A, application and acceptance
Enterprises log on to the Beijing Municipal Drug Administration enterprise service platform for online reporting, and in accordance with the provisions of the scope of acceptance, the applicant is required to submit the following application materials:
1. "Beijing Drug Retailer License Replacement Application Form";
2. Original and copy of the original and copy of the license;
3. Copy of Business License;
4. Copy of Certificate of Quality Management Standard for Pharmaceutical Business;
5. Geographic location map of the registered address of the enterprise, the floor plan of the place of business (indicating the area), the geographic location map of the warehouse, the floor plan, and proof of property rights or the right to use the house;
6. Legal representative, the person in charge of the enterprise, the person in charge of quality of the biography, academic certification, identity card, original, copy (return the original after verification); quality of the person in charge of the license or title of the original, copy (return the original after verification);
7, according to the qualification of professional and technical personnel of the qualifications of pharmacy and the letter of appointment;
8, the quality of the enterprise management Document catalog, storage facilities and equipment;
9. If the headquarters of a pharmaceutical retail chain enterprise applies for renewal of license, it is also required to submit a summary table of the chain stores under it;
10. Self-assurance statement of the authenticity of the application materials and commitment to bear legal responsibility for the materials in case of falsity.
11. When applying for enterprise declaration materials, the applicant is not the legal representative or the person in charge himself, the enterprise should submit two copies of the "power of attorney";
12. Pharmaceutical retail chain enterprises applying for approval of the scope of operation of the second category of psychotropic substances, toxic Chinese medicine and drinking tablets, should also provide the following materials (bound separately):
(1) "Retail Chain Enterprises operating special Managed Drugs Application Form" online (in duplicate);
(2) a copy of the "Administrative License Decision" (approval to operate Class II psychotropic substances) and "Approval" (approval to operate toxic Chinese medicine tablets);
(3) the framework chart of the enterprise's special managed drugs organization and a list of the persons in charge of each department;
(4) resumes and biographies of the person in charge of the enterprise and stores, the person in charge of quality, the person in charge of the enterprise and the person specialized in Special management of drugs business personnel resume and academic qualifications, titles, licensed pharmacists and other certificates of qualification copies;
(5) enterprise storage of special management of drugs in the warehouse location plan, library layout and security monitoring facilities and equipment layout;
(6) store storage of special management of drugs in the facilities and equipment details and security monitoring measures description;
(7) enterprise and store special management of drugs Drug safety management system.
Remarks: If the content of the Drug Operation License changes when the enterprise renews its license, it should fill in the "Application Form for Renewal of License for Drug Retail Enterprises in Beijing" according to the changed content, and submit a description of the change of the enterprise according to the content of the change as well as the relevant materials required by the relevant change procedures. One copy of the same material can be submitted.
Standards:
1. The application materials should be complete and clear, with signatures where required, and the official seal of the enterprise affixed to each copy. Printed or copied on A4 paper, bound in accordance with the order of the application materials;
2. Where the application materials need to submit a copy, the applicant shall date the copy, stamped with the official seal of the enterprise;
3. Verification of the "Drug License" original, copy, "Drug Certification of Quality Management Standards" original, the copy confirmed to be retained, the original returned;
4. p>4. Self-assurance statement of the authenticity of the application materials should be signed by the legal representative and stamped with the official seal of the enterprise.
5. Replacement of the license at the same time change the "Drug License", should be checked at the same time according to the standard of the content of the change.
Here is another link, you see for yourself /publish/main/4/44/822/2011/20110406104922420619629/20110406104922420619629_.html