Drug Supervision And Administration Of Circulation Method

Original Language Title: 药品流通监督管理办法

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(January 31, 2007 national food drug supervision authority makes 26th, announced since May 1, 2007 up purposes) first chapter General first article for strengthening drug supervision management, specification drug circulation order, guarantee drug quality, according to People's Republic of China drug management method (following referred to drug management method), and People's Republic of China drug management method implementation Ordinance (following referred to drug management method implementation Ordinance) and about legal, and regulations of provides, developed this approach.
    Article in the People's Republic of China territory and drug sales and supervision units or individuals shall abide by these measures.
    Third drug-producing, trading enterprises and medical organizations should be on the production, distribution, use, is responsible for the quality of medicines.
    Pharmaceutical production and management enterprises on the premise of ensuring quality and safety of drugs, should adapt to the development direction of modern drug distribution, reform and innovation. Fourth pharmaceutical supervision and management departments to encourage individuals and organizations to impose supervision on drug distribution.
    For acts in violation of these measures, no individual or organization has the right to report drug regulatory authorities and charges.
    Chapter II administration of pharmaceutical production, supervision and management of business enterprises and selling drugs article fifth drug production and management enterprises responsible for their drug purchases and sales, its sales staff or set up offices in the name of the enterprise engaged in the purchase and sale of Drugs Act liability.
    Sixth drug-producing, and trading enterprises shall, on their purchases and sales people for drug-related laws, regulations and professional knowledge training, establish training records, training records should document the training time, place, content and training of personnel.
    Article seventh drug production and trading enterprises shall strengthen the management of drug sales, and specifically provide for its sales practices.
    Article eighth drug production and trading enterprises shall not be approved by the pharmaceutical supervisory and Administrative Department an address other than the place of storage or from stock sales.
    Nineth pharmaceutical producing enterprises can only sell the production of drugs, should not sell this or other production of the enterprise was entrusted with the production of medicines.
    Tenth Article drug production enterprise, and drug wholesale enterprise sales drug Shi, should provides following information: (a) stamped this enterprise original seal of drug production license or drug business license and license of copies; (ii) stamped this enterprise original seal of by sales drug of approved proved file copies; (three) sales imports drug of, according to national about provides provides related proved file. Pharmaceutical manufacturers, drug wholesaler to send sales people selling drugs, in addition to information specified in the preceding paragraph of this article, should also provide copies of authorizations with the original seal. Authorization shall set forth the authorized the sale of the original variety, region, period, indicate the salesperson's ID number, and stamped with the seal of the original seal and legal representative of the enterprise (signature).
    Sales staff should be original and I show them the authorization ID original, for drug purchases by check.
    11th drug-producing enterprises, drug wholesale enterprises selling products, should be issued indicating the supplier name, drug name, manufacturer, lot number, quantity, price and other sales documents.
    Drug retailers selling products, he issued shall be marked with a drug name, manufacturer, lot number, quantity, price and other sales documents.
    Article 12th drug production and business enterprises in the procurement of medicines should be provided for in this article tenth request, identification, retired supply business documents and information obtained pursuant to this way to 11th, retired sales documents.
    Drugs production, management of enterprises in accordance with the provisions of the preceding paragraph of this article retention of information and sales documents, shall be kept until the more than medicine valid for 1 year, but not less than 3 years.
    13th drug-producing, drug distributors knew or should have known that others engaged in unlicensed production, Drugs Act, shall not be provided with drugs.
    Article 14th drug production and trading enterprises may not for others in the name of the company provide a forum for drug or qualification documents or instruments such as convenience.
    15th Strip pharmaceuticals production and management enterprises are allowed to shows, expositions, fairs, orders, product information, such as cash selling drugs.
    16th pharmaceutical trading enterprises may not purchase and sale of medical institutions of the medicinal preparations.
    Article 17th without approval of drug regulatory authorities, pharmaceutical trading enterprises may not change the way of doing business.
    Pharmaceutical trading enterprises shall, in accordance with the business license in drug industry drugs.
    Article 18th drug retail enterprises shall, in accordance with provisions of the food and Drug Administration drug classification requirements, prescription sales of prescription drugs.
    Management of prescription and non-prescription drug retailers, pharmacist or lawful pharmaceutical technical personnel when the absence of qualification, listed should be informed, and to stop sales of prescription and non-prescription drugs.
    Article 19th specification low temperature refrigerated storage of medicines, pharmaceutical production and trading enterprises shall, in accordance with the relevant provisions, low temperature, cold storage facilities and equipment, transportation and storage.
    Drug regulatory agency found that drug production and management enterprises that violate the provisions of the preceding paragraph of this article shall immediately seize, seizure of drugs covered and dealt with according to law.
    20th Strip pharmaceuticals production and management enterprises shall not be tying, buy drugs get drug, buy merchandise donated medicines to the public prescription drug or non-prescription drugs.
    Article 21st drug production and trading enterprises may not sell by mail, Internet trading, including direct sales to the public prescription drug.
    22nd against the illicit acquisition of drugs.
    Chapter III medical institution purchases, Stockpiling pharmaceuticals supervision and management of the 23rd medical treatment institutions pharmacies should have commensurate with drug use premises, equipment, storage facilities and a hygienic environment, equipped with the appropriate pharmaceutical technical personnel, and the establishment of quality management or quality management staff, establish rules for storage of pharmaceuticals.
    When the 24th purchase drugs in medical institutions shall, in accordance with article 12th in these measures, obtained, identification, preservation and corporate documents and material delivery, Bill. 25th medical institutions buy drugs, must establish and implement incoming inspection system and has built a complete drug purchase records.
    Drug purchase records must indicate the drug's generic name, manufacturer (indicating their origin of Chinese herbal medicines), dosage form, specifications, batch number, production date, expiry date, approval number, supplier, quantity, price, and date of purchase.
    Drug purchase records must be kept to more than drugs valid for 1 year, but not less than 3 years.
    Article 26th stockpiling medicines in medical institutions, should develop and implement drug storage, maintenance system, and take the necessary refrigeration, freezing, moisture, protected from light, ventilation, fire protection, pest control, prevention measures and ensure the quality of medicines.
    Drug and non-drug medical institutions shall be separate; Chinese herbal medicine, Chinese herbal medicine, chemical medicines, Chinese medicines should be stored separately, and store.
    27th medical institutions and family planning technical service institutions not to provide medicines directly to patients without a diagnosis and treatment.
    28th medical agencies shall not sell by mail, Internet trading, including direct sales to the public prescription drug.
    29th medical institution Central bidding and procurement of drugs, shall comply with the drug administration law and the implementing regulations of the pharmaceutical administration law and the relevant provisions of these measures.
    Fourth chapter legal responsibility 30th article has following case one of of, ordered deadline corrected, give warning; late not corrected of, sentenced 5,000 yuan above 20,000 yuan following of fine: (a) drug production, and business enterprise violation this approach sixth article provides of; (ii) drug production, and wholesale Enterprise violation this approach 11th article first paragraph provides of; (three) drug production, and business enterprise violation this approach 12th article, not according to provides retained about information, and sales voucher of.
    31st Strip pharmaceuticals production and management enterprises in violation of the provisions of article seventh and give a warning, rectification. 32nd article has following case one of of, in accordance with drug management method 73rd article provides, confiscated illegal sales of drug and illegal proceeds, and at illegal sales of drug goods value amount twice times above five times times following of fine: (a) drug production, and business enterprise violation this approach eighth article provides, in by drug supervision management sector approved of address yiwai of places spot sales drug of; (ii) drug production enterprise violation this approach Nineth article provides of; (three) drug production, and
    Business enterprises that violate the provisions of article 15th; (iv) drug-handling enterprises in violation of the provisions of article 17th.
    Article 33rd drug production and management company violates these measures under article eighth, approved by the pharmaceutical supervisory and Administrative Department an address other than the place of storage of drugs, according to the pharmaceutical administration law of 74th of the implementing regulation shall be punished.
    Article 34th drug retail enterprises that violate the provisions of the second paragraph of this article 11th, correction is given a warning; fails to correct, punishable by fines of less than 500 Yuan.
    35th disobey article 13th, pharmaceutical production, business knew or should have known that others engaged in unlicensed production, Drugs Act to provide drugs and given a warning and order them to correct, and a fine of up to 10,000 yuan, in serious cases, fines of between 10,000 yuan and 30,000 yuan.
    Article 36th drug production and management enterprises in violation of the provisions of article 14th, 82nd according to the pharmaceutical administration law of the rules will be punished.
    37th disobey article 16th, drug-handling Enterprise purchases or sales of the medicinal preparations of medical institutions, in accordance with article 80th of the pharmaceutical administration law will be punished. Article 38th drug retail enterprises in violation of the provisions of the first paragraph of article 18th, rectification and give a warning; fails or if the circumstances are serious, fined 1000 Yuan fine.

    Violation of paragraph II of this article 18th, drug retailers licensed pharmacists or other legally certified pharmaceutical technical personnel not employed selling prescription drugs or classes of non-prescription drugs, rectification and give a warning; it fails, and fined 1000 Yuan fine.
    39th drug production, wholesale business in violation of these regulations under article 19th, not medicines under the condition of low temperature refrigerated drugs stated, given a warning and a rectification; fails, fined 5,000 yuan and 20,000 yuan fines; drug confirmed by law belong to the counterfeit drug, in accordance with the relevant provisions of the drug administration law will be punished.
    Drug manufacturing, wholesale business in violation of these regulations under article 19th, cold, frozen conditions that are not stipulated in the drug store drugs, in accordance with article 79th of the drug administration law shall be punished; drug confirmed by law belong to the counterfeit drug, in accordance with the relevant provisions of the drug administration law will be punished.
    40th Strip pharmaceuticals production and management enterprises in violation of the provisions of article 20th, rectify and give a warning; fails or if the circumstances are serious, giving values of drugs twice times the amount of a fine, but not more than 30,000 yuan.
    41st article violates this article 23rd to 27th, rectification, if the circumstances are serious, informed.
    42nd Strip pharmaceuticals production and management enterprises in violation of the article 21st, medical institution in violation of the provisions in article 28th, to sell by mail, Internet trading and other direct sales of prescription drugs to the public, shall be ordered to correct, given a warning and fined not more than twice times the amount value of domestic sales, but up to 30,000 yuan.
    43rd in violation of provisions of this article 22nd of purchasing drugs, in accordance with the provisions of 73rd of the drug administration law will be punished.
    44th pharmaceuticals supervision and management departments and neglects his duty, shall stop the action to stop violations and penalties, penalties, the supervisor directly responsible and other persons directly responsible shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
    The fifth chapter by-laws article 45th spot sales of drugs in these measures refers to drug production, business enterprise or of its delegate sales team in drug supervision and management departments approved an address other than the other places, carrying drug spot specific objects field sales behavior.
    Article 46th special management of medicines, vaccines, the army, with the supervision and administration of circulation of medicines, otherwise provided by the relevant laws, rules and regulations, from its provisions. 47th article of the rules take effect on May 1, 2007.
                  From the date of implementation of this approach, implemented on August 1, 1999, the State food and drug administration the measures for the supervision and administration of circulation of medicines (interim) (State Drug Administration 7th order) repealed simultaneously.

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