1. with the qualification of pharmacy technicians according to law
2. with the drugs operated by the appropriate business premises, equipment, storage facilities, sanitation
3. with the drugs operated by the appropriate quality management organization or personnel
4. with the regulations to ensure the quality of the drugs operated by the regulations
Specifically, to declare the submission of materials strong>Extended information
Specifically for the declaration of materials submitted: 1, the legal representative of the applicant, the person in charge of the enterprise, the person in charge of quality of the original certificate of academic qualifications, photocopies and biographical data; 2, the original certificate of practice of pharmacists, photocopies; 3, the scope of the proposed operation of pharmaceutical products; 4, the proposed establishment of the business premises, equipment, warehousing facilities and the surrounding sanitary environment. Situation. Start-up capital, usually about 500,000
Drug business license management methods ? General principles
Article 1 In order to strengthen the supervision and management of drug licensing work, according to the "People's Republic of China *** and the State Drug Administration Law", "People's Republic of China *** and the State Drug Administration Law Enforcement Regulations" (hereinafter referred to as the "Drug Administration Law," "Drug Administration Law Enforcement Regulations") of the relevant provisions of the formulation of these measures.
Second Article "Drug License" issuance, renewal, change and supervision and management of the application of these measures.
Article 3 The State Food and Drug Administration is in charge of the supervision and management of the national drug license.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration is responsible for the jurisdiction of the pharmaceutical wholesale enterprises "drug license" issued, renewed, changed and daily supervision and management, and guidance and supervision of lower-level food and drug supervision and management departments to carry out "drug license" supervision and management work.
The municipal food and drug supervision and management departments or provinces, autonomous regions and municipalities directly under the central food and drug supervision and management departments directly set up county-level food and drug supervision and management departments are responsible for the jurisdiction of the drug retail enterprise "drug license" issuance, renewal, change and day-to-day supervision and management work.
Chapter II 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 drug wholesale enterprise shall comply with the requirements of the rational distribution of drug wholesale enterprises of the province, autonomous region and province-level municipality directly under the central government, and shall meet the following standards for setting up a drug wholesale enterprise:
(1) It has the rules and regulations to ensure the quality of the drugs it operates;
( (ii) The enterprise, its legal representative or person in charge of the enterprise, and the person in charge of quality management do not have the circumstances stipulated in Articles 75 and 82 of the Drug Administration Law;
(iii) It has 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 otherwise provided for, from its provisions.
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