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据悉,卫生部不久前对部分新药品种的包装和说明书进行了审查,发现存在不少违反《药品管理法》及相关法规的现象。检查中发现,有的药品包装中没有附上药品说明书,仅在药品外包装上印制上简单的说明有的药品说明书不一致,如扩大或夸大药品使用范围,更改“用法用量”、“禁忌症”及“注意事项”等;有的使用商品的药品不印制药品通用名称,中成药制剂擅自使用商品名称等;还有的说明书使用文字不规范,用繁体、异体字、汉语拼音和外文而不用中文。
It is reported that the Ministry of Health recently reviewed the packaging of some new drug varieties and specifications, and found that there are many violations of the “Drug Administration Law” and related laws and regulations. Inspection found that some drug packaging did not attach the drug instructions, only printed on the drug packaging on some instructions inconsistent with drug instructions, such as expanding or exaggerating the scope of the use of drugs, change the “usage and dosage”, “contraindications ”And“ precautions ”, etc .; some do not use drugs printed on the generic name of drugs, proprietary Chinese medicines, such as the use of product names without authorization; there are instructions to use the text is not standardized, with different characters, Pinyin and foreign languages instead of Chinese.