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(Adopted at the 19th ordinary meeting of the Government of the Southern Province, on 7 November 2003, No. 182 of the Order of the People's Government of the Southern Province of the Lake, which was published as effective 1 February 2004) In order to strengthen the monitoring of the use of medicines by medical institutions and to ensure the effective safety of human drug use, this approach is developed in the light of the laws and regulations such as the People's Republic of China Drug Management Act, the People's Republic of China Act on the Control of Drugs. Article 2 The medical institutions referred to in the previous paragraph include hospitals, maternity and child health, hygienic, nursing homes, clinics (individuals), health clinics (indoors), first aid centres (stays), sickness control boards (stays, stations), care centres (stations), community health services centres (starts) and family planning technology services. Article 3 The urban, autonomous, district, and district (commune, district) drug surveillance management is responsible for monitoring the management of pharmaceuticals used by medical institutions in the present administration. The Government of the people at the district level is responsible for the management of pharmaceutical use by medical institutions within their respective responsibilities. Article IV Medical institutions must, within the use of medicines approved by law for medical treatment subjects, family planning technology services projects, be equipped with medicines by practitioners from practitioners, practitioners, or village doctors who have obtained certificates of registration in rural doctors. Article 5 Medical institutions may establish pharmacies or pharmacies in accordance with the relevant provisions of the State. Medical institutions should have the appropriate place, equipment, warehousing facilities and the sanitation environment, with the corresponding technicians, establish a quality management structure for drug use or a quality manager, and establish a drug use management system. Medical institutions such as the Médecins, Clinic, Health (rooms), the Centre for Community Health Services (at station) shall not be equipped with medicines other than those that are commonly used in drugs and first aid. Using drugs, the scope and variety of first-aid medicines, the Ministry of Health of the Provincial People's Government, together with the Government's drug surveillance management. The scope of the drug use of family planning technology services should be consistent with the authorized range of services, services projects, operating articies, and should not be used for the basic use of medicines in family planning technology services. The basic pharmacies of the Family Planning Technology Service are provided by the Ministry's Government's drug control management and the provincial Government's Government's family planning administration. The scope and variety of medicines used by medical institutions listed in article 6 of this approach shall not be changed. Changes should be communicated in writing to host drug surveillance management, the health administration or the family planning administration. Article 8. Medical institutions must procure medicines from the manufacture of medicines with a licence for the production of medicines, a licence for the operation of medicines and a licence for business. The village health room, the personal clinic may also be entrusted to the commune for the purchase of medicines. In the village health room in the town of commune, the personal clinic procurement of medicines should be held in the village health room, the commissioner of the individual clinic, the supervision of the host drug surveillance management, the non-appropriation of medicines to individuals or other units, and the sale of medicines to the village health room, the personal clinic. Article 9. Medical institutions are required to purchase drugs and strict compliance with national provisions to establish a system for import inspection, to test the qualifications of medicines and other markings, and to refrain from buying and using medicines incompatible with the provisions. Article 10 Medical institutions must establish authentic and complete drug purchase records. The drug acquisition record should have the following: (i) The generic name, agent, specifications, quantifications and duration of medicines; (ii) The number of purchases, the purchase price and the date of purchase; (iii) Production plants, supply units; (iv) Other provisions of laws, regulations and regulations. A record-keeping period for drug purchases shall not be less than three years; the effective period for medicines exceeds three years and is maintained for one year after the period of effectiveness of medicines. Article 11. Medical institutions shall not operate or operate drugs in a mail, counterfeiting, counter-licensor's self-selection and diagnosis, sale, counselling, probationary, nominal and other manner. Article 12 Medical institutions must develop and implement systems for the custody of medicines and classify them in accordance with the provisions on the quality of medicines. Drugs and non-pharmacies, indoor medicine and inject drugs, poisoning, hazardous medicines, hard-won medicines and other medicines should be stored separately. Narcotic drugs, such as mental medicine, medical toxic medicines, radioactive drugs, drug-recruiting drugs, should be stored either in a pool or in a specific counter, and dual-locked maintenance and specialized records. Article 13. Medical institutions should store medicines in accordance with the quality requirements of medicines by taking measures such as refrigeration, defence, stifling, ventilation, fire prevention, pests and rats to prevent drug contamination, variability, failure. Medical institutions should conserve stored medicines and should not use obsolete, invalidated, phased-out, vincing, pests and qualitative drugs. Article 14. Medical institutions are to review and redeploy the pharmacies of the distributors and must be qualified technicians in accordance with the law. The transferee must be checked and no change should be made. pharmacists should refuse to redeploy, with the exception of veterans, pregnancy bans, disease banners or ultra-dose dose, and, if necessary, with the corrections of the original licensor or the resignment of the confirmation. The medical institutions should be kept in accordance with the State's time limit. Article 15. Medical institutions are in charge of the transfer of metrics of medicines by the quality technical supervision sector. The adaptation of medicines must be accurate. Article 16 The redeployment of medicines by medical institutions requires the destruction of medicines that are the lowest packagings, which should be kept in a piecemeal record and retaining the smallest packaging. The trajectory of a piecemeal substance should indicate the name, specifications, use and quantity of medicines. Article 17 Medical institutions should conduct a follow-up study on the quality, effectiveness and response of the unit to use medicines in accordance with the relevant national provisions. In identifying serious adverse responses that may be related to the use of medicines, it is important to report on a timely basis to the provincial Government's drug surveillance management, the health administration or the family planning administration. Article 18 Medical institutions shall not purchase, use false medicines. In the course of drug use, it is necessary to immediately cease the use of false medicines and to report to the host drug control authorities in a timely manner and not to do so. The drug surveillance management should be checked by law in a timely manner after the report was received. Medical institutions have found quality of suspicious drugs in the use of medicines, should be suspended, the timely delivery of a drug surveillance management or the identification of a drug inspection body, which is to be processed in accordance with the preceding paragraph. Article 19 Medical institutions must conduct health inspections every year and establish health files. Medical agencies have direct access to medicines for persons with infectious diseases or suspected communicable diseases, as well as those with other diseases that may be contaminated with drugs, and may not engage in direct access to medicines before they are treated or excluded from diseases that may be contaminated. Article 20 Medical institutions are involved in the procurement, custody, maintenance, inspection and distribution of medicines and should receive professional training and continuing education. State provisions should be made in terms of employment qualifications. Article 21 Medical institutions must strictly implement the provisions of the State Department and the provincial Government's price authorities relating to the price of medicines, and to impose government pricing, government guidance and government price interventions, without allowing for the improvement of prices in any form. The procurement of medicines by means of tendering, in accordance with the law, should be procured by tenders in accordance with the law and reduce the prices of medicines. The prohibition of riots and the damage to prices of patients' interests is prohibited. Medical institutions should introduce a drug price alert, referral system that protects the legitimate rights and interests of the patient if the patient provides a real list of the medicines used. The Government's price authorities at the district level monitor the prices of medical institutions for the distribution of medicines in accordance with the law, receive complaints and reports of drug prices and promptly investigate drug price violations in accordance with the law. No medical agency may use medical operations to advertise drug propaganda, and its consignments may not be advertising. In violation of article 8, paragraph 2, of the present approach, the commune of the town's commune is selling the price of the commune, the individual clinic procurement of medicines, or transferring the qualification of medicines to individuals or other units, with a fine of up to $50 million from the head of the drug surveillance management. Article 24, in violation of article 10, article 19 of this approach, provides that medical institutions do not establish a record of real and complete drug purchases, or that persons who are directly exposed to drugs are not subject to a prescribed health check, are ordered by the host drug control supervisory authorities to give warning, and that the delay is not rectified, with a fine of up to $50 million. Article 25, in violation of article 11 of this approach, provides that medical institutions operate medicines or operate drugs, are subject to correction by the host drug control supervisory authority and fines of up to $300,000. Article 26, in violation of article 21 of this approach, provides that medical institutions, in violation of the drug price provision, have taken themselves to improve prices, or have a price fraud that would undermine the interests of the patient, by law by the price authorities. Article 27, in violation of article 22 of this approach, provides that medical agencies use medical operations to advertise drug propaganda, or to issue advertisements of medical institutions, are governed by the law. Article 28, in violation of other acts under this scheme, provides for penalties under the relevant laws and regulations. Article 29, staff of the drug surveillance management and other administrations, abuse of authority, provocative fraud, and neglect in the use of surveillance in medical institutions, are subject to administrative disposition by law, which constitutes a crime, and criminal liability by law. Article 33 |
