China Decree No. 24: Drug Label and Package Insert Rules for Pharmaceutical Packaging
Decree No. 24, formally titled the Provisions for the Administration of Drug Package Inserts and Labels, governs what appears on drug packaging labels and package inserts. It does not regulate the packaging materials themselves. Its main requirements are summarized below.
What must be shown on packaging
Labels and package inserts: drug packaging must carry printed or affixed labels in line with the rules, and even the smallest sales pack must include a package insert.
Inserted materials prohibited: no written, audio-visual or other materials that introduce or promote the product or its company may be placed inside the packaging.
How label content should be written
Inner labels: these must at least state the generic name, specification, product batch number and expiry date; if space is too limited, certain items may be left out.
Outer labels: they need to include the generic name, ingredients, indications, dosage and administration, adverse reactions, contraindications, precautions, storage conditions, production date, product batch number, expiry date, approval number and manufacturer, among other items.
Consistency rule: when the same company makes the same drug with identical specifications and pack sizes, the label content, format and color must be the same.
How names and marks should be labelled
Name prominence: the generic name must stand out clearly and must not share a line with the brand name; the brand name's font size cannot exceed half that of the generic name.
Special marks: narcotic drugs, psychotropic drugs, radioactive drugs, external-use drugs and over-the-counter drugs, among others, must display the required special marks.
Expiry date format: it should be shown in year, month and day order, with a four-digit year and two-digit month and day.
Effective June 1, 2006, the provisions remain the primary basis for drug label regulation today.
——This article is reprinted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-379896.html
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