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Pharmaceutical packaging and printing standards unchanged

2014/6/7      view:
      From the National Food and Drug Administration, the Registry Beijing Food and Drug Administration, Marketing Division, Beijing overhaul the drug packaging materials and other relevant agencies learned: Indian-owned packaging materials that prints (posted outside the pharmaceutical package insert and labeling) Printed scale based upon the March 15, 2006 promulgated the "drug labeling and label management designated" (ie, National Food and Drug Administration Decree 24) execution.
      Related printed scale policy:
      State Food and Drug Administration Order No. 24 "package insert and label management designated" on March 10, 2006 by the State Food and Drug Administration Bureau Works Council, is hereby announced that since June 1, 2006 from the date of promulgation.
      Chapter I General Provisions
      The first order to regulate drug labeling and labeling of governance, according to the "People's Republic of China Drug Treatment Law" and the "People's Republic of China Drug Treatment Act implementing regulations" enactment of this designation.
      The second article in the territory of People's Republic of China marketed drugs, its imitation of single and labels shall comply with the requirements delineated.
      Third package insert and label be approved by the State Food and Drug Administration.
      That labeling should be based on a single copy, which shall not exceed the scope of the content of the instruction sheet shall not be printed imply efficacy, misleading and inappropriate use of text and logo promotional products.
      Article pharmaceutical packaging must be designated in accordance with printed or labeled not entrained He Xianrong or any other promotional products, corporate text, audio and other data. Pharmaceutical production enterprises produce for sale must be accompanied by a minimum package instruction sheet.
      Article textual representation of the package insert and labeling should be scientific, standardized and correct. Non-prescription drugs should also make use of a single imitation easily understandable textual representation, so that the patient self-determination, selection and use.
      Article VI package insert and label text should be clearly legible, logo should be clearly visible, without shedding or printing paste is not strong and so are not allowed to paste, cut, modified or altered, etc. additions.
      Article VII of the drug labeling and labels should use the State Language Work Committee announced the standardization of Chinese characters, the increase in other words control shall be subject to the presentation of Chinese characters.
     Article VIII for the purpose of protecting public health and the fair and accurate medication guide, drug production companies can take the initiative to raise warnings on the package insert or label, the State Food and Drug Administration may also require pharmaceutical production enterprises in imitation of one or Fill warnings on the label.
      Chapter II drug labeling
      Article IX drug labeling should include drug safety, effectiveness of important scientific data, conclusions and information to guide safe, rational use of medicines. Detailed pattern of drug labeling, content and writing requirements formulated and issued by the State Food and Drug Administration.
      Article X of the instruction sheet for the names of diseases, pharmacy professional terms, drug names, clinical presentation and outcome overhaul name drugs, countries should adopt the same terminology enacted or standardized units of measurement shall comply with the designated national scale.
      Article XI drug labeling should list all active ingredients of traditional Chinese medicine Smell all prescription or group. Playing injection and non-prescription drugs should also be listed in the name of all the materials used.
     Prescription drugs contain ingredients may cause severe adverse reactions or materials shall be described.
      Article XII pharmaceutical production enterprises should take the initiative to track the drugs listed in the safety, effectiveness, it is necessary to modify the drug labeling shall promptly submit an application.
      According to adverse drug reaction monitoring, drug re-evaluation results and other information, the State Food and Drug Administration may also require pharmaceutical companies to modify production package insert.
      Article 13 allowed to modify the drug labeling, drug production enterprises should be notified immediately modify the contents of pharmaceutical trading enterprises, and other parts related to the use of units, as required in a timely manner using the instruction sheet and label after modification.
      Article XIV drug labeling should contain sufficient information on adverse drug reactions, specifically indicate adverse drug reactions. Drug companies are not produced in accordance with the listing of drugs safety and effectiveness in a timely manner or not to modify the instruction sheet and adverse drug reactions in imitation of a single fully described adverse consequences arising therefrom shall be borne by the producing companies.