各区市场监管局、临港新片区市场监管局、机关各处、稽查局：
为规范药品行政处罚行为，根据《行政处罚法》《药品管理法》《医疗器械监督管理条例》等法律法规和规章的规定，结合工作实际，我局制定了《上海市药品监督管理局行政处罚执法文书》（以下简称《执法文书》），已经2021年第3次局长办公会审议通过，现印发给你们。
《执法文书》适用于上海市药品监督管理局稽查局查处办理药品、医疗器械、化妆品行政处罚、行政强制等行政执法案件。
特此通知。
附件：
1、编写说明
2、上海市药品监督管理局行政处罚执法文书目录
3、上海市药品监督管理局行政处罚执法文书（样张）
上海市药品监督管理局
2021年4月6日
（公开范围：主动公开）
附件1
编写说明
一、编写目的
统一药品行政处罚文书，规范药品行政处罚行为，提升药品监管的依法行政水平。
二、适用范围
《执法文书》适用于上海市药品监督管理局稽查局查处办理药品、医疗器械、化妆品行政处罚、行政强制等行政执法案件。
三、文书种类及目录编排
为方便执法人员使用，《执法文书》目录按照行政处罚程序编排，共编写《执法文书》49份。
立案阶段文书6份：《案件来源登记表》、《案件移送函》《涉嫌犯罪案件移送书》《立案审批表》《不予立案审批表》《查封（扣押）财物移送通知书》；
调查取证阶段文书12份：《现场笔录》《授权委托书》《询问通知书》《询问笔录》《限期提供材料通知书》《协助调查函》《协助扣押通知书》《检测/检验/检疫/鉴定委托书》《检测/检验/检疫/鉴定期间告知书》《检测/检验/检疫/鉴定结果告知书》《案件调查终结报告》《行政处罚案件合议记录》；
强制措施阶段文书7份：《先行登记保存证据通知书》《解除先行登记保存证据通知书》《实施行政强制措施决定书》《延长行政强制措施期限决定书》《解除行政强制措施决定书》《场所/设施/财物清单》《先行处理物品通知书》；
处罚告知和听证阶段文书5份：《行政处罚告知书》《行政处罚听证告知书》《行政处罚听证通知书》《听证笔录》《听证报告》；
案件审批和处罚决定阶段文书10份：《行政处罚案件有关事项审批表》《行政处罚案件有关事项报请市药监局审批表》《责令改正通知书》《案件审核表》《复核意见》《行政处理决定审批表》《当场行政处罚决定书》《行政处罚决定书》《不予行政处罚决定书》《涉案物品处理记录》；
强制执行阶段文书3份：《延期/分期缴纳罚款通知书》《行政处罚加处罚款决定书》《行政处罚决定履行催告书》；
结案归档阶段文书4份：《结案审批表》《行政处罚案件卷宗封面》《卷内文件目录》《卷内备考表》；
通用文书2份：《当事人送达地址确认书》《送达回证》。
四、文书编号
《执法文书》使用文书编号方案如下：
沪药监稽+文书类别+字+年号+第+机构代码+年号+顺序号+号，机构代码为市市场局行政处罚系统自动生成的编号，顺序号采6位流水号。
比如《上海市药品监督管理局询问通知书》，文书编号为沪药监稽询通字〔2021〕第362021000001号，其中36为市市场局行政处罚系统自动生成的机构代码编号，2021为年份，最后6位数字为案件流水号。
附件2
目录
1．案件来源登记表······························1
2．案件移送函·································2
3．涉嫌犯罪案件移送书··························3
4．立案审批表·································4
5．不予立案审批表····························5
6．行政处罚案件有关事项审批表················6
7．行政处罚案件有关事项报请市药监局审批表·····7
8．现场笔录···································8
9．当事人送达地址确认书·······················12
10．授权委托书·································13
11．询问通知书·································14
12．询问笔录···································15
13．限期提供材料通知书·························18
14．协助调查函··································19
15．协助扣押通知书······························20
16．先行登记保存证据通知书·······················21
17．解除先行登记保存证据通知书···················22
18．实施行政强制措施决定书·······················23
19．延长行政强制措施期限决定书··················25
20．解除行政强制措施决定书·······················26
21．场所/设施/财物清单···························27
22．查封（扣押）财物移送通知书····················29
23．先行处理物品通知书····························30
24．检测/检验/检疫/鉴定委托书·····················31
25．检测/检验/检疫/鉴定期间告知书·················32
26．检测/检验/检疫/鉴定结果告知书·················33
27．责令改正通知书································34
28．案件调查终结报告······························35
29.行政处罚案件合议记录··························37
30．案件审核表····································38
31．复核意见······································39
32．行政处罚告知书································40
33．行政处罚听证告知书····························41
34．行政处罚听证通知书····························42
35．听证笔录······································43
36．听证报告······································47
37．行政处理决定审批表····························49
38．当场行政处罚决定书····························50
39．行政处罚决定书································52
40．不予行政处罚决定书····························54
41．延期/分期缴纳罚款通知书·······················55
42．行政处罚加处罚款决定书························57
43．行政处罚决定履行催告书························58
44．送达回证······································59
45．涉案物品处理记录······························60
46．结案审批表····································62
47．行政处罚案件卷宗封面··························63
48．卷内文件目录··································64
49．卷内备考表····································65
附件3上海市药品监督管理局行政处罚执法文书（样张）下载：
