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(The 83th ordinary meeting of the Government of the State of the State of War, held on 12 September 2005, considered the adoption of laws, regulations, such as the People's Government Ordinance No. 222 of 20 September 2005 for the publication of the People's Government Ordinance No. 222 of 1 November 2005)*** Article 1, in order to strengthen the quality supervision of the use of medicines in medical institutions, to guarantee the effective safety of human drug use, to develop this approach in conjunction with the laws, regulations and regulations of the People's Republic of China Drug Management Act. Article 2. This approach applies to the acquisition, under the law, of medical institutions in the administration of the city, of medical institutions involved in disease diagnosis, treatment activities, and to the management of the quality of the drug use components, such as pharmaceutical procurement, inspection, storage, maintenance, distribution and distribution. The use of narcotic drugs, mental medicine, medical toxic medicines, radioactive drugs and vaccines and their quality monitoring should be governed by national legislation, regulations and regulations. Article 3. Management of quality surveillance of the drug use components of the health-care institutions throughout the city. Various districts, districts and districts (markets) food drug surveillance management is responsible for the quality supervision of the drug use components within the current jurisdiction. The executive branch, such as health, prices, and business, should be responsible, within their respective responsibilities, for monitoring the management of pharmaceutical use by medical institutions. Article IV. Medical institutions should establish a sound quality management system for the following medicines, as well as regular inspections and appraisal of the implementation of the nuclear system, with corresponding records: (i) The drug quality management responsibility regime; (ii) Human health management system; (iii) Procurement of medicines, inspection management systems; (iv) The quality information management system for medicines; (v) Drug storage, conservation management systems; (vi) The use management system for drug measurements and storage, conservation equipment; (vii) Special drug management systems; (viii) Health management systems; (ix) Transdeployment management systems; (x) Unqualified drug control and the shipment drug management system; (xi) Management system for reporting on adverse responses to drugs; (xii) Quality accident report and management system. Article 5 Medical institutions should establish a drug quality management body, in accordance with their scale and management needs, or implement a drug quality manager and clarify their responsibilities. The composition of the drug quality management body or the drug quality manager shall be appointed by qualified drug technicians or by the pharmacist. Article 6. The supervisors of medical institutions shall be appointed by a pharmacist or an pharmacist with qualifications in the professional technical office of the pharmacist or the pharmacist, who shall be appointed by legally qualified technicians or by the pharmacist. Article 7. Direct access by medical institutions to drug users should be carried out through the supervision of health inspections of projects by the urban food medicine management and the establishment of health files. Persons with mental illness, epidemic or other potential pollutant drug diseases may not be involved in direct access to medicines. Article 8. Medical institutions should conduct regular training of personnel working in pharmaceutical procurement, inspection, storage, conservation, distribution, distribution and delivery, and develop training files. Article 9 pharmacologists and practitioners of medical institutions should use expertise and pharmacological information, provide advisory services to health-care personnel and patients, participate in clinical work and make sound drug recommendations. Article 10 Medical institutions should 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 medical institutions should seek and identify relevant information in accordance with the relevant provisions when they occur for the first time in the manufacture of pharmaceutical products or in the manufacture of pharmaceutical companies (the first-served enterprises) or in the procurement of the first-to-size medicines (the first-clocks) and the import of medicines. Article 11. The acquisition of medicines by medical institutions should be strictly followed by the relevant provisions of the State, the establishment of a system for import inspection, the identification of qualified medicines and other markings, and the acquisition and use of medicines incompatible with the requirements. Article 12 Medical institutions should establish authentic and complete drug acquisition 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 13 Medical institutions should establish appropriate pharmacies, pharmacies (pharmacies) in accordance with the subjects of medical treatment and the scope of drug use approved by law. pharmacies, pharmacies (pharmacies) should be distinguished from regions such as medical treatment, office and life, and with the following equipment accordingly: (i) Equipment that facilitates access to medicines; (ii) Prevalence, cholera, refrigeration and refrigeration of equipment consistent with the requirements of the drug characteristics; (iii) Maintaining a certain distance between drugs and the ground; (iv) Equipment such as pharmaceutical dust, smoking, pollution and pests, rats and miles; (v) Resistance of light, wind and equipment; (vi) The equipment required for the use of pharmacies; (vii) Other equipment to ensure the safe use of medicines. Article 14. (c) The arsenal (zone) of the qualified drug bank (zone), the pharmacies (zone) of the medium-chained pharmaceuticals; Article 15. 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 16 The drug conservants should be able to monitor and manage the temperatures of the pharmacies, pharmacies (pharmacies). When temperatures, humidity exceeds the scope of the provision, regulatory measures should be taken in a timely manner and recorded. The normal temperature of the storage of medicines should be maintained at 10-30°C; the bleak temperature should not exceed 20°C; the temperature of the refrigeration (contra) should be maintained at 2-10°C; the relative humidity of the pharmacies and pharmacies should be maintained at 45-75 per cent. Article 17 facilities for the storage of medicines by medical institutions should have a range of intervals or separate measures between the ground, the wall, roofs (location), heaters, heating pipelines, and the drug laying. Of these, the interval between drugs and walls, roofs and roofs cannot be less than 30 cm, and the intervals with distributors or heating pipelines must not be less than 30 cm and no less than 10 cm. Article 18 Storage of medicines by medical institutions should be stored in a relatively concentrated manner, disaggregated by type of goods. Drugs should be stored separately from non-pharmacies, in-house drugs and injecting drugs; easily resistant medicines, medical materials, pharmacies and dangerous goods. Article 19 Medical institutions should regularly check the medicines stored. A shorter inspection cycle should be seen in the case of near-efficiency medicines and flammable drugs. Article 20 recognizes, reports, reports, damage, destruction should be well documented by medical institutions and place quality-of-qualified medicines in unqualified drug banks (zones). Article 21, where medical institutions are able to redeploy medicines, facilities and packaging materials, should be in line with health and quality safety requirements and should not be contaminated with drugs and affect the quality of medicines. The medicines used by medical institutions should be adapted to the scope of the treatment and be equipped with medicines by practitioners of practitioners, practitioners of practitioners, practitioners or village doctors who have obtained certificates of service. Article 23 should be strictly based on the transfer of medicines by the user, and the transfer of the personnel to the medicines listed by the other party should not be redirected or replaced. For those with a veterans or supersses, it should be refused to redeploy, return to a doctor from the start-up, with a medical corrections from the opening-up or resigning the party. The author's review, the drug transferee shall be signed by the head or chapter, and the other party shall maintain the record as specified. Article 24 quantification of medicines by medical institutions should be accurate. The pharmacization of medicines required to be determined by law shall be subject to mandatory screening and shall be used in an effective period. Article 25 Medical institutions need to disprovide pharmaceuticals for the lowest packaging and should be kept in a piecemeal record. Distinctional medicines should include references to the name, specifications, use, use, ratifications, medical orders, and medical agency name. Special requests should be made in writing on matters of concern. Article 26 Medical institutions shall not sell drugs to non-institutes. Medical institutions shall not operate or operate drugs in the form of street counters or in the form of referral, counselling, probationary, etc., other than this body. In article 27, medical institutions may not use medical operations to advertise drug propaganda, and their confiscates shall not be subject to advertising. The twenty-eighth medical institution shall not use a pseudonym or a poor medicine. Article 29 Medical institutions have found quality of suspicious drugs in the use of medicines and should immediately cease their use, maintain and report to host food drug control monitoring authorities in a timely manner. Food drug surveillance authorities should be treated in a timely manner in accordance with the law and, prior to the determination of their testing, medical institutions shall not be able to carry out their own transfers, freight or destruction. Article 33 provides for a pseudonym, poor medicine recognized by the Food Medicine Monitoring Administration, which should immediately cease the use of medical institutions and report to host food drug surveillance authorities in a timely manner, in accordance with the law. Medical institutions shall not be allowed to do so, for example or to destroy it. Article 31 Medical institutions should strictly monitor the occurrence of ill-treatment of medicines, in accordance with national regulations. In identifying suspicious cases of malicious responses to drugs, records, surveys, analyses, evaluations and treatment should be made available, and in the first month of each quarter, a centralized report should be made available to provincial drug abuse monitoring bodies. It was found that new or severe adverse responses to medicines should be taken immediately by medical institutions and reported to provincial drug abuse monitoring bodies within 7 days of the discovery, while reporting to provincial, municipal and district, district, and district, district (market) food drug surveillance authorities. There is a need to report immediately to provincial, municipal and district, district (market) food drug surveillance authorities, the health administration and provincial drug abuse monitoring institutions. Article 32 violates the provisions of this approach, which stipulate that the laws, regulations, regulations and regulations have been penalized. Article 33, medical institutions violate articles 4, 5, 6, 7, 11, 12, 13, 15 and 23 of this approach, by the location's food drug control surveillance management responsible for their corrections, warnings and fines of up to €200,000, which are less than 1,000 dollars, are overdue and fines of up to $100,000. Article 34, in violation of articles 22, 26, 29 and 30 of this approach, is subject to a fine of up to $100,000 for the management of food medicine at the location. In violation of article 27 of the scheme, medical institutions use medical operations to advertise drug propaganda or to issue the advertisement of the agents, which is governed by the law. Article XVI does not have a licence for the operation of a medical institution to use drugs in the name of a medical institution, which is determined by law by the host health administration. Article 37 |
