Author: Unknown Source: US Food and Drug Administration Date: September 23, 2009 Reading Times: 354
Hengshui drug retail enterprise drug business license
Application and Licensing Law (Revised Edition)
First, in order to strengthen the supervision and management of drug retail business license and promote the construction of drug supply network in our city, these measures are formulated in accordance with the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law, the Measures for the Administration of Drug Business License, the approval procedures for the establishment of drug retail chain enterprises in Hebei Province and the implementation standards for the acceptance of drug retail enterprises in Hebei Province.
Ii. Hengshui The US Food and Drug Administration is responsible for the examination and approval of the establishment of pharmaceutical retail enterprises within its jurisdiction. The approval of the establishment of pharmaceutical retail enterprises shall follow the principle of rational distribution and convenience for the masses to purchase drugs.
Three, the establishment of pharmaceutical retail enterprises to the administrative service center of Hengshui Municipal People's government food and drug administration window to submit an application and go through the relevant formalities.
Four, drug retail enterprises refer to the drug business enterprises that directly sell the purchased drugs to consumers. Drug retail enterprises are divided into retail and retail chains according to their business forms. A pharmaceutical retail chain enterprise refers to a pharmaceutical retail enterprise that uses a number of stores with a unified name and logo, operates under the unified management of the same headquarters, and adopts the organizational form of unified procurement and distribution, unified quality management standards, separation of purchase and sale, and large-scale operation. Drug retail chain enterprises should be legal persons and should be composed of headquarters, distribution centers and several stores. Each store shall hold the Pharmaceutical Business License issued by the pharmaceutical supervisory and administrative department, and the business form shall be retail chain.
V. Starting conditions:
(a) the operating conditions of retail pharmacies (including retail chain stores)
1, should have a relatively independent business premises, and the surrounding environment is clean. Temporary buildings shall not be used for operation and storage.
2. The use area of the business premises shall not be less than 40 square meters (on the same plane), and the storage area shall not be less than 20 square meters. The use area of the business premises dealing in traditional Chinese medicine formulas shall not be less than 60 square meters, and the storage area shall not be less than 30 square meters. The shop area and warehouse area do not include the office and living area. Having equipment, storage facilities and sanitary environment suitable for dealing in drugs. A relatively independent business area shall be established for the operation of Chinese herbal pieces. Drug retail chain stores shall not set up warehouses; Non-retail chain pharmacies may sign supply contracts and quality assurance agreements with legal drug wholesale enterprises, and have fixed drug supply channels, and may not set up warehouses; However, the drugs in the store must be stored according to the specified requirements. The establishment of retail pharmacies in supermarkets and other commercial enterprises must have relatively independent business areas.
3. The legal representative or person in charge of the enterprise and the person in charge of quality management should work full-time in the established enterprise; There are no circumstances stipulated in Articles 76 and 83 of the Drug Administration Law; Personnel and salespersons engaged in quality management and acceptance of enterprises should undergo professional training or on-the-job training, and pass the unified examination organized by Hengshui Food and Drug Administration to obtain qualification certificates.
4. The enterprise is equipped with the person in charge of quality management, and the quality management personnel, acceptance personnel, maintenance personnel, metrology personnel, shop assistants and prescription drug management personnel must be equipped with prescription auditors. The person in charge of enterprise quality, quality management personnel and prescription auditors shall not work part-time in other units; Located in the county (including the county), the person in charge of quality management should be a licensed pharmacist or a pharmaceutical technician above the pharmacist; If a retail pharmacy below the county level deals in OTC drugs of Class B, the person in charge of quality management shall have the title of pharmacist or above or be staffed in accordance with Article 15 of the Regulations for the Implementation of the Drug Administration Law; The person in charge of quality management should have more than one year (including one year) experience in quality management of pharmaceutical business.
5, there are rules and regulations to ensure the quality of drugs.
6. Have the ability to supply drugs that meet the needs of local consumers, and have the ability to supply when there is a 24-hour demand.
7. If the state has other provisions on the operation of narcotic drugs, psychotropic drugs, toxic drugs for medical use and biological products for prevention, those provisions shall prevail.
(2) Conditions for establishing a pharmaceutical retail chain enterprise (headquarters)
1. The pharmaceutical retail chain enterprise (headquarters) shall be an enterprise legal person.
2. There are more than 10 directly operated asset holding stores (including 10), and all the stores have held the Pharmaceutical Business License.
3, there are rules and regulations to ensure the quality of drugs.
4. The enterprise, its legal representative or person in charge and the person in charge of quality management have no circumstances as stipulated in Articles 76 and 83 of the Drug Administration Law.
5, with a certain number of licensed pharmacists to adapt to the scale of operation. The person in charge of enterprise quality management or the person in charge of enterprise management organization shall be a licensed pharmacist and have more than three years (including three years) working experience in drug management quality.
6. Having business premises and quality management institutions suitable for the drugs handled.
7, can ensure the quality requirements of drugs in and out of the warehouse and storage, and there are cold storage and cold storage suitable for its business variety and scale. The total warehouse area (construction area, the same below) shall not be less than 500 square meters, of which the cold storage area shall not be less than 200 square meters, and the cold storage volume shall not be less than 12 cubic meters. Devices and equipment with modern logistics system suitable for drug storage.
8. It has an independent computer management information system, which can cover the whole process of drug procurement, storage, sales and quality control; Information that can comprehensively record the enterprise management and the implementation of the "Good Manufacturing Practices"; All aspects of drug trading meet the requirements of "Quality Management Standards for Pharmaceutical Trading" and are subject to the supervision of local (food) drug supervision and management departments (institutions).
9. Meet the requirements of drug business premises and auxiliary rooms, office rooms and warehouse management, drug quality and safety guarantee in the warehouse, warehouse access, warehouse storage and maintenance.
10. Those who have the ability to provide drugs that meet the needs of local consumers should have more than 70% of national essential drugs. When there is a 24-hour demand, it has the ability to provide this service. If the state has other provisions on dealing in narcotic drugs, psychotropic drugs, toxic drugs for medical use and biological products for prevention, those provisions shall prevail.
Six, the establishment of pharmaceutical retail enterprises shall submit the following information (in duplicate, printed on A4 paper):
(1) Retail pharmacies (including retail chain stores)
1. A written application for opening a retail pharmacy.
2. A written statement issued by the enterprise, its legal representative, the person in charge of the enterprise and the person in charge of quality management that the (food) drug supervision and administration department where the enterprise is located has no circumstances stipulated in Articles 76 and 83 of the Drug Administration Law.
3. Location map and floor plan of the proposed business and warehouse.
4, the legal representative of the proposed enterprise, the person in charge of the enterprise, the person in charge of quality management, the person in charge of the quality organization, the original and photocopy of the academic qualifications, professional qualifications or professional titles, and the photocopy of the resume and ID card; Professional and technical personnel qualification certificate and letter of appointment.
5. Certificate of the name of the proposed enterprise approved in advance by the administrative department for industry and commerce.
(2) Drug retail chain enterprises
1, a written application for starting a pharmaceutical retail chain enterprise.
2. A written statement issued by the enterprise, its legal representative, the person in charge of the enterprise and the person in charge of quality management that the (food) drug supervision and administration department where the enterprise is located has no circumstances stipulated in Articles 76 and 83 of the Drug Administration Law.
3, the legal representative of the proposed enterprise, the person in charge of the enterprise, the person in charge of quality management, the person in charge of the quality organization, the original and photocopy of the academic qualifications, professional qualifications or professional titles, and the photocopy of the resume and ID card; Professional and technical personnel qualification certificate and letter of appointment.
4. Geographical location map and floor plan of the business place, distribution center warehouse and franchise store to be established. The floor plan shall indicate the area of business premises, normal temperature warehouse, cold storage warehouse and acceptance and maintenance premises.
5, the proposed business premises, warehouse facilities and equipment and the surrounding sanitary environment, etc.
6. It is suggested to configure the computer management information system.
7. Name and address of retail chain stores, names of responsible persons and quality management personnel, technical titles, originals and photocopies of academic certificates, and originals and photocopies of Drug Business License held by each store.
8, the administrative department for Industry and commerce pre-approved the name of the enterprise file.
Seven, the examination and approval procedures for the establishment of pharmaceutical retail enterprises are: examination and acceptance of materials, examination and approval of preparations, on-site acceptance, and issuance of Drug Business License.
(1) Inspection and acceptance of data
The window of the US Food and Drug Administration of the Administrative Service Center of Hengshui Municipal People's Government examines the submitted application materials to see whether the materials are complete, whether the contents meet the requirements and whether the handwriting is clear. If the information is complete and meets the requirements, it shall be accepted and the application materials shall be submitted to the market supervision department of the US Food and Drug Administration within 2 working days. If the application matters do not fall within the scope of functions and powers of the department, it shall immediately make a decision not to accept them. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot. If the information is incomplete or does not meet the statutory form, the applicant shall be issued a Notice of Supplementary Materials on the spot or within 5 days to inform all the information that needs to be supplemented at one time.
(2) Examination and approval.
1. After receiving all the information, the market supervision department of the US Food and Drug Administration in 10 shall conduct a comprehensive review of the application materials in accordance with the relevant regulations and conduct on-site inspection when necessary. In the process of examination, if it is found that the administrative licensing matters directly involve the major interests of others, it shall inform the interested parties. Listen to the statements and arguments of the applicant and interested parties. If a hearing should be held according to law, it should be held according to law. The approval document for the preparation of the project that has passed the examination shall be issued with a notice of refusal, and the reasons shall be explained and reported to the competent director for approval. The competent leader shall complete the examination and approval within 3 working days. The market supervision department will send a notice of approval or disapproval to the government service center within 2 working days. The approval of the preparation should be copied to the local county (city) US Food and Drug Administration.
2. The window of the Food and Drug Administration of the government service center shall notify the applicant to receive the notice of approval or disapproval within 1 working day, and inform relevant matters, subject to the recording time of the telephone notice. If the applicant has any objection to the preparation, it shall inform the applicant of the right to administrative reconsideration and bring an administrative lawsuit according to law.
3. The applicant shall complete the preparation and submit the acceptance application within 90 days, otherwise the bidding qualification will be cancelled.
(3) Acceptance
After the applicant completes the preparation, the US Food and Drug Administration will organize the acceptance. The applicant shall submit an application for acceptance to the drug regulatory agency designated by the US Food and Drug Administration, and submit the following materials:
1. Documents approved by the Municipal Bureau for preparation.
2, drug business license application review form (see annex).
3. The organizational structure of the proposed enterprise, indicating the responsibilities, relationships and post leaders of each post.
4, according to the qualification of pharmaceutical professional and technical personnel qualification certificate, letter of appointment and all personnel basic information registration form; (Name, gender, position, education, major, technical title, qualification certificate, etc. ).
5, the layout of the business premises and warehouses and proof of property rights or the right to use the house.
6, enterprise management, quality management system file directory and main facilities and equipment directory.
7, the administrative department for Industry and commerce pre-approved the name of the enterprise file.
8. To establish a pharmaceutical retail chain enterprise, submit the certificate that the legal representative has passed the examination of national laws and regulations on drug management organized by the US Food and Drug Administration.
The pharmaceutical supervisory and administrative department shall, within 7 working days from the date of receiving the application for acceptance, organize the acceptance in accordance with the Implementation Standards for Acceptance of Pharmaceutical Retail Enterprises in Hebei Province or the Implementation Standards for Acceptance of Pharmaceutical Retail Chain Enterprises in Hebei Province. The acceptance team shall fill in the Application Review Form for Drug Business License on the spot, make a decision on whether it meets the standards, and report to the market supervision department of the US Food and Drug Administration within 3 days.
(4) Issuing certificates
The market supervision department of the US Food and Drug Administration shall, within five working days, report the qualified enterprises to the competent director for approval, make a Drug Business License and hand it over to the drug supervision window of the government service center for distribution; Do not meet the conditions, after being reported to the competent director for approval, the food and drug supervision window of Hengshui Municipal People's Government Administrative Service Center shall inform the applicant in writing and explain the reasons, and inform the applicant of the right to apply for reconsideration or bring an administrative lawsuit according to law.
Eight, the drug supervision and management departments of the "drug business license" issued by the relevant information in Hengshui City Drug Administration website to be open, the public has the right to consult. If an enterprise is found to have provided false documents, materials or other deceptive acts in the process of applying for a Drug Business License after the information is disclosed, it shall be dealt with according to law.
Nine, this approach and the "application form for the establishment of pharmaceutical retail enterprises" model text in Hengshui, www.hsda.gov.cn, the United States Food and Drug Administration website published.
Ten, these measures shall come into force as of the date of promulgation, and the original Hengshui drug retail enterprises "drug business license" application method shall be abolished at the same time.
Heng Shi Yao Guan [2006] No.63
On the issuance of "Hengshui drug retail enterprises"
License > Notice of Application Method (Amendment)
American Food and Drug Administration county drug and medical device production and operation enterprises:
The Measures for the Application of Drug Retail Enterprises in Hengshui City (Revised) has been discussed and passed at the office meeting of the Director of the US Food and Drug Administration in Hengshui City, and is hereby issued to you, please follow it. The original Measures for the Application of Drug Retail Enterprises in Hengshui City shall be abolished at the same time.
Attachment: Measures for Applying for Drug Business License of Drug Retail Enterprises in Hengshui City (Revised)
June 2006 16
Appendix 2: Implementation Standards for Acceptance of Pharmaceutical Retail Enterprises in Hebei Province
Annex 3: Approval Form for Drug Business License Application
Application for administrative license
Notice on Printing and Distributing the Change Procedure of Drug Business License (Retail)
Author: Unknown Source: US Food and Drug Administration Date: September 23, 2009 Reading Times: 352
County (city) drug administration, the drug business enterprises in the city:
In order to implement the administrative licensing law, according to the Measures for the Administration of Drug Business License and the Detailed Rules for the Implementation of the Measures for the Administration of Drug Business License in Hebei Province (for Trial Implementation), our bureau revised the conditions and procedures for changing the Drug Business License. It is issued to you, please follow it carefully. The conditions and procedures for changing the original Drug Business License shall be abolished immediately.