Shenyang City's Drug And Medical Device Regulatory Approach

Original Language Title: 沈阳市药品和医疗器械监督管理办法

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(June 2, 2008, Shenyang city people's Government, the 5th Executive meeting on June 30, 2008, Shenyang city people's Government promulgated as of August 1, 2008, 4th) first in order to strengthen the supervision and administration of drugs and medical devices, human drug and medical device is safe and effective, according to the People's Republic of China pharmaceutical administration law, the State Council of the supervision and administration of medical devices regulations and other laws and regulations, combined with the city's actual, these measures are formulated.
    Article within the administrative area of the city engaged in development, production of drugs and medical devices (preparation), operation and use of the units and individuals shall abide by these measures.
    Third municipal food and drug supervision and Administration Department is responsible for the administrative area of the city of drugs and medical equipment supervision and management.
    Relevant government departments at all levels within their respective areas of responsibility do drugs and supervision and administration of medical devices. Fourth article drug production enterprise purchased into raw materials drug and made medicinal approved paper, of medicinal accessories (following referred to medicinal accessories), should to supply units obtained following proved file, and save to raw materials drug, and medicinal accessories effective expires Hou one years; validity discontent two years of, should save three years: (a) stamped supply units original seal of drug production license or drug business license copies; (ii) stamped supply units original seal of license copies; (three) stamped supply units original seal of
    Drug production quality management specification or drug business quality management specification certification certificate copies; (four) supply units statutory representative people signed or sealed of authorized Attorney (authorized attorney should contains Ming authorized sales of varieties, and geographical, and term, indicate sales personnel of ID number; authorized Attorney is copies of should stamped supply units original seal and Enterprise statutory representative people of original seal or signature); (five) sales personnel ID copies;
    (Vi) sealed by the supply units of the original drugs sold by copies of approval documents; (VII) drug quality certificates, test reports and invoice of purchased drugs; (h) copies of other supporting documents according to law.
    Fifth article drug production enterprise production drug or medical institutions preparation preparations shall not has following behavior: (a) from not has drug production, and wholesale business qualification of enterprise purchased into raw materials drug and medicinal accessories; (ii) using should marked and not marked validity or over validity of raw materials drug and medicinal accessories; (three) will not meet legal, and regulations provides and national mandatory standard of raw materials drug, and medicinal accessories input production; (four) using should approved and without approved of raw materials drug, and medicinal accessories.
    Sixth drug-producing enterprises producing medicines must be in accordance with the provisions of national drug standards prescribed ingredients and prescriptions feeding, and according to the State food and Drug Administration approval of production processes.
    Article seventh production of medicines must be examined and passed before the factory.
    Pharmaceutical producing enterprises shall not be forged, such as inspection reports and drug certificate.
    Eighth article drug business enterprise shall not has following behavior: (a) from drug retail enterprise purchased into drug; (ii) purchased into or sales medical institutions preparations; (three) unauthorized change drug business way; (four) beyond drug license business range business drug; (five) in drug counter, and drug shelf placed drug yiwai of other commodity; (six) drug retail enterprise rental, and lending drug business license, in business places within different of counter or shelf placed same drug;
    (VII) ways to give prescription or non-prescription drugs.
    Nineth drug retailer standardizes sales tool that drug use should be complete, clean and sanitary, and sale of medicines should be indicated on the packaging bags drug name, specifications, batch number, dosage, dosage, duration, and so on.
    Article tenth drug manufacturers and wholesale enterprises shall not without the pharmaceutical production license, drug trading license, medical institutions unit and individual sales of the license to practice medicine.
    Drug production and trading enterprises may not approved by the food and Drug Administration outside sites store or selling drugs.
    11th inspection should be carried out in accordance with regulations or approved drugs without testing or without examination and approval by any unit or individual shall sell or import.
    Article 12th drug production, operation corporate takeover expired drugs should be in 7th to buy drugs reported to the food and drug administration, and carried out under the supervision of the food and drug administration.
    Against the illicit acquisition of drugs.
    13th medical device manufacturing enterprise license management of medical equipment, at the time of purchase of raw materials or parts shall be obtained from the supplier of the following documents: (a) stamped copy of business license of the original seal of the supply unit, (ii) product quality certification and the purchase invoice.
    Raw materials or parts are included in the license management of medical devices, and in conformity with the provisions of the preceding paragraph shall also be obtained with supply unit the original seal of the medical device manufacturing enterprise license or copy of the medical device distributing Enterprise license, as well as with supply unit the original seal of the copy of the registration certificate of medical devices.
    Raw materials or parts mentioned above belong to fungus-free products, and supporting documents shall be kept until one year after the expiry date of the product without valid, shall be kept until after the product sale or stop sales after three years belongs to the implantation of key product categories, such as in national requirements, supporting documents should be stored permanently.
    14th production of medical devices shall meet the approval of the registration certificate of medical devices standards.
    Medical equipment manuals, labels, packaging shall be consistent with the relevant content of the registration certificate of medical devices.
    15th medical apparatus production and trading enterprises may not without the approval of the business premises operating medical devices must not store medical devices approved without. 16th article medical institutions should established following management system: (a) drug and medical devices procurement acceptance; (ii) drug and medical devices out, and storage review; (three) drug and medical devices quality problem report and bad reaction (event) monitoring and report; (four) drug deployment, and review and drug custody conservation; (five) drug validity monitoring; (six) preparations of preparation, and custody and using; (seven) medical devices using and maintenance maintenance; (eight) implanted sex medical devices quality track; (nine) once
    Use sterile medical devices reprocessing.
    Article 17th keep drugs in medical institutions shall, in accordance with the implementation provisions of the medicine quality control specifications, expired drugs on a regular basis the stocktaking exercise, expiry of medicines in accordance with the regulations.
    Places for storage of medical equipment of medical institutions, facilities and conditions shall conform to the standards of product quality and safety of medical devices. 18th article medical institutions shall not has following behavior: (a) from not has drug production, and business qualification of enterprise procurement drug; (ii) from drug retail enterprise procurement drug; (three) not by prescription using drug; (four) unauthorized using other medical institutions preparations; (five) from not has production, and business qualification of enterprise purchased into medical devices or purchased into no medical devices registered card of medical devices; (six) received and using has expired, and failure or no medical devices registered card, and no certificate ming, and
    No purchase invoices a license management for medical equipment, (VII) changed medical apparatus factory standards; (VIII) accepting other medical institutions by processing agents without authorization.
    Article 19th drug advertising and promotion the written statement and accompanying drug labels, brochures, package marking of indications or indications shall not exceed the limits prescribed by the national drug standards.
    Article 20th non-pharmaceutical advertising and promotional written statement and accompanying labels, brochures, packaging, shall not contain any indications, indications, usage and dosage of medicines.
    Article 21st drug and medical device production and management enterprises in China should be in accordance with State regulations qualify as a corresponding and regular education and training expertise and knowledge of the law.
    22nd in pharmaceutical and medical device manufacturing, operating company personnel in direct contact with the pharmaceuticals and sterile medical devices, should health examinations every year and setting up health records.
    Suffering from infectious diseases and other disease could contaminate drugs and personnel of sterile medical devices, in cure or to exclude possible pollution before, may not engage in direct contact with the pharmaceuticals and sterile medical devices work.
    23rd of drug production, trading enterprises and medical organizations in medicine purchase and sale and found in the use of fake medicines and medicines of inferior quality, and should immediately stop sales and use, and to immediately report to the food and Drug Administration; to have sales of the drug should immediately stop sale and purchase; has been sold to individuals, should be announced to the public, to voluntarily recall the batch of drugs.
    Drug manufacturers found that the production of drugs are unsafe, may cause harm to human health and safety, shall be announced to the public for information, notification and consumers to stop sale and purchase, voluntarily recalled the drug, and reported to the food and drug administration.
    24th medical device distribution business of sterile medical devices through inspection of substandard products or there are security risks, may pose a risk to human health, it shall immediately notify the purchase and end the sale and use of medical institutions, and reports to the food and Drug Administration; on sale for personal use shall be announced to the public, to voluntarily recall the product.
    Medical device manufacturers found that the production of unsafe medical devices may pose a risk to human health and safety, shall be announced to the public for information, notify the medical device business to stop sales, informed medical institutions and consumers to stop using the voluntary recall of medical devices, and report to the food and drug administration. 25th without approval of the State drug should not be used for the human body.

    26th article food drug supervision management sector in check in the can seized, and seized has following case one of of drug: (a) national food drug supervision management sector provides ban using of; (ii) should to approved and without approved production, and preparation, and business, and imports, or should to test and without test that sales, and preparation, and using of; (three) using not made approved paper, of raw materials drug engaged in production of; (four) by marked of indications or function attending beyond provides range of;
    (Five) should marked and not marked validity or change validity of; (six) not indicate or change production batch of; (seven) over validity continues to business, and using of; (eight) directly contact drug of packaging material and container without approved of; (nine) unauthorized added coloring agent, and preservatives, and spice, and straightening taste agent and the accessories of; (10) production, and preparation drug using of accessories not meet drug standard provides of;
    (11) is not in accordance with the standards or not in accordance with the approved production process and is not in accordance with the approved standards in the preparation of (12) unauthorized OEM (13) go beyond the scope of the production, preparation or business (14) no production or formulation batch records production, formulation, wholesale without buying or selling records, retail without purchase records.
    27th article drug production, and business enterprise violation this approach provides, has following case one of of, by food drug supervision management sector according to People's Republic of China drug management method 73rd article, and 74th article, and 75th article, and 80th article, and 82nd article, State on strengthening food, products security supervision management of special provides third article, and fourth article, national food drug supervision authority drug circulation supervision management approach 35th article, and 40th article of provides, give punishment:
    (A) in food drug supervision management sector approved of places yiwai store or sales drug of; (ii) unauthorized change drug business way of; (three) beyond license business range business drug of; (four) using should approved and without approved of raw materials drug, and medicinal accessories of; (five) should to test or audit approved of drug, and without test or audit approved, unauthorized sales or imports of; (six) acquisition expired drug of; (seven) purchased into or sales medical institutions preparations of;
    (Eight) from drug retail enterprise purchased into drug of; (nine) from not has drug production, and wholesale business qualification of enterprise purchased into raw materials drug and medicinal accessories of; (10) drug retail enterprise rental, and lending drug business license, in business places within different of counter or shelf placed same drug of; (11) not according to national drug standard provides of prescription components and prescription volume feeding or not according to national food drug supervision management sector approved of production process production drug of; (12) not on drug for test or by test not qualified and forged test report, qualified proved file factory sales of; (13) purchased into raw materials drug and medicinal accessories, not obtained and save supply units about proved file of; (14) using not marked validity or over validity of raw materials drug, and medicinal accessories of; (15) will not meet legal, and regulations provides and national mandatory standard of raw materials drug, and medicinal accessories input production of; (16) to no drug production license, and drug business license
    And the practising certificate for medical institution units and individuals selling medicines (17) in a variety of ways give prescription or non-prescription drugs.
    28th article medical devices production, and business enterprise violation this approach provides, has following case one of of, by food drug supervision management sector according to state medical devices supervision Management Ordinance 37th article, and 38th article, and 39th article of provides, give punishment: (a) production of medical devices not meet medical devices registered card approved implementation standard of; medical devices business enterprise business of medical devices manual, and label, and packaging identifies and medical devices registered card of related content not consistent of;
    (B) approved by the food and Drug Administration outside sites store or sales of medical devices, (iii) production license management medical device companies in the purchase of raw materials or parts, no copies of the supporting documents.
    29th article medical institutions violation this approach provides, has following case one of of, by food drug supervision management sector according to People's Republic of China drug management method 73rd article, and 74th article, and 80th article, State medical devices supervision Management Ordinance 42nd article, Liaoning province medical institutions drug and medical devices using supervision management approach 31st article of provides, give punishment: (a) not by prescription using drug of; (ii) accept other medical institutions delegate processing preparations of; (Three) from not has drug production, and business qualification of enterprise procurement drug of; (four) from drug retail enterprise procurement drug of; (five) unauthorized using other medical institutions preparations of; (six) from not has production, and business qualification of enterprise purchased into medical devices or purchased into no medical devices registered card of medical devices of; (seven) received, and using has expired, and failure or no registered card, and no certificate ming, and no purchased into invoice, and implementation license management of medical devices of; (eight) change medical devices factory standard,
    Unqualified medical devices; (IX) failing to establish a management system and (10) keep medicines and medical devices do not meet the requirements of.
    30th article violation this approach provides, has following case one of of, by food drug supervision management sector according to People's Republic of China drug management method 73rd article, and 74th article, State medical devices supervision Management Ordinance 42nd article, State on strengthening food, products security supervision management of special provides Nineth article, national food drug supervision authority drug circulation supervision management approach 30th article of provides, give punishment: (a) illegal acquisition drug of; (Ii) will without approved of drug for human of; (three) drug advertising and promotions publicity written statement and the with attached of drug label, and manual, and packaging, by marked of indications or function attending, beyond national drug standard of; (four) non-drug advertising and promotions publicity written statement and the with attached of label, and manual, and packaging,, contains drug indications, and function attending, and usage and dosage content of; (five) not according to requirements recovered or recalled drug, and medical devices of; (six) drug and medical devices production, and
    Annual expertise and knowledge of the law by operating enterprises in China that are not education.
    31st article violation this approach provides, has following case one of of, by food drug supervision management sector ordered corrected, law give punishment: (a) drug retail enterprise standardizes sales drug not meet provides requirements of; (ii) drug and medical devices production, and business enterprise of practitioners not according to national provides made corresponding qualification of; (three) drug and medical devices production, and business enterprise of about personnel not for health check, not established health archives of;
    (D) suffering from infectious diseases and other disease could contaminate drugs and medical devices staff, engaged in direct contact with the pharmaceuticals, prior to the cure of sterile medical devices. 32nd subsection violation drug, and medical devices supervision management legal, and regulations and regulations, has following case one of of, for plot serious, from heavy punishment: (a) to anesthesia drug, and spirit drug, and medical with toxicity drug, and radioactive drug posing as other drug, or to other drug posing as above drug of; (ii) production, and sales to pregnancy maternal, and infant and the children for main using object of counterfeit, and bad drug of; (three) production, and sales of biological products, and blood products belongs to counterfeit, and bad drug of; (four) production, and sales
    , And using counterfeit, and bad drug, caused personnel hurt consequences of; (five) production, and sales, and using counterfeit, and bad drug, by processing Hou repeated of; (six) refused to, and escape supervision check, or forged, and destroyed, and hidden about evidence material, or unauthorized use seized, and seized items of; (seven) from illegal channel purchased into and sales counterfeit of; (eight) with a violations reached three times above of (containing three times); (nine) other legal, and regulations and regulations provides plot serious or consequences serious of. Violation of these rules, and result in significant harm to the person and property of others, and shall bear the liability for damages.
    Serious enough to constitute a crime, criminal responsibility shall be investigated by judicial organs.
    33rd party refuses to accept the decision on administrative penalty may apply for administrative reconsideration or bring an administrative lawsuit in accordance with law, if no application for reconsideration, not prosecuted, nor performs the decision on punishment, made the decision to apply to the people's Court for compulsory execution.
    Article 34th drug regulatory abuse, malpractice, neglect their duties, constitutes a crime, criminal responsibility shall be investigated according to law; do not constitute a crime, administrative sanctions according to law.
            35th these measures shall come into force on August 1, 2008.

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