Guangdong Zhongshan US Food and Drug Administration

Procedures and Requirements for Zhongshan City to Apply for Drug Business License (Retail)

1. The applicant shall apply to the business acceptance office of our bureau for preparation and submit the following materials:

(a), the legal representative of the enterprise to be established, the person in charge of the enterprise, the person in charge of quality, the original and photocopy of the academic qualifications, professional qualifications or professional title certificates, as well as resumes, professional and technical personnel qualification certificates and letters of appointment;

(2) An application report (including: the scope of drugs to be handled, business premises, storage facilities, equipment, contact information, applicants, and the application time appropriate to the intended business scope). )

Two, I accept the business office of the applicant's application, should be handled according to the following circumstances:

(a) the application matters do not belong to the scope of authority of the department, it shall immediately make a decision not to accept, send a notice of rejection, and inform the applicant to apply to the relevant (food) drug supervision and administration department;

(2) 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;

(3) If the application materials are not standardized or do not conform to the statutory form, the applicant shall be issued with a Notice of Supplementary Materials on the spot or within 5 days to inform all the contents that need to be supplemented at one time. Fails to inform, since the date of receipt of the application materials is accepted;

(4) If the application matters fall within the scope of functions and powers of the department, the materials are complete and conform to the statutory form, or the applicant submits all the corrected materials as required, it shall issue a notice of acceptance to the applicant. The date indicated in the bid-winning notice is the bid-winning date.

Three, our bureau shall, within 30 working days from the date of accepting the application, review the application materials and issue a notice of consent to the preparation. If the applicant disagrees with the preparation, it shall notify the applicant in writing, explain the reasons, and inform the applicant that he has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

Four, the applicant completed the preparation, put forward an application for acceptance to our bureau, and submit the following materials:

(a), drug business license application form (in triplicate);

(2) The original and photocopy of the approval certificate of the proposed enterprise issued by the administrative department for industry and commerce;

(three), the business premises, warehouse layout and the original and photocopy of the certificate of property rights or the right to use the house;

(4) Qualification certificates and letters of appointment of pharmaceutical professional and technical personnel who have obtained qualifications according to law;

(five), the proposed enterprise quality management documents and the main facilities and equipment directory;

The drug quality management system formulated by an enterprise shall include the following contents:

1, quality responsibility of business and management positions;

2, drug procurement management system;

3, drug acceptance management regulations;

4, drug display management regulations;

5, drug maintenance management regulations;

6, the provisions of the first camp enterprises and the first camp variety audit;

7, drug sales and prescription management regulations;

8. Provisions on the administration of disassembled drugs;

9. Provisions on handling and reporting of quality accidents;

10, quality inquiry and quality complaint management regulations;

1 1, quality information management regulations;

12, Provisions on Reporting Adverse Drug Reactions;

13, Regulations on Health and Personnel Health Status Management;

14, service quality management regulations;

15, dealing in Chinese herbal pieces, in line with the regulations on the purchase, sale and storage management of Chinese herbal pieces.

(6) Notice of consent to preparation.

Five, my bureau from the date of acceptance of the application 15 working days, according to the "Guangdong Province to start a drug retail enterprise acceptance implementation standards" to organize the acceptance, make a decision on whether to issue a "drug business license". If it does not meet the requirements, it shall notify the applicant in writing and explain the reasons. At the same time, the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.

Six, in the decision to issue the "drug business license" within ten working days from the date of issuing the "drug business license".

Seven, matters needing attention:

(1) All application materials should be printed or copied on A4 paper, and the applicant should sign the application materials.

(two), must submit a copy of the document, the applicant should write "the copy is the same as the original" and sign for confirmation.

(3) Business scope of retail enterprises:

The business categories of 1 are: dealing in prescription drugs or over-the-counter drugs and Class B over-the-counter drugs.

2 The specific business scope includes: narcotic drugs, psychotropic drugs and toxic drugs for medical use; Biological products; Chinese herbal medicines, Chinese herbal pieces, Chinese patent medicines, chemical raw materials and their preparations, antibiotic raw materials and their preparations, biochemical drugs.

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