Drugs And Medical Devices Used In Anhui Province Supervision And Administration

Original Language Title: 安徽省药品和医疗器械使用监督管理办法

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(November 26, 2007 Anhui Province Government 59th times Executive Conference considered through December 18, 2007 Anhui Province Government makes No. 207, announced since March 1, 2008 up purposes) first chapter General first article to specification drug and medical devices of using, maintenance human health and life security, according to People's Republic of China drug management method, and medical devices supervision Management Ordinance and State on strengthening food, products security supervision management of special provides, legal, and
    Regulations, and the facts of the province, these measures are formulated.
    Article II of this regulation is applicable in the province within the administrative area of medical institutions, family planning technical service institutions (hereinafter referred to as users) of pharmaceuticals and medical devices and regulatory implementation of supervisory activities.
    Article use the practising unit shall obtain the relevant permission to use medicine and medical equipment, and shall bear responsibility for security in the use of medicines and medical devices.
    Fourth units should be established in accordance with national drug and medical device purchasing, acceptance, storage, maintenance, and deployment of management systems.
    Article fifth food and drug supervision and administration departments at or above the county level (hereinafter referred to as the drug agency) is responsible for the supervision and administration of drugs and medical devices used in the administrative area.
    Health, population and family planning, industry and commerce, quality, price and other departments according to their respective duties, is responsible for supervision and administration relevant to drugs and medical devices. Chapter II purchase acceptance management article sixth use units from drug or medical device production, qualified enterprises to purchase drugs or medical devices.
    Buy without approval, management of Chinese crude drugs and licensing management of medical devices, except not.
    Article seventh implementation and distribution capacity of drug-handling Enterprise Unified distribution of supply of drugs to rural medical institutions, establishing and improving drug supply networks in rural areas.
    Article eighth Central bidding and procurement of pharmaceuticals and medical devices, users should strictly implement the relevant provisions of the national and provincial, and accept supervision by the drug regulatory Department and other relevant departments.
    Nineth article using units purchased into drug, and medical devices, should identification, and obtained following information, and established procurement archives: (a) drug, and medical devices production or business license and license of copies; (ii) drug production or business quality management specification certification certificate of copies; (three) imports drug registered card or medicine products registered card, and medical devices registered card of copies; (four) drug test report book, and biological products batch issued certificate ming, and medical devices qualified proved of copies;
    (E) drugs or sales of single-use sterile medical device authorization and identity and sales documents.
    The preceding paragraph (a) to (d) provides copies of the information, shall be affixed to the supplier of the seal.
    The national compulsory safety certification for medical devices, should also be in accordance with the People's Republic of China measurement provisions of the law, examine and obtain relevant information. Article tenth users purchase drugs should be batch-by-batch inspection of medicines, identification of the appearance of pharmaceutical, packaging, labels, instructions, and fill out the drug acceptance record.
    Drug acceptance record shall include the drug's generic name, manufacturer (indicating their origin of Chinese herbal medicines), dosage form, specifications, production batch number, expiry date, the approval number, supply unit, quantity, date of purchase, acceptance of the conclusion, signature of acceptance. 11th use of units purchased medical equipment shall conduct incoming inspection, fill out the medical devices inspection record. Medical device inspection record should include the product name, size (type), manufacturers, suppliers, production lot number (serial number or a serial number or manufacture date), registration certificate number, expiry date, quantity, acceptance of the conclusion and acceptance signatures, and so on.
    Sterilized medical devices should also record the date of sterilization or sterilization lot number.
    Use foreign physician's medical devices, should be carried out according to the provisions of the preceding paragraph examined. Article 12th acceptance records kept for not less than 2 years.
    Drugs effective for more than 2 years, drugs acceptance record-keeping to 1 year after the expiry date of the medicine. Medical device inspection record shall be kept until the expiry or to stop after 1 year, but not less than 2 years.
    Implantable medical device inspection record should save a trace to the end of the product.
    13th article using units shall not has following behavior: (a) from not has production, and business qualification of enterprise purchased into drug or medical devices; (ii) without approved unauthorized using or purchase other medical institutions preparation of preparations or development of medical devices; (three) purchased into packaging, and label, and manual not meet provides of drug or medical devices; (four) from Super business way or Super business range of enterprise purchased into drug or medical devices.
    14th chapter store maintenance management using units shall establish a standard pharmacy, places for stockpiling medicines and medical equipment, facilities and conditions shall comply with the relevant regulations of the State, as well as drug and medical device manufacturer's instructions. 15th using unit on stocks of drugs and medical devices should be checked on a regular basis, to check the records.
    Expired, invalid or deteriorated, mildew and insect borers, damage and eliminate drugs and expired, damaged, out of medical devices shall immediately seal registration and reporting.
    16th units should be established according to stipulations in the equipment category of medical devices archive, timely maintenance and calibration devices class I medical devices, and make maintenance and calibration records.
    Maintenance and calibration devices do not meet standard requirements class I medical devices, users shall not use, and in accordance with the relevant provisions.
    Fourth chapter article 17th deployment using management unit shall, in accordance with the law approved by the medical subjects or services within the scope of the project deployment and use of drugs and medical devices.
    18th units should be by prescription dispensing medicine, auditing and prescription dispensing pharmacy personnel should be through the qualification of pharmacy technicians.
    Village clinics, clinic, community health service institutions, private clinics used units such as the lack of qualification of pharmacy technician shall be organized by the drug administration departments at or above the county level pharmaceutical law examination in professional knowledge and qualified personnel according to the prescription dispensing medicines. Article 19th unit personnel in direct contact with the pharmaceuticals and sterile medical devices, shall undergo an annual health check.
    Suffering from a communicable disease or other disease may contaminate the drug, sterile medical devices, may not engage in direct contact with the drug or sterile medical device work.
    Article 20th deployment medicine tool, work environment, packaging materials and containers shall meet the quality and hygiene requirements. Use unit leveling drugs requiring the original minimum packaging standardizes, standardizes record and keep the original minimal packaging to use up.
    Standardizes the packaging should indicate the name, specifications, usage, dosage, duration, and so on. 21st medical institutions should track the use of implanted medical device records using records. Records should include the medical record number is used, patient name, hospital number, duration of surgery, the surgeon's name, implantable device name, specifications, product serial number, or serial number, registration number, manufacturer, and supplier information.
    Use record management together with the medical records, visit records.
    22nd use unit, used equipment donated medical equipment shall examine their legal certificates and statutory inspection body inspected before use, without inspection or failed to pass the examination shall not be used.
    Article 23rd unit shall, in accordance with the relevant provisions of the State monitoring and reporting of adverse drug reactions and adverse events of medical devices.
    Users found the use of unsafe drugs and medical devices, can cause damage to human health and safety, should immediately stop using the drug or medical device, production enterprises, and report to the drug agency.
    24th article using units shall not has following behavior: (a) used mail business, and Internet trading, way directly to public sold prescription drug; (ii) to clinic, and sale, and trial, and retail, way sales drug, and medical devices; (three) without approved in medical advertising in the for drug or medical devices publicity; (four) on preparation of preparations or development of medical devices released advertising; (five) using not meet quality standard or beyond applies range using medical devices; (six) will development of medical devices foreign sold.
    Fifth chapter supervision check 25th article drug prison sector should on using units of following matters for supervision check, using units should truthfully provides situation and corresponding information, shall not refused to and hide: (a) drug, and medical devices management system of established and implementation situation; (ii) drug, and medical devices procurement archives, and purchased goods voucher, and acceptance records and implanted human medical devices track registration, management situation; (three) drug, and medical devices of deployment using, and store conservation, situation.
    Article 26th health departments shall, in accordance with the People's Republic of China Law on drug management and related legal responsibilities and regulations on medical drugs and medical devices used to implement pharmaceutical management.
    Departments for industry and commerce shall conduct supervision and inspection on use of advertising to receive complaints and reports of drugs and medical equipment, and pharmaceutical and medical device advertising violations.
    Price departments shall use units of medicines and medical equipment price supervision and inspection, receiving complaints and reports of drug and medical device prices, investigate and deal with illegal pricing of medicines and medical devices. 27th drug, health, price, industry and commerce, quality supervision, population and family planning departments should be based on their respective duties, in accordance with statutory authority and procedures for drug and medical devices using conducting supervision and inspection, and to use the unit to comply with mandatory standards and legal requirements of record, signed by the supervising personnel filed after. Supervision and inspection records should be as a part of these departments are directly responsible for regularly checking. The public right of access supervision and inspection records.

    28th drug, health, price, industry and commerce, quality supervision, population and family planning departments should publicize the e-mail addresses or telephone; reports of received, shall, without delay, fully documented and properly preserved.
    Tipoff belongs to the duties of the Department, should be inadmissible and shall verify, process, respond to; not part of the duties of the Department, shall be referred to the right of the Department and inform the informers.
    Article 29th drug administrations should establish drug and medical devices using a credit management system, will not be used legally safe and effective medicines and medical devices unit included in the record list. Drug Administration departments should establish drug and medical device using the emergent group emergency response plan for adverse events.
    Drug agency received medicines and medical devices using the emergent group adverse event reports, shall promptly start emergency plans to ensure public safety.
    Sixth chapter legal responsibility 30th article using units has following case one of of, by drug prison sector ordered corrected, give warning, and at 1000 Yuan above 5000 Yuan following fine: (a) purchased into drug or medical devices not obtained, and identification, and retained related proved material of; (ii) purchased into drug or medical devices not acceptance, or no acceptance records, and acceptance records not real, and not full of; (three) foreign please physician since with of medical devices qualification documents not by provides identification of;
    (D) storage conservation of medicines or medical devices not according to stipulations; (v) failure to establish quality track record of implanted medical devices, (vi) devices class I medical devices do not establish device files, no periodic maintenance and calibration.
    31st units using untested or unqualified, used equipment donated medical equipment from the drug agency ordered corrective action and more than 5000 Yuan and fined a maximum of 10000 Yuan.
    Article 32nd unit sell by mail, Internet transactions directly to the public by way of sale of prescription drugs from the drug agency ordered corrective action and give a warning, and a sales value of more than 1 time penalty of twice, but up to 30,000 yuan.
    Article 33rd units to free clinics, charity, probation, retail sales, including pharmaceuticals, medical devices, and 73rd respectively, in accordance with the drug administration law and the regulation on supervision and administration of medical devices article 38th of the regulations will be punished.
    Article 34th and use unauthorized medical advertisements for drug and medical device promotion, of the medicinal preparations or develop advertising of medical devices, be investigated by the Commerce Department.
    Article 35th units do not meet the quality standards of or beyond the scope of the use of medical devices, from the drug agency ordered corrective action and give a warning, and illegal gains more than 1 time penalty of 3 times, but no more than 30,000 yuan.
    36th medical devices developed by it using the units on sale, from the drug agency ordered corrective action and give a warning and fined a maximum of illegal income more than twice times 3 times, but no more than 30,000 yuan.
    37th article drug prison sector and other about administrative sector of staff has following case one of of, law give administrative sanctions; constitute crime of, law held criminal: (a) on illegal using drug and medical devices behavior of reported or drug and medical devices quality problem of report not timely processing, caused bad consequences of; (ii) participation drug or medical devices purchase and sale activities of; (three) to using units recommended drug or medical devices of;
    (D) does not perform the duty of supervision and inspection or found violations are not investigated; (e) other acts of dereliction of duty, abuse of authority or engages in.
                    Seventh chapter supplementary articles article 38th these measures shall take effect on March 1, 2008.