1, drug license application form; 2, the administrative department for industry and commerce issued by the proposed business approval documents; 3, business premises, warehouse layout and proof of property rights or the right to use the house; 4, according to the qualification of pharmacy professionals and technicians after qualification certificate and letter of appointment; 5, the proposed enterprise quality management documents and major facilities and equipment directory. equipment catalog.
Second, the opening of pharmaceutical retail enterprises in accordance with the "Drug License"
Three 1, with the qualification of pharmacy technicians according to law; at least one resident pharmacist, a salesman (to be more than a high school or pharmacy-related graduates or through the drug supervision department to obtain the assessment of the staff of the certificate of competency). 2, with the operation of the drug business premises, equipment, Warehousing facilities, sanitation; business premises of not less than 40 square meters, warehouse of not less than 20 square meters. 3, to apply for the "Drug License", ＜＜Medical Device License＞＞, and then have to go to the business license, tax registration certificate, health license, health certificate. 4, with a guarantee of the quality of the medicines operated by the regulatory system.
Legal basis
"Chinese People's **** and the State Drug Administration Law" Article 6 of the State of the implementation of drug management of drug marketing license holder system. The holder of the marketing authorization for medicines is responsible for the safety, effectiveness and controllable quality of medicines in the whole process of development, production, operation and use of medicines in accordance with the law.
Article 8 of the Law of the People's Republic of China on the Administration of Medicines, the State Council Drug Administration is in charge of the supervision and administration of medicines throughout the country. The relevant departments of the State Council are responsible for the supervision and management of drugs within their respective areas of responsibility. The drug supervision and management department of the state council with the relevant departments of the state council, the implementation of the national drug industry development planning and industrial policy. The drug supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government are responsible for the supervision and management of drugs in their own administrative regions. Municipal and county people's governments are responsible for drug supervision and management (hereinafter referred to as drug supervision and management department) is responsible for drug supervision and management in the administrative area. The relevant departments of the local people's governments at or above the county level are responsible for the supervision and management of drug-related work within their respective areas of responsibility.