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Drug Quality Assurance Agreement


Party A: _________

Party B: _________

In order to implement the "Good Manufacturing Practices", clarify the quality responsibility, and ensure the quality and safety of the drugs, the following quality assurance agreements are reached through negotiation between Party A and Party B.

Party A’s obligations:

1. Party A shall provide Party B with a copy of the drug production license and business license, and affix the official seal of Party A.

2. The drugs sold by Party A must meet the following requirements:

1. Compliance with statutory quality standards;

2. There should be a statutory approval number and production batch number;

3. The packaging label complies with relevant regulations and storage and transportation requirements;

4, generally should be issued within three months of the drug, and attached a certificate, the first business varieties must be accompanied by a factory inspection report;

5, the batch number of each shipment of the same variety, can not exceed 1 batch number within 10 pieces, can not exceed 2 batch numbers within 100 pieces;

6, Chinese herbal medicines should be marked with the origin.

3. If Party A provides imported drugs, it must submit the copy of the inspection report form and the registration certificate of the imported drug to the Party B at the copy of the inspection certificate of the imported drug control office. The copy should be clearly identifiable.

4. Party A shall bear full responsibility for the drugs provided. If the quality of the drugs is unqualified, it shall bear all costs such as inspection fees, confiscation of fines and handling.

Party B’s obligations:

1. Party B shall also provide Party A with a copy of the license and business license of the pharmaceutical business enterprise, and affix the official seal of Party B.

Agreement Description:

1. This Agreement applies to written purchase contracts and purchase contracts not established in writing.

2. This Agreement shall be in duplicate, and both Party A and Party B shall each hold a copy.

3. This Agreement shall be valid for three years from the date of signing by both parties.

4. Matters not covered in this Agreement will be resolved by negotiation between Party A and Party B.

Party A: _________ Party B: _________ Representative: _________ Representative: _________ _________Year ____________________________________________

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