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请论述国家关于换发药品批准文号格式的几点说明?

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正确答案:

答:一、凡原卫生部核发的药品批准文号,统一换发为国药准(试)字相应类别,数字前两位为“10”,3、4位为原批准文号年份的后两位数字,后4位顺序号重新编排。

二、2001年12月31日以前由国家药品监督管理局核发的药品批准文号,凡不同于新的批准文号格式的,也按新格式进行统一换发。原年份为“1998”、“1999”的,换发后第1、2位为“19”,原年份为“2000”、“2001”的,换发后第1、2位为“20”,第3、4位仍为原批准文号年份后两位。

三、原省级药品监督管理部门换发的药品批准文号,换发时,应根据其批准文号中的年份简称,在新格式药品批准文号中使用相应省份代码,新批准文号数字第3、4位为换发年份的后两位,顺序号重新编排

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