( March 15, 2006 the State Food and Drug Administration Order No. 24, promulgated and shall take effect June 1, 2006 )
Chapter I General
The first to regulate the management of drug instructions and labels , according to "Drug Administration Law" and " Drug Administration Law Implementation Regulations " enactment of this provision .
Article in the PRC marketed drugs, their instructions and labels shall comply with the requirements of the regulations.
Third package insert and label be approved by the State Food and Drug Administration .
That labeling should be based on the specification , the contents shall not exceed the scope of the specification, shall be printed with the implied effect , misleading and inappropriate use of text and logo promotional products .
Article printed pharmaceutical packaging must be labeled in accordance with regulations or not entrainment or any other introductory promotional products , corporate text , audio and other data.
Pharmaceutical production enterprises for sale must be accompanied by a minimum package instructions .
Article written expression package insert and labeling should be scientific, standardized and accurate. Non- prescription drugs should also use the easy to understand instructions textual representation , so that patients make their own judgment , selection and use .
Article VI package insert and label text should be legible , logo should be clearly visible, or may not have come off the printing paste is not strong and so are not allowed to paste, cut , altered , etc. modify or supplement .
Article VII of the package insert and labeling should use the State Language Work Committee announced the standardization of Chinese characters, the increase in other words the control shall be subject to the presentation of Chinese characters .
Article VIII for the purpose of protecting public health and the correct guidance of rational use of drugs , drug manufacturers can take the initiative to raise warnings on the package insert or label , the State Food and Drug Administration may also require drug manufacturers in the manual or on the label fill warnings .
Chapter II drug instructions
Article 9 Pharmaceutical drug safety manual should contain important scientific data validation , conclusions and information to guide the safe and rational use of medicines. Specific package insert format , content and writing required to develop and release by the State Food and Drug Administration .
Article X of the package insert name of disease , pharmacy professional terms , drug name , the name of the clinical examination and results presentation , uniform terminology should be adopted or promulgated national standard units of measurement should be in line with national standards.
Article XI drug instructions should list all active ingredients of traditional Chinese medicine Smell all prescription or group . Injections and non- prescription drugs should also list the name of all the materials used .
Prescription drugs may cause serious adverse reactions containing ingredients or excipients , should be explained.
Article XII of pharmaceutical production enterprises should take the initiative to track the drugs listed on the safety, effectiveness , it is necessary to make changes to the package insert shall promptly submit an application.
According to the monitoring of adverse drug reactions , drug re-evaluation results and other information , the State Food and Drug Administration requires drug manufacturers can modify the package insert .
Article 13 is permitted to modify the package insert , pharmaceutical manufacturers should notify the relevant contents of the modified pharmaceutical trading enterprises , units and other departments use immediately , as required, in a timely manner using the modified instructions and labels .
Article XIV drug instructions shall contain sufficient information on adverse drug reactions , specify in detail the adverse drug reactions. According to the drug manufacturer is not listed drugs safety and effectiveness in a timely manner to modify the specification or not the adverse drug reactions fully described in the specification , the adverse consequences arising therefrom shall be borne by the manufacturer .
Article XV approved package insert date , and modification date shall be prominently marked on the specification.
Chapter III drug label
Article XVI drug label refers to the pharmaceutical packaging printed or posted some of the content is divided into inner and outer labels labels . Direct contact with the drug label refers to the packaging of pharmaceutical labels, packaging labels refer to the label other than the label.
Article XVII of the tag should contain pharmaceutical drugs generic names , indications or content Indications , specifications, usage, dosage, production date, batch number , expiry date, production enterprises.
Package size is too small to be marked above all , at least for generic drugs should be marked name, size , batch number , date and content.
Article 18 Pharmaceutical drugs off-label should indicate the generic name , ingredients , characteristics, indications or functions , specifications, usage, dosage, adverse reactions, contraindications , precautions, storage, production date, batch number , expiry date, the approval number , manufacturers and other content. Indications or functions , usage, dosage, adverse reactions, contraindications , precautions can not be fully specified , shall mark the main contents and marked " see instructions ."
Article XIX label for the transport , storage and packaging of generic drugs should at least indicate the name, size , storage, production date, batch number , expiry date, approval number, manufacturer , you can also specify the number of packaging required, Note that the necessary transport matters or other markings content .
Diershitiao APIs should indicate the name of the drug 's labeling , storage, production date, batch number , expiry date, the implementation of standards , approval number , manufacturer , and need to specify the number of elements necessary packaging and transport precautions.
Article 21 of the same drugs produce the same drug manufacturers , drug specifications and packaging specifications are the same , the content of its label , format and color must be consistent ; pharmaceutical packaging specifications of different specifications or their labels should be clear distinction or specification items clearly marked .
The same drugs in the same drug manufacturers produced , respectively prescription and non-prescription medicines management , both should be significantly different packaging colors .
Twenty- two pairs of drugs stored there special requirements should be prominently marked on the label.
Article 23 The validity of the drug label should be in the order of year, month , day of the mark, with a four-digit year , month , daily two digits . The specific label format is " valid until XXXX XX " or " valid until XXXX XX XX days" ; also use numbers and other symbols as " valid until XXXX.XX." or " valid until XXXX / XX / XX " , etc.
Preventive biological products labeled in accordance with the standards for registration validity of the State Food and Drug Administration approved the execution , validity of therapeutic biological products from the packing date marked , marked the validity of other drugs from the production date .
If the mark is valid to date , should correspond to the starting date prior to the date of the day , if marked to month, should be the starting date of the corresponding month of the previous month .
Use Chapter IV drug names and trademarks
Article 24 Drug Name Drug label instructions and labels must comply with the principles of drugs generic names and naming the State Food and Drug Administration published trade names , and with the drug approval documents consistent with the corresponding content .
Twenty- five generic names of drugs should be significant , highlighting its font, size and color must be consistent and comply with the following requirements:
( A ) For the horizontal version of the label must be prominently marked in the upper third of the range ; For vertical version label must be prominently marked in the right range of third ;
(B ) not selected cursive , seal and other difficult to identify fonts may not use italic, hollow , shadows and other forms of font modification ;
( C) The font color should use black or white, with a corresponding light or dark background in stark contrast ;
(D ) Except for limiting the size of the package and can not peer writing , shall Branch writing .
Article 26 Drug Product name not be written with the generic name counterparts , its font and color may not be more prominent than the common name and the significant area of the font with the word shall not be greater than the generic name used by half of the font.
Article 27 of the package insert and label banned drug names and other unregistered trademarks without the State Food and Drug Administration approval .
Drug labels using the registered trademark shall be printed on the drug label corners, including text , its font to the word of area no larger than a quarter of the generic name of the font used .
Chapter 5 Other Provisions
Article 28 The State of narcotic drugs, psychotropic substances , medicinal toxic drugs, radioactive drugs , topical drugs and non-prescription medicines and other provisions have specific identification of their instructions and labels must be printed on the identification requirements .
State drug instructions and labels have special provisions prevail .
Article 29 Chinese herbs, Chinese Herbal Medicine labeling regulations shall be formulated by the State Food and Drug Administration .
Article 30 of the package insert and labeling does not meet the requirements , be punished in accordance with the relevant provisions of the "Drug Administration Law" .
Chapter VI Supplementary
Article 31 The provisions go into effect June 1, 2006 . State Drug Administration on October 15, 2000 release of " drug packaging , labels and instructions Regulations ( Provisional)" shall be repealed simultaneously .
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