One, the opening of pharmaceutical wholesale enterprises in accordance with the following procedures for the "Drug Business License":
(a) the applicant to the proposed business location of the provinces, autonomous regions, municipalities directly under the central food and drug supervision and management department of the preparatory application, and submit the following materials:
1, the proposed legal representative, the person in charge of the business, the person in charge of quality of the original academic certificate, copy and personal resume;
2, licensed pharmacist practice certificate original, copy;
3, the scope of the proposed business of drugs;
4, the proposed business premises, equipment, storage facilities and the surrounding health environment.
Two, the start of drug retail enterprises in accordance with the following procedures for "Drug License":
(a) the applicant to the proposed business location of the municipal food and drug supervision and management departments or provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration directly set up county-level food and drug supervision and management departments to submit an application for preparatory work and the following materials:
1, the legal representative of the proposed enterprise, the person in charge of the enterprise, the quality of the person in charge of the education, practicing qualifications or title certificate original, copy and personal resume and professional and technical personnel qualification certificate, letter of appointment;
2, the scope of the proposed business drugs;
3, the proposed business premises, warehousing facilities, equipment.
Three, Chengdu processing organization: the Food and Drug Administration where the enterprise.
Expanded Information:
The conditions for applying for a Drug Operation License
Article 4 In accordance with the provisions of Article 14 of the Drug Administration Law, the establishment of a pharmaceutical wholesale enterprise shall comply with the requirements of the province, autonomous region and municipality directly under the Central Government of the pharmaceutical wholesale enterprise rational layout, and Meet the following setup standards:
(1) have rules and regulations to ensure the quality of the drugs they deal with;
(2) the enterprise, its legal representative or the person in charge of the enterprise, and the person in charge of quality management do not have any of the circumstances stipulated in Articles 75 and 82 of the Drug Administration Law;
(3) have a certain number of practicing 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.
The state on the operation of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products, other provisions, from its provisions.
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