1. Drug packaging and labels must be printed in accordance with the requirements stipulated by the State Food and Drug Administration, and any content that has not been approved by the State Food and Drug Administration must not be added to the text and graphics. The packaging of medicines is divided into inner packaging and outer packaging. The content of drug packaging and labels shall not exceed the content limited by the drug instructions approved by the State Food and Drug Administration.
2. The content printed on drug packaging and labels must describe the product accurately. In addition to words describing safe and rational use of drugs, any inappropriate words and logos that promote the product must not be printed. Such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "imported raw material packaging", "supervisory production", "honorary production", "award-winning products", "insurance company quality insurance", "public expense reimbursement" , "modern technology", "precious medicinal materials", etc.
3. The trade name of a drug must be approved by the State Food and Drug Administration before it can be used on packaging and labels. The product name must not be written in conjunction with the common name and must be written separately. After a trade name is registered as a trademark, it must still comply with the principles of trade name management. The ratio of common names to trade names shall not be less than 1:2 (referring to area). Common names should be of the same font size without parentheses. Registered trademarks that are used as trade names without the approval of the State Food and Drug Administration may be printed on the upper left corner or upper right corner of the packaging label, and the font size shall not be larger than the generic name.
4. For the same enterprise and the same drug of the same specifications (referring to both drug specifications and packaging specifications), the format and color of the packaging and labels must be consistent, and different trademarks are not allowed. If the same product of the same enterprise has different specifications, the packaging and labeling of the smallest sales unit should be clearly differentiated or the specifications should be clearly marked.
5. The minimum sales unit of a drug refers to the smallest package of a drug directly for sale. The packaging of each minimum sales unit must be labeled and accompanied by instructions in accordance with regulations.
6. Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other specially managed drugs, external drugs and over-the-counter drugs must be printed on their large packages, medium packages, minimum sales units and labels. Marks that comply with regulations; drugs that have special requirements for storage must be marked in a conspicuous position on the packaging and labels.
7. In addition to complying with the provisions of these rules, the packaging and labels of imported drugs should also be marked with the "Import Drug Registration Certificate Number" or "Pharmaceutical Product Registration Certificate Number", the name of the manufacturer, etc.; imported sub-packaging The packaging and labels of drugs should indicate the name of the company in the country or region of origin, production date, batch number, expiration date, and the name of the domestic sub-packaging company.
8. The packaging and labels of drugs that have been approved to be produced in other places should also indicate the name of the group, production enterprise, and production location; the packaging and labels of drugs that have been approved for entrustment processing should also indicate the names of both entrusting companies. , processing location.
9. For all drugs sold and used in China, the text used in packaging and labels must be mainly in Chinese and use the current standard text published by the National Language and Writing Working Committee. Ethnic medicines can add their ethnic characters. Enterprises can use bar codes and foreign language comparisons on their pharmaceutical packaging according to needs; products that have obtained Chinese patents can also be marked with patent marks and patent numbers, and indicate the type of patent license.
10. How to express the validity period on packaging labels, in order of year and month. Generally, the expression can be valid until a certain year and month, or it can only be 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 numbers from January to September must be preceded by 0 to represent the month by two digits.