Article 5 The establishment of pharmaceutical retail enterprises shall conform to the number, region, traffic conditions and actual needs of local permanent residents, the principle of facilitating people to buy medicines, and the following requirements:
(1) It has rules and regulations to ensure the quality of the drugs it deals in;
(2) Having qualified pharmaceutical technicians according to law;
Pharmaceutical retail enterprises dealing in prescription drugs and Class A OTC drugs must be equipped with licensed pharmacists or other qualified pharmaceutical technicians according to law. The person in charge of quality should have more than one year (including one year) experience in quality management of drug business.
Pharmaceutical retail enterprises dealing in Class B over-the-counter drugs and those established in rural areas below the township level shall be equipped with business personnel in accordance with Article 15 of the Regulations for the Implementation of the Drug Administration Law, and licensed pharmacists if conditions permit. During the business hours of the enterprise, the above-mentioned personnel shall be on duty.
(3) The enterprise, its legal representative, the person in charge of the enterprise and the person in charge of quality do not have the circumstances stipulated in Articles 75 and 82 of the Drug Administration Law;
(4) Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled. The establishment of retail pharmacies in supermarkets and other commercial enterprises must have independent areas;
(five) have the ability to meet the needs of local consumers, and can guarantee the 24-hour supply. The quantity of national essential drugs that pharmaceutical retail enterprises should possess shall be determined by the food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government in light of local specific conditions.
If the state has other provisions on dealing in narcotic drugs, psychotropic drugs, toxic drugs for medical use and biological products for prevention, those provisions shall prevail.
Article 6 The implementation standards for the opening acceptance of pharmaceutical wholesale enterprises shall be formulated by the State Food and Drug Administration. The implementation standards for the establishment and acceptance of pharmaceutical retail enterprises shall be formulated by the food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government in accordance with the relevant contents of these Measures and the Quality Management Standards for Pharmaceutical Trading, and reported to China Food and Drug Administration for the record.
Article 7 Verification of the business scope of pharmaceutical trading enterprises.
Business scope of pharmaceutical trading enterprises:
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.
Engaged in drug retail, should first verify the business category, determine the applicant's qualification to operate prescription drugs or over-the-counter drugs and Class B over-the-counter drugs, and make it clear in the business scope, and then verify the specific business scope.
The examination and approval of toxic drugs, narcotic drugs, psychotropic drugs, radioactive drugs and preventive biological products for medical use shall be carried out in accordance with the relevant provisions of the state on the management of special drugs and preventive biological products.
Article 8 To establish a pharmaceutical wholesale enterprise, a Pharmaceutical Business License shall be handled in accordance with the following procedures:
(1) The applicant submits an application to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise to be applied is located, and submits the following materials:
1. Original, photocopy and resume of the academic credentials of the legal representative, person in charge of the enterprise and person in charge of quality of the proposed enterprise;
2. The original and photocopy of the practicing certificate of licensed pharmacist;
3. The scope of drugs to be handled;
4. Proposed business premises, equipment, storage facilities and surrounding sanitary environment.
(2) The food and drug supervision and administration department shall handle the application submitted by the applicant according to the following circumstances:
1. If the application matters do not fall within the authority of the department, it shall immediately make a decision of rejection, issue a notice of rejection, and inform the applicant to apply to the relevant food and drug supervision and administration department.
2. If the application materials can be corrected on the spot, the applicant shall be allowed to correct them on the spot.
3. If the application materials do not conform to the statutory form, the applicant shall issue 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.
(3) The food and drug supervision and administration department shall, within 30 working days from the date of accepting the application, review the application materials according to the provisions of Article 4 of these Measures, make a decision on whether to approve the preparation, and notify the applicant in writing. If the applicant disagrees with the preparation, it shall explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
(four) after the preparation is completed, the applicant shall submit an application for acceptance to the food and drug supervision and administration department that accepts the application, and submit the following materials:
1, drug business license application form;
2. Business license of the enterprise;
3, the organization of the proposed enterprise;
4, business premises, warehouse layout and housing property rights or use rights certificate;
5. Qualification certificates and letters of appointment of pharmaceutical professional and technical personnel who have obtained qualifications according to law;
6, the proposed enterprise quality management documents and storage facilities, equipment directory.
(5) The food and drug supervision and administration department that accepts the application shall, within 30 working days from the date of receiving the application, organize the acceptance according to the Implementation Standards for the Acceptance of the Establishment of Pharmaceutical Wholesale Enterprises, and make a decision on whether to issue the Pharmaceutical Business License.
If it meets the requirements, it shall be issued with a Drug Business License; If it does not meet the requirements, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article 9 To establish a pharmaceutical retail enterprise, a Pharmaceutical Business License shall be handled according to the following procedures:
(1) The applicant submits an application for preparation to the food and drug supervision and administration department at the municipal level located in the district where the proposed enterprise is located or the food and drug supervision and administration department at the county level directly established by the food and drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government, and submits the following materials:
1, the legal representative of the proposed enterprise, the person in charge of the enterprise and the person in charge of quality, the original and photocopy of the certificate of education, professional qualification or professional title, resume, professional and technical personnel qualification certificate and letter of appointment;
2. The scope of drugs to be handled;
3, the proposed business premises, storage facilities and equipment.
(2) The food and drug supervision and administration department shall handle the application submitted by the applicant according to the following circumstances:
1. If the application matters do not fall within the authority of the department, it shall immediately make a decision of rejection, issue a notice of rejection, and inform the applicant to apply to the relevant food and 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 do not conform to the statutory form, the applicant shall issue 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.
(3) The food and drug supervision and administration department shall, within 30 working days from the date of accepting the application, review the application materials according to the provisions of Article 5 of these Measures, make a decision on whether to approve the preparation, and notify the applicant in writing. If the applicant disagrees with the preparation, it shall explain the reasons and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
(four) after the preparation is completed, the applicant shall submit an application for acceptance to the food and drug supervision and administration department that accepts the application, and submit the following materials:
1, drug business license application form;
2. Business license of the enterprise;
3, business premises, warehouse layout and housing property rights or use rights certificate;
4. Qualification certificates and letters of appointment of pharmaceutical professional and technical personnel who have obtained qualifications according to law;
5, the proposed enterprise quality management documents and main facilities and equipment directory.
(5) The food and drug supervision and administration department that accepts the application shall, within 15 working days from the date of receiving the application, organize the acceptance according to the Implementation Standards for Accepting the Establishment of Pharmaceutical Retail Enterprises, and make a decision on whether to issue the Pharmaceutical 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.
Extended data:
According to the Measures for the Administration of Drug Business License
Article 26 Under any of the following circumstances, the original license-issuing organ shall cancel the Pharmaceutical Business License:
(1) The Drug Business License has not been renewed upon expiration;
(2) The pharmaceutical trading enterprise stops trading drugs or closes down;
(3) The Drug Business License has been revoked, withdrawn, revoked, withdrawn, cancelled or declared invalid according to law;
(four) due to force majeure, the licensing items of the Drug Business License cannot be implemented;
(five) other circumstances in which the administrative license shall be cancelled according to laws and regulations.
If the food and drug supervision and administration department cancels the Drug Business License, it shall notify the relevant administrative department for industry and commerce within 5 working days from the date of cancellation.
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