Regulations on the Supervision and Administration of Drugs and Medical Devices in Hunan Province

*General rules

* In order to strengthen the supervision and management of the circulation of drugs and medical devices, ensure the safe and effective use of drugs and medical devices, and maintain human health and life safety, these Regulations are formulated in accordance with the relevant laws and administrative regulations of the State and in light of the actual conditions of the province.

Article 2 These Regulations apply to the procurement, transportation, storage, sale, use and supervision and management of drugs and medical devices within the administrative region of this Province.

Article 3 The people's government at or above the county level shall establish and improve a coordination mechanism and responsibility mechanism for the supervision and management of drugs and medical devices, and uniformly organize and coordinate the supervision and administration of the circulation of drugs and medical devices within its administrative region.

The drug regulatory authorities of the provinces, autonomous prefectures, counties (cities, districts) (hereinafter referred to as the drug regulatory authorities 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 comply with Responsible for the supervision and management of the circulation of drugs and medical devices in accordance with the law.

The township people's government assists in the supervision and management of the circulation of drugs and medical devices within its jurisdiction.

Article 4 The production, operation and use of drugs and medical devices shall guarantee the quality and safety of the drugs and medical devices they purchase, transport, store, sell and use.

Article 5 The units or individuals that have made outstanding achievements in the supervision activities of drugs and medical devices shall be commended and rewarded by the people's governments at or above the county level or the drug supervision and administration departments at or above the county level.

Chapter II Drug Circulation

Article 6 The units for the production, operation and use of pharmaceuticals shall, in accordance with the scope of production, operation and use approved in accordance with the law, purchase medicines from enterprises with qualifications for the production and operation of pharmaceuticals; however, except for Chinese herbal medicines that have not been subject to the approval of the approval number management.

Pharmaceutical production and wholesale enterprises shall not sell drugs to units that produce, operate or use drugs that do not have legal qualifications.

Article 7 A pharmaceutical production or wholesale enterprise selling a drug shall issue a sales certificate indicating the name of the purchaser, the generic name of the drug, the manufacturer, the dosage form, the specification, the batch number, the quantity, the price, etc., and stamp it.

Pharmaceutical retailers selling prescription drugs and Class A non-prescription drugs should issue sales vouchers indicating the generic name, quantity, price, batch number, etc. of the drug.

Article 8 Pharmaceutical products produced, operated and used by the unit for purchasing medicines shall obtain and retain the sales vouchers and relevant materials prescribed by the State; for the units that supply them for the first time, they shall also request the following documents affixed with the seal of the unit:

(1) A copy of the drug production license or the drug business license and business license;

(2) A copy of the "Quality Management Regulations for Pharmaceutical Production" or the "Quality Management Regulations for Pharmaceutical Products" and a copy of the certificate of approval of the drug;

(3) The power supply order of the supplier unit;

(4) A copy of the valid identification of the salesperson;

(5) Sales certificate sample ticket.