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What are the requirements and standards for pharmaceutical packaging regulations?

2026-11-08 03:14
2026-11-08 03:37

The pharmaceutical packaging regulations have the following requirements and standards: 1. ** Requirements for content printing ** - The packaging and labels of the drugs must be printed in accordance with the requirements stipulated by the State Drug Administration. The words and patterns must not be added with content that has not been approved, and the content must not exceed the content limited by the drug instructions approved by the State Drug Administration. - The description of the product on the packaging and label must be accurate and without error. In addition to describing the safe and reasonable use of drugs, there must not be any words and labels that do not properly promote the product, such as "National New Drug". - The trade name of the drug must be approved before it can be used on the packaging and label. The trade name cannot be written in conjunction with the common name and should be written separately. After the trade name is registered, it must still comply with the management principles. The ratio of the common name to the trade name should not be less than 1:2 (referring to the area). The font size of the common name should be consistent and not bracketed. A registered trademark that has not been approved for use as a trade name may be printed on the upper left corner or upper right corner of the packaging label, and the font must not be larger than the common name. 2. ** Requirements for format compatibility ** - For the same enterprise, the same drugs of the same specifications (referring to the drug specifications and packaging specifications), the packaging, label format and color must be consistent, and different brands must not be used. If the same variety of the same enterprise has different specifications, the packaging and labels of the smallest sales unit should be clearly different or the specifications should be clearly marked. 3. ** Min sales unit requirement ** - The smallest sales unit of a drug refers to the smallest package of a drug that is directly available for marketing. The packaging of each smallest sales unit must be printed with a label and attached with an instruction manual. 4. ** Requirements for special drug labels ** - For anesthetics, psychotropics, toxic drugs for medical use, radioactive drugs, and other drugs under special management, drugs for external use, and over-the-counter drugs, a mark that conforms to the regulations must be printed on the large package, medium package, the smallest sales unit, and the label. For drugs that have special requirements for storage, a clear indication must be made on the packaging and the label. 5. ** Requirements for the packaging of imported drugs ** - In addition to the above provisions, the packaging and labels of imported drugs should also be marked with the "Registration Certificate No. of imported drugs" or "Registration Certificate No. of pharmaceutical products", the name of the manufacturer, etc.; the packaging and labels of imported subpackaged drugs should be marked with the name of the original manufacturer or region, the production date, the batch number, the validity period, and the name of the domestic subpackaged enterprise, etc. 6. ** Requirements for the packaging of drugs produced and commissioned for processing in other places ** - For drugs approved to be produced in other places, the packaging and labels shall also indicate the name of the group, the manufacturer, and the place of production; for drugs approved to be commissioned for processing, the packaging and labels shall also indicate the name of the entrusting parties and the place of processing. 7. ** Text Usage Requirements ** - For drugs sold and used in China, the packaging and labels must be mainly in Chinese and use the current standard language published by the State Language and Character Work Committee. Read more exciting novels for free

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