Fushun City, Drug And Medical Device Regulatory Requirements

Original Language Title: 抚顺市药品和医疗器械监督管理规定

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Fushun city, drug and medical device regulatory requirements

    (March 30, 2009, Fushun city people's Government, the 10th General meeting on March 30, 2009, Fushun city people's Government, the 139th announce as of May 1, 2009) 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 supervision and administration of medical devices Ordinance and other laws, regulations, combined with the city's actual, these provisions are formulated. Article working in the administrative area of the city of drugs and medical devices production, formulation, management, use, supervision and management of units and individuals shall abide by these provisions.

    Otherwise provided by laws and regulations, from its provisions.

    Article city and County Food and drug regulatory agency responsible for the administration of drugs and the supervision and administration of medical devices.

    City and County quality and technology supervision departments within their respective administrative areas include management according to law and mandatory testing of medical devices in the list of measuring instruments production, use, supervision and administration.

    Departments shall, in accordance with their respective responsibilities related to city and county governments do drugs and supervision and administration of medical devices.

    Fourth manufacturer production of pharmaceuticals and medical agencies prepared agents when purchasing raw materials and auxiliary materials should be obtained from the supplier with supply unit the original seal of the business license copy, product certificates and invoices.

    Purchase raw material drug and excipient at medical approval must be obtained, in addition to requests for outside the supporting documents prescribed in the preceding paragraph shall also obtain the following documents:

    (A) with supply unit the original seal of the pharmaceuticals production license or copy of the pharmaceutical business license;

    (B) with supply unit the original seal of good manufacturing practices or the certified copy of the certificate of medicine quality control specifications;

    (C) the sealed by the supply units of the original drug copies of approval documents;

    (D) the supplier signed or sealed by the legal representative set forth the authorized sales, territory and term for security, sales ID number of Attorney; copy of power of Attorney is, shall be affixed to the supplier the original seal and the original seal or signature of the legal representative of the enterprise;

    (E) sales copy of ID card;

    (F) containing the drug batch number and so on sales documents;

    (G) other relevant documentation obtained according to law.

    Obtain the above documents, shall be kept until the raw and supplementary materials after the expiry of one year validity period of less than two years, should be kept for three years.

    Fifth prohibits the use does not comply with the national standard of medicinal raw materials, auxiliary materials production of pharmaceuticals, formulation agents.

    Prohibition of use shall indicate its period and is not marked or expired medicinal raw materials, auxiliary materials production of pharmaceuticals, formulation agents.

    Sixth production of 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 drug production and management enterprises established the Treasury sales of pharmaceuticals without approval, according to unlicensed medicines.

    Eighth prohibits pharmaceutical producing enterprises, trading enterprises and medical institutions from drug retailers purchase drugs or purchase medical preparations.

    Nineth prohibits drug manufacturers and wholesale businesses without the pharmaceutical production license, drug trading license, medical institutions unit and individual sales of the license to practice medicine.

    Tenth Strip pharmaceuticals, medical apparatus purchase drugs and State regulations the class II and class III medical device quality check should be carried out, and fill in the real and complete inspection records. Drug inspection records kept for not less than three years.

    Drugs more than three years, drugs acceptance record is saved to the drug after the expiry of one year. Medical device inspection record shall be kept until the expiry or to stop after a year, but not less than three years.

    Implantable medical device inspection record and quality track record of saving over the same period.

    11th drugs retail enterprises and standardizes sales of drugs in medical institutions using tools, packaging bags should be 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.

    12th prohibited drug-handling Enterprise rental counters; prohibit drug retailer in the same place of business of different counters or placed on the shelves with a drug prohibited drugs retail enterprises in pharmaceutical counters, shelves hold drugs other than other commodities.

    13th prohibits the illicit acquisition of drugs.

    Drug recall expired products from production and operation enterprises can engage in public activities, but should start in the 7th to the recovery activities Recovery Act report of the food and drug administration, and accept supervision by the local food and drug supervision and Administration Department.

    Food and drug supervision and management departments should monitor the recovery to the destruction of the whole process.

    14th level or above (level) medical institutions shall set its size relatively independent of drug and medical device Depot.

    Specific management measures shall be formulated separately by the municipal food and drug supervision and Administration Department.

    15th medical organizations within the Department must use unified purchasing drugs in medical institutions; purchase drugs without authorization, in accordance with the unlicensed drug treatment.

    The 16th drug advertising, promotional literature, and internal training materials, written declarations, labels, brochures, packaging, publicity, labelling indications or indications, beyond the scope of national drug standards, by selling fake medicines.

    Non-pharmaceutical advertising, promotional literature, and internal training materials, written declarations, labels, brochures, packaging, containing drug indications, indications and usage, and the amount of content, by selling fake medicines.

    17th medical device manufacturing enterprises producing medical devices, at the time of purchase of raw materials, components, should be obtained from the supplier with supply unit the original seal of the business license copy of invoice, product certificates and products.

    Purchase of raw materials, components are included in the license management, in addition to obtain the documents provided for in the preceding paragraph, a supplier sheet-should also be obtained from 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.

    Buy raw materials, spare parts belong to fungus-free products, request supporting documents shall be kept until the product after the expiry of one year; no validity, 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.

    18th is prohibited outside the approved premises, warehouse sale, storage of class II and class III medical devices prescribed by the State.

    19th medicines and medical equipment for the production and management enterprises in China should be organized on a regular basis for appropriate expertise and legal training. Pharmaceutical production in China, trading enterprises shall, in accordance with the national provisions corresponding professional skills qualification.

    Vocational qualification training organized by the food and drug administration, Department of labor is responsible for examination and issuance of national vocational qualifications.

    20th in pharmaceutical and medical device manufacturing, trading enterprises and medical institutions should be organized every year in direct contact with drugs and staff health examination of sterile medical devices and setting up health records.

    Prohibits health check and suffering from infectious diseases and other disease could contaminate drugs and sterile medical devices staff in healing or removing possible prior to direct contact with the pharmaceuticals and sterile medical devices work.

    21st release of false advertising of pharmaceuticals, medical devices, advertising management laws and regulations by administrative departments for industry and Commerce investigated.

    22nd article on one of the following drugs, the food and Drug Administration can seal up, distrain:

    (A) the State food and Drug Administration ban;

    (B) shall be approved without being approved for production, formulation, management, import, or be without test marketing, formulation, and use of;

    (C) use without obtaining the approval number is engaged in the manufacture of APIs;

    (D) labelled indications or indications outside the specified limits;

    (E) should be marked and unmarked or change the validity period;

    (Vi) does not indicate or change batch;

    (VII) expired to continue to operate, use;

    (VIII) packaging materials and containers in direct contact with drugs without approval;

    (IX) added colouring agents, preservatives, spices, flavorings and accessories;

    (J) the production, formulation and drug use does not comply with the drug standard set of accessories;

    (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) the commissioning process without permission;

    (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;

    (15) the laws, regulations and other potentially harmful drugs. 23rd article violation this provides, purchased into raw materials drug and must made medicinal approved paper, of medicinal accessories, not obtained and save this provides fourth article second paragraph (a), and (ii), and (three), and (six) items proved file one of of, by food drug, and supervision management sector confiscated illegal proceeds, goods value amount insufficient 5000 Yuan of, and at 20,000 yuan fine; goods value amount 5000 Yuan above insufficient 10,000 yuan of, and at 50,000 yuan fine; goods value amount 10,000 yuan above of,

    5 times more than double the amount in value terms and fined not more than 10 times, causing serious consequences, the original license issuing Department revoked as constitutes a crime, criminal responsibility shall be investigated according to law.

    Purchase raw materials and Excipients, medical approval must be obtained, did not request and save the second paragraph of this article fourth (iv), (v) one of the supporting documents, rectification and give a warning; it fails, more than 5000 Yuan and fined a maximum of 20,000 yuan. 24th article violation this provides fifth article, using not meet national standards of medicinal raw materials, and accessories, using should marked validity and not marked validity or over validity of medicinal raw materials, and accessories production drug, and preparation preparations of, by food drug supervision management sector confiscated illegal proceeds, goods value amount insufficient 5000 Yuan of, and at 20,000 yuan fine; goods value amount 5000 Yuan above insufficient 10,000 yuan of, and at 50,000 yuan fine; goods value amount 10,000 yuan above of,

    5 times more than double the amount in value terms and fined not more than 10 times, causing serious consequences, the original license issuing Department revoked as constitutes a crime, criminal responsibility shall be investigated according to law. 25th article violation this provides sixth article, not according to national drug standard provides of prescription components or prescription volume feeding of, not according to national food drug supervision management sector approved of production process production drug of, by food drug supervision management sector confiscated illegal proceeds and products, goods value amount insufficient 5000 Yuan of, and at 50,000 yuan fine; goods value amount 5000 Yuan above insufficient 10,000 yuan of, and at 100,000 yuan fine; goods value amount 10,000 yuan above of, and at goods value amount 10 times times above 20 times times following of fine

    Causing serious consequences, the original license issuing Department revoked as constitutes a crime, criminal responsibility shall be investigated according to law.

    26th article, violation of the provisions of the eighth article, pharmaceutical producing enterprises, trading enterprises and medical institutions from drug retailers purchase drugs or purchase of medical preparations, according to the People's Republic of China article 80th of the drug administration law and punished as such.

    27th article in violation of the provisions of article Nineth, drug manufacturers and wholesalers to the drug-free production license, drug trading license, medical institutions unit and individual sales of the license to practice medicine shall be ordered to correct, given a warning and a fine of 10,000 yuan in serious cases, fined 20,000 yuan.

    28th article in violation of the provisions of article tenth, drug and medical device distributing Enterprise purchase drugs and State regulations the class II and class III medical device is not acceptance, no true and complete record of acceptance, acceptance records were not saved to the specified time, by the food and Drug Administration ordered corrective action and give a warning and fined a maximum of between 1000 and 500 Yuan RMB.

    29th article in violation of the provisions of article 12th, drug retailers in the same place of business of different counters, placed on the shelves with a drug or place other than medicine at the drug counter, shelves of other commodities, by the food and drug administration a fine 1000 Yuan in serious cases, fined a maximum of between 5000 and 1000 Yuan.

    30th in violation of paragraph one of this article 13th, purchasing drugs, according to the People's Republic of China article 73rd of the drug administration law and punished as such.

    31st in violation of paragraph one of this article 14th, level or above (level) corresponding to its size has not been set by the medical institution independent of medicines and medical equipment warehouse, by the food and Drug Administration ordered to rectify disciplinary warning; fails, fined a maximum of between 5000 and 1000 Yuan.

    32nd breach of the provisions of article 17th the second and third paragraphs, purchase medical device manufacturing enterprise license management of raw materials and accessories, is not required to obtain and keep all supporting documents, by the food and Drug Administration penalty of between 2000 Yuan and 10,000 yuan. 33rd article violation this provides 18th article, in food drug supervision management sector approved of places yiwai sales, and store national provides of second class, and third class medical devices of, by food drug supervision management sector ordered stop business, confiscated illegal business of products and illegal proceeds, illegal proceeds 5000 Yuan above of, and at illegal proceeds twice times above 5 times times following fine; no illegal proceeds or illegal proceeds insufficient 5000 Yuan of, and at 5000 Yuan above 20,000 yuan following fine; constitute crime of,

    Criminal responsibility shall be investigated according to law.

    19th 34th in violation of these provisions, medicines and medical equipment production and management enterprises in China does not organize regular training on expertise and knowledge of the law, allowing professional does not have a corresponding professional skills qualifications, by the food and Drug Administration ordered to rectify disciplinary warning; it fails to, more than 5000 Yuan and fined a maximum of 20,000 yuan. 35th article violation this provides 20th article, drug and medical devices production, and business enterprise and the medical institutions not according to provides organization directly contact drug and no bacteria medical devices personnel for health check, allows not for health check and with infectious diseases and other disease may pollution drug and no bacteria medical devices personnel cure or excluded may pollution Qian engaged in directly contact drug and no bacteria medical devices work of, by food drug supervision management sector ordered corrected, give warning,

    Penalty of between 1000 and 500 Yuan RMB.

    Article 36th food and drug supervision and administration officers do not perform their duties seriously, abuse of power, deception, negligence, by this unit or the supervisory authorities in accordance with the relevant provisions of administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law. 37th article of the regulations come into force on May 1, 2009.