Author: unknown Source: Drug Administration Date: 2009-09-23 Read: 354
Hengshui City, Hengshui City, drug retailers, "Drug License"
Apply for the law (revised)
I. In order to enhance the work of the retail drug license supervision and management, to promote the construction of the city's drug supply network, according to the Drug Administration Law, the Drug Administration Law Enforcement Regulations, "Drug License Management Measures" and "Hebei Province" to open a drugstore procedures. In order to strengthen the supervision and management of the work of drug retail business license and to promote the construction of the city's drug supply network, according to the Drug Administration Law, Regulations for the Implementation of the Drug Administration Law, Measures for the Administration of Drug Business License, and Approval Procedures for the Opening of Drug Retail Chain Enterprises in Hebei Province, and Implementation Standards for the Acceptance of Drug Retail Enterprises in Hebei Province, the measures are hereby formulated.
Second, Hengshui City Food and Drug Administration is responsible for the jurisdiction of the opening of the drug retail enterprise approval and licensing work. Approval of the opening of drug retailers should follow a rational layout and the convenience of the masses to buy drugs principle.
Three, the start of drug retailers to Hengshui City People's Government Government Service Center Food and Drug Administration window to submit an application and handle the relevant procedures.
Four, drug retailers refers to the purchase of drugs sold directly to consumers of the drug business enterprises. Drug retailers are divided into retail and retail chain according to the form of operation. Drug retail chain refers to the use of a unified trade name and a unified logo of a number of stores, under the unified management of the same headquarters, to take a unified procurement and distribution, unified quality management standards, procurement and sales are separated from the implementation of large-scale management of the organizational form of operation of the drug retail enterprises. A drug retail chain enterprise shall be an enterprise legal person and shall consist of a headquarters, a distribution center and a number of stores. Each store shall hold a Drug Operation License issued by the drug supervision and management department, and operate in the form of a retail chain.
V. Start-up conditions:
(A) retail pharmacy (including retail chain stores) start-up conditions
1, should have a relatively independent place of business, the surrounding environment is clean. Temporary buildings shall not be used for business and storage.
2, the use of business premises area of not less than 40 square meters (required in the same plane), storage area of not less than 20 square meters. Chinese medicine formula business scope of the use of business premises shall not be less than 60 square meters, the storage area shall not be less than 30 square meters. Store area, warehouse area does not include office, living space area. With equipment and storage facilities and sanitary environment appropriate to the operation of drugs. The operation of traditional Chinese medicine tablets should set up a relatively independent business area. Drug retail chain stores may not set up warehouses; non-retail chain drugstores such as legal drug wholesalers to sign supply contracts and quality assurance agreements, there are fixed drug supply channels, can not set up warehouses; but the store must be stored in accordance with the requirements of the provisions of the drug. In supermarkets and other commercial enterprises to set up retail pharmacies, must have a relatively independent business area.
3, the legal representative or person in charge of the enterprise, the person in charge of quality management should be full-time in the opening of the enterprise; no "Drug Administration Law," Article 76, Article 83 of the circumstances; the enterprise engaged in quality management and acceptance of the work of the staff and sales staff should be professional or job training, and through the Hengshui City, Hengshui Food and Drug Administration organization of a unified examination to obtain a certificate of qualification.
4, the enterprise is equipped with the person in charge of quality management, quality management, acceptance, maintenance, measurement staff, salespersons, operating prescription drugs must be equipped with prescription reviewers. Enterprise quality management staff, quality management staff, prescription reviewers shall not be part-time in other units; located in the county (including the county) above, the person in charge of quality management shall be a licensed pharmacist or pharmacist or above, pharmacy technicians; located in the county below and the operation of Category B non-prescription drugs in the retail pharmacy, the person in charge of quality management shall have a pharmacist or above, professional and technical titles or according to "Regulations for the Implementation of the Pharmaceutical Affairs Law," Article 15 The person in charge of quality management shall have more than one year (including one year) of experience in quality management of drug business.
5, with rules and regulations to ensure the quality of the drugs operated.
6, with the ability to meet the needs of local consumers with the ability to meet the needs of local consumers with the ability to supply 24-hour demand.
7, the state on the operation of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products, otherwise provided, shall be subject to its provisions.
(B) Drug retail chain enterprises (headquarters) start-up conditions
1, drug retail chain enterprises (headquarters) should be a corporate legal entity.
2, with assets holding, and directly operated stores reached 10 (including 10) or more, all stores have held the "Drug License".
3, with rules and regulations to ensure the quality of the drugs operated.
4. The enterprise, its legal representative or person in charge, and the person in charge of quality management are free from the circumstances stipulated in Articles 76 and 83 of the Drug Administration Law.
5, with a certain number of licensed pharmacists appropriate to the scale of operation. The person in charge of enterprise quality management or the head of the enterprise management organization should be a licensed pharmacist, and have more than three years (including three years) of quality work experience in drug business.
6, with the business premises and quality management organization appropriate to the drugs operated.
7, with the ability to ensure that the quality of drugs in and out of the warehouse and storage requirements, with its business varieties and scale of room temperature warehouse, cool warehouse, cold storage. The total area of the warehouse (floor area, the same below) shall not be less than 500 square meters, of which the area of the cool storage of not less than 200 square meters, cold storage volume of not less than 12 cubic meters. The warehouse has devices and equipment of modern logistics system suitable for drug storage.
8, with an independent computer management information system that can cover the purchase of drugs, storage, sales and quality control of the whole process of business; can be comprehensively recorded business management and implementation of the "Drug Certification Practice" information; in line with the "Drug Certification Practice" of the requirements of the various segments of the drug business, and has the realization of the acceptance of the local (food) drug supervision and management department (agency) supervision conditions.
9, with the "Drug Business Quality Management Code" on drug business premises and auxiliary, office premises and warehouse management, warehouse drug quality and safety and security in the warehouse and in and out of the warehouse, in the warehouse storage and maintenance of the conditions.
10, with the ability to be able to equip the distribution of drugs to meet the needs of local consumers, should have more than 70% of the national essential drug varieties, there is a 24-hour demand for the ability to provide such services. The state on the operation of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products otherwise provided for, shall be subject to its provisions.
6, the opening of drug retailers should submit the following information (in duplicate, printed on A4 paper):
(A) retail pharmacy (including retail chain stores)
1, the opening of the retail pharmacy written application.
2, the location of the enterprise (food) drug supervision and management department issued by the enterprise, the enterprise's legal representative, the person in charge of the enterprise, the person in charge of quality management without the "Drug Administration Law," Article 76, Article 83 of the circumstances of the written statement.
3, the proposed business, warehouse address geographic location map and layout plan.
4, the proposed legal representative of the enterprise, the person in charge of business, quality management, quality institutions responsible for the original academic qualifications, practicing qualifications or professional title certificate, copy and resume, copy of ID card; professional and technical personnel qualifications, letter of appointment.
5, pre-approved by the administration for industry and commerce of the proposed business name documents.
(B) pharmaceutical retail chain
1, the opening of a pharmaceutical retail chain written application.
2, the location of the enterprise (food) drug supervision and management department issued by the enterprise, the enterprise's legal representative, the person in charge of the enterprise, the person in charge of quality management without the "Drug Administration Law," Article 76, Article 83 of the circumstances of the written statement.
3, the proposed legal representative of the enterprise, the person in charge of the enterprise, the person in charge of quality management, the person in charge of the quality of the organization's academic qualifications, practicing qualifications or professional title certificate original, copy and resume, copy of ID card; professional and technical personnel qualifications, letter of appointment.
4, the proposed enterprise's business premises, distribution center warehouse, the geographic location of the stores belonging to the map and floor plan, floor plan should indicate the business room, room temperature warehouse, cooler, cold storage, acceptance and maintenance of the area of the room.
5, the proposed business premises, warehouse facilities and equipment and the surrounding health environment.
6, the proposed configuration of computer management information system.
7, the name, address, person in charge of the retail chain stores, quality management personnel list and technical titles, academic certificates, originals and copies, as well as the stores originally held the original "Drug License," originals and copies.
8. Documents certifying the name of the proposed enterprise pre-approved by the administration for industry and commerce.
Seven, the approval process for starting a drug retail enterprise: data review and acceptance, review and approval of the preparatory work, on-site acceptance, and the issuance of the "Drug Business License".
(a) information review acceptance
Hengshui City People's Government Government Service Center Food and Drug Administration window on the application information submitted for review, to see whether the information is complete, whether the content is in line with the provisions of the writing is clear. The information is complete, in line with the provisions of the application to be accepted and within two working days of the application information will be sent to the City Food and Drug Administration Market Supervision. Application matters do not belong to the department's terms of reference, should be made immediately inadmissible decisions. Application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot. Incomplete or not in accordance with the statutory form of information on the spot or within 5 days to the applicant, "Supplemental Materials Notice", a one-time notice of the need to supplement the full content of the information.
(B) review and approval of the preparatory work
1, the City Food and Drug Administration Market Supervision Section received all the information, within 10 working days in accordance with the relevant provisions of the declaration of information for a comprehensive review, on-site inspection when necessary. In the review, found that the administrative licensing matters directly related to the significant interests of others, shall inform the interested party. And listen to the applicant, the interested party's statement and defense. Should be heard in accordance with the law, in accordance with the provisions of the law to hold a hearing. Qualified for the review of the preparation of consent to the preparation of the approval, the review failed to prepare a notice of rejection, indicating the reasons, and submit to the competent director for approval. The competent director within 3 working days to complete the approval. The Market Supervision Section will send the approval letter or notice of rejection to the Government Service Center within 2 working days. Agree to build the approval letter copied to the county (city) Drug Administration.
2, the Government Service Center, Food and Drug Administration window within 1 working day to notify the applicant to receive consent to build the approval or rejection of the notice, and inform the relevant matters to the telephone notification record time shall prevail. Do not agree with the preparatory work, inform the applicant of the right to administrative reconsideration and administrative litigation in accordance with the law.
3. The applicant shall complete the preparatory construction and submit the application for acceptance within 90 days, or the application shall be canceled.
(C) acceptance
After the applicant completes the preparatory work, the Municipal Food and Drug Administration to organize acceptance. The applicant to the Municipal Food and Drug Administration designated drug supervision and management organization to submit an application for acceptance, and submit the following information:
1, the Municipal Council agreed to the preparatory work of the instrument.
2, drug license application review form (see attached).
3, the organization of the proposed enterprise, indicating the duties of each post, the relationship between each other and the person in charge of the post.
4, the qualification certificate of pharmacy professionals and technicians who have been accredited in accordance with the law, the appointment letter and the basic information of all personnel registration form; (name, gender, position, education, major, technical title, qualification certificates, etc.).
5, business premises and warehouse layout plan and proof of property rights or the right to use the house.
6, business management, quality management system document catalog and the main facilities, equipment catalog.
7, industrial and commercial administration pre-approved by the proposed business name documents.
8, the start of drug retail chain enterprises to submit their legal representatives by the provincial Food and Drug Administration organized by the state of the relevant drug management laws and regulations of the examination certificate.
Pharmaceutical supervision and management departments in the application for acceptance received within seven working days from the date of acceptance based on "Hebei Province, the implementation of standards for acceptance of drug retail enterprises" or "Hebei Province, the implementation of standards for acceptance of drug retail chain enterprises," the organization of acceptance. Acceptance inspection team on-site to fill out the "Drug License Application Review Form", and make a decision on whether to meet the standards, within three days to the Municipal Food and Drug Administration Market Supervision Section.
(D) licensing
Municipal Food and Drug Administration Market Supervision Section within five working days of acceptance of qualified enterprises reported to the competent director for approval and consent, the production of "Drug License" and handed over to the Government Service Center and Drug Administration window issuance; does not meet the conditions, reported to the competent director for approval and consent by the People's Government of Hengshui City Government Service Center Food and Drug Administration window. Drug Administration window to inform the applicant in writing and explain the reasons, while informing the applicant of the right to apply for reconsideration or administrative litigation according to law.
Eight, drug supervision and management of the issued "drug license" of the relevant information in Hengshui City Drug Administration website to be open, the public has the right to access. Public information found after the enterprise in the process of applying for a "drug license", there is the provision of false documents, data or other deceptive behavior, shall be dealt with according to law.
Nine, this approach and the opening of drug retail enterprises in Hengshui City Food and Drug Administration application form model text on the website, Hengshui City Food and Drug Administration website URL: www.hsda.gov.cn
Ten, this approach shall come into force on the date of publication of the original Hengshui City, Hengshui City, drug retailers, "Drug License" to apply for the abolition of the same time.
Hengshui Food and Drug Administration [2006] No. 63
On the issuance of "Hengshui City, pharmaceutical retail enterprises & lt; drug business
License & gt; application methods (revised)" notice
Counties and cities of the Food and Drug Administration, the drug and medical equipment production and management enterprises:
"Hengshui City, pharmaceutical retail enterprises & lt; drug business License> application methods (revised)" by the Hengshui City Food and Drug Administration Director of the Office of the meeting, is issued to you, please comply with the implementation. The original "Hengshui City, drug retailers & lt; drug license & gt; application methods" is repealed at the same time.
Attachment: Hengshui City, Hengshui City, drug retail enterprises, "Drug License" application methods (revised)
June 16, 2006
Attachment 2: "Hebei Province, the start of the drug retail enterprise acceptance of the implementation of the standards"
Attachment 3: Drug License application review form
Administrative License Application Form
Applications on the Issuance of "Drug License" (retail) change procedures for the notice
Author: unknown Source: Drug Administration Date: 2009-09-23 Read: 352
Counties (cities) and Drug Administration, the urban areas of the drug business enterprises:
In order to implement the "Administrative Licensing Law", according to the "Drug License Administration" and "Drug License Administration" and the "Drug License Administration" and the "Drug License Administration" and the "Drug License Administration". Hebei Province, drug license management approach to the implementation of the rules (for trial implementation)", I Bureau of the "drug license" to change the conditions and procedures for revision. It is hereby issued to you, please follow it seriously. The original "drug license" change conditions and procedures are abolished.