No.: 38-2-0 1
Law enforcer: Beijing Drug Administration or its branches.
according to
1. Drug Administration Law of People's Republic of China (PRC) (Article 14 of Decree No.45 of the President of the People's Republic of China)
2 "Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC)" (Article 12 of Order No.360th of the State Council of the People's Republic of China)
3. Measures for the Administration of Drug Business License (Articles 5 and 9 of State Order No.6 of the US Food and Drug Administration)
4. Articles 6 to 21 of the Interim Provisions of Beijing Municipality on the Establishment of Drug Retail Enterprises (Beijing Drug Administration [2004] No.20)
5. Implementation Standards for Acceptance of Drug Retailers in Beijing (Trial) (Beijing Drug Administration [2004] 167)
Charging standard: no charge.
Time limit: 30 working days from the date of acceptance (excluding delivery time)
Scope of acceptance: The site selection and preparation of pharmaceutical retail (chain) enterprises within the administrative area shall be accepted by the Municipal Drug Administration, and the site selection and preparation of pharmaceutical retail enterprises shall be accepted by the drug supervision and administration sub-bureau where the enterprises are located.
Licensing procedures: Anyone who applies for setting up a pharmaceutical retail (chain) enterprise shall apply to the Municipal Drug Administration; if applying for setting up a pharmaceutical retail enterprise, he shall apply to the drug regulatory sub-bureau where the proposed enterprise is located (if applying for setting up a retail (chain) enterprise, the chain management system shall be explained), and submit the following application materials:
1. Pharmaceutical Medical Device Business License Management System Enterprise Preparation Application (3.5-inch disk) (the applicant downloads the enterprise-side program on the website and correctly fills in and exports it);
2. The original, photocopy and resume of the academic certificate, professional qualification or title certificate of the legal representative and person-in-charge of the proposed enterprise;
3 types and scope of drugs to be handled;
4. The business premises, storage facilities and equipment to be established (with the geographical location map and floor plan of the registered address (indicating the area), and indicating the shortest distance from the drug retail enterprise); Geographical location map and floor plan of the proposed warehouse (indicating area, length, width and height);
5. To start a retail (chain) enterprise, it shall also submit a copy of the Drug Business License, Business License and assets related certificates of its franchise stores;
6. Apply for a self-assurance statement of the authenticity of the materials, and promise to bear legal responsibility for the falsehood of the materials; If you need to submit a floppy disk, promise to be responsible for the loss of data files caused by the virus;
7. If the applicant is not the legal representative or person in charge when the enterprise applies for the materials, the enterprise shall submit 2 copies of the power of attorney;
8. Make a catalogue in the order of application materials.
standard
1. The application materials should be complete and clear, signed and stamped with the official seal of the enterprise, and signed and stamped with the official seal of the individual application. Print or copy on A4 paper. Binding in book order;
2. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit; Individual applications should be signed or sealed;
3. Drug and medical device business license management system Enterprise Preparation Application Form is complete and correct, and meets the requirements of import system.
Person-in-charge of post: the accepting personnel of the accepting office.
Job responsibilities and authority:
1. Check the application materials according to the standards.
2. If the application materials are complete and meet the requirements of formal examination, it shall be accepted in a timely manner, and the Notice of Acceptance shall be filled in and handed over to the applicant as an acceptance certificate.
3. If the application materials submitted by the applicant are incomplete or do not meet the requirements of formal examination, the accepting personnel shall inform the applicant to supplement the relevant materials at one time on the spot, fill in the Notice of Supplementary Materials, and indicate the contents that have been supplemented and need to be supplemented. If the accepting personnel cannot inform the applicant of the contents that need to be corrected on the spot, they shall fill in the Certificate of Accepted Materials and submit it to the applicant, and issue a Notice of Corrected Materials within five working days to inform the applicant to correct the relevant materials.
4. If the application matters do not fall within the scope of authority of the department or the application matters do not need administrative license, it will not be accepted, and a notice of rejection will be filled out.
Time limit: 2 working days standard:
1. The driving distance from the existing drug retail enterprises should be more than 350 meters;
2. The use area of the store is more than 100 square meter (decoction pieces are increased by 30 square meters), and the use area of the store in ten districts (counties) in the suburbs of Beijing (excluding the administrative area of the town where the government is located) is more than 40 square meters;
3. To apply for the establishment of a pharmaceutical retail (chain) enterprise, it shall have asset holding, more than 20 direct-operated stores, and all of them hold the Pharmaceutical Business License;
4. Issue audit opinions and fill in the "Drug Retail Enterprise Approval Process Table (Compilation)".
Person in charge of post: auditor of Market Supervision Department (Branch).
Job responsibilities and authority:
1. Review the application materials and field measurement according to the Interim Provisions of Beijing Municipality on Setting up Pharmaceutical Retail Enterprises.
2. Actual measurement: the use area of the store and the travel distance of the new drug retail enterprise. Fill in the Actual Measurement Receipt of Beijing Pharmaceutical Retail Enterprises, affix the official seal of the administrative organ, and be signed by both the applicant and the reviewer.
3 in line with the standards, sign the audit opinion; For those who do not meet the standards, issue opinions and reasons for not agreeing to pass the audit, and forward them to the auditor together with the application materials.
Time limit: 22 working days standard:
1. Whether the program meets the specified requirements;
2 whether it is completed within the prescribed time limit;
3. Confirm the material audit opinions and on-site audit results.
Person in charge of post: Director of Market Supervision Department (Division)
Job responsibilities and authority:
1. Review the application materials handed over by auditors according to the standards.
2. Agree with the auditor's opinion, put forward the audit opinion and then transfer it to the auditor.
3. If you disagree with the auditor, you should exchange views with the auditor, put forward the review opinions and reasons, and send them to the auditor together with the auditor's opinions.
Time limit: 3 working days. Standard: Confirm the review opinions and issue the review opinions.
Person in charge of post: Director of Municipal Drug Administration (sub-bureau)
Job responsibilities and authority:
1. Examine and approve the application materials submitted by the reviewers according to the standards.
2. Agree with the auditor's opinion, and put forward the examination and approval opinions and then forward them to the market supervision department (branch) auditor.
3 do not agree with the examiner's opinion, should exchange views with the examiner, put forward the examination opinions and reasons, and turn to the market supervision department (branch) examiner.
Time limit: 3 working days standard:
1. Signature specification for personnel accepting, reviewing and approving license documents;
2. A complete set of application materials meets the specified requirements;
3. The license documents meet the requirements of official documents;
4. The "Notice of Agreeing to Start a Drug Retail Enterprise" made is complete, correct and effective, with correct format and text;
5. The data saved and archived are complete and standardized;
6. For those who agree to the preparation, make the Notice of Approval for the Preparation of Pharmaceutical Retail Enterprises;
7. For those who disagree with the preparation, make a "Decision on No Administrative License", explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law and the complaint channels.
Person in charge of post: auditor of Market Supervision Department (Branch).
Job responsibilities and authority:
1. Make a notice of approval to start a pharmaceutical retail enterprise or a decision of disapproval of administrative license.
2. Bind it into a book and file it. Standard: inform the applicant of the license result in time and accurately, receive the approval document with the acceptance notice, and sign the delivery receipt.
Person in charge of the post: the service personnel of the acceptance office.
Time limit: 10 working days