Ningbo Drug Supervision And Administration

Original Language Title: 宁波市药品经营监督管理办法

Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/dfzfgz/201303/20130300384533.shtml

Ningbo drug supervision and administration

    (December 17, 2012 Ningbo Municipal People's Government at the 16th Executive meeting of December 21, 2012 Ningbo Municipal People's Government announced order No. 200, come into force on February 1, 2013) Chapter I General provisions

    First to strengthen pharmaceutical supervision and management, standardize drug business order to ensure drug quality and safety, in accordance with the People's Republic of China pharmaceutical administration law and the People's Republic of China such as drug administration regulations for the implementation of laws and regulations, combined with the city's actual, these measures are formulated.

    Article within the administrative area of the city engaged in pharmaceutical wholesale, retail, and business and medicine storage, transportation, supervision and management of the entity or individual, should comply with these measures.

Article city and County (City) food and drug supervision and management is responsible for the supervision and administration of drug distribution within the administrative area.

Commerce, industry, health, transportation and other administrative departments within the scope of their respective duties, is responsible for the supervision and administration of drug-related work.

    Town of township people's Government, neighborhood offices should assist in food and drug supervision and management departments in the area of drug supervision and administration.

    Article fourth pharmaceutical industry should strengthen supervision and management of the Association, industry self-regulation, the promotion of pharmaceutical business law.

    Chapter II administration of operations

    Article fifth established enterprises, shall comply with the conditions laid down in laws and regulations, and in accordance with the law of administrative licensing, registration and other related procedures.

    Sixth pharmaceutical trading enterprises shall establish branch offices or sent on behalf of sales to the enterprise engaged in the drug business liability.

    Seventh pharmaceutical trading enterprises shall establish a computerized management information system through computer faithfully record the purchase, storage and sale of the drugs, and in accordance with the requirements of the food and drug administration, timely and accurate reporting of the drugs from the enterprises to purchase, storage and sale of the data. Article eighth pharmaceutical enterprises should keep trading places size and layout is relatively stable.

    Drug supply management need to adjust size and layout of the place, and shall not reduce the operating conditions and adjust the date should be reported to the food and Drug Administration for record in the 15th. Nineth pharmaceutical business enterprise logistics enterprises to take medicines transport or storage, should be responsible for the safety in quality during the transport or storage of drugs.

The temperature requirements of the transport or storage of medicines, pharmaceutical trading enterprises shall supervise the logistics enterprises in accordance with the provisions to take the necessary heat or freezing measures.

Drug distributor by postal service or courier companies operating will drug by mail, shall produce proof legitimacy of drug-related material should postal service or courier companies operating on the spot inspection.

    Narcotic drugs, psychotropic drugs, medical toxic drugs and radioactive drugs, special drugs transport, storage, post and shall be handled in accordance with the relevant provisions.

    Tenth first battalion of the pharmaceutical wholesale business selling non-drug, from a drug manufacturer or other pharmaceutical wholesale enterprises directly allocate purchase enterprises, subject to the approval of the enterprise quality management staff acceptance, and check records in accordance with the regulations.

    11th drug wholesale business with special compound drug preparation, shall establish customer files, verify and retain purchase qualification certificate, purchases and sales personnel legal power of Attorney and a certified copy of such information.

    12th trading enterprises sold medicines, should be required to issue sales vouchers.

13th drug distributors to buy drugs should be legal bills, according to regulations and establish a record of purchase and acceptance; the Bill does not comply with the provisions of, or tickets, account, the goods do not match the drug, no acceptance of storage.

    Drug distributors purchase products receive complimentary medicines, the corresponding voucher should be requested to prove drugs from an approved source and in accordance with the requirements for acceptance.

    Article 14th trading enterprises and selling drugs sales voucher sales name should be consistent with the actual payment flows, sales amount should correspond to the purchase and sale of financial accounts.

    15th drug retailers should take prescription and non-prescription drugs classification management provisions of the required sales of prescription drugs.

    16th drug retail sales with special compound drug preparation should be according to the rules to register, sales must not exceed prescribed quantities, drugs may not be directly sold to minors. Article 17th without approval of the Administrative Department of public health, pharmaceutical retail enterprise may not conduct treatment activities in their premises.

    Approved by the health administrative departments engaged in the diagnosis and treatment of Pharma sales area and treatment area shall have distinctive physical isolation.

    18th trading enterprises shall, in accordance with the business license in drug management and operating a drug operation.

Article 19th drug distributors sell products other than drugs, medicines and other products stored in the subregion, should be displayed, clear identification.

The following products may not be sold in drug-handling enterprises:

(A) the common name, trade name or other referring to name names had been registered as drug products;

(B) packaging, labels, instructions and related information on the diagnosis, treatment, mitigation or prevention of promotional products;

    (C) an add drug ingredient products.

    20th pharmaceutical trading enterprises shall be permitted within the pharmaceutical packaging with bonus promotional materials or drugs or any other means, of drug indications or indications outside the scope approved by the State food and Drug Administration introduced.

    21st pharmaceutical trading enterprises shall regularly inventory the quality checks and storage conditions, and recording; on expired, spoiled by pollution, substandard drugs, should be inventoried and destroyed in accordance with the relevant provisions.

    22nd pharmaceutical trading enterprises may not be through investment, sale, rental counters, contract, invoice forms for other units or individuals provided to the enterprise on behalf of drugs.

23rd pharmaceutical trading company donated medicines, shall provide the recipient with the drug business license, drug approval documents, drug manufacturers or inspection reports issued by the statutory bodies, such as copies of national data.

    Donation of medicines effective period of not less than 6 months.

    24th article of the city imposed on drug-handling enterprise credit rating, specific evaluation criteria and measures formulated by the municipal food and drug supervision and Administration Department.

    Chapter III administration in China

    25th head of pharmaceutical trading enterprises shall be familiar with the drug control laws, regulations, rules and basic knowledge of the drugs, the enterprise is responsible for the quality of medicines.

Article 26th drug-handling enterprise quality management and drug approval shall have a Pharmacy degree or related field, or have the pharmacy professional technical titles.

    Prescription of pharmaceutical retail enterprise auditor should have pharmacists professional titles above.

    27th pharmaceutical trading enterprises ' quality management, inspection and acceptance, storage, maintenance, operating staff should be subject to food and drug supervision and management organizations, such as professional training, after passing the examination certificates.

    28th pharmaceutical retail enterprise quality management and inspection personnel shall work on the job, not in any other business part-time. Article 29th of drug supply enterprises shall organize and direct contact with the pharmaceuticals each year health checks of people and setting up health records.

    Found to be suffering from mental diseases, infections, and other potentially contaminated drugs officers shall be promptly removed from their jobs.

    Article 30th drug production, wholesale and corporate sales staff selling drugs outside the scope of the enterprise's business, without marketing, set up stalls to sell or drugs as illegal propaganda acts without drugs opened, modified.

    The fourth chapter legal liability

    31st article violates these rules, laws, rules and regulations on penalties, in accordance with the provisions of the relevant laws, rules and regulations.

32nd pharmaceutical trading enterprises, one of the following circumstances, granted by the food and Drug Administration warning that a rectification; fails, more than 5000 Yuan and fined not more than 50,000 Yuan:

(A) in violation of these regulations article seventh, unused computer management information systems record purchase, storage and sale of drugs, or is not timely, accurate reporting of relevant data;

(B) violation of these measures article tenth, from a drug manufacturer, or other first battalion of pharmaceutical wholesale enterprises directly allocate drugs or redeployment of non-acceptance of camp medicine without the quality of enterprise management personnel;

(C) in violation of these regulations section 11th, operating with a special medicine compound preparation in accordance with stipulations to establish customer files, or hang in the air and retained the purchase and sale of the relevant information;

(D) violation of these measures article 12th, selling drugs is not required to issue sales vouchers;

(E) violating these rules article 13th, purchased drugs there is no legal instrument, is not required for acceptance, or accept a bonus when the drug does not ask for the appropriate certificate of acceptance, usage not in accordance with the regulations;

(Vi) violates these measures provided for in article 14th, marketing name for the sales voucher and payment flow is inconsistent, or purchase and sale amount and the related financial accounts do not correspond;

(VII) in violation of these regulations article 16th, sale of special compound drug preparation is not required for registration, a sale exceeding a specified amount, or sell drugs directly to minors;

    (VIII) violation of these measures article 21st, not regularly check the drug inventory, or elimination of substandard drugs not according to stipulations.

33rd drug distributor has any of the following circumstances, granted by the food and Drug Administration warning that a rectification; fails, fined not more than 2000 Yuan and 20,000 Yuan:

(A) in violation of these regulations under article eighth, adjusting drug premises area and layout leads to reduced operating conditions, or adjust the site area and the layout is not in accordance with the regulations to the food and Drug Administration for the record;

(B) violation of these measures article 15th, pending classification of prescription and non-prescription medicines prescribed by the management and marketing;

(C) in violation of these regulations article 17th, not in a sales area and clinic set the physical isolation of the region;
(D) violation of the first paragraph of this article 19th, they sell products other than drugs non-region storage, display, setting clearly identified;

(E) violation of these measures article 20th, indications or indications for exceeding the scope of drug introduction;

(F) the violation of these measures stipulated in article 26th and 27th, quality control, testing, inspection, storage, maintenance, staff in the business without obtaining the relevant certificate of professional titles and post;

    (VII) violates the provisions article 29th of this approach, arranging staff engaged in direct contact with hamper drug safety diseases drugs.

Article 34th disobey Nineth article, the temperature requirements of the transport or storage of medicines, insulation or refrigeration that are not taking the necessary measures, by the food and drug administration of pharmaceutical trading enterprises of less than 2000 Yuan and 20,000 yuan fine.

    Violation of paragraph II of this article Nineth, drug-handling enterprise mailing drugs did not show any to prove legality of drugs related materials, by the food and Drug Administration warning, correction, and a fine of less than 3000 Yuan and 30,000 yuan; post office or courier companies not complying with the requirement for acceptance to send medicines, by the postal administration according to law.

    35th in violation of paragraph II of this article 19th, drug-handling enterprise in violation of regulations for pharmaceutical products other than, by the food and Drug Administration warning, correction and value of illegal products twice times the amount of a fine, but not more than 50,000 yuan.

    36th article in violation of the provisions in article 28th, pharmaceutical retail enterprise quality management and inspection personnel not required working on the job, part-time or in other enterprises, by the food and Drug Administration warning and order them to correct, and to a fine of up to 500 Yuan more than 2000.

    37th in violation of the provisions article 30th, a pharmaceutical salesperson selling drugs outside the entrusted business scope of the enterprise, marketing, set up stalls to sell on the way, drugs for illegal propaganda, or drugs opened or modified without authorization, granted by the food and Drug Administration warned, correction, and a fine of less than 2000 Yuan and 20,000 yuan. 

    Article 38th food and drug supervision and management departments and their staff in the supervision and administration of pharmaceutical trading malpractices for personal gain, dereliction of duty and abuse of power, 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 39th these measures come into force February 1, 2013.