The drug supervision and administration departments of provinces, cities divided into districts, autonomous prefectures and counties (cities, districts) (hereinafter referred to as drug supervision and administration departments at or above the county level) shall be responsible for the supervision and administration of the circulation of drugs and medical devices within their respective administrative areas; Other relevant administrative departments shall, in accordance with their respective duties, do a good job in the supervision and management of the circulation of drugs and medical devices according to law.
Township people's governments shall assist in the supervision and management of the circulation of drugs and medical devices within their respective jurisdictions. Article 4 Units producing, trading and using drugs and medical devices shall ensure the quality and safety of drugs and medical devices they purchase, transport, store, sell and use. Article 5 The people's governments at or above the county level or the pharmaceutical supervisory and administrative departments at or above the county level shall commend and reward the units or individuals that have made remarkable achievements in the supervision of the circulation of drugs and medical devices. Chapter II Circulation of Drugs Article 6 Units producing, trading and using drugs shall purchase drugs from enterprises qualified for drug production and trading within the scope of production, trading and use approved according to law; However, the purchase of Chinese herbal medicines without approval number management is excluded.
Pharmaceutical production and wholesale enterprises shall not sell drugs to pharmaceutical production, marketing and use units that do not have legal qualifications. Article 7 When selling drugs, pharmaceutical production and wholesale enterprises shall issue sales vouchers indicating the name of the buyer, the generic name of the drug, the manufacturer, dosage form, specification, batch number, quantity and price, and affix their seals.
Pharmaceutical retail enterprises selling prescription drugs and Class A OTC drugs shall issue sales vouchers indicating the generic name, quantity, price, batch number and other contents of the drugs. Article 8 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and pharmaceutical users shall, when purchasing pharmaceuticals, obtain and keep the sales vouchers and relevant materials stipulated by the state. The unit that supplies for the first time shall also obtain the following materials sealed by the unit for archiving:
(a) a copy of the drug production license or drug business license and business license;
(two) a copy of the certification certificate and drug approval certificate of good manufacturing practice or the quality management standard for drug trading;
(3) the power of attorney for drug sales of the supplier;
(four) a copy of the valid identity certificate of the salesperson;
(5) sales voucher samples. Article 9 When purchasing drugs, pharmaceutical production, marketing and use units shall establish a system of inspection and acceptance of incoming goods, and establish a record of inspection and acceptance of incoming goods in accordance with state regulations. Sales records shall be established for the sale of drugs.
The records of drug purchase, acceptance and sales shall indicate the general name, manufacturer, dosage form, specification, batch number, validity period, approval number, purchase and sale unit, purchase and sale quantity, purchase and sale price, purchase and sale date, etc. The drug acceptance record should also indicate the acceptance quality status and treatment opinions, and be signed by the acceptance personnel for confirmation.
Records of drug procurement, acceptance and sales shall be kept for more than one year and not less than three years. Article 10 Units producing, trading and using drugs and enterprises engaged in drug logistics business shall transport and store drugs according to the requirements of product specifications, and have corresponding conditions such as cool, cold storage, light protection, ventilation, anti-freezing, moisture-proof, insect-proof, dust-proof and rodent-proof facilities and temperature and humidity control equipment, and establish drug monitoring and maintenance records. Article 11 Where a pharmaceutical trading enterprise concurrently engages in non-pharmaceuticals, it shall display the pharmaceuticals and non-pharmaceuticals in different regions and counters, and set up obvious signs. Article 12 The indications or functional indications indicated in the packaging, labels, instructions and relevant publicity materials of drugs shall not exceed the scope approved by the State pharmaceutical supervisory and administrative department.
Non-drugs shall not be marked with the generic name of the drug, and their instructions, labels and packaging instructions shall not contain contents related to the indications or functional indications of the drug. Article 13 Medical institutions shall equip and use essential drugs in accordance with state regulations.
Medical institutions should provide drugs to patients according to the doctor's position of the unit. If the patient requests a paper prescription, the medical institution must provide it.
Medical institutions shall not sell or sell drugs in disguised form by mail, opening counters, self-selection or trial sale. Article 14 A pharmacy or medicine cabinet set up by a drug-using unit shall have corresponding personnel, places, equipment, storage facilities, sanitary environment and other conditions to ensure the safety of patients' medication, and abide by the quality management standards for drug use formulated by the relevant competent departments of the provincial people's government. Article 15 The tools, packaging materials, containers and working environment for drug preparation by drug retail enterprises and drug users shall meet the requirements of drug hygiene, quality and safety.
Drug retail enterprises and drug users shall record the disassembly of the smallest packaged drugs, and keep the packages, labels and instructions until the drugs are sold or used. The generic name, dosage form, specification, batch number, usage, dosage and expiration date of the drug shall be marked on the unpacked container or packaging surface.