To establish a pharmaceutical trading enterprise, the following conditions must be met: (1) having qualified pharmaceutical technicians according to law; There must be at least one resident pharmacist and one shop assistant (a person who has graduated from high school or above or majored in pharmacy, or who has obtained an employment certificate after examination by the drug supervision department). (2) Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled; The business site is not less than 40 square meters, and the warehouse is not less than 20 square meters. (3) First, apply for the Drug Business License or Medical Device Business License, and then apply for the Business License, Tax Registration Certificate, Hygiene License and Health Certificate. (4) A pharmaceutical retail enterprise has rules and regulations to ensure the quality of the drugs it deals in, and applies for a Pharmaceutical Trading License according to the following procedures: The applicant shall apply to the municipal (food) drug regulatory agency with districts or the county (food) drug regulatory agency directly established by the drug regulatory agencies of provinces, autonomous regions and municipalities directly under the Central Government where the enterprise to be applied for is located. And submit the following materials: 1. The original and photocopy of the academic qualifications, professional qualifications or professional titles of the legal representative, person in charge of the enterprise and person in charge of quality, resumes, professional and technical personnel qualification certificates and letters of appointment; 2. The scope of drugs to be handled; 3 business premises, storage facilities and equipment to be established. 2. After the preparation is completed, the applicant shall submit an application for acceptance to the (food) drug supervision and administration institution that accepted the application, and submit the following materials: 1. Application Form for Drug Business License; 2. The approval certificate of the proposed enterprise issued by the administrative department for industry and commerce; 3 business premises, warehouse layout and proof of property right or use right of the house; 4. Qualification certificates and letters of appointment of pharmaceutical professional and technical personnel who have obtained qualifications according to law; 5. Quality management documents and main facilities and equipment catalogue of the enterprise to be established. Annexes: 1. Licensing Contents "Pharmaceutical Trading License" (Retail) 2. Legal and regulatory basis for setting up the license (1) Drug Administration Law of People's Republic of China (PRC), Regulations for the Implementation of Drug Administration Law of People's Republic of China (PRC) (2) Standards for Quality Management of Pharmaceutical Trading, Detailed Rules for the Implementation of Standards for Quality Management of Pharmaceutical Trading (3) Measures for the Administration of Pharmaceutical Trading Licenses. (2) Pharmaceutical technicians with legal recognition; Among them, the establishment of retail pharmacies in urban areas must be equipped with two pharmaceutical technicians with the title of pharmacist or above, of which 1 is the quality supervisor; The establishment of township retail pharmacies must be equipped with 1 pharmaceutical technicians. (3) Having business premises, equipment, storage facilities and a hygienic environment suitable for handling drugs; Among them, the business area of urban retail pharmacies shall not be less than 40 square meters. The business area of retail pharmacies in the town shall not be less than 30 square meters, and the business area of retail pharmacies in the village shall not be less than 20 square meters. (4) Having rules and regulations to ensure the quality of the drugs handled; (5) Having rules and regulations to ensure the quality of the drugs handled; (6) meeting the requirements of GSP. Four. Licensing procedure (1) Applicants who apply for preparation submit the preparation application materials in the acceptance window-acceptance-review by the US Food and Drug Administration and issue opinions-and receive the approval results in the window (2) Applicants who apply for acceptance have completed preparation. Submit the acceptance application materials in the acceptance window-acceptance-inspection organized by the municipal US Food and Drug Administration-examination by the municipal US Food and Drug Administration-window to receive the approval results V. Preparation of application materials (I) The applicant submits an application for preparation to the municipal US Food and Drug Administration and submits the following materials: (in duplicate) 1 Business application report. Explain the basic situation of the applicant, the reasons for starting, the nature of the enterprise, the business address, scope, staffing, equipment and facilities, etc. 2. Notice of pre-registration and approval of new enterprise name issued by the administrative department for industry and commerce. 3. Legal representative (person in charge of the enterprise): A. ID card, temporary residence permit or household registration book B. Notice of appointment (state-owned, collective and joint-stock enterprises). 4. Pharmaceutical technicians: A. Identity card, temporary residence permit or household registration book; B. professional qualifications and professional title certificates; C. labor contracts and letters of appointment; D. on-the-job certification materials. 5. Property right certificate and lease agreement or property right certificate for managing the warehouse site. 6, quality management system directory. Note: Submit a copy of the certificate in the above materials, and return the original to the applicant after verification. (II) Accepting the application (III) After the applicant completes the preparation, he shall submit an application for acceptance to the US Food and Drug Administration and submit the following materials (in duplicate): 1 Apply for acceptance and certification; 2, "Drug Business License" (retail) application form; 3, enterprise self-inspection report; 4 legal representative (person in charge of the enterprise) ID card, residence booklet or temporary residence permit, training certificate of drug-related laws and regulations, and 5 resumes. Copy of professional title certificate, unemployment certificate and ID card of registered pharmaceutical professional and technical personnel suitable for business, and copy of employment letter and labor contract of pharmaceutical professional and technical personnel; 6. Proof of the use of business premises and warehouses; 7, all kinds of management rules and regulations (especially drug quality management system); 8. Schematic diagram of classified display scheme of drugs in business premises. 9. Catalogue of facilities and equipment suitable for handling drugs. 10, other information that needs to be provided. (Note: the application materials must be stamped or signed by the applicant) After receiving the application, the US Food and Drug Administration will organize relevant personnel to conduct on-site acceptance, and those who fail to pass the acceptance will be rectified within a time limit and re-apply for acceptance. The intransitive verb material requires that the application materials should be true and complete, printed or copied on A4 paper, marked with contents and page numbers, and bound into a book. Seven. Application form download
Please accept it, thank you!