Two. The legal and regulatory basis for setting the license (1): Drug Administration Law of People's Republic of China (PRC), Regulations for the Implementation of Drug Administration Law of People's Republic of China (PRC), Standards for the Quality Management of Pharmaceutical Trading, Detailed Rules for the Implementation of Standards for the Quality Management of Pharmaceutical Trading, and Measures for the Administration of Pharmaceutical Trading Licenses?

Third, licensing conditions.

(1) The legal representative of the enterprise or the person in charge of the enterprise or the person in charge of quality management does not meet the requirements of Articles 76 and 83 of the Drug Administration Law;

(2) Pharmaceutical technicians with legal recognition; Among them, the establishment of retail pharmacies in urban areas must be equipped with two pharmaceutical technicians with the title of pharmacist or above, of which 1 is the quality supervisor; The establishment of township retail pharmacies must be equipped with 1 pharmaceutical technicians.

(3) Having business premises, equipment, storage facilities and a hygienic environment suitable for handling drugs; Among them, the business area of urban retail pharmacies shall not be less than 40 square meters. The business area of retail pharmacies in the town shall not be less than 30 square meters, and the business area of retail pharmacies in the village shall not be less than 20 square meters.

(4) Having rules and regulations to ensure the quality of the drugs handled.

(5) Having rules and regulations to ensure the quality of the drugs handled.

(6) meeting the requirements of GSP. ?

Four. Licensing procedure

(a) to apply for the preparation, the applicant shall submit the application materials in the acceptance window, and after acceptance, go to the US Food and Drug Administration for review and issue opinions, and then receive the examination and approval results in the window.

(two) the application is accepted, and the applicant has completed the preparation and submitted the application materials to the acceptance window. After acceptance, we will go to the municipal US Food and Drug Administration to organize inspection, and after being audited by the municipal US Food and Drug Administration, we will go to the window to receive the examination and approval results. ?

Verb (abbreviation of verb) application materials

(1) Application preparation? The applicant applies to the US Food and Drug Administration for preparation and submits the following materials: (in duplicate) 1. Business application report. Explain the basic situation of the applicant, the reasons for starting, the nature of the enterprise, the business address, scope, staffing, equipment and facilities, etc.

2. Notice of pre-registration and approval of new enterprise name issued by the administrative department for industry and commerce.

3. Legal representative (person in charge of the enterprise): A. ID card, temporary residence permit or household registration book B. Notice of appointment (state-owned, collective and joint-stock enterprises).

4. Pharmaceutical technicians: A. Identity card, temporary residence permit or household registration book; B. professional qualifications and professional title certificates; C. labor contracts and letters of appointment; D. on-the-job certification materials.

5. Property right certificate and lease agreement or property right certificate for managing the warehouse site.

6, quality management system directory.

1. Acceptance and certification application.

2 pharmaceutical trading enterprise license (retail) application form. ?

3, enterprise self-inspection report. ?

4, the legal representative (person in charge of the enterprise) ID card, residence booklet or temporary residence permit, drug-related laws and regulations training certificate, resume. ?

5. Copies of professional title certificates, unemployment certificates and ID cards of registered pharmaceutical professional technicians, letters of appointment and labor contracts of pharmaceutical professional technicians. ?

6. Proof materials for the use of business premises and warehouses. ?

7, all kinds of management rules and regulations (especially drug quality management system).

8. Schematic diagram of classified display scheme of drugs in business premises.

9. Catalogue of facilities and equipment suitable for handling drugs.

10, other information that needs to be provided.

Requirements for intransitive verbs: The application materials should be true and complete, printed or copied on A4 paper, marked with contents and page numbers, and bound into a book.

7. Download the application form.

Extended data:

To establish a pharmaceutical retail enterprise, the following conditions shall be met:

1. The employees are familiar with the laws and regulations on pharmaceutical affairs management, and the legal representative, person in charge and person in charge of quality of the enterprise have no circumstances as stipulated in Articles 76 and 83 of the Drug Administration Law; ?

2, pharmaceutical retail enterprises have a good health environment, equipped with facilities and equipment to adapt to business norms. ?

3, drug retail enterprises to develop rules and regulations to ensure the quality of drugs, with the ability to meet the needs of local consumers, and can ensure that drugs are sold 24 hours a day. ?

4. Minimum requirements for business premises: set up drug retail (chain store) enterprises in the main streets of the county, with a business area of not less than 100 square meter; The business area opened in towns and villages is not less than 40 square meters, and the business area of village drug retail enterprises is not less than 20 square meters; There is no need to set up a warehouse on the premise of realizing electronic information technology to order drugs, having reliable drug supply channels and being replenished in time after drugs are sold. ?

5. Minimum requirements for the person in charge of enterprise quality: county-level single pharmacies should have the qualification of pharmacists, township chain stores and township and village-level single pharmacies should have the technical title of pharmacists or above, and village-level chain pharmacies can be held by high school graduates who have obtained the qualification certificate of pharmacy practitioners in village-level pharmacies after training. ?

6. All employees in the pharmacy have obtained the qualification certificate of on-the-job training. ?

Materials to be provided:?

1. The following materials shall be submitted when applying for preparation:

1, ID card, academic certificate, copy of professional title certificate, and resume of the person in charge of the proposed enterprise; ?

2 copies and resumes of ID cards and professional titles of the person in charge of enterprise quality and professional and technical personnel to be established;

3. Description of the scope of drugs to be handled (equivalent to the application report); ?

4, the geographical location map of the proposed pharmacy; ?

5. Schematic diagram of the proposed business premises and warehouse (indicating the usable area); ?

6. Facilities and equipment equipped in business premises and warehouses; ?

7. A copy of the qualification certificate of all personnel in the proposed pharmacy, and the pharmacy practitioners in the village-level pharmacy applicants shall provide a copy of the qualification certificate of pharmacy practitioners. ?

8, the administrative license (administrative confirmation) application materials authenticity guarantee statement.

State Pharmaceutical Products Supervision and Administration-Measures for the Administration of Pharmaceutical Business Licenses