Подробные правила упаковки и маркировки фармацевтической продукции

1. Pharmaceutical packaging and labels must be printed in accordance with the requirements stipulated by the State Drug Administration, and no content that has not been examined and approved may be added to their text or graphics. Pharmaceutical packaging is divided into inner packaging and outer packaging. The content of pharmaceutical packaging and labels must not exceed the content defined in the drug instructions approved by the State Drug Administration.
2. The content printed on pharmaceutical packaging and labels must describe the product accurately and without error. Apart from wording that describes safe and rational drug use, no text or logos that improperly promote the product may be printed, such as "new drug", "protected variety of traditional Chinese medicine", "GMP certification", "sub-packaging of imported raw materials", "supervised by", "honorary product", "award-winning product", "quality insurance by an insurance company", "reimbursable by public funds", "modern technology" and "precious medicinal materials".
3. The brand name of a drug may be used on packaging and labels only after approval by the State Drug Administration. The brand name must not be written together with the generic name and must be on a separate line. Even after trademark registration, a brand name must still comply with the principles of brand name management. The ratio of the characters used for the generic name to those used for the brand name must be no less than 1:2 (by area). The font size of the generic name must be uniform, and no parentheses may be used. A registered trademark not approved by the State Drug Administration for use as a brand name may be printed in the upper-left or upper-right corner of the packaging label, and its font size must not be larger than the characters of the generic name.
4. For the same enterprise and the same drug in the same specifications (referring both to drug specifications and to packaging specifications), the format and color of the packaging and labels must be consistent, and different trademarks must not be used. If the same variety from the same enterprise comes in different specifications, the packaging and labels of its smallest sales unit must be clearly distinguished or the specification item must be clearly marked.
5. The smallest sales unit of a drug refers to the small package directly supplied for marketed drugs. The packaging of each smallest sales unit must, in accordance with regulations, bear a label and be accompanied by instructions.
6. Drugs under special control such as narcotic drugs, psychotropic drugs, medicinal toxic drugs and radioactive drugs, as well as drugs for external use and non-prescription drugs, must bear markings that comply with regulations on their large packaging, medium packaging, smallest sales units and labels; for drugs with special storage requirements, these must be indicated in a prominent position on the packaging and labels.
7. In addition to complying with the provisions of these detailed rules, the packaging and labels of imported drugs must also indicate the "import drug registration certificate number" or the "pharmaceutical product registration certificate number", the name of the manufacturing enterprise, and so on; the packaging and labels of drugs imported in bulk and sub-packaged domestically must indicate the name of the enterprise in the original producing country or region, the production date, batch number and expiry date, as well as the name of the domestic sub-packaging enterprise.
8. For drugs approved for production in a different location, the packaging and labels must also indicate the name of the group, the manufacturing enterprise and the place of production; for drugs approved for contract processing, the packaging and labels must also indicate the names of the enterprises of both commissioning parties and the processing location.
9. For all drugs sold and used within the territory of China, the text used on packaging and labels must be mainly in Chinese and must use the currently standard characters published by the State Language Commission. Ethnic medicines may add their ethnic script. Enterprises may, as needed, use barcodes and foreign-language equivalents on their drug packaging; products that have obtained approval in China may also be marked with the mark and number and indicate the type of license.
10. The method of expressing the expiry date on packaging labels follows the order of year and month. It may generally be expressed as valid until a certain year and month, or with digits only, for example valid until October 2001, or expressed as valid until 2001.10, 2001/10, 2001-10 and other forms. The year must be expressed with four digits, and for the months from January to September a 0 must be added before the number so that the month is expressed with two digits.

——This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362237.html