2. Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled.

3. Having a quality management organization or personnel suitable for the drugs handled.

4. There are rules and regulations to ensure the quality of drugs.

Extended data

Specific application materials: 1, originals, photocopies and resumes of the legal representative, person in charge of the enterprise and person in charge of quality of the bidding 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. Start-up capital is generally around 500 thousand.

Measures for the administration of drug business licenses? General rule

Article 1 In order to strengthen the supervision and administration of drug business license, these Measures are formulated in accordance with the relevant provisions of the Drug Administration Law of People's Republic of China (PRC) and the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law).

Article 2 These Measures shall apply to the issuance, renewal, alteration, supervision and administration of the Pharmaceutical Trading License.

Article 3 China Food and Drug Administration shall be responsible for the supervision and administration of the national drug business license.

The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the issuance, renewal, alteration and daily supervision and administration of the Drug Business License of drug wholesale enterprises within their respective jurisdictions, and guide and supervise the food and drug supervision and administration departments at lower levels to carry out the supervision and administration of the Drug Business License.

The food and drug supervision and administration departments at the county level directly established by the food and drug supervision and administration departments at the municipal level with districts or provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the issuance, renewal, alteration and daily supervision and administration of the Drug Business License of drug retail enterprises within their respective jurisdictions.

Chapter II Conditions for Applying for a Drug Business License

Article 4 According to Article 14 of the Drug Administration Law, the establishment of pharmaceutical wholesale enterprises shall meet the requirements of rational distribution of pharmaceutical wholesale enterprises in provinces, autonomous regions and municipalities directly under the Central Government, and meet the following establishment standards:

(1) It has rules and regulations to ensure the quality of the drugs it deals in;

(2) The enterprise and its legal representative or the person in charge of the enterprise and the person in charge of quality management have no circumstances as stipulated in Articles 75 and 82 of the Drug Administration Law;

(3) Having a certain number of licensed pharmacists suitable for the business scale. The person in charge of quality management has a college degree or above and must be a licensed pharmacist;

(4) Having normal-temperature warehouses, refrigerated warehouses and frozen warehouses that meet the quality requirements for drug storage and are suitable for its business variety and scale. The warehouse has special shelves suitable for drug storage and devices and equipment of modern logistics system for drug storage, transportation, sorting, shelving and delivery;

(5) Having an independent computer management information system, which can cover the whole process of drug procurement, storage, sales, management and quality control; Information that can comprehensively record the enterprise management and the implementation of the "Good Manufacturing Practices"; It meets the requirements of "Quality Management Standards for Drug Trading" on all aspects of drug trading, and has the conditions to accept the supervision of local food and drug supervision and management departments;

(6) It meets the requirements of drug business premises and auxiliary facilities, management of office buildings and warehouses, quality and safety guarantee of drugs in warehouses, storage and maintenance of drugs in warehouses.

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.

References:

Measures for the administration of drug business licenses