药品说明书和标签管理规定（Provisions for the administration of drug instructions and labels）.docVIP

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药品说明书和标签管理规定（Provisions for the administration of drug instructions and labels）.doc

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药品说明书和标签管理规定（Provisions for the administration of drug instructions and labels）

药品说明书和标签管理规定（Provisions for the administration of drug instructions and labels） The drug instructions and labeling provisions (March 15, 2006 the State Food and Drug Administration promulgated by Decree No. twenty-fourth since June 1, 2006) Chapter I General Provisions Article 1 to regulate the management of drug instructions and labels, according to the Peoples Republic of China Drug Administration Law and the Peoples Republic of China implementation of the drug administration law of the enactment of this Ordinance. Second of the drug marketed within the territory of Peoples Republic of China, the directions and labels shall meet the requirements of the provisions. The third drugs manual and labels shall be approved by the State Food and drug administration. Drug labels should be on the basis of the specification, the content shall not exceed the scope of the specification shall be printed with the implied effect, misleading and inappropriate use of advertising text and logo. Fourth packages of pharmaceuticals must be labeled in accordance with the provisions, and shall not carry any other enterprise or promotional products, text, audio-visual and other information. The minimum packaging manufacturer for marketing of the drug must be accompanied by instructions. The fifth drugs manual and description of the label shall be scientific, standardized and accurate. Non prescription drug should use easy to understand words, so that the patients on their own judgment, selection and use. Sixth words in pharmaceutical directions and labels shall be legible marks shall be clear and eye-catching, cant be ablated or loose adhesion phenomenon, not to paste, shear and altered modified or supplemented. The seventh drugs manual and labels should use standard Chinese characters the State Language Work Committee announced, the versions in other languages, to be described as quasi Chinese characters. Eighth for the protection of public health and to guide the rational use of drugs, d