State Drug Administration Law", "the People's Republic of China *** and the State Anti-Unfair Competition Law" of the relevant provisions of the implementation of the penalties.
Physicians in violation of the provisions of Article 42 of these measures, profiting from improper interests, in accordance with the "Chinese People's *** and the State Practitioners Law" Article 37 of the implementation of penalties.
Article 52 of the medical institutions conceal the report, slow report of adverse drug reactions, adverse events of medical devices, by the health administrative department at or above the county level to give a notice of criticism, may be fined more than 1,000 yuan to 30,000 yuan; directly responsible for the supervisor and other personnel directly responsible for the competent authority by the competent authorities to give disciplinary action.
Article 53 of the medical institutions to conceal the report, slow report of the use of drugs and medical equipment safety accidents, by the food and drug supervision and management departments at or above the county level shall be notified of the criticism, and may be fined more than 3,000 yuan 30,000 yuan; the directly responsible officers in charge and other personnel directly responsible for the competent authorities shall be given by the competent authorities to take disciplinary action.
Article 54 of the medical institutions in accordance with the provisions of this Measures did not publish the prices of drugs and medical devices, the administrative department in charge of prices shall be dealt with according to law.
Article 55 of the medical institutions in violation of the provisions of these Measures, causing damage to the patient, shall bear the responsibility for compensation. Chapter VI Supplementary Provisions
Article 56 of the supervision and management of the use of narcotic drugs, psychotropic substances, toxic drugs, radiopharmaceuticals and vaccines in medical institutions, in accordance with relevant laws and regulations.
Article 57 The supervision and management of the use of drugs and medical devices in family planning technical service organizations shall be implemented with reference to these Measures.
Article 58 These Measures shall come into force on December 1, 2007 .