The relevant departments of the people's governments at or above the county level shall be responsible for drug supervision and administration within the scope of their respective duties. Article 6 The drug listing license holder system shall be implemented according to law. The holder of the drug marketing license is responsible for the safety, effectiveness and quality controllability of the whole process of drug research and development, production, management and use according to law. Seventh to encourage the public to report illegal acts in the development, production, marketing and use of drugs. The relevant departments shall, in accordance with the provisions, reward those who report the truth. Chapter II Pharmaceutical Production and Marketing Article 8 Whoever engages in pharmaceutical production activities shall obtain a pharmaceutical production license in accordance with the law, abide by the good manufacturing practice, establish and improve the quality management system of pharmaceutical production, and ensure that the whole process of pharmaceutical production continuously meets the statutory requirements.
The electronic certificate of Pharmaceutical Production License has the same legal effect as the paper certificate. Article 9 Drug marketing license holders and drug production enterprises shall produce drugs according to the national drug standards or the drug registration standards and production processes approved by the drug supervision and administration department, and administer drugs according to the ingredients and quantities specified in the prescription. Article 10 The raw materials and auxiliary materials used by drug marketing license holders and drug production enterprises to produce drugs shall meet the requirements of medicinal use and the relevant requirements of good manufacturing practice.
The raw materials used in the production of drugs shall be tested in accordance with the national drug standards, and the Chinese herbal medicines and Chinese herbal pieces that have not been managed with the approval number shall be tested in accordance with the relevant national and provincial standards, and can only be put into use after passing the inspection.
It is forbidden to use expired excipients, excipients that do not meet the relevant standards, and excipients that have not been approved or have not passed the relevant review and approval to produce drugs. Article 11 The pharmaceutical supervisory and administrative department of the provincial people's government shall, according to the relevant technical guiding principles formulated by the national pharmaceutical supervisory and administrative department, organize the formulation of the processing specifications of Chinese herbal pieces in this province. Article 12 Whoever engages in pharmaceutical trading activities shall obtain a pharmaceutical trading license in accordance with the law, abide by the quality management standards for pharmaceutical trading, establish and improve the quality management system for pharmaceutical trading, and ensure that the whole process of pharmaceutical trading continues to meet the statutory requirements.
The electronic certificate of Drug Business License has the same legal effect as the paper certificate. Article 13 A pharmaceutical trading enterprise shall sell drugs within the business scope permitted by the Pharmaceutical Trading License.
Without the approval of the pharmaceutical supervisory and administrative department, pharmaceutical trading enterprises shall not change their business methods without authorization; No drugs may be sold on the spot in places other than those approved by the drug supervision and administration department. Article 14 Where a drug marketing license holder entrusts a pharmaceutical trading enterprise to sell drugs, he shall sign an entrustment agreement with the entrusted trading enterprise, and provide traceable information such as entrustment scope and entrustment method in accordance with regulations.
A pharmaceutical production enterprise may sell the drugs it produces, but it shall not sell the drugs it entrusts to produce or the drugs produced by other drug marketing license holders or pharmaceutical production enterprises. Article 15 Drug marketing license holders, pharmaceutical production enterprises and pharmaceutical wholesale enterprises shall not provide drugs to individuals and units engaged in production and business operation without a Drug Production License, a Drug Business License or a Medical Institution Practice License. Sixteenth to encourage and guide drug retail chain operation. The headquarters of an enterprise engaged in drug retail chain business activities shall, in accordance with the requirements of the "Standards for Quality Management of Drug Business", establish and improve a drug quality management system and a unified drug quality management system covering the headquarters of the enterprise, all chain stores and distribution centers, and fulfill the management responsibility for chain store business activities.
Chain stores shall carry out drug retail activities as required. Article 17 A pharmaceutical retail enterprise shall sell prescription drugs on the basis of prescriptions of medical practitioners, assistant medical practitioners or registered rural doctors.
Electronic prescriptions issued by medical institutions according to the Internet diagnosis and treatment norms formulated by the national health administration departments have the same effect as paper prescriptions. Article 18 The pharmaceutical supervisory and administrative department of the people's government of the province shall, according to the actual situation of licensed pharmacists and pharmaceutical technicians in this province, combine the factors such as the variety, scale, regional differences and drug safety risks of pharmaceutical retail enterprises, formulate regulations on the differentiated allocation of licensed pharmacists and other pharmaceutical technicians, and link them with the relevant provisions of the national pharmaceutical supervisory and administrative department to steadily increase the proportion of licensed pharmacists.