1, application: to the location of the provincial Food and Drug Administration to submit an application for preparatory work;
2, submit materials: submit materials related to the type of business applied for;
3, material correction: the acceptance of the department in accordance with the handling of different circumstances, and inform the applicant unit to correct the material;
4, audit stage: the audit cycle for 30 working days;
5, qualification issuance: the qualified units issued drug license. It takes a long period of time from application to preparation.
Expanded InformationIn accordance with Article 14 of the Drug Administration Law, the establishment of a pharmaceutical wholesale enterprise shall comply with the requirements of the rational distribution of pharmaceutical wholesale enterprises in provinces, autonomous regions and municipalities directly under the Central Government, and shall meet the following standards for setting up a pharmaceutical wholesale enterprise:
(a) it has rules and regulations to ensure the quality of the pharmaceutical products it operates;
(b) the enterprise, its legal representative or person in charge of the enterprise, and the person in charge of quality management do not have any of the requirements stipulated in the Drug Administration Law. The person in charge does not have the circumstances stipulated in Articles 75 and 82 of the Drug Administration Law;
(iii) It has a certain number of licensed pharmacists appropriate to the scale of operation. The person in charge of quality management has a university degree or above, and must be a licensed pharmacist;
(d) has a room temperature warehouse, cool warehouse, cold warehouse that can ensure the quality requirements for the storage of medicines, and that is suitable for the variety and scale of its business. The warehouse has special shelves suitable for the storage of drugs and devices and equipments for realizing the modern logistics system of drug entry, transmission, sorting, shelving and exit;
(v) it has an independent computer management information system, which can cover the whole process of drug purchase, storage, sale, operation and quality control in the enterprise; it can comprehensively record the information on the management of business operation and the implementation of the "Code of Practice for the Quality Management of Pharmaceutical Business"; it is in line with the "Code of Practice for the Quality Management of Pharmaceutical Business"; and it is in line with the "Code of Practice for the Management of Pharmaceutical Business". Information; in line with the "Good Manufacturing Practice" on the requirements of the various aspects of drug business, and has the conditions to realize the acceptance of the local food and drug supervision and management department supervision;
(f) with the "Good Manufacturing Practice" on the drug business premises and auxiliary, office space and warehouse management, quality and safety of the drugs in the warehouse, and in and out of the library, in the library storage and conservation Conditions.
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