Article 1 In order to strengthen the supervision and management of medicines, standardize the order of circulation of medicines, and ensure the quality of medicines, these Measures are formulated in accordance with the provisions of the Law of the People's Republic of China on the Administration of Medicines of the Chinese People's Republic of China (hereinafter referred to as the "Law on the Administration of Medicines"), Regulations for the Implementation of the Law of the Chinese People's Republic of China on the Administration of Medicines of the Chinese People's Republic of China (hereinafter referred to as the "Regulations for the Implementation of the Law on the Administration of Medicines"), and relevant laws and regulations.
Second Article: Units or individuals engaged in the purchase and sale of medicines and their supervision and management within the territory of the People's Republic of China*** and the People's Republic of China shall comply with these Measures.
Article 3 Drug production, management enterprises, medical institutions shall be responsible for the quality of the drugs they produce, operate and use.
Pharmaceutical production and management enterprises to ensure the quality and safety of drugs under the premise, should be adapted to the direction of the development of modern drug distribution, reform and innovation.
Article 4 The Drug Administration encourages individuals and organizations to implement social supervision of drug circulation. Any individual or organization has the right to report to the drug supervision and management department for violation of these measures. Article 5 The drug production and management enterprises are responsible for their drug purchase and sale behavior, their sales staff or the establishment of the office in the name of the enterprise engaged in the purchase and sale of drugs bear legal responsibility.
Article 6 The drug production and management enterprises shall train their purchase and sale personnel in drug-related laws, regulations and specialized knowledge, and establish training files, which shall record the time, place and content of the training as well as the personnel who have received the training.
Article 7 Drug production and management enterprises shall strengthen the management of drug sales personnel, and make specific provisions for their sales behavior.
Article 8 Drug production and management enterprises shall not store or sell drugs on the spot in places other than the addresses approved by the drug supervision and management department.
Article 9 A drug manufacturer may only sell the drugs produced by the enterprise, and may not sell the drugs entrusted to the enterprise or produced by others.
Article 10 When selling drugs, drug manufacturers and drug wholesalers shall provide the following information:
(1) a copy of the Drug Manufacturing License or the Drug Operation License and the business license with the original seal of the enterprise;
(2) a copy of the approval documents of the drugs sold with the original seal of the enterprise;
(3) in the case of selling imported drugs, a copy of the approval documents in accordance with the State Law;
(4) a copy of the approval documents in accordance with the State Law. ) Sales of imported drugs, in accordance with relevant state regulations to provide relevant documents.
Pharmaceutical manufacturers, pharmaceutical wholesalers to send sales staff to sell drugs, in addition to the information provided in the preceding paragraph of this article, should also provide a copy of the authorization letter stamped with the original seal of the enterprise. The original authorization shall set out the authorized sales of varieties, geographic area, period, indicating the salesperson's identity card number, and stamped with the original seal of the enterprise and the enterprise's legal representative seal (or signature). The salesperson shall present the original authorization and his original identity card for verification by the drug purchaser.
Article XI of the drug manufacturers, drug wholesalers selling drugs, shall issue sales vouchers labeled with the name of the supplier, the name of the drug, manufacturer, batch number, quantity, price and other content.
Drug retailers selling drugs, should be issued with the name of the drug, manufacturer, quantity, price, batch number and other content of the sales voucher.
Article XII of the drug production and management enterprises to purchase drugs, should be in accordance with the provisions of Article 10 of these measures to obtain, check, and retain the relevant documents and information of the supplying enterprises, in accordance with the provisions of Article 11 of these measures to obtain and retain sales vouchers.
Pharmaceutical production and operation of enterprises in accordance with the provisions of the preceding paragraph of this article to retain information and sales vouchers, should be kept until more than the expiration date of the drug 1 year, but not less than 3 years.
Article 13 If a drug manufacturer or business enterprise knows or should know that another person is engaged in the unlicensed production or operation of drugs, it shall not provide drugs for him.
Article 14 A drug manufacturing or operating enterprise shall not provide premises, or qualification documents, or bills and other facilities for others to operate drugs in the name of the enterprise.
Article 15 A pharmaceutical manufacturer or business enterprise shall not sell pharmaceutical products on the spot by way of exhibitions, fairs, trade fairs, ordering fairs, or product publicity meetings.
Article 16 Drug business enterprises shall not purchase and sell preparations prepared by medical institutions.
Article 17 Without the examination and approval of the drug supervision and management department, the drug business enterprises shall not change the mode of operation.
Drug business enterprises shall operate drugs in accordance with the business scope permitted by the Drug Business License.
Article XVIII of the drug retail enterprises shall, in accordance with the requirements of the State Food and Drug Administration regulations on drug classification and management, with prescription sales of prescription drugs.
Prescription drugs and Class A non-prescription drugs in the operation of drug retail enterprises, licensed pharmacists or other legally qualified pharmacy technicians are not on duty, should be listed to inform, and stop selling prescription drugs and Class A non-prescription drugs.
Article 19 of the drug instructions require low-temperature, refrigerated storage of medicines, drug manufacturers and operators shall, in accordance with the relevant provisions, the use of low-temperature, refrigerated facilities and equipment for transportation and storage.
The drug supervision and management department finds that the drug production and management enterprises violate the provisions of the preceding paragraph of this article, shall immediately seize and detain the drugs involved, and deal with them according to law.
Article 20 Drug manufacturers and operators shall not give away prescription drugs or Class A non-prescription drugs to the public by means of tie-in sales, buying drugs for free, or buying commodities for free.
Article 21 Drug manufacturers and operators shall not sell prescription drugs directly to the public by means of postal sales or Internet transactions.
Article 22 prohibits the illegal acquisition of medicines. Article 23 The pharmacy set up by a medical institution shall have premises, equipment, storage facilities and sanitary environment appropriate to the drugs used, be equipped with appropriate pharmacy technicians, and set up a drug quality management organization or quality management personnel, and establish a drug storage system.
Article 24 of the medical institutions to purchase drugs, should be in accordance with the provisions of Article XII of these Measures, request, check, and save the relevant documents of the supplying enterprise, information, bills.
Article 25 of the medical institutions to purchase drugs, must establish and implement the purchase inspection and acceptance system, and build a true and complete record of drug purchases. Records of drug purchases must indicate the generic name of the drug, manufacturer (Chinese herbal medicine marked origin), dosage form, specifications, batch number, date of manufacture, expiration date, approval number, supply unit, quantity, price, date of purchase.
The record of drug purchases must be kept until more than 1 year beyond the expiration date of the drug, but not less than 3 years.
Article 26 of the medical institutions to store drugs, should be formulated and implemented in relation to drug storage, maintenance system, and take the necessary refrigeration, anti-freezing, moisture, light, ventilation, fire, insects, rodents and other measures to ensure the quality of drugs.
Medical institutions shall store medicines separately from non-medicines; Chinese herbal medicines, Chinese medicinal herbs, chemical medicines and proprietary Chinese medicines shall be stored separately and categorized.
Article 27 Medical institutions and family planning technical service organizations shall not directly provide medicines to patients without diagnosis and treatment.
Article 28 Medical institutions shall not use postal sales, Internet transactions and other means to sell prescription drugs directly to the public.
Article 29 Medical institutions shall comply with the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law and the relevant provisions of these Measures in the procurement of medicines by means of centralized bidding. Article 30 Any of the following circumstances, shall be ordered to make corrections within a certain period of time, and shall be given a warning; if the corrections are not made after the expiration of the period of time, a fine of not less than 5,000 Yuan and not more than 20,000 Yuan shall be imposed:
(1) Pharmaceutical production and operation enterprises in violation of the provisions of Article 6 of the present Measures;
(2) Pharmaceutical production and wholesale enterprises in violation of the provisions of the first paragraph of Article 11 of the present Measures;
(3) Pharmaceutical production , operating enterprises in violation of Article 12 of these Measures, not in accordance with the provisions of the retention of relevant information, sales vouchers.
Article 31 The drug production and management enterprises in violation of the provisions of Article 7 of these Measures, shall be given a warning and ordered to make corrections within a specified period of time.
Article 32 Any one of the following circumstances, in accordance with the provisions of Article 73 of the Drug Administration Law, confiscate the illegal sale of drugs and illegal income, and impose a fine of more than two times the amount of the value of the illegal sale of drugs not exceeding five times:
(1) Drug production and management enterprises in violation of the provisions of Article 8 of these Measures, in the drug supervision and management department approved by the address of the place other than the spot Sales of drugs;
(2) drug manufacturers in violation of the provisions of Article 9 of these Measures;
(3) drug production and management enterprises in violation of the provisions of Article 15 of these Measures;
(4) drug business enterprises in violation of the provisions of Article 17 of these Measures.
Article 33 If a drug manufacturer or business enterprise violates the provisions of Article 8 of these Measures by storing drugs in a place other than the address approved by the drug administration department, it shall be punished in accordance with the provisions of Article 74 of the Regulations for the Implementation of the Drug Administration Law.
Article 34 If a drug retailer violates the provisions of Paragraph 2 of Article 11 of these Measures, it shall be ordered to make corrections and be given a warning; if it fails to make corrections, it shall be fined not more than 500 yuan.
Article 35 violation of the provisions of Article 13 of these Measures, drug production and management enterprises know or should know that others are engaged in the production and operation of drugs without a license and provide them with medicines, shall be given a warning, ordered to make corrections, and impose a fine of less than 10,000 yuan; if the circumstances are serious, shall be imposed on more than 10,000 yuan 30,000 yuan fine.
Article 36 If a drug manufacturer or business enterprise violates the provisions of Article 14 of these Measures, it shall be punished in accordance with the provisions of Article 82 of the Drug Administration Law.
Article 37 Violation of the provisions of Article 16 of these Measures, drug business enterprises to purchase or sale of preparations prepared by medical institutions, in accordance with the provisions of Article 80 of the Drug Administration Law shall be punished.
Article 38 of the drug retail enterprises in violation of the provisions of paragraph 1 of Article 18 of these Measures, shall order rectification within a period of time, and shall be given a warning; if it fails to rectify the situation or the circumstances are serious, shall be imposed a fine of not more than 1,000 yuan.
Violation of the provisions of the second paragraph of Article 18 of these Measures, drug retail enterprises in the licensed pharmacists or other qualified pharmacy technicians are not on duty when the sale of prescription drugs or non-prescription drugs of Category A, ordered to make corrections within a certain period of time, and shall be given a warning; failing to make corrections after the expiration of the period of time, shall be sentenced to a fine of not more than 1,000 yuan.
Article 39 If a drug manufacturer or wholesaler violates the provisions of Article 19 of these Measures by failing to transport a drug under the low-temperature and refrigerated conditions stipulated in the drug's specification, it shall be given a warning and ordered to make corrections within a specified period of time; if it fails to make corrections within a specified period of time, it shall be fined not less than RMB 5,000 yuan and not more than RMB 20,000 yuan; and if the drug in question has been confirmed to be a fake or shoddy one, it shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Pharmaceutical manufacturers and wholesalers who violate the provisions of Article 19 of these Measures, and fail to store the drugs under the low temperature and refrigeration conditions stipulated in the instructions for the drugs shall be punished in accordance with the provisions of Article 79 of the Drug Administration Law; the drugs concerned shall be punished in accordance with the relevant provisions of the Drug Administration Law if the drugs concerned are confirmed to be counterfeit or shoddy drugs according to the law.
Article 40 If a drug manufacturer or business enterprise violates the provisions of Article 20 of these Measures, it shall make corrections within a certain period of time and be given a warning; if it fails to make corrections after the expiration of the period of time or if the circumstances are serious, it shall be punished by a fine of not more than two times of the amount of the goods value of the complimentary drugs, but the maximum shall not be more than 30,000 yuan.
Article 41 violation of Article 23 to Article 27 of these measures, ordered to make corrections within a period of time, the circumstances are serious, shall be notified.
Article 42 The pharmaceutical production and management enterprises in violation of Article 21 of these measures, medical institutions in violation of the provisions of Article 28 of these measures, the sale of prescription drugs directly to the public by mail, Internet transactions, etc., shall be ordered to make corrections, given a warning, and impose a sales of medicines less than twice the value of the amount of a fine, but the maximum of not more than 30,000 yuan.
Article 43 Anyone who violates the provisions of Article 22 of these Measures and illegally acquires drugs shall be punished in accordance with the provisions of Article 73 of the Drug Administration Law.
Article 44 of the drug supervision and management departments and their staff dereliction of duty, should be stopped and punished for illegal behavior is not stopped, punished, the directly responsible officer in charge and other personnel directly responsible for administrative sanctions; constitutes a crime, shall be investigated for criminal responsibility. Article 45 The drug spot sales referred to in these Measures, refers to the drug production, management enterprises or their appointed sales staff, in the drug supervision and management department approved address other than the other places, carrying drugs spot to the unspecified object on-site sales of drugs behavior.
Article 46 The supervision and management of the circulation of medicines under special management, vaccines and medicines for military use shall be governed by the relevant laws, rules and regulations if they provide otherwise.
Article 47 These Measures shall come into force on May 1, 2007 . Since the date of implementation of these Measures, August 1, 1999 implementation of the State Drug Administration "supervision and management of the circulation of drugs (provisional)" (State Drug Administration Order No. 7) shall be repealed simultaneously.