Measures for the Supervision and Administration of Circulation of Pharmaceuticals

Measures for the Supervision and Administration of Circulation of Pharmaceuticals Order of the State Food and Drug Administration (No. 26) The “Measures for the Supervision and Administration of Circulation of Pharmaceuticals”, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, are hereby promulgated, and shall come into force on May 1, 2007. Director General Shao Mingli January 31, 2007 Measures for the Supervision and Administration of Circulation of Pharmaceuticals Chapter I General Provisions Article 1 The present Measures are formulated in accordance with the “ Pharmaceutical Administration Law of the People's Republic of China ” (hereinafter referred to as the “ Pharmaceutical Administration Law ”), the “ Regulation for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China ” (hereinafter referred to as the “ Regulation for the Implementation of the Pharmaceutical Administration Law ”) as well as other relevant laws and regulations for the purpose of strengthening the supervision and administration of pharmaceuticals, regulating the order of circulation of pharmaceuticals, and guaranteeing the quality of pharmaceuticals. Article 2 The entities and individuals who are engaged in purchase or sale or supervision and administration of pharmaceuticals within the territory of the People's Republic of China shall abide by the present Measures. Article 3 Pharmaceutical manufacturing or operating enterprises and medical institutions shall be responsible for the quality of pharmaceuticals they manufacture, operate and use. A pharmaceutical manufacturing or operating enterprise shall, on the premise of guaranteeing the quality safety of pharmaceuticals, adapt to the development direction of modern circulation of pharmaceuticals to carry out reforms and innovations. Article 4 The pharmaceutical administrative departments encourage individuals and organizations to conduct public supervision over circulation of pharmaceuticals. In case of any act violating the present Measures, any individual or organization may have the right to tip off or accuse the act to the pharmaceutical administrative departments. Chapter II Supervision and Administration of Pharmaceutical Manufacturing or Operation Enterprises' Purchase or Sale of Pharmaceuticals Article 5 A pharmaceutical manufacturing or operating enterprise shall be responsible for its purchase or sale of pharmaceuticals, and bear legal liabilities for the purchase or sale of pharmaceuticals by its sales staff or any of its representative offices in the name of the enterprise. Article 6 A pharmaceutical manufacturing or operating enterprise shall hold trainings on relevant laws and regulations on pharmaceuticals as well as professional knowledge for its purchasing or sales employees, set up training archives, and shall record the time, the training place, the training contents, and the trainees, in the training archives, as well. Article 7 A pharmaceutical manufacturing or operating enterprise shall strengthen the administration of the pharmaceutical sales staff, and make specific provisions on their sales activities. Article 8 No pharmaceutical manufacturing or operating enterprise shall store or sell spot pharmaceuticals at a place other than the address ratified by the pharmaceutical administrative department. Article 9 A pharmaceutical manufacturing enterprise may only sell the pharmaceuticals manufactured by itself, and shall not sell any pharmaceutical manufactured upon entrustment or by others. Article 10 A pharmaceutical manufacturing enterprise or a pharmaceutical wholesaling enterprise shall, when selling pharmaceuticals, provide the following materials: (1) photocopies of the “Permit for Pharmaceutical Manufacturing” or the “Permit for Pharmaceutical Business Operation” and the business license, which are affixed with the original seal of the enterprise; (2) a photocopy of the approval testimonial for the pharmaceuticals on sale, which is affixed with the original seal of the enterprise; and (3) relevant testimonials provided in accordance with relevant provisions of the state if any imported pharmaceutical is for sale. Where a pharmaceutical manufacturing enterprise or a pharmaceutical wholesaling enterprise sends any of its sales staff to sell pharmaceuticals, it shall, in addition to providing the materials prescribed in the preceding paragraph, provide a photocopy of the power of attorney affixed with the original seal of the enterprise, in addition. The original copy of the power of attorney shall state the varieties, territory and period of the pharmaceuticals for authorized sale, indicate the identity card number of the sales staff member, and be affixed with the enterprise's original seal and legal representative's seal (or signature). The sales staff member shall show the original copy of the power of attorney and the original copy of his identity card for the pharmaceutical purchasers' verification. Article 11 A pharmaceutical manufacturing enterprise or a pharmaceutical wholesaling enterprise shall, when selling a pharmaceutical, issue sales vouchers indicating the contents such as the supplier's name, the pharmaceutical's name, the manufacturer, the batch number, the quantity, and the price, etc. A pharmaceutical retail enterprise shall, when selling a pharmaceutical, issue sales vouchers indicating the contents such as the pharmaceutical's name, the manufacturer, the quantity, the price and the batch number, etc. Article 12 A pharmaceutical manufacturing or operating enterprise shall, when purchasing pharmaceuticals, ask for, check and preserve the relevant certificates and documents of the supplying enterprise in accordance with Article 10 of the present Measures, as well as ask for and preserve sales vouchers in accordance with Article 11 of the present Measures. The documents and sales vouchers to b......