Article 1 In order to strengthen the management of medicines and medical devices in medical institutions, to ensure the safe and effective use of medicines and medical devices, according to the "Chinese People's Republic of China *** and the State Drug Administration Law", "Chinese People's Republic of China *** and the State Drug Administration Law Enforcement Regulations", as well as "Medical Devices Supervision and Administration Regulations" and relevant laws and regulations, combined with the actual situation in this province, the formulation of these measures.
Second Article The management of medicines and medical devices in medical institutions within the administrative area of this province shall be governed by these Measures.
The medical institutions referred to in the preceding paragraph, including hospitals, maternal and child health centers, health centers, sanatoriums, outpatient clinics (including individual), clinics (including individual), health centers (rooms), emergency centers (stations), hospitals for the prevention and control of disease (station), nursing homes (station), community health service centers (station) and other diagnostic and treatment institutions engaged in disease prevention, diagnosis, treatment, health care activities and family planning technical service institutions. The third part of the report is that it is the first to be published in the United States.
Article 3 The food and drug supervision and management department of the provincial people's government is responsible for the supervision and management of the province's medical institutions, drugs and medical devices. Municipal, county and district people's government food and drug supervision and management department is responsible for the supervision and management of medical institutions within the administrative area of drugs and medical devices.
The relevant administrative departments of the people's governments at or above the county level are responsible for the supervision and management of drugs and medical devices in medical institutions within their respective areas of responsibility.
Article IV of the medical institutions shall be approved in accordance with the law of the diagnosis and treatment subjects, family planning technical services within the scope of the use of medicines, with a licensed physician, physician assistant or obtain a certificate of registration of rural doctors to practice rural doctor's prescription allocation of medicines.
Article 5 medical institutions may, in accordance with the relevant provisions of the State, in accordance with the approved diagnostic and therapeutic subjects and the use of drugs within the scope of the pharmacy or medicine cabinet.
Medical institutions to set up a pharmacy or medicine cabinet, shall comply with the provincial people's government food and drug supervision and management departments to develop management norms.
Article VI individual outpatient clinics, clinics and other medical institutions, shall not be equipped with commonly used drugs and first aid drugs other than drugs. The scope and varieties of commonly used drugs and first-aid drugs shall be formulated and announced by the health administrative department of the provincial people's government in conjunction with the food and drug administration department of the provincial people's government.
The scope of drugs used in family planning technical service institutions shall be consistent with the approved scope of services, services, surgical procedures, and shall not use drugs other than the basic drug list of family planning technical service institutions, except for those who have obtained a medical practice license. The basic medication catalog for family planning technical service institutions shall be formulated and published by the food and drug administration department of the provincial people's government in conjunction with the family planning administrative department of the provincial people's government.
Article VII of Article 6 of these measures shall not be unauthorized changes in the scope and variety of drugs used in medical institutions. Need to change, should be reported to the local food and drug supervision and management departments, health administrative departments or family planning administrative departments for approval.
Article VIII of the medical institutions should be from the "Drug Production License" or "Drug Business License" of the drug production and business enterprises to purchase drugs, except for the implementation of the management of the approval number of Chinese herbal medicines. Village health offices and individual clinics may also entrust their township health centers to procure drugs on their behalf or have them distributed by local drug distribution centers.
The township health center to purchase drugs on behalf of the village health office, individual clinics should hold a letter of entrustment issued by the local food and drug supervision and management department to accept the supervision and inspection.
Article IX of the medical institutions to purchase medicines, shall establish a purchase inspection and acceptance system, inspection of drug certificates and other packaging identification; does not meet the prescribed requirements, shall not be purchased.
Article 10 of the medical institutions shall, in accordance with laws and regulations, the establishment of true and complete records of drug purchases. Records of drug purchases shall not be kept for less than three years; drug expiration date of more than three years, save until one year after the expiration of the validity of drugs.
Article XI of the medical institutions shall dispense medicines by prescription, shall not be mailed, forged prescriptions, counter open shelves and self-selection and charity clinics, charity sales, consulting, trial, exhibitions and other ways of operating or disguised operation of medicines.
Article XII of the medical institutions shall formulate and implement the drug storage system, in accordance with the provisions of the quality and safety of the drugs classified storage, to take measures to ensure the quality of drugs such as refrigeration, anti-freezing, moisture-proof, light, ventilation, fire prevention, pest control, rodent and other measures.
Medical institutions of the stored medicines should be maintained on a regular basis.
Article XIII of the medical institutions to deploy drugs, packaging materials, containers and the working environment, should meet the hygiene requirements to prevent contamination of drugs.
Medical institutions need to dispense drugs on the original minimum packaging of the drug split, should make a good record of the split, and retain the original minimum packaging and drug instructions until the end of the sale. The surface of the packaging of the drugs after the split, should indicate the name of the drug, specifications, usage, dosage, expiration date and other content.
Article XIV of the hospital category of medical institutions approved by the preparation of Chinese medicinal preparations, approved by the provincial people's government food and drug supervision and management department, can be entrusted to the drug manufacturer or a "preparation license" of the preparation room of the medical institution preparation.
Article 15 The internal departments of medical institutions shall not set up private pharmacies, medical personnel of medical institutions shall not sell drugs and preparations privately.
Medical institutions shall not use preparations prepared by other medical institutions without approval.
Article 16 Medical institutions shall not use counterfeit or inferior medicines.
Medical institutions in the use of drugs found in the process of counterfeit drugs, substandard drugs, shall immediately stop using, and promptly report to the local food and drug supervision and management department, shall not be disposed of without authorization.
Medical institutions found that the quality of the drug is suspicious, should suspend the use of drug testing organizations at the same time sent to the test; test to determine the counterfeit drugs, substandard drugs, should be promptly reported to the local food and drug supervision and management departments.
Article XVII of the medical institutions for direct contact with the drug personnel, should be conducted annually for health checks, and the establishment of health records. Suffering from infectious diseases, suspected infectious diseases and other diseases that may contaminate the drugs, shall not engage in direct contact with drugs.
Medical institutions engaged in drug procurement, storage, maintenance, acceptance, deployment of personnel shall receive professional training and continuing education. Where the state stipulates that professional qualifications should be obtained, it shall follow its regulations.
Article 18 Medical institutions shall not utilize medical business advertisements to promote medicines, and their dispensed preparations shall not be advertised.
Article 19 Medical institutions shall purchase medical devices from manufacturing and operating enterprises that have a Medical Device Manufacturer's License or a Medical Device Operator's License.
Medical institutions to purchase medical devices, shall establish a purchase inspection and acceptance system, inspection of medical equipment product certification and other packaging identification, shall not purchase unregistered, no proof of conformity, expired, invalid, obsolete or does not meet the registration standards of medical devices.
Article 20 Medical institutions purchasing medical devices shall establish a true and complete record of purchase, the record shall have the following contents:
(a) the trademark and name of the medical device, specifications (model), batch number, expiration date, sterilized products should also be recorded in the sterilized batch number;
(b) the number of purchases, the purchase price, date of purchase;
(c) the manufacturer, the supplier, the "medical device", the "medical device", the "medical device", the "medical device", the "medical device", the "medical device", the "medical device" and the "medical device". Manufacturer, supplier, "Medical Device Registration Certificate" copy, "Medical Device Manufacturer License" copy or supplier of "Medical Device Business License" copy;
(d) acceptance conclusion, the operator, the person in charge of the signature or seal.
Purchase record retention time shall not be less than one year after the expiration of the product or termination of use, implantable medical devices purchase records should be permanently stored.
Article 21 of the medical institutions to store medical devices in the warehouse, shall comply with laws, regulations, rules or provincial people's government food and drug supervision and management departments.
Article 22 of the medical institutions shall not use unregistered, no proof of conformity, expired, expired, eliminated or do not meet the registration standards of medical devices. Medical institutions shall not expand the use of clinical trial stage of medical devices without authorization.
Medical institutions to develop medical devices should be used in the unit, shall not be sold to the market.
Article 23 of the medical institutions in the use of sterile medical devices before, should carefully check its packaging. For direct contact with the medical device packaging breakage, should stop using, and in accordance with the relevant provisions of the treatment.
Medical institutions use special equipment and the inclusion of the national mandatory calibration directory of measuring instruments, should be designated by the quality and technical supervision of the administrative department of the calibration agency qualified to use.
Article 24 of the medical institutions using implantable medical devices should be established using records. Records include:
(a) the patient's name, contact address, telephone;
(b) the date of surgery, the name of the surgeon;
(c) the product name, specifications (model), the name of the manufacturer, the production batch number (factory number or serial number), the date of production;
(d) the supply unit, the date of purchase, the supplier's contact address, Telephone.
Implantable medical devices should be permanently stored records.
Article 25 of the medical institutions shall implement the State Council and the provincial people's government departments in charge of prices of drugs. The implementation of government pricing, government guidance and government price intervention measures for drugs, shall not in any form of unauthorized price increases. For drugs that should be purchased by bidding in accordance with the law, should be purchased by bidding in accordance with the law, and reduce the price of drugs. Prohibit profiteering and price fraud to the detriment of patients.
Medical institutions should be used by patients with drugs, medical equipment, price announcement, query system, to provide patients with a truthful list of prices of drugs and medical equipment used.
Article 26 of the medical institutions shall, in accordance with the relevant provisions of the state, the use of drugs and medical devices for the quality of the unit, efficacy and response to tracking and observation. Found that may be related to the use of drugs or devices, adverse reactions, shall promptly report to the provincial people's government food and drug supervision and management department, health administrative department or family planning administrative department.
Article 27 Violation of the provisions of Article 6, paragraph 2, Article 7 of these measures, by the local food and drug supervision and management department shall order rectification within a certain period of time; failure to do so shall result in a fine of not less than 200 yuan and not more than 1,000 yuan.
Article 28 violation of the provisions of Article 10, Article 21, by the local food and drug supervision and management department shall order rectification, and impose a fine of 500 yuan or more than 3000 yuan.
Article 29 violation of the provisions of Article XI of these measures, by the local food and drug supervision and management department shall order rectification, and impose a fine of 2000 yuan or more than 20,000 yuan.
Article 30 violation of the provisions of Article XIV of these measures, without the approval of the provincial people's government food and drug supervision and management department, entrusted to other units of the production of medical institutions, by the location of the food and drug supervision and management department to supervise the destruction of the illegal preparations and impose a fine of more than 2,000 yuan 20,000 yuan.
Article 31 Violation of the provisions of Article 15 of these measures, by the local food and drug supervision and management department shall order correction, and impose a fine of 1000 yuan or more than 10,000 yuan.
Article 32 violation of the provisions of Article 16, paragraph 2, paragraph 3, failure to timely report to the local food and drug supervision and management department, the local food and drug supervision and management department shall be warned, and impose a fine of 200 yuan to 1000 yuan.
Article 33 violation of the provisions of Article 17 of these measures, by the local food and drug supervision and management department shall order correction, and impose a fine of 500 yuan or more than 5000 yuan.
Thirty-four violation of the provisions of these measures, medical institutions to purchase or use medical equipment does not meet the registration standards, by the local food and drug supervision and management department to supervise the destruction, and impose a fine of 200 yuan or more than 2,000 yuan.
Article 35 violation of the provisions of this Measures of other acts, laws and regulations provide penalties, from its provisions.
Article 36 The staff of the Food and Drug Administration and other administrative departments, in the supervision and management of the use of medicines and medical devices in medical institutions, abuse of power, favoritism, negligence, by their units or higher authorities shall be given administrative sanctions; suspected of committing a crime, be transferred to the judicial organs for investigation and punishment according to law.
Article 37 These measures shall come into force on December 10, 2006 .