Requirements for applying for a drug business license:
1. Drug business license application form.
2. Approval document for the proposed enterprise issued by the industrial and commercial administration department.
3. Business premises, warehouse floor plan and certificate of property rights or use rights.
4. Qualification certificates and letters of appointment for pharmaceutical professional technicians who have been qualified in accordance with the law.
5. Quality management documents of the proposed enterprise and catalog of main facilities and equipment.
Standards for application materials
1. The application materials should be complete and clear, signed and stamped with the official seal of the company, and the signature and seal of the individual application. Print or copy on A4 paper. Bind into a volume in the order of the catalog;
2. If the application materials need to be submitted as copies, the applicant (unit) must mark the words "This copy is consistent with the original" or a written explanation on the copy. Indicate the date and stamp the official seal of the unit; individual applications must be signed or sealed;
3. The "Enterprise Establishment Application" on the enterprise side of the drug and medical device business license management system is completed and correct, and complies with the introduction system conditions.
To open a pharmaceutical wholesale enterprise, apply for a "Pharmaceutical Business License" according to the following procedures:
(1) The applicant shall apply to the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the proposed enterprise is located. Submit an application for establishment preparation and submit the following materials:
1. Originals, copies and resumes of the academic qualifications of the legal representative, person in charge of the company, and quality director of the proposed enterprise;
2. Original and copy of practicing pharmacist’s practicing certificate;
3. The scope of the proposed pharmaceutical business;
4. The proposed business premises, equipment, storage facilities and surrounding sanitary environment.
(2) The food and drug regulatory department shall handle the application submitted by the sponsor according to the following circumstances:
1. If the application matters do not fall within the scope of authority of this department, a decision to reject the application shall be made immediately, a "Notice of Acceptance" shall be issued, and the applicant shall be informed to apply to the relevant food and drug regulatory authorities.
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 incomplete or do not comply with the legal form, a "Notice of Supplementary and Corrected Materials" shall be issued to the applicant on the spot or within 5 days, informing all contents that need to be supplemented and corrected at once. If no notification is made within the time limit, the application will be accepted from the date of receipt of the application materials.
4. If the application matters fall within the scope of authority of this department, and the materials are complete and comply with the legal form, or the applicant submits all supplementary and corrected materials as required, the applicant will be issued an "Acceptance Notice". The date stated in the "Notice of Acceptance" is the date of acceptance.
(3) Within 30 working days from the date of acceptance of the application, the food and drug administration department will review the application materials in accordance with the provisions of Article 4 of these Measures, make a decision on whether to agree to the establishment, and notify the applicant in writing Sponsor. If the applicant disagrees with the establishment, the reasons shall be explained and the applicant shall be informed that it has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.
(4) After completing the preparation, the sponsor shall submit an acceptance application to the food and drug regulatory department that accepts the application and submit the following materials:
1. Drug business license application form;
2. Enterprise business license;
3. The organizational structure of the proposed enterprise;
4. Floor plan of business premises, warehouse and certificate of property or use rights;
5. Qualification certificates and letters of appointment for pharmaceutical professional technicians who have been qualified in accordance with the law;
6. Proposed enterprise quality management documents and storage facilities and equipment catalogue.
(5) The food and drug regulatory department that accepts the application shall, within 30 working days from the date of receipt of the acceptance application, organize the acceptance based on the acceptance implementation standards for drug wholesale enterprises and decide whether to issue the "Pharmaceutical Business Administration" License decision. If the conditions are met, a "Drug Business License" will be issued; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained, and the applicant shall be informed of its right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.
In summary, these are the materials that should be prepared for applying for a drug business license and the standards for application materials. Each operator must prepare relevant materials in strict accordance with the standards to be able to successfully apply for a drug business license.
Although the process is cumbersome, it is a necessary process and cannot be changed. People's livelihood issues are no small matter.
Legal basis:
"Measures for the Administration of Pharmaceutical Business Licenses"
Article 8 To open a pharmaceutical wholesale enterprise, apply for a "Pharmaceutical Business License" according to the following procedures:
(1) The applicant submits an application for establishment to the food and drug regulatory department of the province, autonomous region, or municipality where the proposed enterprise is located, and submits the following materials:
1. Originals, copies and resumes of the academic qualifications of the legal representative, person in charge of the company, and quality director of the proposed enterprise;
2. Original and copy of practicing pharmacist’s practicing certificate;
3. The scope of the proposed pharmaceutical business;
4. The proposed business premises, equipment, storage facilities and surrounding sanitary environment. (2) The food and drug regulatory department shall handle the application submitted by the sponsor according to the following circumstances:
1. If the application matters do not fall within the scope of authority of this department, a decision to reject the application shall be made immediately, a "Notice of Acceptance" shall be issued, and the applicant shall be informed to apply to the relevant food and drug regulatory authorities.
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 incomplete or do not comply with the legal form, a "Notice of Supplementary and Corrected Materials" shall be issued to the applicant on the spot or within 5 days, informing all contents that need to be supplemented and corrected at once. If no notification is made within the time limit, the application will be accepted from the date of receipt of the application materials.
4. If the application matters fall within the scope of authority of this department, and the materials are complete and comply with the legal form, or the applicant submits all supplementary and corrected materials as required, the applicant will be issued an "Acceptance Notice". The date stated in the "Notice of Acceptance" is the date of acceptance.
(3) Within 30 working days from the date of acceptance of the application, the food and drug administration department will review the application materials in accordance with the provisions of Article 4 of these Measures, make a decision on whether to agree to the establishment, and notify the applicant in writing Sponsor. If the applicant disagrees with the establishment, the reasons shall be explained and the applicant shall be informed that it has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law. (4) After completing the preparation, the sponsor shall submit an acceptance application to the food and drug regulatory department that accepts the application and submit the following materials:
1. Drug business license application form;
2. Enterprise business license;
3. The organizational structure of the proposed enterprise;
4. Floor plan of business premises, warehouse and certificate of property or use rights;
5. Qualification certificates and letters of appointment for pharmaceutical professional technicians who have been qualified in accordance with the law;
6. Proposed enterprise quality management documents and storage facilities and equipment catalogue.
(5) The food and drug regulatory department that accepts the application shall, within 30 working days from the date of receipt of the acceptance application, organize the acceptance based on the acceptance implementation standards for drug wholesale enterprises and decide whether to issue the "Pharmaceutical Business Administration" License decision. If the conditions are met, a "Drug Business License" will be issued; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained, and the applicant shall be informed of its right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.
Article 9 To open a pharmaceutical retail enterprise, apply for a "Pharmaceutical Business License" according to the following procedures:
(1) The applicant shall apply to the food and drug supervision and administration department of the districted municipality where the proposed enterprise is located. The administrative department or the county-level food and drug supervision and administration department directly established by the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government shall submit an application for preparation and submit the following materials:
1. The original and photocopy of the academic qualifications, professional qualifications or professional title certificates of the proposed enterprise’s legal representative, the person in charge of the enterprise, and the person in charge of quality, as well as resumes, professional and technical personnel qualification certificates, and letters of appointment;
2. The scope of the proposed pharmaceutical business;
3. Proposed business premises, storage facilities, and equipment.
(2) The food and drug regulatory department shall handle the application submitted by the sponsor according to the following circumstances:
1. If the application matter does not fall within the scope of authority of this department, it shall immediately make a decision not to accept the application, issue a "Notice of Non-Acceptance", and inform the applicant to apply to the relevant food and drug regulatory authorities.
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 incomplete or do not comply with the legal form, a "Notice of Supplementary and Corrected Materials" shall be issued to the applicant on the spot or within 5 days, informing all contents that need to be supplemented and corrected at once. If no notification is made within the time limit, the application will be accepted from the date of receipt of the application materials.
4. If the application matters fall within the scope of authority of this department, and the materials are complete and comply with the legal form, or the applicant submits all supplementary and corrected materials as required, the applicant will be issued an "Acceptance Notice". The date stated in the "Notice of Acceptance" is the date of acceptance.
(3) Within 30 working days from the date of acceptance of the application, the food and drug administration department will review the application materials in accordance with the provisions of Article 5 of these Measures, make a decision on whether to agree to the establishment, and notify in writing Sponsor. If the applicant disagrees with the establishment, the reasons shall be explained and the applicant shall be informed that it has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.
(4) After completing the preparation, the sponsor shall submit an acceptance application to the food and drug regulatory department that accepts the application and submit the following materials:
1. Drug business license application form;
2. Enterprise business license;
3. Floor plan of business premises, warehouse and certificate of property or use rights;
4. Qualification certificates and letters of appointment for pharmaceutical professional technicians who have been qualified in accordance with the law;
5. Proposed enterprise quality management documents and catalog of main facilities and equipment.
(5) The food and drug regulatory department that accepts the application shall, within 15 working days from the date of receipt of the acceptance application, organize acceptance based on the implementation standards for acceptance of drug retail enterprises and decide whether to issue the "Pharmaceutical Business Administration" License decision. If the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained. At the same time, the applicant shall be informed of its right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.