Health, industry and commerce, price and other departments in accordance with their respective responsibilities for supervision and management work related to drugs. Chapter II Drug Development and Production Management Article 5 The development of drugs should be in line with the provisions of the "Code of Practice for the Quality Management of Non-clinical Studies of Drugs" and "Code of Practice for the Quality Management of Clinical Trials of Drugs".
The original records of the development of drugs and application for registration of drugs should be true, complete and standardized, shall not be forged, fabricated test data and other information. Article 6 Drug Production
Enterprises shall have the conditions stipulated in the Drug Administration Law and the Good Manufacturing Practice.
The persons in charge of the production management department and the quality management department of a drug manufacturing enterprise shall not work concurrently with each other.
The appointment and change of the person in charge as stipulated in the preceding paragraph shall be reported to the provincial drug supervision and management department for the record within thirty days after the decision is made. Article 7 Drug manufacturers shall organize the production of drugs in accordance with national drug standards, registration and declaration of the prescription and production process; if necessary to change the prescription or change the production process affecting the quality of drugs, shall be in accordance with the relevant provisions of the declaration and approval.
Drug manufacturers produce drugs using raw materials, auxiliary materials and direct contact with the drug packaging materials and containers should meet the requirements of the relevant state regulations. Article VIII of the drug manufacturers shall have a true and complete raw materials, excipients, packaging materials and containers directly in contact with the drug purchase, inspection and acceptance records, the production of finished products inspection and sales records, as well as the necessary intermediary inspection records.
The records stipulated in the preceding paragraph shall be kept until one year after the expiration of the batch of products, and shall be kept for three years if the expiration date is not specified. Article IX of the drug manufacturers shall produce drugs before leaving the factory in accordance with the drug standard for full inspection. Shall not forge or alter the original records of drug inspection and inspection report. Article X. Drug packaging should be printed or labeled in accordance with state regulations and instructions. Labels and instructions should use standardized Chinese characters, the text should be clear and legible. The expiration date of the drug should be clear, clear, and labeled in the drug labeling and external labeling. Article XI accept foreign entrusted in the administrative region of the province to process pharmaceutical products for export, should obtain "Drug Production License" and with the entrusted processing of drugs compatible with the "Drug Production Quality Management Standard" certification. Drug manufacturers shall, within thirty days after the signing of the entrusted processing contract, to the provincial drug supervision and management department for the record. Chapter III of the drug business management Article XII does not obtain the "drug business license" shall not engage in drug business activities.
Drug business enterprises shall operate in accordance with the "Drug Business License" stipulates the mode of operation and business scope of drugs.
Drug manufacturers and business enterprises shall not sell drugs on the spot at addresses not approved by the drug supervision and management department.
It is prohibited for individuals to acquire medicines, except for Chinese herbal medicines whose acquisition is permitted by the State. Article 13 Drug manufacturers shall not sell drugs entrusted for production or drugs produced by others.
Pharmaceutical enterprises shall not purchase and sell preparations prepared by medical institutions. Article 14 If a drug manufacturer or business enterprise knows or should know that another person is engaged in drug production or business activities without the qualification of drug production or business, it shall not provide drugs for him.
Drug manufacturing and operating enterprises shall not provide qualification documents, bills and other facilities for others to operate drugs in the name of the enterprise. Article 15 The drug manufacturers and drug wholesalers shall issue sales vouchers indicating the name of the supplying organization, the name of the drug, the manufacturer, the batch number, the quantity and the price of the drug when selling the drug.
Drug retailers selling drugs, should be issued with the name of the drug, manufacturer, batch number, quantity, price and other content of the sales voucher. Article XVI of the drug business enterprises should have a full-time professional and technical personnel engaged in drug quality management.
Prescription drugs and Class A non-prescription drugs operating in the pharmaceutical retail enterprises of licensed pharmacists or other qualifications according to law by the pharmacy technicians should be listed on duty, not on duty, should stop selling prescription drugs and Class A non-prescription drugs. Chapter IV Pharmacy Management in Medical Institutions Article 17 Medical institutions may, in accordance with the relevant provisions of the state, in accordance with the law approved by the diagnosis and treatment subjects and the use of drugs within the scope of the pharmacy or medicine cabinet, its internal departments shall not be privately set up medicine cabinets.
Medical institutions set up a pharmacy or medicine cabinet, should have the appropriate place, equipment, storage facilities, sanitation and other conditions to ensure the safety of patients with medication, the specific provisions of the provincial drug supervision and management department and the provincial health administrative departments.