First business information

1. Production enterprise:

1. Corporate business license;

2. Drug production license;

3. GMP (Good Manufacturing Practices)

4. Organization code of the People’s Republic of China;

5 , Tax registration certificate;

6. Annual tax report;

7. Enterprise quality survey form;

8. Quality assurance agreement.

2. Product materials:

7. Product production approval document (or drug registration certificate);

8. Product inspection report (the latest provincial inspection, Generally required within 2 years);

9. Product price documents (medical insurance products need to include price);

10. Product patent certificate documents (provided, if not, omit this item);

11. Trademark documents;

12. Inspection report for each batch of products (used for factory inspection and first-camp sampling inspection);

13. Minimum product packaging Box (sample);

14. Copy of drug instructions;

15. General taxpayer identification record (optional);

16. Legal person Authorization letter (power of attorney for legal persons);

17. Copy of ID card;

18. Product production standards;

19. Purchase and sale contract;

20. Approval documents for product internal and external packaging and instructions;

21. Purchaser and salesperson qualification certificate.

3. Pharmaceutical company’s first business information:

1. Corporate business license;

2. Pharmaceutical business license

3 , tax registration certificate;

4. Organization code of the People's Republic of China;

5. GSP (Good Supplying Practice);

6. Account opening license;

7. Bank transfer account number (name of the invoicing unit, taxpayer identification number, address, phone number, account opening bank and account number);

8. Quality assurance of the supplier System questionnaire;

9. Quality assurance agreement.

Extended information:

According to the "Drug Administration Law of the People's Republic of China":

Article 14 To open a pharmaceutical wholesale enterprise, the enterprise must The drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall approve and issue a "Pharmaceutical Business License"; to open a drug retail enterprise, it must be approved by the local drug regulatory department at or above the county level where the enterprise is located and issued a "Pharmaceutical Business License". Without a "Pharmaceutical Business License", no pharmaceuticals are allowed.

The "Drug Business License" should indicate the validity period and business scope, and the license will be re-examined and issued upon expiration.

When the drug regulatory department approves the establishment of a pharmaceutical business enterprise, in addition to the conditions stipulated in Article 15 of this Law, it must also follow the principles of rational layout and convenience for the public to purchase medicines.

Article 15 The following conditions must be met to open a pharmaceutical business enterprise:

(1) Have pharmaceutical technicians who have been qualified in accordance with the law;

(2) Have business premises, equipment, storage facilities, and hygienic environments that are suitable for the drugs it operates;

(3) Have quality management institutions or personnel that are suitable for the drugs it operates;

(4) Have rules and regulations to ensure the quality of the drugs it operates. ?

Article 16 Pharmaceutical trading enterprises must operate pharmaceuticals in accordance with the "Pharmaceutical Distribution Quality Management Practices" formulated by the drug regulatory department of the State Council in accordance with this law. The drug regulatory department shall certify whether pharmaceutical operating enterprises meet the requirements of the "Good Manufacturing Practices for Pharmaceutical Distribution" in accordance with regulations; and issue certification certificates to those that pass the certification.

The specific implementation methods and implementation steps of the "Good Manufacturing Practices for Pharmaceutical Products" shall be stipulated by the drug regulatory department of the State Council.

Article 17 When purchasing drugs, pharmaceutical trading enterprises must establish and implement a purchasing inspection and acceptance system, and verify the drug's certificate of conformity and other identifications; any drug that does not meet the prescribed requirements shall not be purchased.

Article 18 When purchasing and selling drugs, pharmaceutical operating enterprises must have true and complete purchase and sales records. The purchase and sale records must indicate the generic name, dosage form, specification, batch number, validity period, manufacturer, purchase (sales) unit, purchase (sale) quantity, purchase and sale price, purchase (sale) date, and the State Council's drug regulatory authority Other content as specified.

Article 19: Drug sales enterprises must be accurate when selling drugs, and correctly explain the usage, dosage and precautions; prescriptions must be checked, and the drugs listed in the prescriptions must not be changed or substituted without authorization. Prescriptions with incompatible or excessive dosages shall be refused to be dispensed; if necessary, they may be dispensed only after being corrected or re-signed by the prescribing physician.

Pharmaceutical business enterprises selling traditional Chinese medicinal materials must indicate the place of origin.

Article 20 Pharmaceutical trading enterprises must formulate and implement a pharmaceutical storage system and take necessary measures such as refrigeration, anti-freeze, moisture-proof, insect-proof, and rodent-proof to ensure the quality of medicines. Inspection systems must be implemented for medicines entering and leaving the warehouse.

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