Key Benefits:
(Act dated 19 September 2007 No. 238 of the People's Government Order No. 238 of the Zangi Province, which came into force on 1 December 2007) Chapter I General In order to strengthen oversight over the use of medicines and medical equipment in medical institutions, to ensure the safe and effective use of medicines and medical equipment, to protect human health and life safety, to develop this approach in line with the laws, regulations, such as the People's Republic of China Drug Management Act, the National People's Republic of China Act on the Control of Drugs, and the Medical Asset Monitoring Regulation Regulation Regulations. Article 2 Article 3. Medical institutions referred to in this approach refer to institutions that have obtained the authorization of the medical institutions in accordance with the provisions of the Medical Institutions Management Regulations. The use of medical institutions medicines and medical equipment is governed by hospitals and non- hospitals. Medical institutions in hospitals include hospitals, maternity and child health centres and higher levels of health. The specific criteria for the size of the larger hygienic are developed by the Provincial Health Administration, the provincial Food Drugs Monitoring Administration. The use of medicines and medical equipment by medical institutions should be guided by the principles of safety, effectiveness and reasonableness. Article 5 In accordance with the division of responsibilities, the health administration is responsible for overseeing the use of related matters by medical institutions in the present administration. Relevant administrations such as business, price, quality technical supervision, population and family planning are administered in accordance with their respective responsibilities in relation to pharmaceutical and medical devices. Article 6. The main heads of medical institutions are fully responsible for the use of pharmaceutical and medical devices in this unit. Medical institutions should set up pharmaceuticals, medical equipment management organizations or managers, in accordance with their scale and management needs, to establish a management system that would clarify and implement responsibilities. Chapter II Article 7. Medical institutions should establish a system of inspection of medicines, medical devices and identification of relevant documentation: (i) The first purchase of medicines, medical equipment and medical equipment from pharmaceutical, medical and manufactured enterprises should be found in the Pharmaceutical Production Licence, the pharmaceutical approval certificate or the Medical Asset Production Business Licence, a certificate of registration of medical equipment products; (ii) For the first time to procure medicines, medical devices from pharmaceutical-produced enterprises, medical companies should be screened for the licensing of the pharmaceutical operation, the pharmaceutical approval certificate or the licence of the medical equipment for the operation, the certificate of registration of medical equipment products; (iii) The procurement of imported drugs should be subject to the verification of import approval documents and import quality reports; the procurement of imported medical equipment should be inspected to import registration certificates for medical equipment and the import quality test requirements should be accompanied by the inspection of the quality of the import inspection reports. Article 8. Medical institutions should receive and record the purchase of imported medicines and medical equipment. Medical institutions receive contributions, grant medicines and medical equipment, relocating first aid from other medical agencies to medicines and medical equipment, or buying medicines directly from pharmaceutical retail enterprises, should be collected and recorded in accordance with the preceding paragraph. Article 9 The medical check-up records should include product names, specifications, product kits (product date of production), production plants, supply units, acquisitions, purchase prices, requisition date, receipt date, inspection date, identification findings, etc.; braces, effective periods should be recorded and effective periods; medical instruments, equipment receipt records should also include relevant and technical indicators. The receipt record is maintained by the recipient's signature or chapter. The receipt records and the relevant vouchers should be kept at least three years; there is an effective product period, which should be preserved for more than one year. Article 10 Medical institutions such as the village health room (provinc), the Community Health Services Centre (SCO) have difficulties in the production of medicines, medical equipment or the operation of enterprises in the procurement of medicines and medical equipment, which can be delegated to other medical institutions for the purpose of procurement. The procurement agreement should be delegated to the district-level food medicine surveillance management. pharmaceuticals, medical equipment operators are encouraged to send drugs, medical devices directly to medical institutions. Article 11. Medical institutions should establish a pharmacies that are adapted to their scale. The pharmacies (pharmacies) should be distinguished from life, office and medical areas and have the necessary means of avoiding, ventilation, pests, defence conditions and temperature, wet control equipment. Medical institutions in hospitals should set up refrigeration packages for the storage of medicines, medical equipment, and abundance. Non-patient medical institutions should establish refrigeration (consistance), abundance and, to the extent possible, a reduction in the stocks of medicines, medical devices. Article 12 Medical institutions should store medicines, medical equipment, and monitor and record temperatures, wets in the storage area, in accordance with the conditions indicated in the product statement. Medical institutions store drugs, medical equipment and weapons in the form of label management. Synergies of medicines, intermediate pharmacies and pharmacies should be stored separately from other medicines; unqualified medicines, medical devices, such as length, variability, invalidity, should be placed in unqualified banks (zone). Article 13 Medical institutions shall inspect and conserve pharmaceuticals, medical equipment, maintain equipment on a regular basis and establish appropriate conservation files on a monthly basis. Article 14. Medical institutions should establish a system for the rehabilitation of medicines, medical devices. Over time, variability, invalidity, phase-out of national orders and other non-qualified medicines, medical devices cannot be used. Article 15. Medical institutions need temporary storage of medicines, medical equipment, etc. in emergency rooms, hospitals and nurses, and should be equipped with medicines, medical equipment storage kits. The equipment should be equipped with refrigeration medicines, medical equipment. Chapter III Article 16 Medical agencies should provide medical care to patients in the direction of the pharmaceutical service of the unit, receive medical certificates from the Unit or provide medical equipment or medical equipment services to the patients in need of medical treatment. In accordance with Article 17, village doctors who are eligible for the operation under the Rural Doctors from Industry Regulations, and in addition to the pharmacies, the drug users should be activated within the framework set out in the Zangang Province's Basic Pharmaceutics. Article 18 pharmacies should be required in accordance with the rules of medical treatment, and in Chinese, for clinical diagnosis, the generic name, specifications, quantity, use and use of drugs. Secondary pharmacies and hospital preparations should be used for officially approved pharmacies. They should write norms that are clear. In the case of the patient's request for paper quality, medical institutions should be provided without denying. Article 19 medical institutions should make a clear sign of the child's drug service and make specialized management of the child's drug users. The use of adult medicine by the child's pharmacies should be in line with the relevant requirements for the use of drugs in the drug notes and with full consideration of the child's physical characteristics, the specificities and differences in the drug function. Article 20 Medical institutions are subject to the technical duties of pharmacies, pharmacies and pharmacies, and are assigned to pharmacists, pharmacies and pharmacology, and pharmacology. Practitioners in the village health room (produced) are eligible for training in pharmaceutical expertise organized by the local food medicine surveillance management, which can be reviewed and coordinated by the local authorities in the village health cell (see table). The food medicine surveillance management does not collect any costs for the training of pharmaceutical expertise for practitioners in the village health room (the) and is charged by the same-level people's Government. Article 21 shall be subject to signature by the head of the office or to the designation of a special drawing order. In the opinion of the author, the medical treatment is inappropriate and should be communicated to the practitioner, requesting him to confirm or reactivate him; in the opinion that there is no reasonable use of drugs or drug abuse errors in the service, it should be refused to redeploy, inform the doctor in a timely manner and submit written reports in accordance with the relevant provisions. The second article of the medical institution's tools, facilities, packaging supplies and theraping of medicines, pooled liquids should be in line with sanitation requirements, and the distribution of liquids should be relatively isolated and consistent with the corresponding clean requirements. In accordance with the requirements of the medical treatment system, medical institutions should be equipped with medicines and provide pharmaceutical guidance in the delivery of medicines. The use of drugs by children should be provided in detail on methods and concerns. Article 24 Medical institutions should use medical equipment as required by the use of the Notes. A one-time medical weapon must not be repeated and should be processed in accordance with the relevant national provisions and recorded. Article 25 Medical institutions should establish a regulatory system for the safe use of medical instruments, equipment, develop a corresponding course of operation and promote strict compliance with operational regulations by technical personnel. The use of technicians should strictly use medical instruments and equipment in accordance with operational regulations. Medical institutions should conduct training and examination of the use of technicians for medical instruments, equipment and intrusive medical equipment; they do not meet the requirements and should not be placed on the ground. Training, archaeological situations should be recorded and archived. Article 26 Medical institutions should establish systems for medical instruments, equipment maintenance and safety testing, and the maintenance and security test results should be recorded and archived. The management of medical equipment that is included in the State's compulsory measurement is carried out in accordance with the relevant provisions of the People's Republic of China Measuring Act. Article 27 uses vegetation medical equipment included in the National Focus Regulatory List, which should be registered by medical institutions, the date of the operation, the name of the physician, the quantity, specifications, the manufacturer, the production plant, the production of the number (referral number), the bribes, the period of effectiveness, and the supply unit. Article 28 Medical institutions that are legally eligible for a clinical test of drug, medical equipment should establish a corresponding management system to test the receipt, storage, maintenance, distribution, use and return of drug, medical equipment, and to follow up on the use, without expanding the scope of use. Article 29 Medical institutions in hospitals should establish systems for the non-regular use of medicines and medical equipment, statistics on the use of medicines and medical equipment in this unit at a monthly rate, and identify the use of medicines, medical equipment, the amount of use, the frequency of use, and the frequency of use, should organize a reasonable analysis of experts and take effective measures in a timely manner. Statistics, analyses and measures taken should be signed by the main heads of medical institutions and archived. Article 33 Medical institutions in the hospital category should establish a system of assessment by side with less than 5 per cent, conduct a monthly screening and conduct a reasonable assessment; identify cases where there is a violation of medicines, abuse of drugs, and the non-reasonable use of medicines, should be responsible for the correction of a medical doctor to the service and be recorded in a medical file. The assessment, processing should form a record and archive. Article 31 Medical institutions should designate specialized personnel to monitor and report on their work in accordance with the provisions of the national drug response and the reporting system on incidents of ill-treatment of medical equipment. The detection of ill-responses of medicines and ill-treatment of medical equipment should be reported in a timely manner, taking effective measures to prevent the spread of adverse consequences and to cooperate actively with investigations in the relevant sectors. Medical institutions may not conceal reports, debriefing malicious responses to drugs and the adverse incidents of medical equipment. Article 32 provides for a safe accident in the use of medicines, medical equipment, and should be reported in a timely manner to local food drug surveillance management and the health administration, in accordance with the requirements of the emergency response case, while taking effective measures to prevent the expansion of accidents. Medical institutions may not conceal security accidents in the use of reports, medicines and medical devices. Article 33 provides for non-qualified or qualitatively suspected medicines and medical equipment, and medical institutions should stop their use, place on the ground and report to local food drug control monitoring authorities in a timely manner. Until the management of food medicine is treated under the law, the medical institutions shall not resign, transfer and destruction. Article 34 medical institutions should make use of generic names of medicines if they are to be published in real terms, prices for the use of medicines, medical devices and a list of prices for the treatment of patients, such as the real availability of medicines, medical devices and weapons. With regard to the dissenting of the prices used in medicines, medical devices, the medical agencies should be given prompt responses. The publication of medical advertisements should be consistent with the relevant national provisions. Medical institutions shall not use medical advertisements to carry out medical, medical and medical information and recommendations. Medical institutions, advertising distributors may not use press coverage, thematic sections of medical information services (column) for advertising or recommending pharmaceutical and medical devices in the form of such advertisements. Chapter IV Oversight management The sectors such as the supervision of food medicine, the management of health administration should be inspected in accordance with the laws, regulations and this approach to the use of medical institutions for medicines, medical equipment, etc., and the need for treatment in other sectors should be transferred in a timely manner. Sectors such as food drug surveillance management and health administration should be synergistic to form joint inspection mechanisms. Monitoring of inspection and processing results should form a written record and be archived after the signature of the inspector. Oversight inspection activities shall not impede the normal treatment of medical institutions and shall not seek or receive the property of the inspectorate and shall not seek other benefits. Medical institutions should refrain from denying and concealing items and information relating to the matter under review. Article 37 Food drug surveillance authorities are not subject to less than one year's supervision of hospitals' medical institutions, and the supervision of non-patient medical institutions is not less than one year. The Health Administration inspection of the implementation of the hospital-based medical institutions' medicine and medical equipment is not less than one year. In accordance with the need to monitor inspections, food drug control surveillance authorities can conduct screening tests of medicines, medical devices used by medical agencies. The test should be sampled according to the prescribed sample and no cost should be charged. In a publication to society on the quality of medicines, medical devices, which are published by the provincial food drug control surveillance management, the results of the testing of the quality of medicines, medical equipment and equipment used by medical institutions should be included. An objection to the quality test results, the review process is implemented in accordance with the relevant national provisions. Article 40 provides for poor responses to drugs, medical incidents or safe accidents in the use of medicines, medical equipment, and medical equipment, supervision of food medicine, and the timely disposal of the health administration, in accordance with the provisions of the emergency advance case. Article 40. Medical institutions shall not receive funds, medical equipment production and operating enterprises or other interests granted by their agents on behalf of medicines, medical devices or companies or agents. The heads of medical institutions, procurement agents, doctors, etc. may not receive any financial or other interest from pharmaceuticals, medical devices and operators or their agents in any name. In article 42, a doctor may not avail himself of a work facility, request or receive a person's property, and may not require or otherwise require the direct purchase of medicines, medical equipment and equipment to the units and individuals designated by the patient in order to profit. Article 43 governs the management of food medicine, the administration of health, etc., should make complaints and reports to society, e-mail boxes, newsletter addresses, and, after receipt of complaints and reports, should be addressed in a timely manner, in order to respond to complaints, reporters, and confidentially to the cases of complainants, reporters. Article 44 should strengthen the supervision of medical advertisements in accordance with laws, regulations and regulations such as the People's Republic of China advertising law, in violation of the relevant laws, regulations and methods by medical institutions, advertising publishers, and in a timely manner by law. Food drug surveillance management, the health administration found that medical institutions, advertising agents were in breach of article 35 of the scheme and should be stopped and communicated in writing or transferred to the business administration. The business administration sector should inform the transfer cell in writing. Business, food drug surveillance management, and the health administration should conduct an integrated assessment of the management of medical advertisements in the Territory every year and make the results available to society in a timely manner. Chapter V Legal responsibility Article 42 violates the provisions of this approach, and the relevant laws, regulations have been penalized and disposed of. Article 46 departments, such as the supervision of food medicine, and their staff, have one of the following acts, which are administratively disposed of by the competent and other persons directly responsible, in accordance with the management authority: (i) Monitoring inspections and inspections are not carried out in accordance with article 37 of this approach, article 38; (ii) The results of the testing of the quality of the use of medicines, medical equipment and equipment to health institutions, in accordance with article 39 of this approach; (iii) No complaints and reports are published and processed in accordance with article 43 of this approach; (iv) No comprehensive assessment of the supervision of medical advertisements, in accordance with article 44 of this approach; (v) There are other provocative fraud, sterilization and abuse of authority. Article 47 contains one of the following cases for medical institutions, which is being converted by the management of the supervision of food medicines at the district level to the time limit; the uncorrected delay is punishable by more than 1,000 dollars: (i) No inspection of pharmaceuticals, medical devices pursuant to article 7 of this approach; (ii) No receipt of the acquisition of medicines, medical devices pursuant to article 8, paragraph 9, of this approach; (iii) No storage, maintenance of medicines, medical equipment, in accordance with this approach; (iv) The establishment and implementation of medical instruments, the security use management system for equipment, the use of induction training systems for personnel and the maintenance and safety testing system, in accordance with article 25 of this approach; (v) No registration of the use of intrusive medical devices pursuant to article 27 of this scheme. Article 48 is one of the following conditions in the health-care institution, which is changing by the time limit for the executive branch of the district and above, and which is not reformulated by the delay, may be fined by more than 1,000 dollars: (i) The use of medicines and medical equipment in violation of article 16 of this approach; (ii) The distribution of medicines, in accordance with the provisions of this approach; (iii) No price list is provided to the patient in accordance with article 34 of this scheme or no response has been provided in a timely manner to the queries of the patient. Article 49 Medical institutions in the hospital category are not established and implemented in accordance with article 29 of this scheme, article 33, and the system for the non-regular use of medicines, medical devices and prescription assessment, which is modified by the time limit for the health administration at the district level, with a fine of up to $30,000 over the previous period. Article 50 medical institutions, in violation of article 33, paragraph 1, of this approach, continue to use non-qualified medicines and medical devices, which are dealt with by food drug surveillance authorities in accordance with the relevant national laws, regulations and regulations; continue to use qualitatively suspicious drugs and medical devices, which are terminated by a food medicine surveillance authority, may be subject to a fine of up to 50 million dollars in circumstances. In violation of article 33, paragraph 2, of this approach, medical institutions may impose a fine of up to 50 million dollars for non-qualified or qualitatively suspected medicines and medical devices. Article 50 provides that medical institutions and their associated personnel are subject to the provisions of article 41 of this scheme, which are taken into account in accordance with the provisions of the People's Republic of China Drug Control Act, the People's Republic of China Anti-Frame Law. In violation of article 42 of this approach, a doctor has unjustifiable interests and has been punished in accordance with article 37 of the Law on the Practice of the People's Republic of China. Article 52 of the medical institution conceals reports, debriefss of malicious responses to medicines, medical defects, which are criticized by the health administration at the district level for more than 30,000 dollars, and imposes a fine of more than 30,000 dollars for the direct responsible supervisors and other direct responsibilities, which is subject to disciplinary action by the authority. Article 53 of the medical institution conceals a safety accident for the use of food and medical equipment, which is criticized by the authorities of more than sanitary medicines at the district level, with a fine of up to 30,000 dollars, for direct responsible supervisors and other direct responsibilities, and is subject to disciplinary action by the competent authority. Article 54 Medical institutions do not publish the price of medicines, medical devices in accordance with this approach, which is governed by the law by the price administration authorities. Article 55 of the medical institution violates the provisions of this approach and imposes liability under the law on the sick. Annex VI Article 56 monitors the use of narcotic drugs, mental medicines, toxic medicines, radioactive drugs and vaccines by medical institutions, in accordance with the relevant laws, regulations. Article 57 Monitoring of the use of medicines, medical devices used by family planning technology services is implemented in the light of this approach. Article 58 |
