Of course it is not a casual design, there are many relevant regulations.

--------------------- Detailed Rules for Drug Packaging and Labeling Regulations (Interim)------------

According to the National Drug In accordance with the Bureau Order No. 23 of the Supervision and Administration Bureau, to further strengthen and standardize the packaging and labeling management of drugs and ensure the implementation of the "Regulations on the Management of Drug Packaging, Labeling and Instructions" (Interim), these detailed rules are formulated.

General requirements

1. Drug packaging and labels must be printed in accordance with the requirements stipulated by the State Food and Drug Administration, and any content that has not been approved by the State Food and Drug Administration must not be added to the text and graphics. The packaging of medicines is divided into inner packaging and outer packaging. The content of drug packaging and labels shall not exceed the content limited by the drug instructions approved by the State Food and Drug Administration.

2. The content printed on drug packaging and labels must describe the product accurately. In addition to words describing safe and rational use of drugs, any inappropriate words and logos that promote the product must not be printed. Such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "imported raw material packaging", "supervisory production", "honorary production", "award-winning products", "insurance company quality insurance", "public expense reimbursement" , "modern technology", "precious medicinal materials", etc.

3. The trade name of a drug must be approved by the State Food and Drug Administration before it can be used on packaging and labels. The product name must not be written in conjunction with the common name and must be written separately. After a trade name is registered as a trademark, it must still comply with the principles of trade name management. The ratio of common names to trade names should not be less than 1:2 (referring to area). Common names should be of the same font size without parentheses. Registered trademarks that are used as trade names without the approval of the State Food and Drug Administration may be printed on the upper left corner or upper right corner of the packaging label, and the font size shall not be larger than the generic name.

4. For the same enterprise and the same drug of the same specifications (referring to both drug specifications and packaging specifications), the format and color of the packaging and labels must be consistent, and different trademarks are not allowed. If the same product of the same enterprise has different specifications, the packaging and labeling of the smallest sales unit should be clearly differentiated or the specifications should be clearly marked.

5. The minimum sales unit of a drug refers to the smallest package of a drug directly for sale. The packaging of each minimum sales unit must be labeled and accompanied by instructions in accordance with regulations.

6. Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other specially managed drugs, external drugs and over-the-counter drugs must be printed on their large packages, medium packages, minimum sales units and labels. Marks that comply with regulations; drugs that have special requirements for storage must be marked in a conspicuous position on the packaging and labels.

7. In addition to complying with the provisions of these rules, the packaging and labels of imported drugs should also be marked with the "Imported Drug Registration Certificate Number"

or the "Pharmaceutical Product Registration Certificate Number", production Company name, etc.; the packaging and labels of imported repackaged drugs should indicate the name of the company in the original country or region of production, production date, batch number, expiration date, and the name of the domestic repackaging company, etc.

8. The packaging and labels of drugs approved for production in other places should also indicate the name of the group, production enterprise, and production location; the packaging and labels of drugs approved for entrustment processing should also indicate the names of both entrusting companies. , processing location.

9. For all drugs sold and used in China, the text used in packaging and labels must be mainly in Chinese and use the current standard text promulgated by the National Language Working Committee. Ethnic medicines can add their ethnic characters. Enterprises can use bar codes and foreign language comparisons on their pharmaceutical packaging according to needs; products that have obtained Chinese patents can also be marked with patent marks and patent numbers, and indicate the type of patent license.

10. How to express the validity period on packaging labels, in order of year and month. Generally, the expression can be valid until a certain year and a certain month, or it can only be expressed by numbers. For example, it is valid until October 2001, or expressed as valid until 2001.10, 2001/10, 2001-10, etc. The year must be represented by four digits, and the numbers from January to September must be preceded by 0 to represent the month by two digits.

Packaging and labeling contents of various types of drugs

1. Chemical drugs, biological products and preparations:

(1) Inner packaging label contents include:

Drug name, specifications, indications, usage and dosage, storage and production date, production batch number, expiration date and manufacturer. If it is impossible to label all the above contents due to packaging size, it can be appropriately reduced, but at least three items must be labeled: drug name, specifications, and production batch number (such as ampoules, eye drop bottles, injection bottles, etc.).

(2) The contents of outer packaging labels that directly contact the inner packaging include:

drug name, ingredients, specifications, indications, usage and dosage, storage,

Adverse reactions, contraindications, precautions, packaging, production date, production batch number, validity period, approval number and production company. If adverse reactions, contraindications, and precautions cannot be stated due to packaging size, the words "see instructions for details" should be noted.

For preventive biological products, the above indications should be listed as vaccination targets.

(3) Large package label content includes:

Drug name, specifications, production batch number, production date, validity period, storage, packaging, approval number, production company and transportation precautions or other marks.

2. API label content includes:

Drug name, packaging specifications, production batch number, production date, validity period, storage, approval number, production company and transportation precautions or other mark.

3. Traditional Chinese Medicine Preparations:

(1) Inner packaging label content includes:

Drug name, specifications, functions and indications, usage and dosage, storage, production Date, production batch number, expiration date and production company. If it is impossible to indicate all the above contents due to label size restrictions, it can be reduced appropriately, but at least three items, such as ampoules, injection bottles, etc., must be marked: drug name, specifications, and production batch number. The wax shell of traditional Chinese medicine honey pills must at least be labeled with the name of the drug.

(2) The contents of outer packaging labels that directly contact the inner packaging include:

Drug name, ingredients, specifications, functions and indications, usage and dosage, storage, adverse reactions, contraindications, Precautions, packaging, production date, production batch number, validity period, approval number and production company. If adverse reactions, contraindications, and precautions cannot be stated due to packaging size, the words "see instructions for details" should be noted.

(3) Large package label content includes:

Drug name, specifications, production batch number, production date, validity period, storage, packaging, approval number, production company and transportation precautions or other marks.

These rules shall come into effect on the date of promulgation.

The State Drug Administration is responsible for the interpretation of these rules.

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