论文部分内容阅读
根据国家药品监督管理局第23号局令,进一步加强和规范药品的包装、标签管理,确保《药品包装、标签和说明书管理规定》(暂行)的贯彻实施,特制定本细则。 总体要求 一、药品包装、标签必须按照国家药品监督管理局规定的要求印制,其文字及图案不得加入任何未经审批同意的内容。药品的包装分为内包装和外包装。药品包装、标签内容不得超出国家药品监督管理局批准的药品说明书所限定的内容。 二、药品包装、标签上印刷的内容对产品的表述要准确无误,除表述安全、合理用药的用词外,不得印有各种不适当宣传产品的文字和标识,如“国家级新药”、“中药保护品种”、“GMP认证”、
According to the State Drug Administration Order No. 23, to further strengthen and standardize the packaging of medicines, labeling management, to ensure that the “Regulations on the Administration of Pharmaceutical Packaging, Labeling and Manual” (interim) the implementation of the special formulation of these rules. General Requirements 1.Packing and labeling of drugs must be printed according to the requirements stipulated by the State Drug Administration, and their texts and motifs shall not be added to any content that has not been approved. Drug packaging is divided into inner and outer packaging. Drug packaging, the contents of the label shall not exceed the content of drug specification approved by the State Drug Administration. Second, the contents of the drug packaging, labeling printed on the product to be accurate, in addition to the expression of safe, rational use of terms, shall not be printed with a variety of inappropriate propaganda product text and logos, such as “state-level new drugs” “Chinese herbal protection varieties,” “GMP certification”