Printed encyclopaedia: Specifications and rules for drug pac
1. The packaging and labels of drugs must be printed in accordance with the requirements stipulated by the State Medical Products Administration, and the words and patterns thereof must not contain any content without approval.The packing of medicine is divided into inner packing and outer packing.The contents of the package and label of the drug shall not exceed those specified in the drug specification approved by the State Medical Products Administration.
Second, drug packaging, label printing content for the product description is accurate, in addition to the state security, rational drug use words, not with text and identify various improper propaganda products, such as "national new medicine", "Chinese medicine to protect species" and "GMP certification", "partial shipments" are imported raw materials, "producer" and "from", "the award-winning products", "insurance company quality insurance", "expense reimbursement", "modern science and technology", "medical", etc.
The trade name of a drug shall be approved by the State Medical Products Administration before it can be used on the package or label.The name of the commodity shall not be linked with the general name.After the trademark is registered, the name of the commodity must conform to the principle of the name management.The proportion of characters used in common names and trade names shall not be less than 1:2 (refers to the area).Generic name fonts should be the same size without parentheses.A registered trademark that has not been approved by the National Medical Products Administration for use as a commodity name may be printed in the upper left or right corner of the package label, and the font shall not be larger than that of the generic name.
The format and color of the package and label must be the same for the same enterprise and for the same drug (referring to the two drug specifications and package specifications), and different trademarks may not be used.If the same variety of the same enterprise has different specifications, the packaging and labels of the minimum sales unit shall be clearly distinguished or the specifications shall be clearly marked.
The minimum sales unit of a drug refers to the minimum package of a drug directly for sale.The packaging of each minimum sales unit must be labeled and accompanied by instructions as required.
Narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs and other drugs under special control, drugs for external use and non-prescription drugs must be marked as conforming to regulations on their large and medium packages, minimum sales units and labels;For the storage of drugs with special requirements, a clear indication must be given in an eye-catching place on the package and label.
7. In addition to implementing the provisions of these Rules, the package and label of imported drugs shall also indicate the "registration Certificate Number of imported drugs" or "Registration Certificate Number of Pharmaceutical products" and the name of the manufacturer.The name, production date, batch number, expiry date and the name of the domestic sub-packaging enterprise shall be indicated on the package and label of the imported sub-packaging medicine.
8. The package and label of a drug approved for production in another place shall also indicate the name of the group, the manufacturer and the place of production;The package and label of the drug approved for consigned processing shall also indicate the name and processing place of both parties.
9. For pharmaceuticals to be sold or used within the territory of China, the language used in the packaging and labels must be mainly Chinese and the current standard language published by the National Language Commission.Ethnic medicine can add its ethnic script.If necessary, enterprises may use bar codes and foreign language comparisons on their drug packages.For products patented in China, the patent mark and patent number may also be indicated, and the type of patent license may also be indicated.
X. The expression method of the expiry date of the packaging label shall be in chronological order.A general expression may be valid until a certain month of a certain year, or may be expressed numerically only.If valid until October 2001, or expressed as valid until October 2001, 2001/10, 2001-10, etc.The year should be represented by four digits, and the number from January to September should be preceded by 0 to indicate the month by two digits.