1. Pharmaceutical packaging and labels must be printed in accordance with the requirements stipulated by the State Administration of Drug Administration, and their words and designs must not include any content without approval. Pharmaceutical packaging is divided into inner packaging and outer packaging. The content of drug packaging and labeling shall not exceed the content specified in the drug insert approved by the State Drug Administration.
2. The contents printed on the packaging and labels of the medicines must be accurate in the description of the products. Except for the expressions of safe and reasonable medicines, there should not be any words and logos that inappropriately promote the products, such as "national new medicines", "Chinese Medicine Protected Varieties", "GMP Certification", "Imported Raw Material Packaging", "Supervision Production", "Honor Produced", "Awarded Products", "Insurance Company Quality Insurance", "Public Expense Reimbursement", "Modern Technology", "Precious herbs" and so on.
3. The trade names of drugs must be approved by the State Drug Administration before they can be used on packaging or labels. The commodity name shall not be connected with the common name, and shall be branched. After a trade name is registered with a trademark, it must still comply with the principles of trade name management. The ratio of common names to trade names should not be less than 1: 2 (referring to area). Generic names should be the same size without parentheses. Registered trademarks used as trade names without the approval of the State Drug Administration can be printed on the upper left corner or upper right corner of the packaging label, and the fonts should not be larger than the words used in the common name.
4. For the same enterprise and the same specification and variety of the same drug (referring to both the drug specification and the packaging specification), the format and color of the packaging and labels must be the same, and different trademarks must not be used. If there are different specifications for the same variety of the same enterprise, the packaging and labels of the smallest sales unit should be clearly different or the specifications should be clearly marked.
5. The smallest sales unit of a drug refers to the smallest package that is directly supplied to the marketed drug. The packaging of each minimum sales unit must be printed with labels and instructions.
6. Specially managed drugs such as narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, external use drugs, and non-prescription drugs must be printed on their large packages, medium packages, minimum sales units, and labels in accordance with regulations; for storage Medicines with special requirements must be indicated in the conspicuous position on the packaging and label.
VII. In addition to the implementation of the packaging and labeling of imported drugs, the "Imported Drug Registration Certificate Number" or "Pharmaceutical Product Registration Certificate Number", the name of the manufacturer, etc. should be marked; the packaging and labeling of imported sub-packaged drugs should be marked The name, production date, batch number, expiration date and domestic sub-packaging company name of the original production country or region.
8. The packaging and labeling of drugs approved for production in other places should also indicate the name of the group, the manufacturing enterprise, and the production location; the packaging and labeling of the drugs authorized for processing should also indicate the name and processing location of the enterprises of both parties.
9. For medicines sold and used in China, the text used in packaging and labeling must be mainly Chinese and use the current standard text published by the National Language and Character Work Committee. Ethnic medicine can increase its ethnic writing. Enterprises can use barcodes and foreign language comparisons on their pharmaceutical packaging as needed; products that have been patented in China can also be marked with patent marks and patent numbers, and indicate the type of patent license.
10. The method of expressing the validity period of packaging labels, in chronological order. The general expression can be valid until a certain year and a certain month, or only expressed by numbers. For example, it is valid until October 2001, or expressed as valid until 2001.10, 2001/10, 2001-10, etc. The year must be represented by four digits, and the digits from 1 to September must be preceded by 0 to indicate the month with two digits.
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