Provisions on Packaging under Decree No. 24
- Decree No. 24, titled Provisions for the Administration of Drug Package Inserts and Labels, mainly regulates label and package insert content on drug packaging rather than the packaging materials themselves.
- Drug packaging must bear printed or affixed labels as required, the smallest sales package must include a package insert, and no textual, audiovisual or other materials promoting the product or company may be included inside the packaging.
- Inner labels must indicate at least the generic name, specification, product batch number and expiry date; outer labels must also indicate ingredients, indications, dosage and administration, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiry date, approval document number and manufacturer.
- For the same drug produced by the same company with the same specification and pack size, label content, format and color must be identical; the generic name must be prominently highlighted, must not share the same line as the brand name, and the brand name font size must not exceed half that of the generic name.
- Narcotic drugs, psychotropic drugs, radioactive drugs, drugs for external use and over-the-counter drugs must bear prescribed special marks, expiry dates must be marked in year-month-day order with a four-digit year and two-digit month and day, and these provisions took effect on June 1, 2006 and remain the primary basis for drug label administration.
The full title of Decree No. 24 is 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. The 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.
Prohibition on inserted materials: no text, audio-visual or other materials introducing or promoting the product or the company may be included inside the packaging.
How the label content is written
Inner labels: at minimum the generic name, specification, product batch number and expiry date must be indicated; 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 document number and manufacturer, among others, must be indicated.
Consistency requirement: for the same drug produced by the same company, when the specification and pack size are the same, the label content, format and color must be identical.
How names and marks are labelled
Prominence of the name: the generic name must be prominently highlighted and must not be written on the same line as the brand name; the font size of the brand name must not exceed half that of the generic name.
Special marks: narcotic drugs, psychotropic drugs, radioactive drugs, drugs for external use and over-the-counter drugs, among others, must bear the prescribed special marks.
Expiry date marking: marked in the order of year, month and day, with a four-digit year and two-digit month and day.
These provisions took effect on June 1, 2006 and remain the primary basis for drug label administration.
——This article is reprinted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-379896.html
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