According to Article 7 of the Measures for the Administration of Drug Operation License The approved business scope of the drug business enterprise.
Drug business license business scope:
1, narcotic drugs, psychotropic substances, toxic drugs for medical use;
2, biological products;
3, Chinese herbal medicines, traditional Chinese medicine, Chinese medicinal herbs, proprietary Chinese medicines, chemical raw materials and their preparations, antibiotic raw materials and their preparations, biochemical drugs.
4, engaged in the retail sale of drugs, should be approved first business category, to determine the applicant's qualifications for the operation of prescription drugs or non-prescription drugs, Class B non-prescription drugs, and to be clear in the scope of business, and then approved the specific scope of business.
5, medical toxic drugs, narcotic drugs, psychotropic drugs, radiopharmaceuticals and prophylactic biological products approved in accordance with the national management of special drugs and prophylactic biological products management of the relevant provisions of the implementation.
Expanded Information:
Article VIII: To set up a pharmaceutical wholesale enterprise shall apply for a "Drugs Business License":
(1) The applicant submits an application for preparation to the food and drug administration department of the province, autonomous region, or municipality directly under the central government where the proposed enterprise is located, and submits the following materials:
1. The original and copy of the academic certificates of the legal representative, the person in charge of the enterprise, and the person in charge of quality, as well as the personal resume of the person in charge of the proposed enterprise;
2. The original of the license certificate of the licensed pharmacist practice, Copies;
3, the scope of the proposed drug business;
4, the proposed business premises, equipment, storage facilities and the surrounding health environment.
Article IX to open a retail drug business in accordance with the following procedures for the "Drug License":
(a) the applicant to the proposed business location of the municipal food and drug supervision and management departments or provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration directly set up county-level food and drug supervision and management departments to submit an application for preparatory work and submit the following materials:
1, the proposed legal representative, the person in charge of the enterprise, the quality of the person in charge of the academic qualifications, practicing qualifications or titles of the original, a copy of the certificate and resume and professional and technical personnel qualification certificates, letters of appointment;
2, the scope of the proposed business drugs;
3, the proposed business premises, warehousing facilities, equipment situation.
(2) food and drug supervision and management department of the application made by the applicant, shall be dealt with according to the following:
Applications do not fall within the purview of the department, should immediately make the decision of inadmissibility, issued a "notice of inadmissibility" and inform the applicant to the relevant food and drug supervision and management department to apply.
2, the application materials can be corrected on the spot there are errors, the applicant should be allowed to correct on the spot.
3, the application materials are not complete or do not meet the statutory form, should be issued on the spot or within 5 days of the applicant "Notice of Corrective Material", a one-time notification of the need to make corrections to all the contents. Late notification, from the date of receipt of the application materials shall be accepted.
4, the application belongs to the department's terms of reference, the materials are complete, in line with the statutory form, or the applicant is required to submit all the corrective materials, issued to the applicant "Notice of Acceptance". The date indicated in the Notice of Acceptance is the date of acceptance.
(C) Food and Drug Administration from the date of acceptance of the application within 30 working days, based on the provisions of Article V of these measures to review the declaration, make a decision on whether to agree to the preparatory work, and notify the applicant in writing. Do not agree with the preparatory work, shall state the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
(d) the applicant to complete the preparatory work, to accept the application of food and drug supervision and management department to submit an application for acceptance, and submit the following materials:
Pharmaceutical License Application Form;
2. business license;
3. business premises, warehouse layout and proof of property rights or the right to use the building;
4. Qualification certificate of pharmacy professionals and technicians and appointment letter;
5. The proposed enterprise quality management documents and the main facilities and equipment catalog.
(E) acceptance of the application of food and drug supervision and management department within 15 working days from the date of receipt of the application for acceptance, based on the implementation of standards for acceptance of the start-up of pharmaceutical retail enterprises to organize acceptance, to make a decision on whether to issue the "drug license". Does not meet the conditions, shall notify the applicant in writing and explain the reasons, at the same time, inform the applicant enjoys the right to apply for administrative reconsideration or administrative litigation according to law.
Baidu Encyclopedia: Administrative Measures for Drug Operation License