In daily life and work, there are more and more occasions where agreements need to be used, and signing agreements is a means to improve economic benefits. So, have you mastered the format of the agreement? The following are five drug quality assurance agreements that I have compiled for reference only. Let's have a look.
Pharmaceutical Quality Assurance Agreement 1 Party A: XXX
Party b: XXX
In order to ensure the quality of the drugs handled and ensure the safety of human medication, according to the relevant provisions of the Drug Administration Law and the Measures for the Supervision and Administration of Drug Circulation (Provisional), Party A and Party B signed the following quality assurance agreement through friendly negotiation:
1. Both Party A and Party B are legal enterprises, and provide each other with copies of Pharmaceutical Business License or Pharmaceutical Production License and Business License, power of attorney of legal person of the agent and copy of ID card for filing.
Second, the quality clause.
1. The quality of drugs provided by Party B shall meet the national drug quality standards and relevant quality requirements; The whole package of drugs should be accompanied by a product certificate; Drug packaging and labeling should comply with the "Regulations on the Administration of Drug Packaging, Labeling and Instructions" and the requirements of cargo transportation;
2. For imported drugs (imported Chinese herbal medicines), a copy of the registration certificate of imported drugs (or the registration certificate of pharmaceutical products) (the approval number of imported medicinal materials) and the inspection report of imported drugs (or the customs clearance form of imported drugs stamped with the words "sampled") shall be provided; For drugs issued in batches of biological products according to the Administrative Measures for Batch Issuance of Biological Products promulgated by the US Food and Drug Administration, a copy of the Batch Issuance Certificate of Biological Products stamped with the official seal of Party B or the official seal of the quality control agency shall also be provided;
3. The quality of Chinese herbal medicines and Chinese herbal pieces provided by Party B shall meet the legal quality standards (including provincial Chinese herbal medicine processing standards). The shipment of Chinese herbal medicines shall be packed, and the name, place of origin, date and transshipment unit shall be indicated. Must be marked, and attached with a quality certificate; The label of Chinese herbal pieces shall indicate the name, specification, origin, production enterprise, batch number, production date and other contents. , and with a quality mark; The approval number of Chinese herbal pieces managed by the approval number must be provided, and the approval number of Chinese herbal pieces must be indicated on the package.
4. The packaging materials of Chinese herbal pieces provided by Party B shall be packaging materials and containers that are suitable for the nature of drugs and meet the quality requirements of drugs.
5. If the drugs provided by Party B have quality problems, Party B shall bear all losses caused thereby.
3. The purchase and sale certificate given by Party B to Party A indicates the full name of Party B's company, which is true and clear, and shall not be altered at will. The name, specification, manufacturer, product batch number and quantity of the drugs on the purchase and sale certificate shall be consistent with the purchase and stamped with the official seal, otherwise Party A has the right to refuse.
4. The time between the drugs provided by Party B and the production date shall not exceed six months (the validity period of imported drugs shall not be less than one year, and if the validity period is only one year, it shall not exceed four months). The batch number of drugs with the same product specification shall not exceed 1 within five pieces, and shall not exceed two pieces within twenty pieces.
Five, the first camp varieties should be accompanied by the factory inspection report stamped with the original seal of the manufacturer's quality inspection agency.
6. If Party A discovers abnormal conditions such as damage, pollution and non-artificial damage of drugs in transit during the sales process, such as no batch number, no expiration date, deterioration of products within the expiration date, etc., Party B shall unconditionally bear all the losses caused thereby, including: return expenses, compensation expenses for customer complaints, transportation expenses, formalities expenses, etc.
7. If Party A is complained by customers, punished by administrative departments or exposed by the media due to the discovery of counterfeit and inferior drugs in the course of business operation, Party B shall bear all direct economic losses and compensate 20xx-20000 yuan for each variety (depending on the circumstances and the severity of the losses).
Eight. If Party A suffers from customer complaints or media exposure due to the adverse reaction of Party B's drug supply, which causes economic and reputation losses to Party A, Party B shall bear all the compensation responsibilities.
IX. Party B shall be able to provide China Commodity Bar Code System Member Certificate when providing Party A with commodity bar code drugs. All responsibilities and expenses caused by fraudulent use or misappropriation of bar codes shall be borne by Party B. ..
10. Party B shall bear all damage and pollution found during transportation during the acceptance period of Party A. ..
XI。 Party A shall store drugs according to GSP requirements and drug storage requirements.
12. This agreement is made in duplicate, with each party holding one copy. Matters not covered herein shall be settled by both parties through consultation.
Thirteen. This agreement shall come into force as of the date of signature by both parties, and the validity period shall be from xx, 20XX to xx, 20xx.
Party A (signature and seal)
Representative: XXX
Party B (signature and seal)
Representative: XXX
20XX x month XX day
Article 2 of Drug Quality Assurance Agreement Party A: (Supplier)
Party B: (Buyer):
(I) Party A's obligations
In order to strengthen drug quality management, Party A and Party B sign this drug quality assurance agreement on the principle of equality and cooperation in accordance with the requirements of the Drug Administration Law of People's Republic of China (PRC), the Product Quality Law, the Quality Management Standard for Drug Trading and the Measures for the Administration of Imported Drugs.
1. When Party A has a business relationship with Party B for the first time, it shall provide copies of the business license, drug trading license and quality system certification certificate stamped with the original seal of the enterprise within the validity period, the original power of attorney of the salesperson, the copy of the ID card and the copy of the employment certificate of the purchasing and selling personnel. If Party A's license expires or changes, it shall notify Party B in writing on the same day and provide Party B with a new license within 7 days, otherwise, Party A shall bear all losses caused thereby.
2. The drugs supplied by Party A must comply with the national drug laws and regulations.
3. Party A shall provide the inspection report of each batch of drugs sold.
4. When the drugs supplied by Party A to Party B belong to the varieties operated by Party B for the first time, Party A shall provide the production approval documents, new drug certificates, quality standards, packaging instructions for filing, drug inspection reports, copies of GSP certification certificates, etc.
5. The whole package of drugs supplied by Party A shall have a certificate of conformity, and an inspection report affixed with the original seal of the quality management department of the enterprise shall be attached.
6. Copies of the Import Drug Inspection Report and the Import Drug Registration Certificate shall be provided for imported drugs, and the original seal of Party A's quality management organization shall be affixed.
(II) Obligations of Party B
1. If Party B is a commercial enterprise, it shall provide the pharmaceutical business license, copy of business license, organization code certificate, tax registration certificate, original legal person power of attorney and copy of ID card of the purchaser, etc. Stamp with official seal; If the procurement enterprise is a medical institution, it shall provide the Practice License of Medical Institution stamped with the original seal of the unit.
2. After the goods are qualified, Party B shall pay within the specified time limit.
(3) Description of the agreement
1. If the quality of the goods provided by Party A does not meet the requirements, Party B has the right to refuse and withhold them, and Party A shall actively deal with the aftermath. Within the validity period of drugs: Party A is responsible for the quality of drugs it sells. If the quality is unqualified, Party A shall bear all economic losses; If the drugs supplied by Party A are notified as unqualified products by the national drug supervision departments at all levels, Party A has the responsibility to recover the products (including the parts that Party B has sold to customers) and bear all the economic losses caused to Party B therefrom. ..
2. Party B shall establish a drug storage warehouse meeting GSP requirements, and be equipped with qualified quality management personnel. However, if quality problems are caused by improper storage by Party B, Party B shall bear the losses. After receiving the drugs supplied by Party A, Party B shall immediately refuse to accept them and notify Party A if it finds any shortage, pollution or damage. ..
3. If there is any dispute between Party A and Party B on the quality of drugs, the results of the inspection reports of provincial and municipal drug inspection offices shall prevail. However, if the inspection report of the provincial or municipal drug inspection institute is considered to be defective, either party may entrust a drug inspection institution at the next higher level to issue a new inspection report, and the expenses shall be borne by the wrong party.
4. This agreement has the same legal effect as the contract. If either party breaches the contract, it shall be settled through consultation. If negotiation fails, the local people's court shall make a judgment.
5. This Agreement is made in duplicate, with each party holding one copy. This agreement is applicable to telephone procurement and contract procurement.
This agreement is valid for 20 years.
Party A (seal): Party B (seal):
Person in charge: person in charge:
Date: Date:
Part III of Drug Quality Assurance Agreement Party A (Buyer):
Limited company Party B (supplier):
In order to ensure the quality of the drugs handled and ensure the safety of people's medication, Party A and Party B, through friendly negotiation, signed the following quality assurance agreement in accordance with the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Drug Handling and relevant laws and regulations:
1. Both Party A and Party B are legal enterprises, and provide each other with valid copies of drug business license or drug production license, business license, GSP certificate or GMP certificate, as well as the original power of attorney of the buyer and the seller and a copy of the resident ID card (the above documents must be stamped with the official seal of the enterprise) for filing.
Second, the quality terms:
1. The drugs provided by Party B must have drug approval number or import drug registration certificate number; The quality of drugs should meet the national drug quality standards and related quality requirements; The whole package of drugs should be accompanied by a product certificate; Drug packaging and labeling shall comply with the relevant provisions of the Regulations on the Administration of Drug Packaging, Labelling and Instructions and the requirements of cargo transportation.
2. For imported drugs (imported Chinese herbal medicines), a copy of the registration certificate of imported drugs (or the registration certificate of pharmaceutical products) (the approval number of imported medicinal materials) and the inspection report of imported drugs (or the customs clearance form of imported drugs stamped with the words "sampled") shall be provided; For drugs that are subject to batch issuance management of biological products according to the Measures for the Administration of Batch Issuance of Biological Products promulgated by the US Food and Drug Administration, a copy of the Batch Issuance Certificate of Biological Products stamped with the official seal of Party B or the official seal of the quality management agency shall also be provided.
3. When transporting drugs with temperature requirements, Party B shall take corresponding heat preservation or cold storage measures to ensure that the temperature in transit meets the requirements.
4. The quality of Chinese herbal medicines and Chinese herbal pieces provided by Party B shall meet the legal quality standards (including provincial Chinese herbal medicine processing standards). The shipment of Chinese herbal medicines should be packed, and the name, place of origin, date, transshipment unit, etc. must be indicated on the package. , and with a quality mark; The label of Chinese herbal pieces shall indicate the name, specification, origin, production enterprise, batch number, production date and other contents. , and with a quality mark; The approval number of Chinese herbal pieces managed by the approval number must be provided, and the approval number of Chinese herbal pieces must be indicated on the package.
5. The packaging materials of Chinese herbal pieces provided by Party B shall be packaging materials and containers that are suitable for the nature of the drugs and meet the quality requirements of the drugs. 6. If the drugs provided by Party B have quality problems within the validity period, Party B shall bear all losses caused thereby.
3. The purchase and sale certificate given by Party B to Party A indicates the full name of Party B's company, which is true and clear, and shall not be altered at will. The name, specification, manufacturer, batch number, production date and other contents on the purchase and sale certificate shall be consistent with the purchase and stamped with the official seal or sales seal, otherwise Party A has the right to refuse.
Four. The drugs provided by Party B shall not exceed six months from the date of production (if the validity period is only one year, it shall not exceed three months); The batch number of drugs of the same product specification should not exceed 1 within 5 tablets and 2 within 20 tablets.
Five, the variety of goods should be accompanied by the factory inspection report stamped with the official seal of Party B or the original seal of the quality management organization.
6. After receiving the quality inquiry letter (telegram) required by Party A, Party B shall give a reply within 7 working days (subject to the date of receiving the letter). If the deadline is exceeded, the consequences arising therefrom shall be borne by Party B..
7. If the drugs are damaged or contaminated during transportation, or Party A finds abnormal conditions such as non-human damage, no batch number, no expiration date and deterioration of the products within the expiration date, Party B shall unconditionally bear all losses caused thereby, including: return expenses, compensation expenses for customer complaints, transportation expenses and formalities expenses.
Eight. If Party A suffers from customer complaints or media exposure due to the adverse events of drugs provided by Party B, Party B shall bear all the compensation responsibilities.
IX. Party B shall be able to provide China Commodity Bar Code System Member Certificate when providing Party A with commodity bar code drugs. All responsibilities and expenses caused by fraudulent use or misappropriation of bar codes shall be borne by Party B. ..
X. Party A shall store drugs according to GSP requirements and drug storage requirements. Party A shall be responsible for the losses caused by improper storage.
XI。 Both parties have the responsibility to collect and provide information on product quality, service quality and adverse drug reactions for each other, so that both parties can continuously improve product quality and service quality.
12. Matters not covered in the terms of this agreement shall be settled by both parties through consultation.
Thirteen. This agreement shall come into force as of the date of signature by both parties, and shall be valid until XX, XX, XX.
This agreement is made in duplicate, one for each party.
Party A (signature): Hunan Pharmaceutical Sales Co., Ltd.
20XX x month XX day
Party B (signature and seal): XXXXXX
20XX x month XX day
Article 4 of Drug Quality Assurance Agreement Party A: (Supplier)
Party B: (Buyer):
(I) Party A's obligations
In order to strengthen drug quality management, Party A and Party B sign this drug quality assurance agreement on the principle of equality and cooperation in accordance with the requirements of the Drug Administration Law of People's Republic of China (PRC), the Product Quality Law, the Quality Management Standard for Drug Trading and the Measures for the Administration of Imported Drugs.
1。 When Party A has business relations with Party B for the first time, it shall provide copies of the business license, drug trading license and quality system certification certificate stamped with the original seal of the enterprise within the validity period, the original power of attorney of the salesperson, the copy of the ID card and the copies of the employment certificates of the buyer and the seller. If Party A's license expires or changes, it shall notify Party B in writing on the same day and provide Party B with a new license within 7 days, otherwise, Party A shall bear all losses caused thereby.
2。 The drugs supplied by Party A must comply with the provisions of national drug laws and regulations.
3。 Party A shall provide the inspection report of each batch of drugs sold.
4。 When the drugs supplied by Party A to Party B belong to the varieties operated by Party B for the first time, Party A shall provide the production approval documents, new drug certificates, quality standards, packaging instructions for filing, drug inspection reports, copies of GSP certification certificates, etc.
5。 The whole package of drugs supplied by Party A shall have a certificate of conformity, and an inspection report affixed with the original seal of the quality management department of the enterprise shall be attached.
6。 Copies of the Import Drug Inspection Report and the Import Drug Registration Certificate shall be provided for imported drugs, and the original seal of Party A's quality management agency shall be affixed.
(II) Obligations of Party B
1。 If Party B wants to run an enterprise, it needs to provide the pharmaceutical business license, a copy of business license, organization code certificate, tax registration certificate, the original legal person power of attorney of the buyer's identity certificate, a copy of ID card, etc. Stamp with official seal; If the procurement enterprise is a medical institution, it shall provide the Practice License of Medical Institution stamped with the original seal of the unit.
2。 After the goods are qualified, Party B shall pay within the specified time limit.
(3) Description of the agreement
1。 If the quality of the goods provided by Party A does not meet the requirements, Party B has the right to refuse and withhold them, and Party A should actively deal with the aftermath. Within the validity period of drugs: Party A is responsible for the quality of drugs it sells. If the quality is unqualified, Party A shall bear all economic losses; If the drugs supplied by Party A are notified as unqualified products by the national drug supervision departments at all levels, Party A has the responsibility to recover the products (including the parts that Party B has sold to customers) and bear all the economic losses caused to Party B therefrom. ..
2。 Party B shall establish a drug storage warehouse meeting GSP requirements, and be equipped with qualified quality management personnel. However, if quality problems are caused by improper storage by Party B, Party B shall bear the losses. After receiving the drugs supplied by Party A, Party B shall immediately refuse to accept them and notify Party A if it finds any shortage, pollution or damage. ..
3。 . If there is any dispute between Party A and Party B on the quality of drugs, the results of inspection reports of provincial and municipal drug inspection offices shall prevail. However, if the inspection report of the provincial or municipal drug inspection institute is found to be defective, either party may entrust a drug inspection institution at the next higher level to issue a new inspection report, and the expenses shall be borne by the wrong party.
4。 This agreement has the same legal effect as the contract. If either party breaches the contract, it shall be settled through consultation. If negotiation fails, it shall be decided by the local people's court.
5。 This agreement is made in duplicate, one for each party. This agreement is applicable to telephone procurement and contract procurement.
6。 This agreement is valid for 20 years.
Party A (seal): Party B (seal):
Person in charge: person in charge:
Date: Date:
Article 5 of Drug Quality Assurance Agreement Party A:
Party B:
In order to ensure the product quality, define the quality responsibility and ensure that consumers use safe and effective products, Party A and Party B have signed the following agreement through consultation:
1. Party A shall provide the qualified qualification certification materials of the enterprise, such as license, business license, power of attorney of legal person, copy of the client's ID card, etc.
2. Party A shall provide the product registration approval documents, inspection reports, quality standards, registered trademarks, samples and other relevant materials for the products it deals in.
Three. The above qualification certificate provided by Party A shall be legal and valid, and all economic losses and legal responsibilities caused by forged or counterfeit certificates shall be borne by Party A. ..
4. The product packaging, labels, brochures and promotional materials provided by Party A must comply with the provisions of relevant products and laws and regulations, and all economic losses and legal liabilities caused by the product packaging and brochures not meeting the requirements of relevant laws and regulations shall be borne by Party A. ..
5. The products provided by Party A must pass the inspection according to the legal standards, and the product inspection report and certificate of conformity with the corresponding batch number are attached with the goods.
6. In case of any quality dispute during the circulation and use of Party A's products, Party A shall promptly send representatives to the site and bear all relevant expenses. When the relevant administrative organs investigate and deal with the quality problems of products provided by Party A, Party B shall notify Party A as soon as possible within the time limit given by the relevant administrative organs to initiate administrative reconsideration or administrative litigation, and Party A shall actively assist Party B in dealing with the quality problems and administrative reconsideration or administrative litigation caused by quality problems. If necessary, Party A shall apply to participate in the litigation as a third party to safeguard the legitimate rights and interests of both parties.
7. If Party A fails to properly handle the quality problems within the time limit required by the relevant administrative authorities or Party B, Party B has the right to choose corresponding handling methods (including administrative reconsideration, administrative litigation or direct compensation for the losses of the third party) according to the agreement of both parties or legal provisions. After Party B assumes the corresponding responsibilities, it shall recover from Party A in time. If Party A refuses to bear the losses caused to Party B due to the quality problems of its products, Party B has the right to bring a lawsuit to the court where Party B is located, and Party A shall pay the liquidated damages for product quality responsibility three times the actual losses of Party B (the actual losses of Party B include fines, compensation, travel expenses, attorney fees, legal fees, etc.). ).
8. Party A shall provide legal bills, and the validity period of the products provided shall be over one year, except for products with special validity period.
Nine. Party B shall provide qualified enterprise qualification information to Party A and guarantee its legality and effectiveness.
X. All losses caused by quality problems of the products provided by Party A under the specified storage conditions shall be borne by Party A. If the products deteriorate due to improper storage, Party B shall bear the responsibilities.
XI。 This agreement is made in duplicate and shall come into force after being sealed by both parties. Matters not covered shall be discussed separately. The validity period is from year month day to year month day.
Party A: Party B:
Year, month, sun, moon, sun.