Name of the licensed project: renewal of the Pharmaceutical Business License of the pharmaceutical wholesale enterprise

Legal implementing body: Shaanxi Food and Drug Administration

basis:

1. Drug Administration Law of the People's Republic of China (Article 14 of Order No. 45 of the President of the People's Republic of China)

2. Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (Article 17 of Order No. 360 of the State Council of the People's Republic of China)

3. Measures for the Administration of Pharmaceutical Business License (Article 19 of Order No. 6 of the State Food and Drug Administration)

Charging standard: no charge.

Total time limit: 35 working days from the date of acceptance (excluding the rectification period).

Scope of acceptance: If the validity of the Pharmaceutical Trading License of the pharmaceutical wholesale enterprises in the administrative region of the province expires and the Pharmaceutical Trading License needs to be renewed, the enterprises shall submit an application to the Provincial Food and Drug Administration within 6 months before the expiry of the Pharmaceutical Trading License.

Licensing procedures:

1、 Acceptance

The applicant shall submit the following application materials:

（1） One application form for certificate renewal of drug trading enterprises (the contents of the application form shall be printed except for signature, and shall not be filled in manually). The format can be downloaded from the government website of Shaanxi Food and Drug Administration at www.sxfda.gov.cn

（2） The duplicate of the Pharmaceutical Trading License, the Certificate of Good Manufacturing Practice for Pharmaceutical Trading, the duplicate of the Business License and the original of the original and duplicate of the Pharmaceutical Trading License. If the branch certified at the same time with the subordinate unit has not issued the certification certificate separately, it can provide a copy of the certification certificate of the subordinate unit.

（3） Copy of ID card and resume of the legal representative and responsible person of the enterprise.

（4） ID card, academic certificate, employment document, qualification certificate of licensed pharmacist, copy of registration certificate and resume of the person in charge of quality and the person in charge of quality management organization.

（5） List of enterprise personnel such as quality administrator, inspector, maintainer, salesperson, storekeeper and computer administrator, including name, education background, professional title, ID number, licensed pharmacist, position and training.

（6） The property right certificate of the registered address and warehouse address of the enterprise, and the property right certificate and lease agreement of the owner shall be provided if the house is leased.

（7） Enterprise self-inspection report.

（8） Administrative punishment in the past five years.

（9） Statement of authenticity assurance of application materials. The format can be downloaded from the government website of Shaanxi Food and Drug Administration at www.sxfda.gov.cn

（10） Where the applicant is not the legal representative or the person in charge when applying for enterprise application materials, the enterprise shall submit a Power of Attorney; The format can be downloaded from the government website of Shaanxi Food and Drug Administration at www.sxfda.gov.cn

（11） The preliminary examination opinion on the renewal of the certificate signed by the city (district) Food and Drug Administration where the enterprise is located.

（12） Bind into volumes according to the order of application materials.

（13） If it is necessary to change the approved items of the Drug Trade License at the same time, the change materials and the renewal materials can be applied at the same time, and the change and renewal review work shall be carried out at the same time. The time limit for the change approval shall be subject to the time limit for the renewal approval.

Standard:

1. The application materials shall be complete and clear, printed or copied on A4 paper, and bound into volumes according to the order of application materials.

2. If a copy of the application materials is required, the official seal of the unit shall be affixed to the copy.

Person in charge of the post: acceptance personnel of the acceptance office of the Provincial Food and Drug Administration.

Post responsibilities and authorities:

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 time, fill in the Acceptance Notice, and submit the Acceptance Notice to the applicant as the acceptance certificate.

3. If the application materials are incomplete or do not conform to the legal form, the applicant shall be notified of all the contents to be supplemented and corrected on the spot or within 5 working days. If the applicant fails to notify within the time limit, the application shall be accepted from the date of receiving the application materials.

4. If the application is not within the authority of the department or does not require administrative permission, the applicant shall fill in the Notice of Rejection, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or file administrative litigation and the complaint channel according to law.

2、 Handover of application materials

Standard: The acceptance personnel shall sort out the application materials, and the handover personnel of the acceptance office shall hand them over to the reviewers of the Market Supervision Office within 2 working days after the acceptance.

Person in charge of the post: Reviewers of the Acceptance Office and the Market Supervision Office.

Post responsibilities and authorities: accurate materials and clear procedures.

3、 Review

Standards: review in accordance with the Measures for the Administration of Pharmaceutical Trading Licenses, the Work Plan for the Renewal of Pharmaceutical Trading Licenses issued by the provincial bureau and the Notice on the Renewal of Pharmaceutical Trading Licenses.

Person in charge of the post: Market Supervision Department's review, review personnel and certificate renewal inspector.

Post responsibilities and authorities:

1. Review the application materials according to the review requirements.

2. Select GSP inspectors to form an inspection team to conduct on-site acceptance of the enterprise.

3. The reviewers sign the review opinions and transfer the application materials to the reviewers.

4. After reviewing the review opinions, the reviewer shall sign the opinions and transfer them to the reviewer.

Time limit: 23 working days.

4、 Audit

Standard:

1. Whether the procedure meets the specified requirements;

2. Whether it is completed within the specified time limit;

3. Confirm the material review opinions and site acceptance results;

4. Sign review comments.

Person in charge: Director of Market Supervision Division.

Post responsibilities and authorities:

1. Review the application materials handed over by the reviewers according to the certificate renewal requirements.

2. For those that meet the requirements, sign the approval opinions and transfer them to the approver. For those that do not meet the requirements, after exchanging views with the review and review personnel, sign the opinions that do not agree to pass the review, and the materials will be handed over to the acceptance office. The original Drug Trading License shall be cancelled and transferred to the approver if the rectification is required to be carried out within 3 months.

Time limit: 2 working days

5、 Approval

Standard:

1. Confirmation of audit opinions.

2. Issue approval opinions.

Person in charge: the director in charge of the Provincial Food and Drug Administration.

Post responsibilities and authorities:

1. Examine and approve the application materials handed over by the auditors according to the standards.

2. If you agree with the opinions of the reviewers, sign the approval opinions; For those who do not agree with the opinions of the reviewers, after exchanging opinions with the reviewers, sign the opinions that do not agree with the approval.

Time limit: 2 working days

6、 Material transfer

Person in charge of the position: the reviewer of the Market Supervision Office, the certification or staff of the acceptance office.

Post responsibilities and authorities:

1. If it is agreed to change the certificate, the materials shall be transferred to the certificate holder of the acceptance office.

2. If you do not agree to change the certificate, the materials will be kept on file, and the notice of not changing the certificate will be sent to the staff of the acceptance office.

Time limit: 1 working day (transfer time limit)

7、 Voucher preparation and delivery

Person in charge of the post: acceptance, handling and certification and staff.

Standard:

1. After the Pharmaceutical Trading License is prepared, the materials shall be returned to the reviewers of the Market Department.

2. Inform the applicant of the permit results in a timely and accurate manner.

3. The relevant information about the renewal of the Drug Trading License shall be announced on the website of the provincial bureau.

Post responsibilities and authorities: the personnel at the delivery window are responsible for informing the applicant of the permit results.

Time limit: 5 working days