Regulations on the Supervision and Management of the Circulation of Drugs and Medical Devices in Lanzhou Municipality

Chapter I General Provisions Article 1 In order to strengthen the supervision and management of the circulation of drugs and medical devices, to ensure the quality of drugs and medical devices, to protect human health and safety, according to the "Chinese People's Republic of China * * * and the State Drug Administration Law", "Medical Devices Supervision and Administration Regulations" and other laws and regulations, combined with the actual situation in the city, to formulate the Regulations. Article 2 The city administrative area of drugs and medical devices business, use and supervision and management activities, the application of these regulations. Article III city, county (district) people's government shall establish and improve the supervision and management of drugs and medical devices circulation coordination mechanism and responsibility mechanism, unified organization and coordination of the administrative area of the supervision and management of the circulation of drugs and medical devices. Article IV city, county (district) drugs and medical devices supervision and management department (hereinafter referred to as "drug supervision department") in charge of the administrative region of the supervision and management of the circulation of drugs and medical devices.

Other relevant administrative departments shall, in accordance with their respective responsibilities, in accordance with the law to do a good job of supervision and management of the circulation of drugs and medical devices. Article 5 The pharmaceutical and medical device industry societies, associations should strengthen industry self-discipline, standardize industry behavior, organize and carry out skills training, information services and other work. Article 6 The people's governments at or above the county level shall give commendation and rewards to the units and individuals who have made outstanding contributions or remarkable achievements in the supervision and management of the circulation of drugs and medical devices. Chapter II Circulation of drugs Article 7 The drug business enterprises and the use of units should be from the drug production and operation of qualified enterprises to purchase drugs; but the procurement of Chinese herbal medicines without the implementation of the approval number management, except.

Government-organized drug-using units to purchase basic drugs should be purchased from the centralized purchasing of basic drugs from the production, wholesale enterprises. Article VIII of the drug business enterprises and the use of units shall, in accordance with national regulations, to ensure that the provision and use of essential drugs. Article 9 The municipal people's government shall establish a drug reserve system to ensure the supply of drugs in the event of disasters, epidemics and other emergencies. Article 10 The drug business enterprises and the use of units to purchase drugs, shall check, request, retain sales vouchers and the following information stamped with the seal of the supply unit:

(a) "Drug Manufacturing License" or "Drug Business License" and a copy of the business license;

(b) "Good Manufacturing Practices for the Quality of Pharmaceutical Products" or "Good Manufacturing Practices for the Quality of Pharmaceutical Products" certificate of authentication and the drug (b) "Drug Production Quality Management Standards" or "Drug Business Quality Management Standards" certification and a copy of the approval documents of the drug;

(c) the authorization letter of the legal person for the sale of medicines;

(d) a copy of the valid identity of the sales staff;

(e) the relevant filing of the foreign drug production and business enterprises;

(f) other information that should be inspected, asked for, and retained. Article XI of the drug business enterprises and the use of units to purchase Chinese herbal medicines, shall request and retain the basic information of the supplier. Article XII of the drug business enterprises and the use of units to purchase drugs, shall establish and implement the purchase inspection and acceptance and record-keeping system, the purchase inspection and acceptance should be examined and certified and other identification of drugs, do not meet the requirements of the regulations, shall not be purchased; the record should be true, and save to more than the validity of the drug for one year, but shall not be less than three years. Article XIII of the pharmaceutical production, wholesale enterprises selling drugs, should be issued with the name of the purchasing unit, generic name of the drug, manufacturer, dosage form, specifications, batch number, quantity, price and other content of the sales voucher, and stamped with a seal.

Drug retailers selling drugs, should be issued with a sales voucher indicating the generic name of the drug, manufacturer, batch number, quantity, price and so on.

Strict implementation of the sales record system, the true record, and save to more than one year beyond the expiration date of the drug, but not less than three years. Article XIV of the drug business enterprises and the use of units shall, in accordance with the drug standards and instructions, take appropriate refrigeration, anti-freezing, moisture-proof, light, ventilation, insect-proof, dust-proof, rodent-proof and other measures for storage and transportation of medicines, the establishment of drug monitoring, maintenance and transportation records, the relevant records should be kept until more than the expiration date of the drug for one year, but shall not be less than three years. Article XV of the drug business enterprises and the use of units should regularly check the inventory of drugs, expired, contaminated, deteriorated and other substandard drugs, should be registered, in accordance with the relevant provisions of the environmental protection department to be destroyed and promptly reported to the local drug supervision department. The destruction of special drugs, supervised by the drug regulatory departments. Article XVI of the use of drugs to provide patients with medicines should be based on the physician's prescription, shall not be open counter self-selection, trial, clinic, charity sales, consulting and other ways to sell or disguised as sales of drugs.

The internal organizations and personnel of drug-using units shall not privately purchase or use drugs. Article XVII of the drug production and management enterprises to donate drugs, should provide the recipient of the drug production or business license, a copy of the drug approval documents, drug manufacturers or statutory bodies issued by the donation of a copy of the drug test report and the relevant information provided by the state. Other donors who do not have the qualification of drug production or operation shall provide the donee with legal proof of drug purchase. The donee shall carry out inspection and acceptance in accordance with the relevant provisions, and establish acceptance records. Chapter III of the circulation of medical devices Article XVIII of the medical device business enterprises and the use of units must have legal qualifications from the production and operation of medical equipment purchase of medical equipment, and inspection of the product qualification certificate.