The applicant shall submit the following application materials:
1) 2 copies of "Application for Certification of Quality Management Standards for Pharmaceutical Trading";
2) Two copies of Drug Business License and Business License (if an enterprise is allowed to deal in special drugs, two copies of corresponding approval documents shall be submitted; Centralized database, should also submit the corresponding reply 2);
3) Two self-inspection reports on GSP implementation by enterprises;
4) 2 copies of the explanation on the illegal distribution of counterfeit and inferior drugs by enterprises;
5) 2 copies of the information form of the person in charge of the enterprise and quality management personnel, professional title or academic certificate;
6) 2 copies of enterprise acceptance and maintenance personnel list, professional title or academic certificate;
7) Two copies of business facilities and equipment;
8) Two copies of the pharmaceutical trading enterprise owned by the enterprise;
9) 2 copies of the catalogue of quality management system for pharmaceutical business of enterprises;
10) 2 copies of the organizational structure and functional framework of enterprise management;
1 1) 2 copies of the orientation map of the enterprise's business premises and warehouse;
12) Two copies of the layout of the business premises and warehouse (indicating the length, width and height of the warehouse and the length and width of the business premises);
13) Two self-assurance statements on the authenticity of the application materials, and promise to bear legal responsibility for any falsehood of the materials;
14) If the applicant is not the legal representative or person in charge, the enterprise shall submit 3 copies of the power of attorney;
15) Make 2 copies of the catalogue according to the order of application materials.
Standard:
1) The application materials shall be complete and clear, signed page by page and stamped with the official seal of the enterprise. Print or copy it on A4 paper, and bind it into volumes in the order of the application materials catalogue;
2) If the application materials need to be copied, the applicant (unit) shall indicate the words "This copy is consistent with the original" or a written description on the copy, indicate the date and affix the official seal of the unit.
6. Handling process: acceptance → preliminary examination → approval → transfer of application materials → formal review → technical review and on-site inspection → review → approval → administrative licensing decision and certificate transfer → delivery.