"Supervision and Administration of the Circulation of Drugs" *** five chapters, forty-seven articles (including bylaws), since May 1, 2007 shall come into force. Specific content is as follows:
Chapter I General Provisions
Article 1 in order to strengthen the supervision and management of drugs, standardize the order of drug distribution, to ensure the quality of drugs, according to the "People's Republic of China *** and the State Drug Administration Law" (hereinafter referred to as the "Drug Administration Law"), the "People's Republic of China *** and the State Drug Administration Law Implementation Regulations" (hereinafter referred to as the "Drug Administration Law Implementation Regulations") and relevant laws, regulations and laws, regulations, and other relevant laws and regulations. (hereinafter referred to as "Regulations on the Implementation of the Drug Administration Law") and relevant laws and regulations, the formulation of these measures.
Second Article in the People's Republic of China *** and the State engaged in the purchase and sale of drugs and supervision and management of units or individuals shall comply with these Measures.
Article 3 of the drug production, management enterprises, medical institutions shall be responsible for the quality of their production, operation, use of drugs. Drug 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 IV of the drug supervision and management departments to encourage individuals and organizations to implement social supervision of drug distribution. Violation of these measures, any individual and organization have the right to report to the drug supervision and management departments and complaints.
Chapter II of the drug production and management enterprises purchase and sale of supervision and management
Article 5 of the drug production and management enterprises are responsible for the purchase and sale of drugs, its 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 VI of the drug production, management enterprises shall purchase and sale of drugs for its staff to carry out training in drug-related laws, regulations and professional knowledge, the establishment of training files, training files should be recorded in the training time, place, content and training of personnel.
Article 7 of the drug production and management enterprises shall strengthen the management of drug sales personnel, and make specific provisions for their sales behavior.
Article VIII of the drug production and management enterprises shall not store or spot sales of drugs in places other than the address approved by the drug supervision and management department.
Article IX drug manufacturers can only sell the drugs produced by the enterprise, and may not sell the enterprise entrusted to produce or the drugs produced by others.
Article 10 of the drug manufacturers, drug wholesalers selling drugs, shall provide the following information:
(1) stamped with the original seal of the enterprise's "Drug Manufacturing License" or "Drug Business License" and a copy of the business license;
(2) stamped with the enterprise's original seal of the approval of the drugs sold a copy of the supporting documents;
(3) sales of imported drugs, in accordance with the State Council, the sales of imported drugs, in accordance with the State Council, the sales of imported drugs. ) 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, pharmaceutical wholesalers selling drugs, should be issued marked with the name of the supplier, the name of the drug, manufacturer, batch number, quantity, price and other content of the sales voucher. 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 this approach to obtain, check, retain the relevant documents and information of the supplier, in accordance with the provisions of Article 11 of this approach 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 the 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 XIII of the drug production and management enterprises know or should know that others engaged in the production and operation of drugs without a license, shall not provide them with drugs.
Article XIV of the drug production and management enterprises 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 of the pharmaceutical production and management enterprises shall not be demonstrations, fairs, trade fairs, ordering meetings, product promotional meetings and other means of spot sales of drugs.
Article XVI of the drug business enterprises shall not purchase and sale of preparations prepared by medical institutions.
Article XVII without the 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 scope of business licensed by the Drug Business License.
Article 18 of the drug retail enterprises shall, in accordance with the requirements of the State Food and Drug Administration drug classification and management provisions, the sale of prescription drugs with a prescription. The operation of prescription drugs and non-prescription drugs Class A drug retail enterprises, licensed pharmacists or other qualifications according to law recognized by the 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 specification requires low temperature, refrigerated storage of drugs, drug manufacturers, operators shall, in accordance with the relevant provisions of the use of low-temperature, refrigerated facilities and equipment for transportation and storage. Drug supervision and management department found that the drug production and management enterprises in violation of the preceding paragraph of this article, shall immediately seize and detain the drugs involved, and deal with it in accordance with the law.
Article 20 of the drug production and management enterprises shall not give away prescription drugs or Class A non-prescription drugs to the public by means of tie-in sales, purchase of drugs for free, purchase of goods for free.
Article 21 of the drug production and management enterprises shall not use mail sales, Internet transactions and other ways to sell prescription drugs directly to the public.
Article 22 prohibits the illegal acquisition of medicines.
Chapter III supervision and management of the purchase and storage of drugs in medical institutions
Article 23 of the medical institutions set up a pharmacy, should have a place, equipment, storage facilities and sanitary environment compatible with the use of drugs, equipped with the appropriate pharmacy technicians, and the establishment of drug quality management organization or quality management personnel, and the establishment of 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 production, expiration date, approval number, supply unit, quantity, price, date of purchase. Records 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 medicines, should be developed and implemented in relation to the storage of drugs, maintenance of the system, and take the necessary refrigeration, anti-freezing, moisture, light, ventilation, fire prevention, pest control, rodent and other measures to ensure the quality of medicines. Medical institutions shall store medicines separately from non-medicines; Chinese herbal medicines, Chinese medicinal herbs, chemical drugs and proprietary Chinese medicines shall be stored separately and categorized.
Article 27 of the medical institutions and family planning technical service organizations shall not provide medicines directly to patients without diagnosis and treatment.
Article 28 of the medical institutions shall not use mail sales, Internet transactions and other means of selling prescription drugs directly to the public.
Article 29 of the medical institutions to centralized bidding for the procurement of drugs, shall comply with the "Drug Administration Law", "Regulations for the Implementation of the Drug Administration Law" and the relevant provisions of these measures.
Chapter IV Legal Liability
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:
(1) Pharmaceutical production and management enterprises in violation of the provisions of Article 6 of these Measures;
(2) Pharmaceutical production and wholesale enterprises in violation of the provisions of the first paragraph of Article 11 of these Measures;
(3) Pharmaceutical production and management 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 of 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 certain period of time.
Article 32 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 five times the amount of fines:
(a) pharmaceutical production, 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 of the 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 other than the storage of drugs, in accordance with the "Drug Administration Law Enforcement Regulations" shall be punished in accordance with the provisions of Article 74.
Article 34 of the drug retail enterprises in violation of the provisions of paragraph 2 of Article 11 of these Measures, shall be ordered to make corrections and given a warning.
Article 35 violates 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 drugs, shall be given a warning and ordered to make corrections.
Article 36 of the drug production and management enterprises in violation of the provisions of Article 14 of these Measures, in accordance with the provisions of Article 82 of the Drug Administration Law shall be punished.
Article 37 violates the provisions of Article 16 of these Measures, the drug business enterprises purchase or sale of preparations prepared by medical institutions, shall be punished in accordance with the provisions of Article 80 of the Drug Administration Law.
Article 38 of the drug retail enterprises in violation of the provisions of the first paragraph of Article 18 of these Measures, shall be ordered to make corrections within a certain period of time, and shall be given a warning.
Violation of the provisions of the second paragraph of Article 18 of these Measures, drug retailers in the licensed pharmacists or other qualified pharmacy technicians are not on duty to sell prescription drugs or non-prescription drugs of Category A, shall order a period of time to make corrections, and shall be given a warning.
Article 39 If a drug manufacturer or wholesaler violates the provisions of Article 19 of these Measures by failing to transport the drugs under the low-temperature and refrigerated conditions stipulated in the instructions for the drugs, it shall be given a warning and ordered to make corrections within a certain period of time; and if the drugs in question are confirmed to be counterfeit or shoddy by law, 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 medicines under the low temperature and refrigerated conditions as stipulated in the instructions for the medicines, shall be punished in accordance with the provisions of Article 79 of the Drug Administration Law; if the medicines in question are confirmed to be counterfeit or shoddy medicines, they shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Article 40 of the pharmaceutical production and management enterprises in violation of the provisions of Article 20 of these Measures, the deadline for correction, given a warning; failure to make corrections or the circumstances are serious, shall be imposed on the gift of drugs less than two times the amount of the value of the fine.
Article 41 violates the provisions of Article 23 to Article 27 of these Measures, shall be ordered to make corrections within a certain period of time, and if the circumstances are serious, shall be notified.
Article 42 of 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, by mail sales, Internet transactions and other means of direct sales of prescription drugs to the public, shall be ordered to make corrections, and given a warning, and impose the sale of medicines less than two times the amount of value of the fine.
Article 43 violates the provisions of Article 22 of the illegal acquisition of drugs, in accordance with the provisions of Article 73 of the Drug Administration Law shall be punished.
Article 44 of the drug supervision and management departments and their staff dereliction of duty, should be stopped and punished for illegal acts are not stopped and punished, the directly responsible person in charge and other directly responsible persons shall be given administrative sanctions; constitutes a crime, shall be investigated for criminal responsibility.
Chapter V Supplementary Provisions
Article 45 of the Measures referred to in the spot sale of drugs, 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 on the spot to the unspecified object on-site sales of drugs behavior.
Article 46 of the implementation of special management of the circulation of drugs, vaccines, military drugs supervision and management, the relevant laws, regulations, rules and regulations otherwise provided for, shall be subject to its provisions.
Article 47 of 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.
Revision of the "supervision and management of the circulation of drugs" of great significance
"Supervision and management of the circulation of drugs" (Interim) (State Drug Administration Decree No. 7) was promulgated on June 15, 1999, August 1 the same year formally implemented. Since its implementation, to strengthen the drug market supervision, rectify and standardize the order of drug circulation, to protect the public safety of drugs has played an important role.
But in recent years, due to the drug market situation in China, the circulation mode, the focus of supervision have undergone major changes, such as some drug shows, expositions and chaotic order, illegal elements take the opportunity to sell fake and shoddy medicines; unlicensed operators involved in the drug business activities; medical institutions to enter the circulation of the preparation; drug retailers to sell prescription drugs in violation of the law; some illegal operators by means of affiliation and other means of pharmaceutical production and operation of enterprises engaged in the name of illegal drugs. production and operation of enterprises in the name of illegal drug business activities, and so on.
In particular, after the promulgation and implementation of the revised Drug Administration Law, the legislative basis of the Measures for the Supervision and Administration of the Circulation of Pharmaceuticals (Provisional) has changed. Therefore, according to the current "Drug Administration Law", "Drug Administration Law Enforcement Regulations" and the reality of drug circulation supervision, the "Drug Circulation Supervision and Administration Measures" (Interim) is imperative for revision.
Reference: Baidu Encyclopedia - Supervision and Administration of the Circulation of Pharmaceuticals