What procedures and conditions are needed to open a pharmacy
To open a pharmacy, you must meet these conditions:\x0d\1. The business space shall be no less than 40 square meters and the warehouse shall be no less than 20 square meters. There must be at least one resident pharmacist and one salesperson (personnel who have graduated from high school or pharmacy-related fields or who have passed the assessment of the drug regulatory department and obtained a job certificate). \x0d\2. To apply for a "Pharmaceutical Business License" and "Medical Device Business License", you must also apply for a business license and a health license. Pharmacy staff must also have health certificates. Newly opened pharmacies must implement GSP certification. GSP refers to: drug operation quality management, and everything must operate according to the GSP model. Attachment: Follow the following procedures to apply for a "Pharmaceutical Business License": \x0d\ (1) The applicant shall apply to the districted municipal (food) drug regulatory agency where the proposed enterprise is located or the (food) drug regulatory agency of the province, autonomous region, or municipality directly under the Central Government. The county-level (food) drug supervision and administration agency directly established by the department shall submit an application for establishment and submit the following materials:\x0d\1. Original and photocopy of academic qualifications, professional qualifications or professional title certificates of the proposed enterprise’s legal representative, person in charge, and quality director, as well as resumes, professional and technical personnel qualification certificates, and letters of appointment;\x0d\2. The scope of the proposed pharmaceutical business;\x0d\3. Proposed business premises, storage facilities, and equipment. \x0d\ (2) The (food) and drug regulatory agency shall handle the application submitted by the sponsor according to the following circumstances: \x0d\1. If the application matters do not fall within the scope of authority of this department, a decision to reject the application shall be made immediately, a "Notice of Non-Acceptance" shall be issued, and the applicant shall be informed to apply to the relevant (food) and drug regulatory authorities;\x0d\2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;\x0d\3. If the application materials are incomplete or do not comply with the legal form, a "Notice of Supplementary and Corrected Materials" shall be issued to the applicant on the spot or within 5 days, informing all contents that need to be supplemented and corrected at once. If no notification is made within the time limit, the application will be accepted from the date of receipt of the application materials;\x0d\4. If the application matters fall within the scope of authority of this department, and the materials are complete and comply with the legal form, or the applicant submits all supplementary and corrected materials as required, the applicant will be issued an "Acceptance Notice". The date stated in the "Notice of Acceptance" is the date of acceptance. \x0d\ (3) The (food) and drug regulatory agency shall, within 30 working days from the date of acceptance of the application, review the application materials in accordance with Article 5 of these Measures, make a decision on whether to agree to the establishment, and notify the applicant in writing . If the applicant disagrees with the establishment, the reasons shall be explained and the applicant shall be informed that it has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law. \x0d\ (4) After completing the preparation, the sponsor shall submit an acceptance application to the (food) and drug regulatory agency that accepted the application and submit the following materials:\x0d\1. Drug business license application form;\x0d\2. Approval document for the proposed enterprise issued by the industrial and commercial administration department;\x0d\3. Floor plan of business premises, warehouse and certificate of property rights or use rights;\x0d\4. Qualification certificates and letters of appointment for pharmaceutical professional technicians who have been qualified in accordance with the law;\x0d\5. Proposed enterprise quality management documents and catalog of main facilities and equipment. \x0d\ (5) The (food) drug regulatory agency that accepts the application shall, within 15 working days from the date of receipt of the acceptance application, organize the acceptance based on the acceptance implementation standards for drug retail enterprises and decide whether to issue a "Drug Business License" 》decision. If the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained. At the same time, the applicant shall be informed of its right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.