The medical institutions referred to in this approach include: engaged in disease diagnosis, treatment activities of hospitals, health centers, sanatoriums, clinics, clinics, health centers (rooms), maternal and child health centers (institutions, stations), community health service centers (stations) and first aid stations. Article III municipal and county food and drug supervision and management departments (hereinafter referred to as the food and drug supervision and management departments) is responsible for the city and county medical institutions, supervision and management of drugs and equipment.
The relevant departments of the municipal and county people's governments shall do a good job in their respective areas of responsibility for the supervision and management of medical institutions and medicines. Article IV medical institutions should be set up or equipped with its size appropriate quality management organization or quality management personnel, clear management responsibilities, the unit is responsible for the quality and safety of medicines and equipment. Article V medical institutions set up a pharmacy or medicine cabinet, should be in line with the provisions of standardized pharmacy set up. Standardized pharmacy set up by the municipal food and drug regulatory departments in conjunction with the city health department. Article VI of the medical institutions should be in accordance with national, provincial and municipal provisions of the unit's purchase, storage and use of medicines and equipment initiative into the management of the remote electronic monitoring system. Article 7 The personnel engaged in the quality management of medicines and devices in medical institutions (hereinafter referred to as medicines and devices practitioners) shall strictly follow the provisions of Article 7, Article 9, Article 10 and Article 15 of the "Measures for Supervision and Management of Drugs and Medical Devices Practices in Lanzhou City". Article 8 The medical institutions shall purchase medicines and instruments from enterprises with legal qualifications for the production and operation of medicines and instruments, and do a good job in the qualification examination of the supplier of medicines and instruments, and establish a standardized supplier file; basic medicines shall be purchased from the centralized purchasing of basic medicines from the bidding production, distribution and wholesale enterprises. Article IX of the medical institutions to purchase medicines and equipment should be asked for the following information and stamped with the original seal of the supplier:
(a) a copy of the supplier's license;
(b) the city's food and drug regulatory departments issued by the foreign pharmaceutical enterprises for the record a copy of the certificate;
(c) the marketing staff of the medicines and equipment practitioners to qualify for the certificate of authorization by the corporate legal representative a copy of power of attorney;
(d) legal tax bills. p>(d) legal tax bills. Article 10 medical institutions to purchase medicines and equipment, shall carry out quality inspection and acceptance, and the establishment of purchase and use of accounts and true and complete records of purchase and acceptance of medicines and equipment.
Pharmaceuticals and equipment purchase and acceptance records saved to more than the expiration date or termination of the use of 1 year, but not less than 3 years; of which, implantable medical devices purchase and acceptance records should be permanently preserved. Article XI of the medical institutions shall establish the installation of medical equipment, storage and transfer of relevant records, records are kept until 1 year after the end of the medical device equipment.
The need for professional installation of medical devices, should be the manufacturer or its authorized with the relevant service qualifications of the unit to implement the installation. Article XII of the medical institutions to provide patients with medicines should be compatible with the scope of treatment, individuals set up clinics, clinics, village health centers and other medical institutions, shall not be equipped with commonly used medicines and first aid medicines other than medicines.
Family planning technical service organizations shall purchase and provide patients with medicines, the scope of which shall be consistent with the approved scope of services, services, surgical procedures, and shall not be equipped with medicines other than those listed in the basic medicines catalog of family planning technical service organizations.
The basic medication catalog for family planning service institutions shall be formulated by the municipal food and drug regulatory departments in conjunction with the municipal population and family planning departments. Article XIII of the medical institutions should be classified in accordance with the norms and requirements of the purchase of medicines and instruments, and according to the characteristics of the medicines and instruments to take refrigeration, anti-freezing, moisture, light, ventilation, fire prevention, pest control, rodent and other measures to ensure the quality of the medicines and instruments. Medical institutions must be stored on a regular basis maintenance of pharmaceutical instruments, and make maintenance records.
Maintenance checks and the use of medicines and instruments found to be of doubtful quality or expired medicines and instruments should be immediately stopped and sealed, shall not be returned or destroyed; expired medicines and instruments should be registered and reported to the food and drug regulatory authorities to supervise the destruction; expired narcotic drugs and psychotropic substances, should be reported to the health sector to supervise the destruction of the quality of doubtful medicines and instruments sent to the inspection agency for testing, the test fails to promptly report the Food and drug regulatory departments. Article XIV of the medical institutions shall take effective ways to use equipment class medical devices for preventive maintenance, testing and calibration, and keep relevant data and records to ensure that the equipment class medical devices in use in good condition and ready to use.
Medical institutions should be established in the use of medical equipment quality management files. Article XV of the medical institutions should be with a licensed physician or physician assistant prescription for the deployment of drugs, no prescription shall not be deployed drugs. Article XVI of the medical institutions shall not be mailed, forged prescriptions, counter open self-service and charity clinics, charity sales, consultation, trial, exhibitions and other ways to sell or disguise the sale of drugs.
The internal departments of medical institutions shall not set up a private pharmacy or medicine cabinet.