Chapter 1 General Principles
Article 1 is the management of regulatory drugs and labels，In accordance with the "Pharmaceutical Management Law of the People's Republic。
Pharmaceuticals sold for sale in the territory of the People's Republic of China，Its manual and label shall meet the requirements of this regulation。
Article 3 Drugs instructions and labels are approved by the State Food and Drug Administration。
The label of the drug should be based on the manual，Its content must not exceed the scope of the manual，Do not print any suggestions、Misacled use and inappropriate publicity of the text and logo of the product。
The fourth pharmaceutical packaging must be printed or labeled in accordance with regulations，Do not bring any other introduction or promotional product、Enterprise text、Audiovisual and other information。
The smallest packaging of drug production enterprises for listing and sales must be attached with a manual。
Fifth pharmaceutical manual and label text should be scientific、Specification、Accurate。African prescription drug manual should also use text expressions that are easy to understand，so that patients can judge themselves、Select and use。
Article 6 Drug Manuals and texts in the label shall be clear and easy to distinguish，The logo should be clear and eye -catching，No printed words must be dropped off or pasted in accordance with the phenomenon，You must not paste、Cutting、Modeling and other methods to modify or supplement。
7 Drug manuals and labels shall use the standardized Chinese characters published by the National stake sports betting appLanguage Working Committee，Add other text control，Should be expressed in Chinese characters。
Article 8: For the purpose of protecting public health and guiding correct and reasonable medication，Drug production enterprises can actively propose to add warnings on the pharmaceutical manual or label，The State Food and Drug Administration can also require drug manufacturers to add warnings on the instructions or labels。
Chapter 2 Drug Manual
9 Pharmaceutical Manual shall contain drug safety、Important scientific data of effectiveness、Conclusion and information，Used to guide safety、Reasonable use of medicines。The specific format of the drug manual、Content and writing requirements are formulated and released by the State Food and Drug Administration。
Article 10 Drug Manual to the name of the disease、Pharmaceutical professional term、Drug name、The expression of the clinical test name and results，Dedicated vocabulary that is uniformly promulgated or regulated by the state，The measurement unit shall meet the requirements of national standards。
Article 11 Drugs instructions shall list all active ingredients or all Chinese medicine flavor in the formula。Injection and non -prescription medicines should also be listed all the names of the auxiliary materials used。
Drug prescription contains ingredients or accessories that may cause serious adverse reactions，It should be explained。
Article 12 Drug production enterprises shall actively track the safety of drugs after the drug listing、Effective situation，You need to modify the drug manual，It should be submitted in time。
Monitor according to adverse drug reactions、Drug re -evaluation results and other information，The State Food and Drug Administration can also require drug production enterprises to modify the drug instructions。
Article 13 After the Drug Manual is approved to be modified，Drug production enterprises shall immediately notify the revised content immediately、Use unit and other departments，and use the modified instructions and labels in time as required。
Article 14 Drugs instructions shall fully include the drug adverse reaction information，Detailed indication of adverse drug reactions。Drug production enterprises have not been safe after the drug listing、Effective conditions modify the instructions in time or not to fully explain the drug adverse reactions，stake online sports bettingThe adverse consequences caused by this manufacturer are borne by the manufacturer。
Article 15 Date of Drug Manual's approval date and modification date shall wake up the target in the manual。
Chapter 3 Drug Tag
Article 16 The label of a drug refers to the content printed or posted on the pharmaceutical packaging，Divided into internal tags and external labels。Tags internal tag refer to the label of the packaging of the drug directly，outer label refers to the labels other than internal tags。
Article 17 The internal labels of the medicine shall contain the common name of the drug、Indications or functions、Specification、Usage and dosage、Production date、Product batch number、Validity period、Production enterprise, etc.。
Packaging size is too small and cannot indicate the above content，At least it should be marked with the common name of the medicine、Specification、Product batch number、Validity period, etc.。
Article 18 Drug Outer Tag shall indicate the common name of the drug、ingredients、Character、Indications or functions、Specification、Usage and dosage、Adverse reactions、Contraindications、Note、Storage、Production date、Product batch number、Validity period、Approval number、Production enterprise, etc.。Indications or functions、Usage and dosage、Adverse reactions、Contraindications、The precautions cannot be specified，The main content of the main content should be marked and the word "see the instructions for details"。
Article 19 for transportation、The tags of the storage packaging，At least the name of the medicine should be indicated、Specification、Storage、Production date、Product batch number、Validity period、Approval number、Production Enterprise，You can also indicate the number of packaging as needed、Precautions for transportation or other marks。
The label of Article 20 The name of the drug should be indicated、Storage、Production date、Product batch number、Validity period、execution standard、Approval number、Production Enterprise，At the same time, it is necessary to indicate the necessary content of packaging and transportation precautions。
21 The same drug produced by the same drug manufacturer，Drug specifications and packaging specifications are the same，The content of its label、Format and color must be consistent; the drug specifications or packaging specifications are different，The label should be obviously different or the specification items are clearly marked。
The My stake betting appsame medicine produced by the same drug manufacturer，According to prescription drugs and non -prescription medicine management，The packaging color of the two should be obviously different。
Article 22 Drugs that have special requirements for storage，It should be indicated at the eye -catching location of the label。
Article 23 The validity period of the drug label shall be based on the year、month、Sequence of the day label，Use four digits for the year，month、Daily use two digits to indicate。Its specific labeling format is "validity to XXXX year XX month" or "validity to xxxx year XX month xx day"; can also be represented by numbers and other symbols as "validity to xxxx.xx." or "validity to xxxxx to xxxxx to xxxxx to xxxxx. /Xx/xx ", etc.。
The label of the validity period of prevention of biological products is implemented in accordance with the registration standards approved by the State Food and Drug Administration，The labeling self -loading date calculation of the effective period of the treatment of biological products，Marking from the validity period of other drugs。
If the validity period is marked to the day，It should be the day before the date of the calculation date，If it is marked to the month，It should be the first month of the previous month of the year。
Chapter 4 Drug Name and Registered Trademark
Article 24 The name of the drug name marked in the drug instructions and labels must meet the naming principles of the common name and product name published by the State Food and Drug Administration，and consistent with the corresponding content of the drug approval document。
Article 25 of the common name of the medicine should be significant、Outstanding，Its font、Font size and color must be consistent，and meet the following requirements:
(1) For the horizontal version tag，It must be marked in a significant position in the previous third range; for the vertical version of the label，Make a significant position in the range of one -third of the right;
(2) Do not choose cursive books、篆，Do not use oblique bodies、hollow、shadow and other forms to modify the fonts;
(3) The color of the font should be used in black or white，A strong contrast with the corresponding light or dark background;
(4) It is impossible to write in except for the limit of packaging size，No branch to write。
Article 26 The name of the drug and goods must not be written with the universal name，Its My stake betting appfont and color must not be more prominent and significant than the universal name，Its font is not greater than one -half of the font used in the universal name。
Article 27 Drugs instructions and labels are prohibited from using unregistered trademarks and other drug names approved by the State Food and Drug Administration。
Drug labels use registered trademark，It should be printed on the corner of the drug label，With text，Its font is not larger than a quarter of the font used in the universal name。
Chapter 5 Other Regulations
Twenty -8 anesthesia drugs、Psychiatric drugs、Medical toxic drugs、Radial drugs、15315_15336，Its manual and label must be printed with specified signs。
The state has special regulations on the drug manual and label of the country，From its regulations。
Article 29 of Chinese medicinal materials、The label management of Chinese medicine drinks is stipulated by the State Food and Drug Administration to formulate it separately。
Article 30 Drug Manuals and Tags do not comply with this regulation，Punishment in accordance with the relevant provisions of the Drug Management Law of the People's Republic of China。
Chapter 6 Attachment
Article 31 This provision shall be implemented from June 1, 2006。The "Pharmaceutical Package released by the National Drug Administration on October 15, 2000、Label and Manual Management Regulations (Interim) "abolition at the same time。
