How to achieve 0 in the label specification of the

How to achieve the label specification of drug packaging

[China Packaging News] the detailed rules for the specification of drug packaging and labeling is a specification formulated and issued by the relevant competent departments as a code of conduct and work code

I. drug packaging and labels must be printed in accordance with the requirements of the State Drug Administration, and their words and patterns must not include any content without approval. The packaging of drugs is divided into inner packaging and outer packaging. The contents of drug packaging and labels shall not exceed the contents specified in the drug instructions approved by the State Drug Administration

II. The content printed on drug packaging and labels should be accurate in the description of products. In addition to the words used to express safe and rational drug use, it is not allowed to print all kinds of inappropriate words and logos to promote products. In this way, we will also grow faster, such as national new drugs, protected varieties of traditional Chinese medicine, GMP certification, sub packaging of imported raw materials, supervision, honorary products, award-winning products, quality insurance of insurance companies, public expense reimbursement Modern science and technology, precious medicinal materials, etc

III. The trade name of drugs must be approved by the State Drug Administration before it can be used on packaging and labels. The trade name shall not be written in conjunction with the common name, but shall be a branch. After a trade name is registered, it must still conform to the principle of trade name administration. The ratio of common name to trade name shall not be less than 1:2 (referring to area). The common name body size should be consistent without parentheses. A registered trademark used as a trade name without the approval of the State Drug Administration may be printed on the upper left or right corner of the package label, and its font shall not be larger than that of the common name

IV. The format and color of the packaging and label of the same enterprise and the same drug of the same specification (referring to drug specification and packaging specification) must be consistent, and different trademarks are not allowed. If the same variety of the same enterprise has different specifications, the packaging and label of the smallest sales unit should be significantly different or the specification items should be clearly marked

v. the minimum sales unit of drugs refers to the minimum package of drugs directly for marketing. The package of each minimum sales unit must be printed with labels and attached with instructions as required

VI. narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other drugs under special management, drugs for external use, and over-the-counter drugs must be printed with marks that meet the regulations on their large packages, medium packages, minimum sales units and labels; Drugs with special requirements for storage must be indicated in eye-catching positions of packages and labels

VII. In addition to the provisions of these rules, the packaging and labeling of imported drugs should also be marked with the registration number of imported drugs or pharmaceutical products, the name of the manufacturer, etc; The import subcontracting mainly uses the air gun to launch pellets to study the packaging and label of composite high-speed impact action packaging drugs. The name of the enterprise in the original production country or region, production date, batch number, expiry date and the name of the domestic subcontracting enterprise should be indicated

VIII. The package and label of drugs produced in other places should also indicate the group name, production enterprise and production location; The package and label of drugs approved for entrusted processing shall also indicate the name of the enterprises of both parties and the processing place

IX. for drugs sold and used in China, the words used in packaging and labeling must be mainly Chinese and use the current standard words published by the national language and writing working committee. Ethnic medicine can increase its ethnic characters. Enterprises can use bar codes and foreign language comparison on their drug packaging as needed; Products patented in China can also be marked with patent marks and patent numbers, and indicate the types of patent licenses

X. The expression method of the validity period of the packaging label is in chronological order. The general expression can be valid until a certain month of a certain year, or it can only be expressed in numbers. For example, it is valid until October 2001, or expressed in the form of valid until October 2001, 2001/10, etc. The year should be represented by four digits, and the months from January to September must be preceded by 0 to represent the months in two digits

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