Excerpts from the regulations on the management of

2022-08-24
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Regulations on the administration of drug instructions and labels (excerpt)

since June 1, 2006, the regulations on the administration of drug instructions and labels (hereinafter referred to as the regulations) issued by the State Drug Administration has been officially implemented, and the regulations on the administration of drug packaging, labeling and instructions (Provisional) issued on October 15, 2000 have been repealed at the same time. This article excerpts the part about drug labels in the regulations for readers' reference

drug label

◇ drug label refers to the content printed or pasted on the drug package, which is divided into internal label and external label. The inner label of drugs refers to the label of the package that directly contacts the drugs, and the outer label refers to the label of other packages other than the inner label. The sampling speed is slow

◇ the internal label of a drug should contain the general name of the drug, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiry date, manufacturer, etc. If the package size is too small to indicate all the above contents, at least the generic name, specification, product batch number, expiry date and other contents of the drug shall be marked

◇ the external label of a drug should indicate the general name of the drug, ingredients, properties, indications or functions, specifications, usage and dosage, adverse reactions, taboos, precautions, storage, production date, product batch number, expiry date, approval number, production enterprise, etc. If the indications or functions, usage and dosage, adverse reactions, taboos and precautions cannot be indicated, the main contents shall be marked and the words "see the instructions for details" shall be indicated

◇ the label of the package used for transportation and storage should at least indicate the general name, specification, storage, production date, product batch number, expiry date, approval number, production enterprise of the drug. It can also indicate the necessary contents such as packaging quantity, transportation precautions or other marks as needed

◇ the label of the API should indicate the drug name, storage, production date, product batch number, expiry date, if the sample between the two fixtures can maintain the same elongation and is assumed to be 500%, the executive standard, approval number, production enterprise, as well as the packaging quantity, transportation precautions and other necessary contents

◇ for the same drug produced by the same drug manufacturer, if the drug specification and packaging specification are the same, the content, format and color of its label must be consistent; If the drug specifications or packaging specifications are different, the labels shall be clearly different or the specification items shall be clearly marked

if the same drug produced by the same drug manufacturing enterprise is managed according to prescription drugs and over-the-counter drugs, the packaging color of the two should be significantly different

◇ drugs with special storage requirements shall be indicated in the eye-catching position of the label

◇ the validity period in the drug label should be marked in the order of year, month and day. The year is represented by four digits, and the month and day are represented by two digits. The specific marking format is "valid until XX month, XXXX" or "valid until XX month, XXXX"; It can also be expressed by numbers and other symbols as "expiration date." Or "valid until xxxx/xx/xx", etc

the validity period of biological products for prevention shall be marked according to the registration standards approved by the State Food and drug administration. The validity period of biological products for treatment shall be calculated from the sub packaging date, and the validity period of other drugs shall be calculated from the production date

if the validity period is marked to date, it should be the day before the starting date corresponding to the month and year. If it is marked to month, it should be the month before the starting month corresponding to the month and year

use of drug names and registered trademarks

◇ the drug names marked in the drug instructions and labels must comply with the naming principles of the general drug names and commodity names published by the State Food and drug administration, and be consistent with the corresponding contents of the drug approval certificate

◇ the generic name of drugs should be prominent and prominent, and its font, size and color must be consistent, and meet the following requirements:

(I) for the horizontal label, the upper third must be able to be prominent within a range on the computer, which was not issued to our colleagues yesterday, and the position was marked; For vertical labels, they must be marked in a prominent position within the right third of the range

(II) it is not allowed to use cursive script, seal script and other fonts that are not easy to recognize, and it is not allowed to use italic, hollow, shadow and other forms to modify the fonts

(III) the font color should be black or white, which forms a strong contrast with the corresponding light or dark background

(IV) unless it is impossible to write in the same line due to the limitation of package size, it shall not be written in separate lines

◇ the drug commodity name shall not be written together with the general name, its font and color shall not be more prominent and prominent than the general name, and its font shall not be greater than half of the font used in the general name in terms of single word area

◇ unregistered trademarks and other drug names not approved by the State Food and drug administration are prohibited in drug instructions and labels

◇ if a drug label uses a registered trademark, it should be printed on the corner of the drug label. If it contains words, the font should not be greater than one quarter of the font used for the general name in terms of single word area

source: State Food and Drug Administration Station

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