1. Drug packages and labels must be printed in accordance with the requirements of National Medical Products Administration, and their words and patterns shall not contain any unapproved contents. The packaging of drugs is divided into inner packaging and outer packaging. The contents of drug packaging and labeling shall not exceed the contents defined in the drug instructions approved by National Medical Products Administration.
2. The contents printed on drug packages and labels should accurately describe the products. Except the words used to express safe and rational drug use, words and labels that improperly promote the products should not be printed, such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "repackaging imported raw materials", "producer", "honorary product" and "award-winning product".
3. The trade name of a drug must be approved by National Medical Products Administration before it can be used on the package and label. The trade name shall not be linked with the common name, but shall be divided into branches. After trademark registration, a trade name must still conform to the principle of trade name management. The ratio of common names to trade names shall not be less than 1: 2 (referring to the area). The font size of common names should be the same, without brackets. A registered trademark used as a trade name without the approval of National Medical Products Administration can be printed on the upper left corner or the upper right corner of the packaging label, and its font shall not be larger than the words used for common names.
four, the same enterprise, the same drug with the same specifications (drug specifications and packaging specifications), the format and color of its 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 label of its minimum sales unit should be obviously different or the specifications should be clearly marked.
5. The minimum sales unit of drugs refers to the minimum packaging of drugs directly available for marketing. The packaging of each minimum sales unit must be labeled and accompanied by instructions in accordance with regulations.
VI. Drugs under special management, such as narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs, must be printed with signs that meet the requirements on their large packages, medium packages, minimum sales units and labels; Drugs with special storage requirements must be indicated in the eye-catching position of packaging and labels.
VII. In addition to the provisions of these Detailed Rules, the packaging and labeling of imported drugs should also be marked with the "registration number of imported drugs" or "registration number of pharmaceutical products" and the name of the manufacturing enterprise; The packaging and labels of imported repackaged drugs shall indicate the name of the enterprise in the original producing country or region, the date of production, the batch number, the expiration date and the name of the domestic repackaged enterprise, etc.
8. The packaging and labels of drugs approved for production in different places shall also indicate the name of the group, the manufacturer and the place of production; The packaging and label of the drugs that are approved to be commissioned for processing shall also indicate the name of the entrusting party and the processing place.
9. For drugs sold and used in China, the language used in packaging and labeling must be mainly Chinese, and the current standard language published by state language commission should be used. National medicine can increase its national characters. Enterprises can use bar codes and foreign language control on their drug packaging according to their needs; Products patented in China can also be marked with patent marks and patent numbers, and indicate the types of patent licenses.
ten, the expression of the validity of the packaging label, in chronological order. General expressions can be valid until a certain year or month, or they can only be expressed by numbers. For example, it is valid until October 21, or expressed as valid until October 21, October 21, October 21, and October 21. The year should be represented by four digits, and the number from January to September should be preceded by to represent the month by two digits.