Fujian Province, supervision and management of the circulation of drugs and medical devices

Chapter I General Provisions Article 1 In order to strengthen the supervision and management of the circulation of drugs and medical devices, to protect the quality of drugs, medical devices and human safety, according to the "Chinese People's Republic of China *** and the State Drug Administration Law", "Medical Device Supervision and Administration Regulations" and other laws and regulations, combined with the actual situation in the province, to formulate these measures. Article 2 The administrative region of this province, the procurement, sale, storage, transportation, use of drugs and medical devices and their supervision and management activities, the application of these measures. Article III above the county food and drug supervision and management department is responsible for the administrative area of the circulation of drugs and medical devices supervision and management work.

The economic and trade departments of the people's governments at or above the county level is responsible for the study and formulation of drugs and medical equipment circulation industry development planning and industrial policy, guide industrial layout, promote technological progress and structural adjustment and other industry management. Above the county food and drug supervision and management departments should cooperate with the economic and trade departments, the implementation of drugs and medical equipment circulation industry development planning and industrial policy.

The health department of the people's government at or above the county level is responsible for guiding the work related to the management of medical institutions, organizing the implementation of the national basic drug system, and participate in the management of clinical trials of drugs and medical devices.

Population and family planning, price, quality and technical supervision, industry and commerce, public security and other relevant departments in their respective areas of responsibility for the supervision and management of the circulation of drugs and medical devices.

The township people's government shall assist in the supervision and management of the circulation of drugs and medical devices within its jurisdiction. Article 4 The production and operation of medicines and medical devices and the use of enterprises and units shall ensure the quality and safety of the medicines and medical devices they purchase, sell, store, transport and use. Article 5 in the central unified policy, unified planning, unified organization of the principle, the provincial people's government to establish a medical reserve system to ensure that the occurrence of disasters, epidemics and other emergencies in the supply of medicines and medical equipment.

Medicine reserve system by the provincial people's government economic and trade departments to organize and implement. Article VI of drugs, medical equipment circulation supervision and management activities to make significant achievements in the unit or individual, above the county food and drug supervision and management departments shall be rewarded. Chapter II Circulation of drugs Article 7 The drug business enterprises and the use of units should be qualified to purchase drugs from the drug production and operation of enterprises; however, the procurement of Chinese herbal medicines without the implementation of the approval of the management of the number of exceptions.

Drug production and wholesale enterprises shall not sell drugs to drug business enterprises and use units that do not have legal qualifications. Article VIII of the drug business enterprises and the use of drugs purchased by the unit, shall request, retain sales vouchers and the relevant information required by the state; for the first time to its supply of units, it shall also request the following information stamped with the seal of the supplying unit for archiving:

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

(b) "Pharmaceutical Quality Management Standards" or "Drug Business Quality Management Standards" or "Drug Business Quality Management Standards" or "Drug Business Quality Management Standards" or "Drug Business Quality Management Standards". Management Standards for Drug Manufacturing" or "Drug Administration Quality Management Standards" certification and a copy of the approval of the drug;

(c) the supply unit of the drug sales power of attorney;

(d) a copy of the salesperson's valid identification.

Pharmaceutical enterprises and the use of units in accordance with the provisions of the preceding paragraph of this article retained sales vouchers and information shall be kept until more than the expiration date of the drug for one year, but shall not be less than three years. Article IX drug business enterprises and the use of units to purchase drugs, shall establish and implement the purchase inspection and acceptance system, inspection of drug certificates of conformity and other identification; does not meet the prescribed requirements, shall not be purchased.

Pharmaceutical enterprises and the use of units purchasing drugs must have a true and complete purchase and acceptance records, purchase and acceptance records should be confirmed by the signature of the acceptance of personnel. Article X drug 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 to indicate the name of the drug, manufacturer, quantity, price, batch number and other content of the sales voucher.

Pharmaceutical production and management enterprises selling drugs must have a true and complete sales records. Article XI of the purchase and acceptance of drugs and sales records, should indicate the generic name of the drug, manufacturer (Chinese herbal medicine marked origin), 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 purchase and sale of the content.

Pharmaceutical purchase, acceptance and sales records should be kept until more than the expiration date of 1 year, but not less than 3 years. Article XII of the drug production, management enterprises and the use of units shall, in accordance with the requirements of the drug standards and instructions, to take appropriate refrigeration, anti-freezing, moisture-proof, light, ventilation, insect-proof, dust-proof, rodent-proof and other measures to store and transport medicines, and the establishment of drug monitoring, maintenance records.

Pharmaceutical production, management enterprises and use of units can be entrusted with the conditions to ensure the quality and safety of pharmaceutical enterprises to store and transport drugs. Article XIII of the drug business enterprises and the use of units shall regularly check the inventory of drugs, expired, contaminated, deteriorated and other unqualified drugs, shall be registered, and in accordance with relevant regulations shall be destroyed. Article XIV of the drug business enterprises operating non-pharmaceuticals, drugs and non-pharmaceuticals should be divided into areas, sub-counter storage, display, and set up obvious signs.