Provisions on packaging under Order No. 24
Order No. 24 is officially titled the Provisions for the Administration of Drug Package Inserts and Labels. It mainly regulates the content of labels and package inserts on drug packaging, rather than the packaging materials themselves. Its core provisions are as follows:
What must appear on the packaging
Labels and package inserts: Drug packaging must bear printed or affixed labels as required, and the smallest sales package must be accompanied by a package insert.
No inserted materials: No text, audio-visual, or other materials introducing or promoting the product or the company may be inserted in the packaging.
How label content should be written
Inner labels: At a minimum, the generic name, specifications, product batch number, and expiry date must be marked; where the size is too small, some items may be omitted.
Outer labels: The generic name, ingredients, indications, dosage and administration, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiry date, approval number, and manufacturing enterprise should be indicated.
Consistency requirements: For the same drug produced by the same enterprise, when the specifications and packaging specifications are the same, the label content, format, and color must be consistent.
How names and markings should be labeled
Prominent name: The generic name should be prominently highlighted and must not be written on the same line as the trade name, and the font size of the trade name must not exceed half that of the generic name.
Special markings: Narcotic drugs, psychotropic drugs, radioactive drugs, drugs for external use, and non-prescription drugs must bear the prescribed special markings.
Expiry date marking: Marked in the order of year, month, and day, with the year in four digits and the month and day in two digits.
These provisions took effect on June 1, 2006, and remain the main basis for the administration of drug labels today.
——This article is reprinted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-379896.html
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