Starting a pharmaceutical business must have the following conditions: (a) with the qualification of pharmacy technicians according to law; at least one resident pharmacist, a salesman (to be more than high school or pharmacy-related graduates or through the drug supervision department to obtain the assessment of the personnel on the license). (B) with the business premises, equipment, storage facilities, sanitation and hygiene environment appropriate to the operation of drugs; business premises of not less than 40 square meters, warehouse of not less than 20 square meters. (C) to apply for "Drug License", "Medical Device License", and then have to do business license, tax registration certificate, health permit, health certificate. (D) has to ensure the quality of the drugs operated by the rules and regulations to open a drug retail business in accordance with the following procedures for the "Drug License": First, the applicant to the proposed business location of the municipal (food) drug supervision and management agencies or provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments set up directly by the county (food) drug supervision and management agencies to apply for the preparation and submission of the following documents 1. the legal representative of the proposed enterprise, the person in charge of the enterprise, the quality of the person in charge of the academic qualifications, practicing qualifications or titles of the original, a copy of the certificate and biographical information and professional and technical personnel qualification certificates, letters of appointment; 2. the scope of the proposed drug business; 3. the proposed place of business, warehousing facilities, equipment. Second, the applicant to complete the preparatory work, to accept the application of (food) drug supervision and management agencies to submit an application for acceptance, and submit the following materials: 1. application form for a drug license; 2. business administration department 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 law, after the qualification of professional and technical qualifications of pharmacy certificate And letter of appointment; 5. Proposed enterprise quality management documents and the main facilities, equipment catalog. Attachment: I. Permit content of the "Drug License" (retail) Second, set the license laws and regulations based on (a) "Chinese People's Republic of China * * * and the State Drug Administration Law", "Chinese People's Republic of China * * * and the State Drug Administration Law Enforcement Regulations" (2) "Drug Business Quality Management Code", "Drug Business Quality Management Code Implementation Rules" (3) "Drug License Measures" Third, the conditions of permission (a) the legal representative of the enterprise or the person in charge of the enterprise. (a) enterprise legal representative or responsible person for enterprise, quality management responsible person without "Drug Administration Law," Article 76, Article 83 of the circumstances; (b) with the law through the identification of pharmacy technicians; which, in the urban area to set up a retail pharmacy, must be equipped with two pharmacist title or higher pharmacy technicians, of which one as the person in charge of quality; set up in the town, village retail pharmacy must be equipped with a pharmacy technicians. technical personnel. (C) with the operation of drugs with appropriate business premises, equipment, storage facilities, sanitation; of which, the urban area of the retail pharmacy business premises area of not less than 40 square meters. The area of the retail pharmacy business premises in the town shall not be less than 30 square meters, and the area of the retail pharmacy business premises in the village shall not be less than 20 square meters. (D) has to ensure the quality of the drugs operated by the rules and regulations; (E) has to ensure the quality of the drugs operated by the rules and regulations; (F) in line with the requirements of the GSP. Fourth, the licensing process (a) application for construction applicants to the acceptance window to submit application materials for construction ---- acceptance ---- Municipal Food and Drug Administration to review and issue comments ---- window to receive the approval results (b) application for acceptance applicants have completed the construction of the applicant to the acceptance window to submit acceptance application materials ---- acceptance ---- Municipal Food and Drug Administration to organize the inspection of the ----- Municipal Food and Drug Administration to review ---- window to receive the approval results. Drug Administration review ---- window to receive approval results V. Application materials (a) application for preparatory construction of the applicant to the Municipal Food and Drug Administration to submit applications for preparatory construction, and submit the following materials: (a) 1, start-up business application report. Description of the basic situation of the applicant, the reason for starting, the nature of the enterprise, business address, scope, staffing, equipment, facilities and so on. 2, the administration for industry and commerce issued by the new business name pre-registration approval notice. 3、Legal representative (person in charge of the enterprise): A, ID card, temporary residence permit or household B, notice of appointment (state-owned, collective, joint-stock enterprises). 4, pharmacy technicians: A, identity card, temporary residence permit or household register; B, licensing qualifications, title certificate; C, labor contract, letter of appointment; D, on-the-job in-service not part-time certificates. 5, business, warehouse site title certificate and lease agreement, or own property rights certificate. 6、Quality management system catalog. Note: The documents in the above materials to submit a copy of the original returned to the applicant after verification. (B) acceptance application (C) after the completion of the preparatory work, the applicant to the Municipal Food and Drug Administration acceptance application, and submit the following information (in duplicate): 1, acceptance of the application for issuance of certificates; 2, "Drug Business License" (retail) application form; 3, enterprise self-examination report; 4, legal representative (person in charge of the enterprise) ID card, household registration or temporary residence permit, drug-related laws and regulations training Qualified certificate, personal resume 5, with the operation of the registered pharmacy professional and technical personnel title certificate, pending license, ID card, etc., pharmacy professional and technical staff of the letter of employment, labor contracts; 6, business premises, warehouses, the use of certificates; 7, a variety of management rules and regulations (in particular, the quality of drugs management system); 8, the business premises of the classification of drugs displayed in the plane schematic diagram. 9, with the operation of pharmaceutical facilities, equipment catalog. 10, should provide other information. (Note: the application materials must be applied for unit seal or signature of the applicant) Municipal Drug Administration received the application, the organization of relevant personnel to the site for inspection and acceptance of the inspection and acceptance of the unqualified should be rectified within a specified period of time, re-apply for acceptance. Sixth, the material requirements Declarations should be true and complete, uniformly printed or photocopied on A4 paper, marked directory and page number and bound. Seven, the application form to download
The trouble adopted, thank you!