How to apply for a pharmaceutical business license, And drug wholesale license?

one, Legal basis for applying for a drug business license: 1, Drug Administration Law of the People's Republic of China;2, Regulations for the Implementation of the Drug Administration Law of the People's Republic of China;3, Administrative Measures for the Operation of Pharmaceutical Business Licenses.

two, Number and method of application: In accordance with Article 14 of the Drug Administration Law, Start a pharmaceutical wholesale business, should comply with provincial, autonomous region, Requirements for the rational layout of pharmaceutical wholesale enterprises in municipalities directly under the Central Government.

three, Conditions that applicants should meet: 1, Have rules and regulations to ensure the quality of the drugs they handle;2, enterprise, Legal representative of the enterprise or person in charge of the enterprise, There is no person in charge of quality management. Article 76 of the Drug Administration Act, Circumstances provided for in Article 83;3, Have a certain number of licensed pharmacists commensurate with the business scale.

The person in charge of quality management must have a college degree or above, and must be a licensed pharmacist;4, Have the requirements to ensure the quality of drug storage, A room temperature warehouse suitable for its business variety and scale, cool library, cold storage.

The warehouse has special shelves suitable for drug storage and realizes drug storage, transmit, Sorting, On the shelves, Devices and equipment for outbound modern logistics systems;5, Have an independent computer management information system, Can cover the purchase of drugs within the enterprise, store, The whole process of sales, operation and quality control;Able to comprehensively record information on business management and implementation of "Good Manufacturing Practices for Pharmaceutical Products";Comply with the requirements of the "Good Manufacturing Practice for Pharmaceutical Distribution" for all aspects of pharmaceutical operation., and has the capability to implement acceptance of local(food)Drug regulatory authorities(mechanism)conditions of supervision;6, Have pharmaceutical business premises and auxiliary facilities that comply with the "Pharmaceutical Goods Management Practice", Office space and warehouse management, Drug quality and safety assurance in the warehouse and entry and exit of the warehouse, Conditions for storage and maintenance in the warehouse.

The state regulates the sale of narcotic drugs, psychotropic drugs, Toxic drugs for medical use, Preventive biological products are otherwise specified, According to its provisions.

Four, Application materials requirements: (one)General requirements for application materials: Application materials should be true, whole, Print or copy on A4 paper, Binned in order;(two)Specific requirements for application materials: 1, Corporate legal person applies, In the applicant column, fill in the name of the corporate legal entity, All application materials must be stamped with the official seal;2, Natural person applies, In the applicant column, fill in the name of the authorized person, All application materials must be signed by the authorized person;3, drug, Complete the "Enterprise Acceptance Application" on the enterprise side of the medical device business license management system, correct, Meet the import system conditions.

4, business place, The warehouse location map should clearly indicate the surrounding streets and landmark buildings., to find.

(If not the entire layer, A floor plan of the location on the floor is also required.)5, The warehouse floor plan must indicate the detailed address(Floor)and various reservoir areas, Check-in nursing room, Warehouse office area;Article 4 In accordance with Article 14 of the Drug Administration Law, Start a pharmaceutical wholesale business, should comply with provincial, autonomous region, Requirements for the rational layout of pharmaceutical wholesale enterprises in municipalities directly under the Central Government, and comply with the following setting standards: (one)Have rules and regulations to ensure the quality of the drugs they handle;(two)enterprise, Legal representative of the enterprise or person in charge of the enterprise, There is no person in charge of quality management. Article 76 of the Drug Administration Act, Circumstances provided for in Article 83;(three)Have a certain number of licensed pharmacists commensurate with the business scale.

The person in charge of quality management must have a college degree or above, and must be a licensed pharmacist;(Four)Have the requirements to ensure the quality of drug storage, A room temperature warehouse suitable for its business variety and scale, cool library, cold storage.

The warehouse has special shelves suitable for drug storage and realizes drug storage, transmit, Sorting, On the shelves, Devices and equipment for outbound modern logistics systems;(five)Have an independent computer management information system, Can cover the purchase of drugs within the enterprise, store, The whole process of sales, operation and quality control;Able to comprehensively record information on business management and implementation of "Good Manufacturing Practices for Pharmaceutical Products";Comply with the requirements of the "Good Manufacturing Practice for Pharmaceutical Distribution" for all aspects of pharmaceutical operation., and has the capability to implement acceptance of local(food)Drug regulatory authorities(mechanism)conditions of supervision;(six)Have pharmaceutical business premises and auxiliary facilities that comply with the "Pharmaceutical Goods Management Practice", Office space and warehouse management, Drug quality and safety assurance in the warehouse and entry and exit of the warehouse, Conditions for storage and maintenance in the warehouse.

The state regulates the sale of narcotic drugs, psychotropic drugs, Toxic drugs for medical use, Preventive biological products are otherwise specified, According to its provisions.

Article 5: Starting a pharmaceutical retail enterprise, Should be consistent with the local resident population, region, Traffic conditions and actual needs require, In line with the principle of making it convenient for the public to purchase medicines, and comply with the following setting requirements: (one)Have rules and regulations to ensure the quality of the drugs they handle;(two)Legally qualified pharmaceutical technicians;Dealing in prescription drugs, Pharmaceutical retail enterprises of Class A over-the-counter drugs, Must be equipped with licensed pharmacists or other pharmaceutical technicians who have been qualified according to law.

The quality manager should have more than one year(Including one year)Pharmaceutical business quality management work experience.

Pharmaceutical retail enterprises operating Class B over-the-counter drugs, and the establishment of drug retail enterprises in rural areas and towns and below., Business personnel should be allocated in accordance with Article 15 of the "Regulations for the Implementation of the Drug Administration Law", If conditions permit, a licensed pharmacist should be provided.

Business hours, The above personnel should be on duty.

(three)enterprise, Legal representative of the enterprise, Business person in charge, There is no quality person in charge Article 76 of the Drug Administration Law, The circumstances specified in Article 83;(Four)Have a business location suitable for the drugs sold, equipment, Warehousing facilities and sanitary environment.

Establishing retail pharmacies in supermarkets and other commercial enterprises, Must have separate area;(five)Have the ability to prepare medicines that meet the needs of local consumers, And can guarantee 24-hour supply.

The number of national essential medicines that drug retail enterprises should stock is determined by each province., autonomous region, municipality(food)The drug supervision and administration department shall determine the.

The state regulates the sale of narcotic drugs, psychotropic drugs, Toxic drugs for medical use, Preventive biological products are otherwise specified, According to its provisions.

Article 6 The implementation standards for acceptance of drug wholesale enterprises shall be formulated by the State Food and Drug Administration.

Implementation standards for acceptance of drug retail enterprises, by provinces, autonomous region, municipality(food)The drug regulatory department organizes and formulates based on the relevant content of these Measures and the "Good Manufacturing Practice for Drug Distribution", and reported to the State Food and Drug Administration for filing.

Article 7 Approval of the business scope of pharmaceutical business enterprises.

Business scope of pharmaceutical business enterprises: Narcotic drugs, psychotropic drugs, Toxic drugs for medical use;biological products;Chinese medicinal materials, Chinese medicine pieces, Chinese patent medicine, Chemical raw materials and preparations, Antibiotic raw materials and preparations, Biochemical drugs.

Engaged in pharmaceutical retail, The business category should be determined first, Determine whether the sponsor deals in prescription or over-the-counter drugs, Eligibility for Class B OTC Drugs, and make it clear in the business scope, Re-verify the specific business scope.

Toxic drugs for medical use, Narcotic drugs, psychotropic drugs, The approval of radioactive drugs and preventive biological products shall be carried out in accordance with the relevant provisions of the state on the management of special drugs and the management of preventive biological products..