- .
According to Decree No.23 of the State Administration of Pharmaceutical Products, we will further strengthen and standardize the management of drug packaging and labeling to ensure that
These rules are formulated in order to implement the Provisions on the Administration of Drug Packaging, Labelling and Instructions (Provisional).
aggregate demand
First, drug packaging and labels must be printed in accordance with the requirements of the State Administration of Pharmaceutical Products, and their words and patterns shall not contain any unapproved contents. The packaging of drugs is divided into inner packaging and outer packaging. The contents of drug packaging and labeling shall not exceed those specified in the drug instructions approved by the State Pharmaceutical Product Supervision and Administration.
Second, the contents printed on drug packaging and labels should accurately describe the products. Except for words used to express safe and rational drug use, words and labels that improperly publicize products such as "national new drugs", "protected varieties of traditional Chinese medicine", "GMP certification", "repackaging imported raw materials", "producer", "honorary products" and "quality of insurance companies" shall not be printed.
Three, the name of the drug must be approved by the State Administration of pharmaceutical products before it can be used on the packaging and labels. A trade name may not be associated with a generic name, but it should be branched. After the trademark is registered, the firm must still conform to the principles of firm management. The ratio of common name to trade name shall not be less than 1: 2 (referring to the area). The font size of common names should be the same, without brackets. A registered trademark used as a trade name without the approval of the State Administration of Pharmaceutical Products may be printed in the upper left corner or the upper right corner of the packaging label, and its font shall not be larger than the words used in the generic name.
Four, the same enterprise, the same drug specifications (drug instructions and packaging instructions), the format and color of the packaging and labeling must be consistent, and different trademarks shall not be used. If the same product of the same enterprise has different specifications, the packaging and label of its smallest sales unit should be obviously different or clearly marked with specifications.
Five, the minimum sales unit of drugs, refers to the minimum packaging of drugs directly facing the market. The packaging of each smallest sales unit must be labeled and accompanied by instructions in accordance with regulations.
Six, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other special management drugs, external drugs, over-the-counter drugs must be printed on their large packaging, medium packaging, minimum sales units and labels that meet the requirements; Drugs with special storage requirements must be clearly marked on the packaging and labels.
Seven, the packaging and labeling of imported drugs, in addition to the provisions of these rules, should also indicate the "imported drug registration certificate number".
Or "drug registration certificate number" and the name of the manufacturer; The packaging and labels of imported repackaged drugs shall indicate the enterprise name, production date, batch number, expiration date and the name of domestic repackaged enterprises in the original production country or region.
Eight, approved off-site production of drugs, the packaging and labels should also indicate the name of the group, production enterprises, production sites; The name of the entrusting party and the place of processing shall also be indicated on the package and label of the drug that is approved to be commissioned for processing.
Nine, all drugs sold and used in China, the language of packaging and labeling must be mainly Chinese, and use the current standards published by the State Language Committee. National medicine can increase its nationality. Enterprises can use bar codes and foreign language controls on their drug packaging according to their needs; Products patented in China can also be marked with patent mark and patent number, and indicate the types of patent license.
Ten, the expression method of the validity of the packaging label, in chronological order. General expressions can be valid until a certain year or month, or they can be expressed only by numbers. For example, the validity period is 200 1 year 10 month, or expressed as 2001.10,20010,2001-/kloc. The year should be represented by four digits, the number from 1 to September should be preceded by 0, and the month should be represented by two digits.
Contents of various drug packages and labels
I. Chemical and biological products and preparations:
(a) The contents of the inner packaging label include:
Name, specifications, indications, usage and dosage, storage and production date, production batch number, expiration date and production enterprise of the drug. If all the above contents cannot be marked due to the size of the package, it can be reduced appropriately, but at least three pieces (such as ampoules, eye drops bottles, injection bottles, etc. ) must be marked.
(two) the contents of the outer packaging label that directly touches the inner packaging include:
Name, ingredients, specifications, indications, usage and dosage, storage,
Adverse reactions, contraindications, precautions, packaging, production date, production batch number, expiration date, approval number and production enterprise. Adverse reactions, contraindications and precautions that cannot be indicated due to the size of the package should be indicated with the words "See the instructions for details".
For preventive biological products, the above indications should be listed as vaccination targets.
(3) The contents of the large package label include:
The name, specifications, production batch number, production date, expiration date, storage, packaging, approval number, matters needing attention in the production enterprise and transportation or other signs of the drug.
Two. The contents of API label include:
Drug name, packaging specifications, production batch number, production date, expiration date, storage, approval number, production enterprise and transportation precautions or other signs.
Three, traditional Chinese medicine preparation:
(a) The contents of the inner packaging label include:
Name, specification, functional indications, usage and dosage, storage, production date, production batch number, expiration date and production enterprise of the drug. If all the above contents cannot be indicated due to the size limit of the label, it may be appropriately reduced, but at least three items such as drug name, specification and production batch number must be indicated, such as ampoules and injection bottles. The wax shell of Chinese medicine honey pills should be marked with the name of the medicine at least.
(two) the contents of the outer packaging label that directly touches the inner packaging include:
Drug name, composition, specification, functional indications, usage and dosage, storage, adverse reactions, contraindications, precautions, packaging, production date, production batch number, expiration date, approval number and production enterprise. Adverse reactions, contraindications and precautions that cannot be indicated due to the size of the package should be indicated with the words "See the instructions for details".
(3) The contents of the large package label include:
The name, specifications, production batch number, production date, expiration date, storage, packaging, approval number, matters needing attention in the production enterprise and transportation or other signs of the drug.
These rules shall come into force as of the date of promulgation.
The State Administration of Pharmaceutical Products shall be responsible for the interpretation of these rules.
/demo/zcfg/y7.htm
There are more relevant regulations on the above page.