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Drug And Medical Devices Used In Medical Institutions In Liaoning Province Supervision And Administration

Original Language Title: 辽宁省医疗机构药品和医疗器械使用监督管理办法

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(Summit No. 64 of 17 October 2006 of the Government of the Greateren Province to consider the adoption of the Decree No. 197 of 14 November 2006 of the Order of the People's Government of the Province of Excellencies, which came into force on 1 December 2006)

Article 1, in order to enhance oversight of the use of medical institutions medicines and medical equipment, to guarantee human health and life safety, to preserve the legitimate rights and interests of the patient, to develop this approach in line with the relevant laws, regulations, such as the People's Republic of China Drug Management Act and the State Department's Health Asset Monitoring Regulation Regulation Regulations.
The use of medicines and medical equipment by medical institutions within my province's administrative region (hereinafter referred to as pharmacies) should be observed.
Monitoring of the implementation of specially administered narcotic drugs, mental medicines, medical toxic medicines and radioactive drugs is carried out in accordance with relevant national provisions.
Article 3 governs the supervision of the provincial food medicine surveillance authorities and the food drug control supervisory authority (hereinafter referred to as the Food Drugs Monitoring Authority) in the management of the drug use of medical institutions in the present administration.
Article IV. Medical institutions should establish drug-arm management bodies that are adapted to their scales or designate eligible persons responsible for the management of arms, guarantee the safety of the use of pharmacies and prevent the occurrence of cases of ill-treatment of pharmacological groups.
Article 5 Medical institutions have direct access to medicines and sterilized persons, and health files should be conducted every year. Persons with communicable diseases and other potential pollutant drugs and sterilized medical diseases shall not engage in direct access to medicines and sterilization before they are treated or excluded.
Article 6. Medical institutions should establish the following management system:
(i) Acquisition procurement inspection;
(ii) Removal of pharmacies;
(iii) The report on the quality of the drug and the monitoring and reporting of the adverse response (in the event);
(iv) Redeployment and re-entry and maintenance of medicines;
(v) Effective drug control;
(vi) The distribution, maintenance and use of the agent;
(vii) Use and maintenance of medical equipment;
(viii) Quality tracking of intrusive medical equipment;
(ix) The destruction of unbirable medical devices after one-time use.
The above-mentioned medical institutions (concluded at this level) should exercise micro-enquiries management on matters under the preceding paragraph.
Article 7. Medical institutions must procure medicines from enterprises with pharmaceutical production or license.
The various clinics in rural areas, health clinics, can be procured from the distribution centres with medicines and their local distribution points; direct procurement is difficult and can be delegated to local communes (communes).
The commune (commune) should enter into a quality liability agreement with the author and be implemented in accordance with the provisions of the scheme relating to the procurement of medicines without any name being transferred to other units or individuals.
Article 8. Medical institutions should harmonize procurement, concentrate on the management of medicines by their drug-arming authorities or designated personnel, and properly preserve the relevant vouchers that can demonstrate information on drug procurement and establish the drug procurement files.
The drug procurement files should include the following information provided by the supplier:
(i) A copy of the licences for the production of medicines or for the licensing and operation of the pharmaceuticals;
(ii) A copy of the certificate of certification for the production or operation of quality management standards;
(iii) Accreditation of importing pharmaceutical products or the registration of pharmaceutical products, as well as a copy of the drug authorization documents, such as the import of pharmaceutical kits;
(iv) A copy of the biological product test document;
(v) A unit authorization or a letter of commission and its identification.
A copy of the information provided in paragraphs (i) to (iv) above shall be added to the printed chapter of the units provided.
Article 9. Medical institutions should conduct a user-recruit for the acquisition of medicines, in addition to the identification of suppliers' qualifications and related pharmaceutical certificates, and should also check the appearance, packaging, labelling, statements, etc. of medicines, and complete the authentic and complete drug collection records.
The data collection records should include generic names, agent, specifications, conscriptions, production dates, production plants, supply units, purchases, purchase prices, purchase date, inspection findings, etc., and the recipient's signature.
The record of the collection of medicines shall not be kept less than three years. For more than three years of effectiveness, the record of the collection of medicines is one year after the expiry of the period.
Article 10 Medical institutions procured pharmacies, each of which should indicate the name of the manufacturer, the name of the supply unit, the place of production, the number of receipts, the date of receipt (processing); the procurement of the pharmacies, the place of the manufacture, the place of production, the production of the enterprise, the production of the products, the date of production, etc.; and the use of the pharmacies, the pharmacies, and the packaging of the books for the procurement.
Package of pharmacies and pharmacies is not in accordance with the preceding paragraph and medical institutions are not subject to procurement.
Article 11. The management of the stocks of medicines by medical institutions is carried out in accordance with the relevant provisions of the National Guidelines on the Quality of Medicine.
Article 12 Medical institutions shall use medicines in the context of medical treatment subjects or services projects approved by law.
Article 13 medical institutions should strictly implement the effective control management system for medicines and carry out regular drug clearance. The use must be stopped immediately and processed in accordance with the relevant provisions.
Article 14. Medical institutions must redeploy medicines according to the medical institution's doctor. Drugs must not be operated or operated by means of probation, sale, counselling services, probation, exhibition, mail and gifts.
Article 15 Medical institutions should be in line with the quality and health requirements of medicines, such as facilities, tools, packaging materials.
Sub-united medicines should be recorded. After-handling drug packagings should indicate the name, specifications, columns, the use of the law, the use of the taboo and the duration of effectiveness.
Article 16 Medical equipment procured by medical institutions should be a licensed for the production of enterprise licences or for the operation of medical equipment for the production of licenses for the production of licensees and products registered within the scope of operation.
Medical institutions shall not procure and use medical devices that are not in compliance with national standards, industry standards and registered product standards.
Article 17 Medical institutions should harmonize the procurement of medical equipment by their pharmacies or designated personnel, and maintain appropriate vouchers capable of demonstrating information on the procurement of medical equipment and establish medical equipment procurement files.
The medical equipment procurement files should include the following information provided by the supplier:
(i) A copy of the licence for the manufacture of an enterprise or the operation of a business;
(ii) Accreditation of medical equipment (concluding annexes) and other documents;
(iii) A copy of the State's report on the testing of medical equipment products (subject to contract products);
(iv) Accreditation of medical equipment products;
(v) A unit authorization or a letter of commission and identification of persons sold by medical equipment.
A copy of the information provided in subparagraphs (i), (ii) and (iii) of the previous paragraph shall be added to the printed chapter of the units provided.
The procurement of medical equipment by medical institutions should be conducted in quality. In addition to the identification of creditworthiness and product certificates, true and complete receipt records should be completed.
The medical check-up records include product names, production plants, supply units, customized specifications, quantity of products, production dates, production kits (numbers, orders), extinguishment, product effectiveness, registration certificates, packaging markings, date of receipt, identification findings, etc., and experience recipients signed.
The medical check-up record should be maintained for one year after the expiry of the effective period or the cessation of its use, but not less than three years. The inspection records of vegetation medical equipment are kept in the same period as their quality tracking.
Before the use of medical equipment by medical institutions, a regular quality inspection should be conducted in accordance with the relevant provisions. Prior to the use of sterilized medical equipment, regular inspections should be carried out on the packaging of direct access to medical devices and their duration. Package breaks, identifiers, exceeds the period of effectiveness or may affect the security of use.
Article 20 provides for the use of intrusive medical equipment by medical institutions and should establish a real and complete quality tracking record.
The contents of the quality tracking record include the name of the section, the name of the patient, sex, age, residence, communication addresses, contact telephones, hospitalization, operating hours, product name, product name, quantity of products, specifications, production of enterprise name and place of registration, place of production of enterprise licences, the registration of medical equipment products, product codes (cereals), the date of production, the production of the production, the production of the production, the production of the goods, the supply unit, the supply unit's licence.
Quality tracking records should be managed by the patient's medical file.
Article 21 provides for medical equipment for medical treatment, and medical institutions shall conduct testing, maintenance and use of maintenance in accordance with the relevant provisions of medical equipment, and establish regular monitoring of maintenance and the use of maintenance records.
The records should include the use of the Section, the name of the equipment, the registration certificate, the specifications, the place of production plants, the time taken to launch, the detection of maintenance time, the detection of maintenance projects, the detection of maintenance units, the detection of maintenance results.
Medical equipment for medical treatment cannot guarantee the safety and effectiveness of clinical treatment, and must be stopped immediately.
The premises, facilities and conditions for the storage of medical equipment by medical institutions should be in line with the needs for the quality of the medical products. Specific management approaches are developed by provincial food medicine surveillance authorities.
Article 23. Medical institutions shall not be sold to other medical institutions for the purpose of profiting from the second category, third category of medical equipment, and no medical body shall receive the second category, third category of medical equipment that has been in effect.
In addition to the medical equipment imported and used abroad as large medical equipment, the second category, three types of medical equipment used by medical institutions, and the medical examination body established by the provincial food medicine surveillance authorities, which is not in effect, may be granted free of charge or transferred to other medical institutions in accordance with national and provincial provisions. The parties should enter into agreements and transfer medical equipment records.
Article 24 Food drug surveillance authorities should conduct oversight inspections of the following matters of medical institutions, and medical institutions should refrain from denying and concealing:
(i) Health inspection of the establishment and personnel of the drug control administration or personnel;
(ii) The establishment and implementation of the drug management system;
(iii) Management of archival information, such as pharmaceutical procurement and receipt records;
(iv) Pooling, singlingering and the distribution, preservation and use of pharmaceuticals;
(v) Deforestation, maintenance, storage management and replacement.
Article 25. When food drug surveillance authorities conduct oversight inspections of medical institutions, the following can be exercised:
(i) A test of the samples of the use of drugs;
(ii) Accreditation of medical institutions for the procurement of pharmacies and related books;
(iii) The adoption of administrative coercive measures by law;
(iv) Other mandates provided by law, regulations.
The sample test shall not be charged.
Article 26 Medical equipment inspection bodies established by the provincial food drug control surveillance management that are eligible for accreditation should carry out a sample test of medical equipment used by medical institutions in accordance with the scope and standards set by the State and, if any, test reports.
The provincial food drug control surveillance management should prepare and monitor implementation of the annual screening plan, in accordance with actual needs, to make regular public reports on the quality of the medical equipment.
The Food Drugs Monitoring Administration should establish a system of credit management for medical institutions. Medical institutions with regard to the use of drugs should be documented and incorporated into the medical institution's credit microframe management system. Medical institutions that refuse to redirect the use of drugs may be made public to society.
Article 28 Food drug surveillance authorities should establish a reporting system for the use of medicines by medical institutions and make the telephone available to society.
Article 29 found a serious quality of their safety and effectiveness in the procurement of inspection, use of medical equipment, and should be placed on the ground and immediately reported on local food drug control surveillance authorities. After reports from the Food Drugs Monitoring Administration, it should be done in a timely manner by law.
Article 33 Food drug surveillance authorities should establish emergency preparedness cases for cases of malicious incidents by drug-arm groups. After reports of incidents of ill-treatment by drug-armed groups, the food drug surveillance management should initiate emergency prestigation and ensure public safety in a timely manner.
Article 31 is one of the following cases in the health-care institution, which is redirected by the Food Medicine Monitoring Administration, which provides warnings that can be fined by more than 500 thousand dollars:
(i) The establishment of a drug management system, as prescribed by this approach;
(ii) Individuals who are directly exposed to medicines and sterilized medical equipment, do not conduct health inspections and establish health files;
(iii) Persons with communicable diseases and other potential pollutant drugs and sterilized medical devices engaged in direct access to medicines and sterilization;
(iv) The stocks of arms are not in accordance with the relevant provisions of States and provinces;
(v) The absence of a medical procurement file or a record of the acquisition of a pharmacies, as well as the incompleteness and integrity of the record;
(vi) After-handling drug packaging is not in accordance with the provisions;
(vii) No periodic drug clearance;
(viii) The use of intrusive medical equipment does not carry out a quality tracking record or record of integrity;
(ix) Unscheduled medical equipment;
(x) To reject the availability of information on the medical file and related vouchers;
(xi) It was found that there was a quality problem for the procurement of pharmacies and refused to report or not to be stored.
Medical institutions do not report poor responses to medicines as prescribed by law and are treated by the health administration.
Article 32 Medical institutions are punished by the Food Medicine Monitoring Administration in accordance with the relevant provisions of the People's Republic of China's Drug Management Act, the People's Republic of China's Drug Management Act.
Article 33 provides for the procurement and use of medical equipment that has expired or has not been completed by the Food Medicine Monitoring Administration, in accordance with the relevant provisions of the Medical Assurance Regulation.
Article XIV Medical institutions have one of the following cases, and are punished by the Food Medicine Monitoring Administration in accordance with the provisions of the People's Republic of China Drug Control Act relating to the penalties for the unauthorized operation of medicines:
(i) In addition to the subject of medical treatment approved by law or to the extent of service, the treatment of medicines is profitable;
(ii) Inadequate treatment of medicines for patients in the direction of the medical institution;
(iii) The commune of the commune (commune) does not enter into a quality liability agreement with the author or, after the conclusion of a quality liability agreement, reproduces medicines from among other units and individuals;
(iv) Removal of medicines, such as probation, sale, counselling services, probation, exhibition, mail and gifts, for example.
Article 335 Medical institutions are sold to other medical institutions for the purpose of profiting from the second category, the third category of medical equipment, which is subject to punishment by the Food Medicine Monitoring Administration in accordance with the provisions of the Medical Assurance Regulation relating to unauthorized operating medical equipment.
Article XVI provides for penalties in accordance with the relevant provisions of the People's Republic of China Pharmaceutical Regulatory Act.
In violation of this approach, medical institutions are suspected of committing crimes and are transferred to the judiciary by the Food Medicine Monitoring Authority to be criminalized by law; civil responsibility is vested in law for the parties' damages.
Article 338 Oversight management of food medicine and its staff in the testing agency are subject to administrative disposition by law; there are suspected criminal offences to be criminalized by law:
(i) The reports of the quality of the arms reported or medical institutions are not dealt with in a timely manner by law, resulting in adverse consequences;
(ii) The failure to launch emergency pre-release cases in a timely manner, resulting in adverse consequences, as reported by the incidents of ill-treatment of pharmacological groups;
(iii) Fee tests, test reports or fees charged in violation;
(iv) Participation in drug purchases;
(v) There are other abuses of authority, provocative fraud, and sterilization.
Article 39 of this approach refers to a second category of medical equipment that is safe and efficient.
The third category of medical equipment refers to the intrusion of human beings; to support, maintain life; to the potential risk of human beings and to the need for strict control of medical equipment for their safety and effectiveness.
Medical equipment of the previous period refers to the use of notes or packagings for the use of medical equipment exceeding that period, the second category of the valid period identified in the label, and the three types of medical equipment.
Unliquidated medical equipment means that it is not in accordance with national standards, industry standards or registered product standards and that it cannot guarantee the second category of safety and effectiveness of their use, and the third category of medical equipment.
Article 40