Provisions on the Administration of Drug Packaging Labels and Instructions:

Article 1 These Provisions are formulated to strengthen the supervision and administration of drugs, standardize the packaging, labels and instructions of drugs, facilitate the transportation, storage and use of drugs, and ensure the safety and effectiveness of people's drug use.

article 2 drug packages, labels and instructions must be printed in accordance with the requirements stipulated by National Medical Products Administration, and their words and designs shall not contain any contents without approval.

Article 3 No unauthorized introduction or promotion of products or enterprises, words, audio-visual and other materials shall be carried in the drug packaging.

Article 4 All drugs sold and used in China must be written in Chinese, and standardized Chinese characters published in state language commission must be used.

article 5 the generic names of drugs must be clearly marked in Chinese. if there are commodity names at the same time, the ratio of words used in generic names and commodity names shall not be less than 1: 2, and there shall be a certain gap between generic names and commodity names, and they shall not be used together.

Article 6 The trade name of a drug shall be approved by National Medical Products Administration before it can be marked on the packaging, labels and instructions of the drug.

Article 7 Signs and written descriptions that provide drug information shall be legible and marked clearly, and shall not be printed off or pasted loosely, and shall not be modified or supplemented by pasting or cutting.

article 8 the packaging of drugs is divided into internal packaging and external packaging.

(1) inner packaging refers to the packaging that comes into direct contact with drugs (such as ampoules, injection bottles, aluminum foil, etc.). Internal packaging should ensure the quality of drugs in the process of production, transportation, storage and use, and facilitate medical use.

when changing the inner packaging materials and containers (drug packaging materials) of drugs, stability tests should be conducted according to the materials of the selected drug packaging materials to investigate the compatibility between the drug packaging materials and drugs.

(2) outer packaging refers to packaging other than inner packaging, which is divided into medium packaging and large packaging from inside to outside. The outer packaging should be selected according to the characteristics of drugs, so as to ensure the quality of drugs during transportation, storage and use.

article 9 the labels of drugs are divided into inner packaging labels and outer packaging labels.

(1) The contents of the inner packaging label and the outer packaging label shall not exceed the contents defined in the drug instructions approved by National Medical Products Administration; The written expression should be consistent with the instruction.

(2) according to its size, the inner packaging label may include the drug name, indications or functional indications, usage and dosage, specifications, storage, production date, production batch number, expiration date, production enterprise, etc. as far as possible, but the drug name, specifications and production batch number must be marked.

(3) The name, main components, properties, indications or functional indications, usage and dosage, adverse reactions, contraindications, specifications, storage, production date, production batch number, expiration date, approval number and manufacturer of the drug shall be indicated on the packaging label.

(4) The label of large package shall indicate the name, specification, storage, production date, production batch number, expiration date, approval number, manufacturer and other necessary contents other than those specified in the instruction manual, including package quantity, transportation precautions or other marks.

(5) The specific expression of the validity period on the label should be: the validity period is from ×× years to × months.

(6) If all the adverse reactions, contraindications and precautions cannot be indicated on the Chinese packaging label due to the size, the words "See the instructions for details" shall be indicated.

article 1 the packaging of APIs shall be carried out with reference to item (1) of article 8 of these provisions, and the labeling shall be handled in accordance with the provisions on large package labeling of preparations.

article 11 the packaging of each minimum sales unit of drugs must be printed or labeled with instructions in accordance with regulations.

article 12 drug instructions should contain basic scientific information about the safety and effectiveness of drugs.

the description of a drug should include the following contents: drug name (common name, English name, Chinese Pinyin, chemical name, molecular formula, molecular weight, structural formula (ingredients should be indicated for compound preparations and biological products), properties, pharmacology and toxicology, pharmacokinetics, indications, usage and dosage, adverse reactions, contraindications, precautions (medication for pregnant and lactating women, medication for children, drug interaction)

if an item is not clear, the word "not clear" should be indicated; If it is clear that there is no impact, it should be marked as "None".

pharmaceutical manufacturers should take the initiative to track the application of drugs after listing, and put forward an application to modify the instructions when necessary.

the printed instructions must be in a unified format (see annexes I and ii for the format of the instructions), and the contents must be consistent with the instructions approved by National Medical Products Administration.

article 13 in addition to the unit content label, the usage and dosage of drugs should also be written in easy-to-understand words, such as "one tablet at a time, x times a day" and "one tablet at a time, x times a day", so as to correctly guide drug use.

Article 14 Drugs under special management, such as narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use, and over-the-counter drugs, must be printed with signs that meet the requirements in their packages, large packages, labels and instructions; Drugs with special storage requirements must be indicated in the eye-catching position of packaging and labels and in the instructions.

article 15 when applying for registration of a drug, the packaging, labels and instructions of the drug shall go through the examination and approval procedures according to the different types of drugs and the corresponding management regulations. Any revision or change of the package, label or instruction manual of the registered drugs must go through the approval procedures in accordance with the original declaration procedures.

article 16 where anyone violates these provisions, the pharmaceutical supervisory and administrative department or the pharmaceutical supervisory and administrative institution shall order the pharmaceutical production enterprises to change their packaging, labels or instructions, and take back the listed drugs that do not meet these provisions. At the same time, it shall be punished in accordance with the relevant provisions of the Drug Administration Law and the Measures for the Implementation of the Drug Administration Law.

Article 17 National Medical Products Administration shall be responsible for the interpretation of these Provisions.

article 18 these provisions shall be implemented as of January 1, 21.

description format of chemical drugs

p>×××× description

drug name

common name:

trade name:

English name:

Chinese pinyin:

The main components of this product and their chemical names are called:,

Its structural formula is:

Molecular formula:

. )

characteristics

pharmacology and toxicology

pharmacokinetics

indications

dosage

adverse reactions

contraindications

precautions

medication for pregnant women and lactating women

medication for children

medication for elderly patients

drug interaction

drug overdose <

instruction format of traditional Chinese medicine

p>×××× instruction

drug name

product name:

Chinese pinyin:

characteristics

main ingredients

pharmacological effects

functions and indications

usage and dosage

adverse reactions

contraindications

. Telephone number)

Extended information:

The Provisions on the Administration of Drug Instructions and Labels was reviewed and approved by the Executive Council of the State Food and Drug Administration on March 1, 26, and is hereby promulgated and shall come into force as of June 1, 26.

General Provisions on the Administration of Drug Instructions and Labels:

Article 1 In order to regulate the administration of drug instructions and labels, these Provisions are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementation Regulations of the Drug Administration Law of the People's Republic of China.

article 2 the instructions and labels of drugs listed and sold in the people's Republic of China shall meet the requirements of these provisions.

article 3 drug instructions and labels shall be approved by the state food and drug administration.

The labels of drugs should be based on the instructions, and their contents should not go beyond the scope of the instructions, and words and labels that imply curative effect, mislead use and improperly publicize the products should not be printed.

article 4 drug packages must be printed or labeled according to regulations, and no other words, audio-visual and other materials that introduce or publicize products and enterprises may be included.

the minimum package produced by a pharmaceutical manufacturer for marketing must be accompanied by instructions.

article 5 the written expression of drug instructions and labels shall be scientific, standardized and accurate. Instructions for over-the-counter drugs should also be expressed in easy-to-understand words, so that patients can judge, choose and use them by themselves.

article 6 the words in drug instructions and labels should be clear and legible, and the labels should be clear and eye-catching, and there should be no phenomenon such as the printed words falling off or the paste is not firm, and it is not allowed to be modified or supplemented by pasting, cutting or altering.

article 7 standardized Chinese characters published by state language commission should be used in drug instructions and labels. if other characters are added for comparison, the Chinese characters shall prevail.

article 8 for the purpose of protecting public health and guiding the correct and rational use of drugs, pharmaceutical production enterprises may take the initiative to put warnings on drug instructions or labels, and the state food and drug administration may also require pharmaceutical production enterprises to put warnings on drug instructions or labels.

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