Chapter 1 General Provisions Article 1 In order to strengthen the supervision and management of drug circulation and ensure the quality and safety of drug use, in accordance with the "Drug Administration Law of the People's Republic of China" and other laws and regulations, combined with the actual situation of the autonomous region, Formulate these measures. Article 2 These Measures apply to the sales, purchase, acceptance, storage, transportation and supervision and management activities of pharmaceuticals within the administrative area of ??the autonomous region. Article 3 The food and drug supervision and administration departments of the people's governments at or above the county level are responsible for the supervision and administration of drugs within their respective administrative regions.
Relevant departments such as health and family planning, industry and commerce, quality supervision, environmental protection, and finance are responsible for the supervision and management of drug-related circulation within the scope of their respective responsibilities. Article 4 Any organization or individual has the right to report violations of these Measures to the food and drug regulatory authorities, to learn drug safety information, and to provide opinions and suggestions on the supervision and management of drug circulation. Chapter 2 Sales, Purchase, and Acceptance of Drugs Article 5 Drug business enterprises and user units shall purchase drugs from enterprises with drug production and operation qualifications in accordance with the business and use scope approved in accordance with the law. Article 6 When a pharmaceutical manufacturing or wholesale enterprise sells pharmaceuticals, it shall issue a sales voucher indicating the name of the pharmaceutical, manufacturer, approval number, dosage form, specifications, product batch number, quantity, price, etc., and affix the corporate seal.
When a drug production or wholesale enterprise supplies drugs to a drug dealer or user unit for the first time, it shall also issue the following documents and stamp the company seal:
(1) "Pharmaceutical Production License" or Copy of "Pharmaceutical Distribution License";
(2) "Good Manufacturing Practice for Pharmaceuticals" certification or "Good Manufacturing Practice for Pharmaceuticals" certification and a copy of the approval document for the drug;
(3) A copy of the business license;
(4) A power of attorney for the legal representative of the supplier;
(5) A copy of the salesperson’s valid identity certificate;
(6) Sample sales voucher;
(7) Quality assurance agreement signed by both parties.
Pharmaceutical retail enterprises selling drugs shall issue sales vouchers indicating the name of the drug, manufacturer, quantity, price, product batch number, etc. Article 7 When pharmaceutical trading enterprises and user units purchase medicines, they shall retain the sales vouchers of the supplier. For units supplying goods to them for the first time, relevant information shall also be obtained in accordance with the provisions of paragraph 2 of Article 6 of these Measures and archived in accordance with regulations. Article 8 When purchasing drugs, drug trading enterprises and user units shall establish and implement a purchase inspection and acceptance system, and verify drug qualification certificates and other identifications; those that do not meet the prescribed requirements shall not be purchased and used.
Drug acceptance records should indicate the generic name of the drug, manufacturer, supplier, approval number, dosage form, specifications, product batch number, production date, validity period, arrival quantity, acceptance results, etc.
The acceptance record of traditional Chinese medicine prepared pieces should include product name, place of origin, specifications, product batch number, production date, manufacturer, acceptance results, etc. Chinese medicine prepared pieces that are subject to approval number management should also record the approval number.
Drug acceptance records should be true and complete and kept in accordance with regulations. Article 9 When purchasing refrigerated or frozen medicines, the transportation method and temperature records during transportation of the medicines must be inspected. Those that do not meet the requirements shall not be accepted into the warehouse. Article 10: Prescription drugs may be sold, purchased and used based on a prescription.
Medical institutions should provide patients with paper prescriptions. Article 11 Drug production and operating enterprises and user units shall provide drug buyers and sellers with pre-job training and continuing education on drug laws, regulations and professional knowledge related to their responsibilities and work content, establish training files, and keep training records . Article 12: Drug production and operating enterprises that provide drug information and transaction services through the Internet must abide by relevant national regulations. Chapter 3 Storage and Transportation of Drugs Article 13 Drug production and operating enterprises and user units shall, in accordance with the requirements of drug standards and instructions, adopt corresponding refrigeration, anti-freeze, moisture-proof, light-proof, ventilation, insect-proof, dust-proof, and rodent-proof measures and other measures to store and transport drugs to ensure the quality and safety of drugs. Article 14 Pharmaceutical trading enterprises and user units shall have business premises, drug warehouses and corresponding facilities and equipment that are commensurate with their pharmaceutical business scope and business scale to ensure the quality and safety of stored drugs.
The location, design, layout, construction, and renovation of drug business premises and drug warehouses must comply with drug storage requirements and prevent drug contamination and confusion.
If a drug user unit does not set up a drug store, its pharmacy and medicine cabinets must have a reasonable layout, a clean environment, no sources of pollution, and meet drug storage requirements. Article 15 Those who store and transport refrigerated or frozen medicines shall be equipped with the following facilities and equipment:
(1) Cold storage and freezers suitable for their scale and variety;
(2) ) Equipment used for temperature monitoring, display, recording, regulation, and alarming in cold storage and freezers;
(3) Refrigerated trucks or vehicle-mounted refrigerated boxes, insulated boxes and other equipment.
Refrigerated trucks, vehicle-mounted refrigerated boxes, and insulated boxes should meet the requirements for temperature control during drug transportation. Article 16 Storage and transportation facilities and equipment should be inspected, cleaned and maintained regularly, and files should be established.
Measuring instruments used in storage and transportation facilities and equipment that require compulsory verification according to law must be regularly verified. Those that are not regularly verified or have failed to pass the verification shall not be used.