Shaanxi Province, Medical Institutions, Pharmaceutical And Medical Device Management

Original Language Title: 陕西省医疗机构药品和医疗器械管理办法

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$19.99.
(On November 4, 2006 Shaanxi Province Government makes 115th, announced since on December 10, 2006 up purposes) first article to strengthening on medical institutions drug and medical devices of management, guarantees human security effective to using drug and medical devices, according to People's Republic of China drug management method, and People's Republic of China drug management method implementation Ordinance and medical devices supervision Management Ordinance and about legal, and regulations, combined this province actual, developed this approach.
    Second medical institution within the administrative area of the province of drug and medical device management, these measures shall apply.
    Qian paragraph by said medical institutions, including hospital, and hospital, and hospitals, and nursing home, and clinic (containing individual), and clinic (containing individual), and clinic (room), and emergency Center (station), and disease control Hospital (by, and station), and nursing Hospital (station), and community health service center (station), engaged in disease prevention, and diagnosis, and treatment, and health activities of clinic institutions and family planning technology service institutions. Third provincial food and drug supervision and management is responsible for the province's drugs in medical institutions and the supervision and administration of medical devices.
    City, County and district people's Government's food and drug regulatory agency responsible for the administration of hospital drug supervision and administration of medical devices.
    Relevant administrative departments of the people's Governments above the county level shall, within their respective areas of responsibility are responsible for drugs in medical institutions and relevant supervision and administration of medical devices.
    Article fourth medical institution shall, in accordance with the law approved by the medical subjects within the scope of the drug use, family planning technical services, licensed physician, licensed physician assistant village doctor practitioner or registered certificates of village doctors ' prescription dispensing medicines.
    The fifth medical institutions in accordance with relevant regulations of the State, legally authorized medical subjects and drug use within the pharmacy or medicine cabinet.
    Medical institutions set the pharmacy or medicine cabinet, shall comply with the provincial food and drug supervision and Management Department of management practices. Sixth individual outpatient departments, clinics and other medical institutions shall not be equipped with first-aid medicines and commonly used drugs other than drugs.
    Range and variety of commonly used drugs, emergency drugs, the provincial health Administrative Department in conjunction with the provincial food and drug administration developed and published. The scope of family planning technical service institutions and drug use should be in accordance with approved service scope, service project, operation is consistent, you may not use family planning technical service institutions other than the essential drug list and drug, medical practice license exception.
    List of family planning technical service institutions use, by the provincial food and drug supervision and management in conjunction with the provincial family planning administrative departments developed and published. Medical institutions provided for in article sixth of seventh article this approach of using drugs ranges and varieties shall not be changed without permission.
    Absolutely necessary to change, it shall be reported to the local food and drug supervision and administration departments, approval of the Administrative Department of health or family planning administration. Eighth medical institutions should be from the drug manufacturing license or a pharmaceutical business of drug production, management of purchasing drugs, except for Chinese herbal medicine without approval number management.
    Village clinics, private clinics can also entrust the Township to buy drugs or by a local distribution center and distribution of drugs.
    Township of purchasing drugs, should hold a village clinics, individual power of Attorney issued by the clinic, and accept the supervision and inspection of local food and drug supervision and Administration Department.
    Nineth purchase drugs in medical institutions, incoming inspection system should be established, qualified certificates and other pharmaceuticals packaging; do not meet the requirements of, and shall not be purchased. The tenth medical institutions shall, in accordance with the provisions of laws and regulations, establish real and complete record of the medicines purchased.
    Drug purchase records kept for not less than 3 years; drug is valid for more than 3 years, saved to the drug after expiry date year 1.
    11th medical institutions should be by prescription dispensing medicines, not by post, open-shelf and clinic on demand, forged prescriptions, over-the-counter sale, counselling, probation, trade shows and other business or disguised drugs.
    12th medical institutions should develop and implement system of storage of pharmaceuticals, in accordance with the provisions relating to the quality and safety of drugs store, refrigeration, freezing, moisture, protected from light, ventilation, fire protection, pest control, prevention and other measures to ensure the quality of drugs.
    For stockpiling medicines in medical institutions should conduct regular maintenance.
    13th deployment of drugs in medical institutions of provisioning tools, packing materials, containers, and the working environment, shall comply with the hygiene requirements, prevent contamination of drugs. Deployment of drugs in medical institutions requiring the original minimum packaging standardizes, shall do standardizes record and retain the original minimum packaging and directions to sale lasts.
    Standardizes the packaging surface, you should indicate the name of the drug, specifications, usage, dosage, duration, and more.
    14th hospital approved categories of medical institutions in the preparation of traditional Chinese medicine preparation, approval by the provincial food and drug administration, may authorize drug manufacturers or pharmaceutical preparation certificate for medical institution of the preparation room preparation.
    15th medical organizations within departments may not be private pharmacies, medical personnel in medical institutions not allowed to sell the drug substances and drug products.
    Medical institutions shall not use other medical institutions without approval of the medicinal preparations.
    16th medical institutions fake medicines and medicines of inferior quality shall be used.
    Medical institutions in drug use found in the fake medicines and medicines of inferior quality shall immediately stop using, report to the local food and drug supervision and Management Department in a timely manner, it may not.
    Quality of medical institutions found that suspected drug should be suspended, and drug Inspection Agency inspection; test identified as fake medicines and medicines of inferior quality shall promptly report to the local food and drug supervision and administration departments. 17th for staff in direct contact with drugs in medical institutions, shall conduct annual health check, and health records.
    Suffering from a communicable disease or suspected infectious diseases and other diseases that might contaminate the drug officers shall not engage in direct contact with the pharmaceuticals. Medical institutions engaged in drug procurement, storage, maintenance, acceptance, deployment of personnel, should receive professional training and continuing education.
    Qualified shall be stipulated by the State, from its provisions.
    18th medical organizations may not use medical drug advocacy ads, which of the medicinal preparations should publish any advertisements.
    19th medical organizations should be a medical device manufacturing enterprise license or medical device distributing Enterprise license production and management enterprises purchased medical equipment.
    Purchase medical equipment of medical institutions, incoming inspection system should be established to adopt medical device certificates and other packaging shall not purchase without registration, without certificates, expired, invalid, out or do not meet the registration standards for medical devices.
    20th article medical institutions purchased into medical devices should established real, and full of purchased into records, records should has following content: (a) medical devices trademark and the name, and specifications (model), and batch, and validity, sterilization products also should records sterilization batch; (ii) purchased goods number, and purchased into price, and purchased goods date; (three) production manufacturers, and supply units, and medical devices registered card copies, and medical devices production enterprise license copies or supply units of medical devices business enterprise license copies;
    (D) inspection findings, Attn, signature or seal.
    Purchased record-keeping time not less than the product after the expiration or 1 year after the termination of use, implantable medical device to buy the records shall be stored permanently.
    21st medical institutions storage warehouse of medical devices, shall comply with laws, regulations, rules or conditions provided for provincial food and drug administration. 22nd medical organizations may not use without registration, free certificates, expired, invalid or obsolete or do not meet the registration standards for medical devices.
    Medical institutions are not allowed to expand clinical trial use of medical devices.
    Medical institutions to develop medical devices should be used in this unit, may not be sold into the market. The 23rd before medical organizations in the use of sterile medical devices should be carefully check the packaging.
    Of direct contact with the medical device packaging appears damaged, should discontinue use and in accordance with the relevant provisions.
    Medical use of special equipment and included in the national list of compulsory certification of measuring instruments shall be designated by the Administrative Department of quality and technical supervision standards institutes to be used. 24th medical institutions shall establish a record of use of implantable medical devices.
    Records include: (a) the patient's name, address, telephone, (ii) the date of surgery, the surgeon's name; (c) the name, specifications of products (models), manufacturer, name, batch number (serial number or serial number), date of production and (iv) supplier, date of purchase, supplier contact address and phone number.
    Records should be stored permanently implantable medical devices. 25th medical institutions shall implement the State Council and the provincial Department in charge of price-related provisions of drug prices. Subject to Government pricing, Government-guided prices and Government price controls of drugs, not to raise rates without in any way. On tender procurement of medicines should be taken according to law, it shall take tender procurement, reduce drug prices.
    Prohibit price fraud profits and harm the interests of patients.
    Medical institutions should use medicines for price announcement, query systems, medical equipment, to provide patients with the drugs and medical equipment price list. 26th medical institutions shall, in accordance with the relevant provisions of the drug and medical device quality, efficacy and response tracking.
    Discovery may be associated with drug or device-related adverse reactions, shall promptly to the provincial food and drug regulatory agency, the Administrative Department of health or family planning administrative departments report.
    27th in violation of the sixth paragraph of this approach, the seventh article, the local food and drug supervision and management departments rectification; fails to change, a fine of 200 Yuan more than 1000 Yuan fine.
    28th article in violation of the measures set forth in the tenth, 21st, the local food and drug supervision and Administration Department shall be ordered to correct, and a fine of 500 Yuan and 3000 Yuan fine.
    29th in violation of the provisions of article 11th, the local food and drug regulatory agency ordered corrective action and imposed fines of less than 2000 Yuan and 20,000 yuan.
    30th article violates this way 14th section, without approval of the provincial food and drug administration, entrust other unit production of medical preparations, the local food and drug supervision and management departments supervise the destruction of illegal agents, and a fine of less than 2000 Yuan and 20,000 yuan fine.
    31st in violation of the provisions of article 15th, the local food and drug supervision and Administration Department shall be ordered to correct, and a fine of 1000 Yuan and 10,000 yuan fine.
    32nd breach of the 16th article of this approach, provisions of the third paragraph, does not report to the local food and drug supervision and Management Department in a timely manner, be warned by the local food and drug supervision and Management Department, and a fine of 200 Yuan more than 1000 Yuan fine.
    33rd in violation of the provisions of article 17th, the local food and drug regulatory agency ordered corrective action and imposed fines of less than 500 Yuan more than 5000 Yuan.
    The 34th article violates these rules, purchase or use of medical institutions do not meet the registration standards of medical devices, the local food and drug supervision and management departments supervise the destruction, and a fine of 200 Yuan more than 2000 Yuan fine.
    35th other acts in violation of these rules, shall be punished by laws and regulations, from its provisions.
    36th food and drug administration and other administrative staff, in the supervision and administration of medical institutions ' use of drugs and medical devices in the abuse, malpractice, negligence, by their work units or by the competent authorities shall be given administrative sanctions; a suspected crime, transferred to the judicial authorities to investigate and punish.
                                                                                                          37th these measures shall come into force on December 10, 2006.

Related Laws