What materials are generally required to apply for the first sale of drugs?

Production license, tax registration certificate, legal representative, drug registration certificate, GMP certificate, drug approval, quality standards, provincial inspection report, factory inspection report, **approval, trademark registration certificate, organization**, inner packaging instructions, the above need to be stamped with a red seal

The first business includes the first enterprise and the first variety.

First enterprise: a pharmaceutical production or business enterprise that has a supply and demand relationship with the enterprise for the first time when purchasing drugs. Therefore, the information of the first company includes:

One certificate, one license, one certificate, (i.e., drug production or business license, business license, GMP or GSP certificate, all of which are copies with red official seals), power of attorney of legal person (with the signature or seal of the legal person in person), and ID card of sales personnel. After agreeing to the relationship between supply and demand, it is necessary to sign: quality assurance agreement.

The first variety: the first purchase of drugs from a pharmaceutical manufacturer. Therefore, the information of the first breed includes:

One certificate, one license, one certificate, (i.e., drug production license, business license, GMP certificate, all copies of the red official seal), the power of attorney of the legal person (with the signature or seal of the legal person in person), and the ID card of the sales personnel. After agreeing to the relationship between supply and demand, it is necessary to sign: quality assurance agreement.

The production approval certificate of the drug (a copy of the approval number), a copy of the quality standard of the drug, a copy of the drug inspection report (a copy with a red seal), a small package, label, and instruction manual of the drug (original). A copy of the drug inspection report (with red seal) of the batch number of the drug accompanied by the goods at the time of the last purchase.

The above is the relevant information required by GSP certification and is statutory.

It is not a legally required information, but some areas also stipulate that it is necessary to have a copy of the organization's ** certificate, a copy of the tax registration certificate, a questionnaire on the quality system of the supplier, a copy of the sales voucher of the drug production and wholesale enterprise (stamped with the official seal of the enterprise and the seal of the goods), a copy of the labor contract signed between the drug production and wholesale enterprise and the sales staff, and the sales staff employment certificate.

Extended Information: The procedures required for the sale of drugs are:

1. To open a pharmacy, in addition to business licenses, tax registration certificates, health licenses, health certificates, etc., you also need "Drug Business License", "Medical Device Business License", etc.

2. Pharmaceutical retail stores have a lot of hardware and software requirements, mainly hardware, housing equipment, etc., and the software mainly has a professional pharmacist certificate.

3. Go to the local drug regulatory department to apply for a drug business license.

4. Then go to the industrial and commercial taxation departments to go through the relevant procedures.

1）。Information of drug manufacturers: including basic information (scale, personnel, quality), production license, GMP certification;

2）。Information of pharmaceutical business enterprises: including basic information (scale, credit, etc.), GSP certification, and quality assurance certificate;

3）。The basic information of the client, a copy of the ID card, and a power of attorney.

The above is the information of the first drug and the first company.

Is it the manufacturer that submits the information to the operating enterprise?

I pour. I don't have a penny.

It's not clear what you're asking. Are you a pharmaceutical manufacturer or a pharmaceutical business? It is better to indicate the position first.

Information on the first camp. First, the production enterprise:

1. Business license of enterprise legal person;

2. Drug production license;

3. GMP (Good Manufacturing Practices).

4. The People's Republic of China organized the promotion of the weaving organization**;

5. Tax registration certificate;

6. Annual tax statement;

7. Questionnaire on the quality of the enterprise;

8. Quality assurance agreement.

Second, the product material:

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

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

9. Product price documents (medical insurance products need to be in the area);

10. Product patent certificate documents (provided, omitted if not);

11. Trademark documents;

12. Inspection report of each batch of products (factory inspection, used in the first sampling);

13. The smallest packaging box of the product (sample);

14. A copy of the drug instructions;

15. Identification records of general taxpayers (dispensable);

16. Power of attorney of legal person (power of attorney of legal person);

17. A copy of ID card;

18. Product production standards;

19. Purchase and sale contract;

20. Approval of product internal and external packaging and instructions;

21. Qualification certificate of purchaser and salesman.

3. Information on the first business of pharmaceutical companies:

1. Business license of enterprise legal person;

2. Drug business license.

3. Tax registration certificate;

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

5、gsp（goodsupplyingpractice）；

6. Account opening permit;

7. Bank transfer account number (name of billing unit, taxpayer identification number, address, **, opening bank and account number);

8. Questionnaire of quality assurance system of supplier;

9. Quality assurance agreement.

The first certification required by pharmaceutical wholesale enterprises includes the following aspects:1Enterprise Qualification Certification:

Pharmaceutical wholesale enterprises need to carry out qualification certifications such as business licenses, organization certificates, and tax registration certificates. 2.Drug Business License Certification:

Pharmaceutical wholesale enterprises need to carry out the certification of drug business license in order to legally deal in drugs. 3.Warehouse Certification:

Pharmaceutical wholesale enterprises need to certify all the management related to drug quality, including drug quality management system, drug standardization management, etc. 5.Employee Qualifications:

Pharmaceutical wholesalers need to certify all employees, such as medical knowledge training, practical experience certification, etc. 6.**Merchant Audit Certification:

Pharmaceutical wholesale enterprises need to conduct quality certification for the drugs they sell, including quality certification documents such as drug quality inspection reports and drug batch numbers.

Information on the first camp.

First, the production enterprise:

1. Business license of enterprise legal person;

2. Drug production license;

3. GMP (Good Manufacturing Practices).

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

5. Tax registration certificate;

6. Annual tax statement;

7. Questionnaire on the quality of the enterprise;

8. Quality assurance agreement.

Second, the product material:

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

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

9. Product price documents (medical insurance products need to be in the area);

10. Product patent certificate documents (provided, omitted if not);

11. Trademark documents;

12. Inspection report of each batch of products (factory inspection, used in the first sampling);

13. The smallest packaging box of the product (sample);

14. A copy of the drug instructions;

15. Identification records of general taxpayers (dispensable);

16. Power of attorney of legal person (power of attorney of legal person);

17. A copy of ID card;

18. Product production standards;

19. Purchase and sale contract;

20. Approval of product internal and external packaging and instructions;

21. Qualification certificate of purchaser and salesman.

3. Information on the first business of pharmaceutical companies:

1. Business license of enterprise legal person;

2. Drug business license.

3. Tax registration certificate;

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

5、gsp（good supplying practice）；

6. Account opening permit;

7. Bank transfer account number (name of billing unit, taxpayer identification number, address, **, opening bank and account number);

8. Questionnaire of quality assurance system of supplier;

9. Quality assurance agreement.

Information on the first business of pharmaceutical companies:

1. Business license of enterprise legal person;

2. Drug business license.

3. Tax registration certificate;

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

5、gsp（good supplying practice）；

6. Account opening permit;

7. Bank transfer account number (name of billing unit, taxpayer identification number, address, **, opening bank and account number);

8. Questionnaire of quality assurance system of supplier;

9. Quality assurance agreement.