First camp information First camp information 1. Production enterprise: 1. Business license of enterprise as a legal person; 2. Pharmaceutical production license; 3. GMP(Good Manufacturing Practices) certificate; 4. Organization code of the People's Republic of China; 5. Tax registration certificate; 6. Annual tax returns; 7, enterprise quality questionnaire; 8. Quality Assurance Agreement. Second, product materials: 7, product production approval (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 area prices); 1, product patent certificate documents (provided, if not, the omission); 11. Trademark documents; 12, each batch of products inspection report (factory inspection, the first camp sampling); 13. Minimum product packaging box (sample); 14, a copy of the drug instructions; 15, the general taxpayer identification records (dispensable); 16. Power of Attorney of Legal Person (Power of Attorney of Legal Person); 17. Copy of ID card; 18, product production standards; 19. Purchase and sale contracts; 2. Approval of internal and external packaging and instructions of products; 21-qualification certificate of purchasing and selling staff. Third, the first business information of the pharmaceutical company: 1. Business license of enterprise legal person; 2. Tax registration certificate; Chicken 3. Organization code of the People's Republic of China; 4、GSP（Good Supplying Practice）； 5. Account opening permit; 6. Bank transfer account number (name of billing unit, taxpayer identification number, address, telephone number, bank and account number); 7, supplier quality assurance system questionnaire; 8. Quality Assurance Agreement;
what are the first operating data of pharmaceutical companies that need to sell drugs?
the first camp includes the first camp enterprises and the first camp varieties.
First-run enterprise: a pharmaceutical production or management enterprise that has the first supply-demand relationship with the enterprise when purchasing drugs. Therefore, the information of the first enterprise includes a certificate, a photo and a certificate (that is, the drug production or business license, business license, GMP or GSP certificate are all copies with red official seals), the power of attorney of the legal person (with the legal person's signature or seal) and the ID card of the salesperson. After the relationship between supply and demand is agreed, a quality assurance agreement should be signed.
first-run varieties: drugs purchased by this enterprise from a pharmaceutical manufacturer for the first time. Therefore, the information of the first variety includes: a certificate, a photo, a certificate, (that is, the pharmaceutical production license, business license, GMP certificate are all copies stamped with the red official seal) the power of attorney of the legal person (with the legal person's personal signature or seal) and the ID card of the salesperson. After the relationship between supply and demand is agreed, a quality assurance agreement should be signed. The production approval certificate of the drug (a copy of the approval number), a copy of the quality standard of the drug, the drug inspection report (a copy with a red seal), the small package, label and instructions (original) of the drug. A copy of the drug inspection report of this batch number of the drug accompanied by the goods at the time of final purchase (stamped with red seal).
The above information is related to GSP certification, which is legal.
it is not required by law, but in some areas, organization code certificate, copy of tax registration certificate, quality system questionnaire of supplier, accompanying sales voucher style of pharmaceutical production and wholesale enterprises (stamped with official seal and accompanying seal), copy of labor contract signed between pharmaceutical production and wholesale enterprises and sales personnel, sales personnel employment certificate and so on are required.
What does the first camp mean?
The first camp enterprise belongs to the category of medical devices, which refers to the pharmaceutical production or management enterprise that has the first supply-demand relationship with the enterprise when purchasing drugs. The selection of the first-run enterprise should be audited including qualification and quality assurance ability.
What
considerations are included in the first marketing materials of Chinese patent medicine products and tennis elbow? Bone hyperplasia. Rheumatic arthralgia syndrome. Strain. Sprain. Being caught in the wind, getting cold and getting wet and so on.
hospital first camp information!
33. what should be included in the provisions on the quality audit of the first-run enterprises and the first-run varieties? A: The provisions on the quality audit of the first battalion enterprise and the first battalion variety should include: (1) The first battalion enterprise and the first battalion variety should strictly implement the quality audit system. After signing the purchase contract for the first business variety, the enterprise should fill in the Approval Form for the first battalion enterprise and the first battalion variety and attach the specified information. The first-time enterprise shall also fill in the Qualified Supplier File Form. The goods can be purchased only after being approved by the quality director. (2) The quality inspection and acceptance personnel shall take the approval form after completing the formalities as the certificate for acceptance or inspection and warehousing. (3) When conducting quality audit on the first battalion enterprise and the first battalion variety, the supplier shall be asked for relevant information according to the provisions of GSP. (4) When accepting the first business varieties, the drug acceptance personnel should ask for the inspection report of the same variety, specification and batch number, and carry out acceptance as required. 5] To investigate and understand the quality assurance system and products of the first battalion enterprise. When necessary, the department in charge of quality will go to the supplier for on-the-spot investigation and verification to ensure the quality of drugs. [6] Make records of the first battalion enterprises and varieties, and establish files.
what materials must be available for the approval of the first battalion enterprise and the first battalion variety
① Obtain and review the completeness, authenticity and validity of the original pharmaceutical production (business) license, business license and quality management system certification certificate stamped with the original seal of the first battalion enterprise, as well as the original power of attorney of the legal representative of the enterprise signed or sealed by the legal representative of the supplier, the copy of the ID card of the pharmaceutical salesperson, the post certificate and the quality assurance agreement. (2) whether the audit is beyond the scope of production (operation) and mode of operation stipulated in the valid license. (3) The first-run enterprise dealing in specially managed drugs must also examine its legal qualification for dealing in specially managed drugs and obtain the approval documents of the drug supervision and administration department stamped with the original seal of the first-run enterprise.
What materials are required to be reviewed by the new gsp first-run enterprises and first-run varieties in 216
Copy of the first-run enterprise's business license (three certificates in one)
Overprint of the bank account opening certificate
Copy of the pharmaceutical production and business license
Copy of GMP or GSP certification certificate
Stamp impression and sample of the accompanying bill
Account opening name, Bank and account number
power of attorney of the legal person of the supplier's salesperson and a copy of the client's ID card (the above documents should be stamped with the company's official seal)
The registration approval document of the first-time drug
The official seal
What materials are needed for the first-time operation of the API?
1）。 Information of pharmaceutical production enterprises: including basic information (scale, personnel and quality), production license and GMP certification;
2）。 Information of pharmaceutical trading enterprises: including basic information (scale, credit, etc.), GSP certification and quality guarantee;
3）。 Basic information of the entrusted agent, copy of ID card and power of attorney.
the above is the information of the first camp drugs and the first camp enterprises.
What information do you need for the new gsp first camp varieties?
You know what to do with the first camp goods.
Details of the first camp enterprise documents and the qualifications of pharmaceutical companies.
First, the first camp enterprise should provide the following information (1) Pharmaceutical production enterprises. 1. Copies of the Business License and Pharmaceutical Production License stamped with the original seal of the production enterprise. Relevant certificates of enterprise quality certification such as GMP certification certificate stamped with the original seal of the production enterprise 3. Copy of trademark registration certificate stamped with the original seal of the production enterprise 4. Power of attorney of legal person stamped with the original seal of the production enterprise and the signature of the legal representative of the enterprise. And indicate the scope and validity period of the authorization. 5. Copy of the ID card of the salesperson. 6. Quality assurance agreement or quality commitment letter. 7. Certificate of honor obtained in enterprise quality. 2. Pharmaceutical trading enterprise. 1. Copy of the Business License and Pharmaceutical Trading License stamped with the original seal of the operating enterprise. 2. Relevant certificates of enterprise quality certification such as GSP certification stamped with the original seal of the operating enterprise. 3. Stamp the original seal of the operating enterprise. Power of attorney signed by the legal representative of the enterprise, And indicate the scope and validity period of the authorization. 4. Copy of ID card of the seller. 5. Quality assurance agreement or quality commitment letter. 6. Certificate of honor obtained in terms of industrial quality. 2. The first variety should provide the following information: (goods from the production enterprise) 1. Copy of the production approval number stamped with the original seal of the production enterprise. 2. Copy of the drug quality standard (national standard) stamped with the original seal of the production enterprise. Copy of qualified drug inspection report (list) stamped with the original seal of the manufacturer or its quality organization. 4. For the first variety of product name, relevant supporting documents stamped with the original seal of the manufacturer should be provided. If the product name is registered as a trademark, a copy of the corresponding trademark registration certificate should also be provided. 5. Copy of the price approval document stamped with the original seal of the manufacturer. 6. For drugs that are new drugs and protected varieties of traditional Chinese medicine, copies of the new drug certificate and protected varieties of traditional Chinese medicine certificate stamped with the original seal of the manufacturer should be provided. 7. Drugs that are stamped with the original seal of the manufacturer.