**Chinese Packaging Network News: Regulations on Pharmaceutical Packaging and Labeling**
The "Pharmaceutical Packaging and Labeling Regulations" are a set of guidelines established by the relevant authorities to ensure proper and standardized practices in the pharmaceutical industry. These rules serve as a code of conduct for manufacturers, distributors, and retailers, ensuring that all packaging and labeling meet strict regulatory standards.
First, all drug packaging and labels must be produced according to the requirements set by the State Drug Administration. Any additional text or graphics not approved by the authority are strictly prohibited. Pharmaceutical products are typically divided into inner and outer packaging, and the content on the packaging and labels must not exceed what is included in the official product manual approved by the administration.
Second, the information printed on pharmaceutical packaging and labels must be accurate and free from misleading or promotional language. Words such as “national new drugs,†“Chinese medicine protection varieties,†“GMP certified,†“imported raw material packaging,†“producer,†“honorary product,†“winning product,†“insurance company quality assurance,†“public expense reimbursement,†“modern technology,†and “valuable herbs†should not appear unless explicitly permitted.
Third, trade names of drugs must be officially approved by the State Drug Administration before they can be used on packaging or labels. The trade name should not be combined with the generic name and must be presented separately. After trademark registration, the product name must still comply with naming regulations. The size ratio between the generic name and the trade name should not be less than 1:2, and both should be clearly visible without parentheses. Unapproved trademarks may only be placed in the top left or right corner of the label, with a font size no larger than the generic name.
Fourth, for the same enterprise producing the same drug with identical specifications, the packaging and label design, including color and format, must remain consistent. Different trademarks cannot be used for the same product. If a product has multiple specifications, the packaging or label of the smallest sales unit must clearly differentiate them, either through visual distinction or by clearly stating the specifications.
Fifth, the minimum sales unit refers to the smallest package that is directly sold to consumers. Each such unit must have a label attached along with the usage instructions.
Sixth, special categories of drugs—such as narcotics, psychotropic substances, toxic drugs, radioactive materials, external-use medicines, and over-the-counter drugs—must include specific warning signs on their large, medium, and small packaging as well as on labels. Medicines with unique storage or handling requirements must also be clearly marked.
Seventh, in addition to following these regulations, imported drugs must also display the "Imported Drug Registration Number" or "Pharmacy Product Registration Number," along with the manufacturer's name. For subpackaged imported drugs, the label must include the origin country’s manufacturer name, date of production, batch number, expiration date, and the name of the domestic subpackaging company.
Eighth, for drugs approved for off-site production, the packaging and labels must include the group name, manufacturer, and production location. Similarly, for drugs processed under contract, the label must indicate the processing company and its location.
Ninth, all pharmaceuticals sold in China must have their packaging and labels written in Chinese, using the standard texts published by the National Language and Linguistics Committee. While national languages can be added, companies may also use barcodes and foreign language translations if needed. Patented medicines in China must also display patent marks and numbers, along with the type of patent license.
Finally, the validity period of packaging and labels should be expressed chronologically. Common formats include "Valid until October 2001" or "2001.10," "2001/10," or "2001-10." The year must be written with four digits, and months from January to September should be represented with a leading zero (e.g., 01, 02). This ensures clarity and consistency across all pharmaceutical products.
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