Provinces, cities, autonomous states, counties (cities, districts) drug supervision and management department (hereinafter referred to as the county drug supervision and management department) is responsible for the administrative area of the supervision and management of the circulation of medicines and medical devices; other relevant administrative departments should be in accordance with their respective responsibilities to do a good job in accordance with their respective responsibilities for the supervision and management of the circulation of medicines and medical devices.
The township people's government to assist in the supervision and management of the circulation of drugs and medical devices within the jurisdiction. Article IV of drugs, medical devices production, operation and use of units shall ensure the quality and safety of its procurement, transportation, storage, sales, use of drugs and medical devices. Article 5 The people's governments at or above the county level or the drug supervision and management departments at or above the county level shall give commendation and reward to the units or individuals who have made remarkable achievements in the supervision and management of the circulation of drugs and medical devices. Chapter II circulation of drugs Article 6 The production, operation and use of drugs shall be approved in accordance with the law, the scope of production, operation and use, from the drug production and operation of qualified enterprises to purchase drugs; however, the procurement of Chinese herbal medicines without the implementation of the approval number management, except.
Drug production and wholesale enterprises shall not sell drugs to drug production, operation and use units that are not legally qualified. Article 7 The drug production and wholesale enterprises to sell drugs, shall issue sales vouchers indicating the name of the purchasing unit, the generic name of the drug, the manufacturer, dosage form, specifications, batch number, quantity, price and other content, and stamped with a seal.
Drug retailers selling prescription drugs and Class A non-prescription drugs, shall issue sales vouchers indicating the generic name of the drug, quantity, price, batch number and other content. Article 8 Drug production, operation and use of drugs purchased by the unit, shall obtain and retain sales vouchers and related information as stipulated by the state; for the first time to supply the unit, it shall also obtain the following information stamped with the seal of the unit for archiving:
(a) a copy of the drug production license or drug business license and business license;
(b) the "Good Manufacturing Practice for Drug Production or "Good Manufacturing Practice in Drug Business" certification and a copy of the drug approval documents;
(C) the supply unit of the drug sales power of attorney;
(D) a copy of the salesperson's valid identification;
(E) sales vouchers sample tickets. Article IX of drug production, management and use of drugs purchased by the unit shall establish the purchase inspection and acceptance system, and in accordance with state regulations to establish the purchase, acceptance records. Sales of drugs shall establish sales records.
Pharmaceutical procurement, acceptance and sales records, should indicate the generic name of the drug, manufacturer, dosage form, specifications, batch number, expiration date, approval number, purchase and sale of units, purchase and sale of quantities, purchase and sale of prices, purchase and sale of the date of content. Drug acceptance records should also indicate the acceptance of the quality of the situation and processing opinions, and acceptance of the signature of the personnel to confirm.
Pharmaceutical purchases, acceptance and sales records should be kept until more than one year of drug expiration date, and shall not be less than three years. Article X drug production, operation and use of units and enterprises engaged in drug logistics business transportation, storage of drugs should be carried out in accordance with the requirements of the product specification, with the appropriate shade, refrigeration, light, ventilation, anti-freezing, moisture-proof, insect-proof, dust-proof, rodent-proof facilities and other conditions, and temperature, humidity control equipment, and the establishment of drug monitoring, maintenance records. Article XI of the drug business enterprises also operating non-pharmaceutical products, drugs and non-pharmaceutical products should be displayed in separate areas and counters, and set up obvious signs. Article XII of the drug packaging, labeling, instructions and related promotional materials indicated indications or functions, shall not exceed the scope approved by the State Drug Administration.
Non-pharmaceutical products shall not be labeled with the common name of drugs, their instructions, labels and packaging identification shall not involve the indications of drugs or the content of the function. Article XIII of the medical institutions shall be equipped with and use of essential drugs in accordance with national regulations.
Medical institutions to provide patients with medicines should be based on the unit's physician's prescription. Patients request a paper prescription, medical institutions must provide.
Medical institutions shall not sell or disguise the sale of drugs by mail, open counter self-selection, trial. Article XIV of the use of drugs set up by the pharmacy or medicine cabinet, shall have the appropriate personnel, premises, equipment, storage facilities, sanitary environment and other conditions to ensure the safety of patients with medication, and to comply with the relevant competent departments of the provincial people's government formulated the quality of the use of medicines management standards. Article XV of the drug retail enterprises and drug use units to dispense drugs, packaging materials, containers and working environment, shall meet the health and quality and safety requirements of drugs.
Pharmaceutical retailers and pharmaceutical units of the smallest package of drugs zero, should make a good record of zero, and will be packaged, labeled and instructions to save until the sale or use of drugs finished. Drugs after the fragmentation of the contents or the surface of the packaging should indicate the generic name of the drug, dosage form, specifications, batch number, usage, dosage, duration of use and other content.