马来西亚传统药物及食品注册法规解读
√ ቤተ መጻሕፍቲ ባይዱ√
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２ ４ 质量要求 ． ２ ４ １ 重金属 （ ．． 见表 ２ ）
表 ２ 重 金属 限量要 求
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９ 销 售授 权 （ 品许 可证 ） 有人 产 持 名称 和地址
１ 产 品 名称和 剂型 ２ 活 性成 分及 含量 ３ 成 分及 食用 量／ 防腐 剂用 量 （ 限液 体制 剂） 仅
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４ 动 物 源成 分 应声 称来 源 ， 括胶 质 包 （ 性成 分 、辅料， 或 胶囊 壳） 活 和／ √ Ｖ 图 １ 马来西 亚传 统药 物 注册流 程 图
５
６
胶 囊
丸剂
３ ｉ ０ｍｎ １０ｍｎ ２ ｉ
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２ ５ １ 功 能宣称 对 于不 同产 品， ． ． 可根据 产品特性 申请具体
的功 能及描述宣称， 以下列出 １ Ｏ个可 申请的功能范畴： 维持身
注 ：崩 解 时限要 求仅 限片 剂 、胶 囊和 丸剂
２ １ 年 １ 月第 １ 卷第 １ 期 ０１ ２ ８ ２
可跻 身马来人市场， 对于 中药产 品进入穆斯林人 群将 奠定 良好
的人 群基础 。马来西亚本 身也是一个草药资源丰富 的国家， 东 哥阿里等药材 已经为 当地人广泛使用在 药品或食 品中， 这就为 中草 药产 品的引入奠定了一定的基础 。 随着 ２ １ ０ ０年 １月中国一 东盟 自由贸易区的启动， 国与东盟各 国间涉及 中药类商品的 我 关税大幅降低， 推动了中药贸易快速增长 。为此， 本文 就中草药 产 品在马来 西亚 的上 市途径及 相关法规技 术要求试 作论述 如 下。
２ １ 年 １ 月第 １ 卷第 １ 期 ０１ ２ ８ ２
中国中医药信 息杂志
・中 医 动 态
・
马来西亚传统药物及食 品注册法规解读
邹士玉， 唐青涛
（ 限 极 （ 国 ） 限公 司 ， 东 广 州 ５０ ６） 无 中 有 广 １６ ５
关键 词： 中药；马来西亚；传统药物；食品 ；注册法规
１ 制造 商名称 和地 址 Ｏ １ 注 册 号码 １ １ 储 存 方法 ２
√
ｌ 包装 规格 ３
１ 建议 食用量 ４
１ 警示 语 （ ５ 如有 ） ｌ 植物 使用 部位 ６
ｌ 不包 衣 片
≤ ３ ｎ ０ ｍｉ ≤ ３ ｉ Ｏ ｍｎ ≤ ６ ｉ Ｏ ｍｎ
一
马来西亚要求所有在马来西亚生产、进 口、 销售 的药 品都
要在 Ｄ Ａ进行登记注册 。 Ｃ 若外 国公司希望产 品以药 品形式进
入马来西亚， 必须在 申请注册前指定马来西亚注册的一家当地
公司作为产品注册证书的持有人。 这个公司将负责产品注册相 关的所有事务或所有的注册事务都要 以这个 公司的名义进行 。
２ ３ 注册 中请 流程 ．
马 来 西 亚 的药 品注 册 均 通 过 网上 提 交 资 料 ， 方 也会 通 过 官
网络把反馈意见返 回给 申请者， 申请人只需向 Ｂ Ｆ 购买一张 ＰＫ 聪 明卡 （ｍ ｒ ａ ｄ ， Ｓ ａ ｔＣ ｒ ） 就可以通过网络完成注册 申请。注 册 申
请 流 程 见 图 １ 。
银杏 叶／ 银杏提取物 、竺葵属植物 、来 自海产 品的物质 、樟脑 、
紫花苜蓿 、金丝桃草 （ 叶连翘） 还有 固定的警示语要 求。 贯 等，
２ ５ ３ 语 言要 求 马来西亚要求所有药 品的标签和药 品说明 ．．
ｃｕ ｍ ） ②胆汁耐受革兰 氏阴性菌 ４２ ０ Ｃ Ｕ ｇ 或 ＣＵ ｍ ） Ｆ／Ｌ； ×１ Ｆ ／ （ Ｆ ／ Ｌ ；
③１ｇ或 １ｍ Ｌ中没有大肠埃希氏；④ｌｇ或 １ｍ Ｌ中没有沙 门氏
菌。
２ ５ 产品标签 （ ． 见表 ４ ）
表 ４ 产 品标签 要求 序 号 项目 内包材 外箱 说 明书 泡 罩包 装
ｌ 酒精 含量 （ 有） ７ 如 １ 维生 素／ ８ 复合 维生 素／ 矿物 质 作为 膳食补 充 剂 的 ＲＡ（ 选） Ｄ 可 ｌ 避免 儿童 获得 （ ９ 马来文 和英 文） ２ 其他 （ 有） Ｏ 如
√ √
２
３ ４
包衣 片
糖衣 片
肠溶 衣 片 酸溶 液 中 １０ｍ ｎ不分解 ， 冲 液 中 ６ ｉ ２ ｉ 缓 ０ｍ ｎ分解
２４ ４２ 完全 由一种或多种草药 （ ．．． 整个或部分或粉末） 组成的 草药制 品 使 用前添加 沸水 的草药制 品， 需氧 微 生物 总量 ≤
２ ０ ＣＵ ｇ 或 Ｃ Ｕｍ ） ×１ Ｆ ／ （ Ｆ ／ Ｌ ；酵 母 菌＆ 霉菌 总 量 ４２ Ｏ ＣＵ ｇ 或 ×ｌ Ｆ ／ （
中国中医药信 息杂志
快， 大概 ３个月就可 以完成。 但值得注意的是， 马来西亚对于可 使用 的食 品清单 并没有详 细列 出， 是否食 品原料还需根据马来 西亚 的食用 习惯结合具体审批官员的认知来决定。 因此对 于大 部分 中草药原料， 当局均会 认为其为 非食品， 如果配方 中使用 量超过 ２ ％ 则可 能被要求进行药品注册 。 ０， ３ ３ 质量要求 ． 马来西 亚食 品标准 是 由马来 西亚行业标准 委员会 （Ｓ ｓ ＩＣ ） 制定的 。马来西亚采用 的食品相关 标准参考 了国际标准化组 织、国际食品法典委员会、国际认证论坛等国际性组织所制定
Ｄ ｌ １ ． ９ ９ ｊ ｉ ． ５ ５ ０ ． ０ １ １ ． ０ Ｏ ： ３ ６ ／ ． ｓ １ ０ － ３ ４ ２ １ ． ２ ０ １ ０ Ｓｎ ０
中图分 类号 ：Ｒ ０ ３ 一 １
文献标识码 ：Ｃ
文章编号：１０ ．３ ４２ １）２０ Ｏ —４ ０ ５５０ （０ １ｌ－Ｏ １０ １ 介乎食品与药品之间的产品 在马来西亚， 越来越 多人关注 自己的健康而选用一些 “ 膳 食补 充产 品／ 保健产 品” 来强身健体 。 而很多时候， 这些产 品的 成 分复杂， 而且在 市面上很容 易获得， 甚至有 的还宣称 可 以治 疗一些慢 性疾 病。于此同时， 很多 当地企业在对如何在市场上 合法地销售 自己的 “ 保健产 品”也有很多困惑。鉴于此 ， 了 为 更好 地解决这些 问题， 并让政府 能快速地定性 一个 产品， 马来 西亚卫生部在 ２ ０ ０ ０年设立了一个 专门的委 员会来分类那些介 乎食 品与 药品之 间 （ｏ ｄ Ｄ ｕ ｎ ｅ ｆ ｃ ， Ｄ ） Ｆ ｏ — ｒ ｇ Ｉ ｔｒ ａ ｅＦ Ｉ 的产 品， 并协 助相关负责部 门去区分食品和药品 。
２ 药 品
２１ 法规 ．
够在健康 人中产生相 同症状 的药剂） Ⅲ。它由马来西亚药品管 理局 （Ｐ Ｋ 和 马来西亚药 品监管机构 （Ｃ ） Ｂ Ｆ） Ｄ Ａ 负责管理 。
在 马 来西亚 ， 当一部 分 的中草 药产 品注册 为传 统 药物 相 （ 当然 也有一部 分作 为非处方药产 品或膳 食补充剂进 行注册， 本文对此 不作论述） 。传统药物是指在本土 医学中使用的包含
生 产传 统 药 物 的 工 厂必 须 是 Ｇ Ｐ 工 厂 ， 关要 求 也 详 细 列 明在 Ｍ 相
２ ４ ３ 装量 差异 ．．
均 重 量 的 ±２％ ０。
仅 限片剂／ 胶囊产 品。不能多于 ２个胶囊／
马来西亚的 《 健康补充品和传统药物 良好操作规范指南》 中。 ２ ２ 注册 中请材料清单 ．
ＣＵｍ） Ｆ ／Ｌ ；特 定 的微 生物 ：大肠 埃希 氏菌 ≤２ ０ Ｆ ／ （ ×１ Ｃ Ｕ ｇ 或 ｃ Ｕ ｍ ） 使 用前不添 加沸 水 的草 药制 品， 氧微 生物 总量≤ Ｆ ／Ｌ 。 需 ２ ０Ｃ Ｕ ｇ 或 Ｃ Ｕ ｍ ） ×１ Ｆ ／ （ Ｆ ／Ｌ ；酵母菌＆ 霉菌 总量４２ ０ ＣＵ ｇ或 ×１ Ｆ ／ （ ＣＵ ｍ ） Ｆ ／Ｌ ；特 定的微生物 ：①大肠埃希 氏菌≤２ ０ Ｆ ／ （ ×１ ＣＵ ｇ 或
书 （ 内有 效 件 ） 当地 公 司 （ 册 申请 者） 册 证 书 等 。 ２年 和 注 注
２４４１ 含 有天然源 （ 、植物或矿物） ．．． 动物 原材料 的 口服剂 型
产 品 需氧微生物总量４２ ０ Ｆ ／ （ Ｃ Ｕｍ ） ×１ ＣＵ ｇ 或 Ｆ ／ Ｌ ；酵母菌＆ 霉菌总量 ４２ ０ ＣＵ ｇ 或 ＣＵ ｍ ） ×１ Ｆ ／ （ Ｆ ／ Ｌ ；特 定的微 生物 ：①胆汁 耐受革兰 氏阴性菌≤２ ０Ｃ Ｕ ｇ或 Ｃ Ｕ ｍ ） ② １ ×１ Ｆ ／ （ Ｆ／ Ｌ ； ０ｇ或 １ Ｌ ０ ｍ 中没有沙 门氏菌 ；⑨１ｇ或 １ｍ Ｌ中没有大肠埃希 氏菌；④ １ｇ 或 １ｍ Ｌ中没有金黄葡 萄球菌 。
的有 关标 准 和 准 则 。
体健康， 血液／ 体液 ， 骨骼 、肌 肉／ 关节， 疼痛／ 发烧 ， 咳嗽／ 感冒， 消化系统， 女性健康 ， 男性健康和皮肤／ 外用等 。
２ ５ ２ 警 示语 因马来西亚有 超过 ７％ ． ． ０ 的穆斯林人 ， 因此产
品标签 对 于穆斯 林人 的使用 有特 殊 的规 定， 对于 动物来 源 如 （ 尤其是猪 原料 来源） 酒精成分等， 、 均需 明确标 出。 于人 参、 对 番泻 叶 （ 肉桂） 和大黄／ 大黄根 、白屈菜提取物 、蜂胶 、蜂王浆 、
中医药 作为中国的 国粹， 一直以来都是我 国的优势产业 。 随着全球经济一体化 的深 入， 国中药产业也开始融入 国际医 我 药市场 。但从 出 口市场的结构分析看， 马来西亚和新加坡等 以 华人为主 的一些市场就 占了中药出 口额 的 ４成左右 。另外， 中草药产 品在世 界的发展受到很多 限制， 如文化壁垒 、技术壁 垒 ， 品安全性问题。等 。因此， 产 。 业界也陆续在研究世界各 国 的法规及 中草药产 品的发展前景 。 马来西亚是 一个 多元种族 国家， 要民族为马来人 、华人 主 和印度人， 国家经济发展 良好， 政局稳定 ；另外， 作为 以伊斯兰 教为国教的 国家， 政府致 力打造清 真食品中心 。 因此， 如果产品
(法律法规)马来西亚食品法规
Food Act 1983An act to protect the public against health hazards and fraud in the preparation, sale and use of food, and for matters incidental thereto or connected therewith.（法律法规）马来西亚食品法规。
[Come into force 1-10-1985. P.U. (B) 446]BE IT ENACTED by the Duli Yang Maha Mulia Seri Paduka Baginda Yang di-Pertuan Agong with the advice and consent of the Dewan Negara and Dewan Rakyat in Parliament assem bled, and by the authority of the same, as follows:Arrangement of Sections:PART ISectionPRELIMINARY1. Short title, application and commencement.（法律法规）马来西亚食品法规。
2. Interpretation.PART IIADMINISTRATION AND ENFORCEMENT3. Appointment of analysts and authorised officers.4. Powers of authorised officers.5. Power to take sample.6. Procedure for taking sample.（法律法规）马来西亚食品法规。
7. Certificate for analyst.8. Power to call for information.9. Power of the Director General to obtain particulars of certain food ingredients.10. Director may order premises or appliances be put into clean and sanitary condition.11. Closure of insanitary premis es.12. Conviction publishe d in newspapers.PART IIIOFFENCES AND EVIDENCE13. Adulteration.（法律法规）马来西亚食品法规。
东南亚国家药品通用技术注册要求
东南亚国家药品通用技术注册要求一、本文概述1、东南亚国家的药品注册法规背景和环境东南亚国家药品注册法规的背景和环境较为复杂，由于各国的政治、经济和文化状况不同，导致药品注册的要求和程序也存在一定的差异。
然而，近年来，随着全球化的发展，东南亚国家的药品注册法规逐渐趋向于统一。
首先，让我们了解一下东南亚国家的药品市场现状和发展趋势。
东南亚地区的药品市场呈现出持续增长的态势，由于人口老龄化、生活方式改变以及疾病谱的变化，使得药品需求不断增加。
同时，东南亚国家也在加强药品研发和生产方面的投入，努力提高本地区的药品供应能力和水平。
在药品安全性和质量标准方面，东南亚国家普遍重视药品注册的技术要求，以确保药品的安全性和质量。
各国均按照国际药品注册的技术要求，制定了本国的药品注册技术规范，对药品的安全性、有效性和质量进行严格的审查和评估。
政府对药品注册管理制度的政策和态度也是影响药品注册的重要因素。
东南亚国家逐步加强了对药品注册的监管力度，以确保公众的健康和安全。
政府也鼓励和支持创新药物的研究和开发，为创新药物提供政策支持和税收优惠等激励措施。
总之，东南亚国家的药品注册法规背景和环境存在着一定的差异，但各国都在努力提高药品注册的技术要求和监管水平，以确保药品的安全性和质量。
政府也在积极推动药品研发和生产的创新发展，以满足本地区日益增长的药品需求。
2、编写本大纲的目的和意义东南亚国家药品通用技术注册要求是一份用于指导药品注册申请人在东南亚国家进行药品注册的指南。
本大纲旨在帮助申请人在不同的东南亚国家进行药品注册，确保申请人在提交注册申请前符合各国的要求和标准。
随着东南亚国家医药行业的不断发展，越来越多的药品生产企业开始关注东南亚市场。
然而，由于各个国家的法规和标准不同，药品注册申请人在不同国家进行注册时需要遵守不同的要求和程序。
因此，编写本大纲的目的在于帮助申请人了解并遵守东南亚国家的药品注册要求，简化注册流程，提高注册效率，从而推动药品在东南亚市场的流通和销售。
马来西亚药品进口程序
马来西亚中药保健品进口程序及要求马来西亚全国人口约2300万，由马来人、华人和印度人三大民族构成。
马来西亚属于英联邦国家，西医西药是主要的医疗手段和应用药物，传统天然药物（包括中药及保健品）在市场上占有市场份额约为20%，而且有上升的趋势。
中药在民间，特别是华人社会被认可，但并未得到政府医院及私立医院的完全接受。
只有很少几家华人经营的私立医院聘请中医师门诊并经营中药，绝大部分传统药物是通过中药店和传销商与消费者见面。
1、马来西亚药品及保健品进口的有关法律、法规共八项，马来西亚不存在因其有法律法规的管制而使我国中药无法以药物名义进口的现象。
八项法规分别为：1952年食品及药品销售法令、1984年药品及化妆品控制条例、1983年药品（广告和销售）法令、1952年毒品法令、专利权法令、农业法令、野生动物保护法令、商品说明法令。
2、马来西亚对我国中药及保健品的进口关税水平和非关税措施。
马来西亚对于中药的进口关税为零，保健品的关税为10%，但在马来西亚市场上销售的药品、保健品必须取得马来西亚卫生部药品监督局（Drug Control Authority，简称DCA）的注册许可。
如无特殊疑问，海关不对中药及保健品进行海关估价，进口费用与其他产品并无区别，数量上也无限制，完全由市场需求调控。
3、马来西亚中药及保健品进口程序、要求及有关负责部门。
马来西亚没有针对中药及保健品的进口程序，涉及的政府部门包括海关（进口）、农业部（动植物检疫）和卫生部（药品注册）。
也没有单独的中药典。
药品检验标准为：重金属不得超过限量：铅（Pb）10ppm，砷(As) 5ppm，汞(Hg) 0.5ppm，铬(Cd) 0.6ppm。
溶解时间不得低于：素片（30分钟），薄膜片（30分钟），糖衣片（60分钟），胶囊（30分钟），丸（120分钟）。
微生物限定量共分为四类，分别为局部用于呼吸道和皮肤贴片的制剂、口服和直肠投药制剂、口服制剂和草药制剂含有一种或者多种植物药。
东南亚药包材法规
东南亚药包材法规一、东南亚药包材法规概述东南亚药包材法规是指针对药品包装材料和容器的设计、生产、检验、注册和使用的法规。
这些法规旨在确保药品的安全、有效和质量可控，从而保障患者用药安全。
东南亚地区各国，如泰国、马来西亚、新加坡、印度尼西亚等，都制定了相应的药包材法规。
二、东南亚药包材法规的关键内容1.法规框架东南亚药包材法规框架大致相似，主要包括以下几个方面：（1）药包材定义与分类：明确药包材的定义，将其分为一类药包材（如注射剂瓶、输液瓶等）和二类药包材（如外包装、说明书等）。
（2）药包材生产企业资质要求：生产企业需具备一定的生产规模、设备和技术能力，并符合药品生产质量管理规范（GMP）要求。
（3）原料和添加剂管理：对药包材的原料和添加剂进行严格管理，要求其符合相关药用要求。
（4）设计与研发：要求药包材设计与研发应基于药物特性，确保药包材与药物相容性良好。
2.法规要求东南亚药包材法规对药包材的生产、检验、注册和上市环节均有严格要求，主要包括：（1）生产过程质量控制：生产企业需建立完善的质量控制体系，确保生产过程符合法规要求。
（2）检验方法与标准：药包材检验需遵循国家标准或国际标准，对药包材的物理、化学、生物学等性能进行严格检测。
（3）注册审批：药包材生产企业在投放市场前，需向相关部门申请注册，经审批合格后方可上市。
（4）说明书与标签：药包材说明书和标签应包含相关信息，如药品名称、用法、规格、生产日期等。
3.法规执行情况东南亚各国药包材法规执行情况不尽相同，但总体上都取得了一定的成效。
通过监管，促使药包材生产企业提高产品质量，降低安全隐患。
三、我国在东南亚药包材市场的机遇与挑战1.机遇（1）市场需求：东南亚地区经济发展迅速，人口众多，药品市场规模逐年扩大，对药包材需求不断增长。
（2）产业转移：随着我国药包材产业技术不断提升，国际竞争力逐渐增强，有望承接更多海外订单。
（3）政策支持：我国政府鼓励企业“走出去”，积极参与国际市场竞争，提高国际市场份额。
马来西亚 1985年 食品法令 Food Act 1983
FOOD ACT 1983Part I Preliminary1 Short Title, Application and Commencement(1) This Act may be cited as the Food Act 1983 and shall apply throughout Malaysia.(2) This Act shall come into force on such date as the Minister may by notification in the Gazette appoint and the Minister may appoint different dates for the coming into force of this Act for different States in Malaysia or for different provisions of this Act.2 InterpretationIn this Act, unless the context otherwise requires -"advertisement" includes any representation by any means whatsoever for the purposes of promoting directly or indirectly the sale or other disposal of any food;"analyst" means any analyst appointed under section 3;"animal" includes any quadruped or bird either domesticated or otherwise, fish, reptile or insect; whole or part of which are used for human consumption;"appliance" includes the whole or any part of any utensil, machinery, instrument, apparatus, or article used for or in connection with the preparation, preservation, packaging, storage, conveyance, distribution or sale of food;"approved laboratory" means any laboratory approved by the Minister under section 3A;"authorized officer" means any medical officer of health or any assistant environmental health officer of the Ministry of Health or of any local. authority, or any suitably qualified person, appointed by the Minister to be an authorized officer under section 3;"compoundable offence" means an offence under this Act or any regulation made under this Act and prescribed to be a compoundable offence by regulations made under this Act;"Director" means the Deputy Director General of Health (Public Health) of the Ministry of Health;"Director General" means the Director General of Health of the Ministry of Health;"entertainment" includes any social or other form of gathering, amusement, festival, exhibition, performance, game, competition, sport or trial of skill;"food" includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances;"food premises" means premises for or in connection with the preparation, preservation, packaging, storage, conveyance, distribution or sale of any food, or the relabelling, reprocessing or reconditioning of any food;"import" means to bring or cause to be brought into Malaysia by land, water or air for the purpose of sale from any place outside Malaysia but does not include the bringing into Malaysia of any food which it is proved is intended to be taken out of Malaysia on the same vehicle, vessel, or aircraft on which such food was brought into Malaysia without any transhipment or landing;"importer" includes any person who, whether as owner, consignor, consignee, agent or broker, is in possession of, or is otherwise entitled to the custody or control, of the imported food;"International Health Regulations" means the International Health Regulations as adopted by the World Health Assembly in 1969 and as amended from time to time;"label" includes any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, painted, embossed or impressed on, or attached to or included in, belonging to, or accompanying any food;"medical examination" includes physical, micro-biological, chemical, serological. and radiological examination, and such examination may include the taking of specimen of any body fluid, tissue or waste product for examination or analysis;"package" includes anything in which or any means by which food is wholly or partly cased, covered, enclosed, contained, placed or otherwise packed in any way whatsoever and includes any basket, pail, tray or receptacle of any kind whether opened or closed;"premises" includes -(a) any building or tent or any other structure, permanent or otherwise together with the land on which the building, tent or other structure is situated and any adjoining land used in connection therewith and any vechicle, conveyance, vessel or aircraft; and(b) for the purposes of section 4 any street, open space or place of public resort or bicycle or any vehicle used for or in connection with the preparation, preservation, packaging, storage, conveyance, distribution or sale of any food;“preparation” includes manufacture, packaging, processing and any form of treatment;“seal” includes the detention in bulk of any fo od, a sample of which has been taken for analysis, pending the result of the analysis;“sell or sale” refers only to sale for human consumption or use and include barter and exchange, offering or attempting to sell, causing or allowing to be sold, exposing for sale, receiving, sending, conveying or delivering for sale or exchange or in pursuance of such sale or exchange, supplying any food where consideration is to be received by the supplier for such supply either specifically or as part of a service contracted for sale, or having in possession any food for sale or exchange, or having in possession any food or appliance knowing that the food or appliance is likely to be sold or offered or displayed or exposed for sale or disposed of for any consideration, and includes electronic sale;“tobacco” means any product obtained from the leaf of Nicotiana Tobacum plant or other related plants and includes any tobacco product;“tobacco product” means tobacco, cigarette or cigar or any other form of tobacco including any mixture containing tobacco which is designed for human consumption but excludes any medicinal product controlled under the Poisons Act 1952 or the Control of Drugs and Cosmetics Regulations, 1984;“vegetable substance” means any plant or part of a plan t, and includes the stem, root, bark, tuber, rhizome, leaf, stalk, inflorescence, bud, shoot, flowers, fruit and seed, or an extract thereof.Part II Administration and Enforcement3 Appointment Of Analysts And Authorized Officers(1) The Minister may appoint such number of analysts as he may consider necessary for the purposes of this Act and may make regulations concerning their qualifications, conduct and duties, and shall prepare or cause to be prepared a list of appointed analysts and revise it as the circumstances may require.(2) The Minister may appoint such number of authorized officers as he may consider necessary for the purposes of this Act and every authorized officer shall be issued with a Certificate of Authorization which certificate shall in any legal proceedings under this Act be admissible in evidence and shall be prima facie evidence of the facts so certified.(3) The Minister may, in relation to any matter which appears to him to affect the general interests of the consumer, authorize any public officer to procure for analysis samples of any food, and thereupon that officer shall have all the powers of an authorized officer under this Act, and this Act shall apply as if the officer was an authorized officer.(4) The analysts and authorized officers appointed under this section shall be deemed to be public servants within the meaning of the Penal Code.3A Approved Laboratories(1) The Minister may, by order , approve such number of laboratories as he may consider necessary for the purposes of this act.(2) A laboratory approved under subsection (1) shall be issued with a Certificate of Approval which certificate shall, in any legal proceedings under this Act, be admissible in evidence and shall be prima facie evidence of the facts so certified.(3) The Minister shall prepare or cause to be prepared a list of approved laboratories and revise it as the circumstances may require.4 Power of Authorized Officer(1) An authorized officer may at any time for the proper and better performance of his duty -(a) enter any premises which he believes to be food premises and examine any food found therein and take samples of such food, and examine anything that he believes is used or capable of being used for the preparation, preservation, packaging, storage, conveyance, distribution or sale of the food;(b) stop, search or detain any aircraft, ship or vehicle in which he believes on reasonable grounds that any food to which this Act applies is being conveyed and examine any such food and take samples thereof for the purposes of this Act, except an aircraft, ship or vehicle making an international voyage in respect of which the International Health Regulations apply.(c) open and examine any package which he believes contains any food to which this Act applies;(d) examine any books, documents or other records found in any food premises that he believes contain any information relevant to the enforcement of this Act with respect to any food to which this Act applies and make copies thereof or take extracts there from;(e) demand the production of the National Registration Identity Card, the Business Registration Certificate or any other relevant document which the authorized officer may require;(f) seize and detain for such time as may be necessary any food or appliance by means of or in relation to which he believes any provision of this Act has been contravened; or(g) mark, seal or otherwise secure, weigh, count or measure any food or appliance, the preparation, preservation, packaging, storage, conveyance, distribution or sale of which is or appears to be contrary to this Act. (1A) In the course of the exercise of his powers under subsection (1) an authorized officer may examine orally the owner, occupier or person in charge of the food premises, or any person found in the food premises, whom he believes to be acquainted with the facts and circumstances of any matter under this Act(1B) A person examined under subsection (1A) shall be legally bound to answer truthfully all questions put to him.(1C) Any authorised officer examining a person under subsection (1A) shall first inform that person of the provisions of subsection (1B).(1D) A statement made by a person under subsections (1A) and (1B) shall, whenever possible, be reduced into writing and signed by the person making it or affixed with his thumb print, as the case may be, after it has been read to him in the language in which he made it and after he has been given an opportunity to make any correction he may wish.(1E) Any statement made and recorded under this section shall be admissible as evidence in any proceedings in Court.(2) An authorized officer acting under this section shall, if so required, produce his Certificate of Authorization.(3) Any owner, occupier or person in charge of any premises entered by any authorized officer pursuant to paragraph (a) of subsection (1), or any person found therein, who does not give to the authorized officer all reasonable assistance in his power or furnish him with all the information as he may reasonably require, commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.(4) Any person who obstructs or impedes any authorized officer in the course of his duty or prevents or attempts to prevent the execution by the authorized officer of his duty commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.(5) An authorized officer may arrest without warrant any person whom he has reason to believe to have committed an offence under this Act or any regulation made thereunder if the person fails to furnish his name and address or there are reasonable grounds for believing that he has furnished a false name or address or that he is likely to abscond: Provided that when any person has been arrested as aforesaid he shall thereafter be dealt with as provided by the Criminal Procedure Code.(6) Any person who knowingly makes any false or misleading statement either verbally or in writing to any authorized officer engaged in carrying out his duty commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.(7) An authorized officer shall release any food seized by him when he is satisfied that all the provisions of the Act with respect to it have been complied.(8) Where an authorized officer has seized any food and the owner or the person in whose possession the food was at the time of seizure consents in writing to its destruction, the food may be destroyed or otherwise disposed of as the authorized officer may direct and if the owner or the person does not consent to the destruction of the food, the authorized officer may apply to a court for the destruction or disposal of the food or any appliance and the court may make an order as it may deem fit, notwithstanding that the owner or the person has not been convicted of any offence in connection with the food.(9) Where an authorized officer has seized any food which is perishable in nature and the owner or the person in whose possession the food was at the time of seizure does not consent in writing to its destruction, the responsibility for proper storage of such food so as to prevent it from deterioration, spoilage, damage or theft, pending judgement by the court, lies with the owner or such person.(10) Where any food or appliance has been seized and detained under paragraph (f) of subsection (1) and the owner thereof has been convicted of an offence the food or appliance may be destroyed or otherwise disposed of as the court may direct.(11) Notwithstanding any other provisions of this section an authorized officer may destroy any food wherever found which is declayed, putrefied or injurious to health or food the importation of which is prohibited or food which is surrendered by the owner for destruction on payment by him of reasonable charges.(12) Any person who removes, alters or interferes in any way with any food seized or sealed under this Act without the authority of an authorised officer commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.(13) Any food seized may at the option of an authorised officer be kept or stored in the premises where it was seized or may at the direction of an authorised officer be removed to any other proper place.(14) An authorised officer may submit any food seized by him or any sample from it or any other sample taken by him to any approved laboratory for analysis or examination.(15) (Deleted).5 Power To Take Sample(1) On payment or tender to any person selling food or to his agent or servant, of the current market value of the food, any authorized officer may at any place demand and select and take or obtain samples of the food for the purpose of analysis.(2) An authorized officer may at any place demand and select and take or obtain samples for the purpose of analysis without payment from any manufacturer making food for sale or from any importer of any food or from his agent or servant.(3) Any such authorized officer may require the person or his agent or servant to show and permit the inspection of the package in which such food is at the time kept and to take therefrom the samples demanded.(4) Where any food is kept for retail sale in an unopened package, no person shall be required by any authorized officer to sell less than the whole of the contents of such package.(5) Any person who refuses or neglects to comply with any demand or requisition made by an authorized officer in pursuance of this section commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.6 Procedure For Taking Sample(1) Where it is intended to submit any sample of any food for analysis the authorized officer purchasing or otherwise procuring the sample shall inform the seller or his agent or servant selling the food that he intends to have the sample analysed by an analyst.(2) The procedure for taking and dealing with the samples shall be as prescribed by regulations.7 Certificate Of Analyst(1) The certificate of the analyst shall be in the form as prescribed by regulations.(2) Where any method of analysis has been prescribed by regulations for the analysis of any food, the analyst shall follow, and in his certificate of analysis declare that he has followed, the prescribed method.(3) A copy of the result of any analysis of any food procured by an authorized officer may be obtained from the analyst by the person from whom the food so analysed was purchased or obtained on payment of such fee as may be prescribed.(4) No copy of the result of any analysis made under this Act or any reproduction thereof shall be displayed or used as an advertisement and if any person so displays or uses such copy or reproduction he commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.8 Power To Call For Information(1) If any authorized officer is of the opinion that there is reasonable ground for suspecting that any person is in possession of any food or other substance or any appliance for the purpose of or in connection with the preparation, preservation, packaging, storage, conveyance, distribution or sale of food in breach of any of the provisions of this Act or any regulations made thereunder he may require such person to produce for his inspection any books, documents or other records or any other information relating to the importion, preparation, reception, possession, purchase, sale or delivery of such food or other substance or any appliance.(2) Any authorized officer mentioned in subsection (1) may make or cause to be made copies of or extracts from any such book, documents or records, or any other information and such copies or extracts certified as such by such authorized officer shall, unless the contrary is proved, be deemed to be true and correct copies or extracts. (3) Any person who refuses or neglects to comply with any requisition made in pursuance of this section commits an offence and is liable on conviction to imprisonment for a term not exceeding one year or to fine or to both.(4) Any authorized officer who -(a) does not maintain the secrecy of all matters which come to his knowledge in the performance of his official duties under this section; or(b) communicates any such matter to any person except for the purpose of carrying into effect the provisions of this Act, commits an offence and is liable on conviction to imprisonment for a term not exceeding three years or to fine or to both.9 Power Of The Director General To Obtain Particulars Of Certain Food Ingredients(1) The Director General may after obtaining an approval in writing from the Minister direct any person who at the date of the direction or at any subsequent time carries on a business which includes the production, importation or use of any substance to which this Act applies to furnish to him, within such time as may bespecified in such direction, such particulars as may be specified, of the composition and use of any such substance sold or for sale in the course of that business or used in the preparation of food.(2) Without prejudice to the generality of subsection (1), a direction made thereunder may require the following particulars to be furnished in respect of any substance, that is to say -(a) particulars of the composition and chemical formula of the substance;(b) particulars of the manner in which the substance is used or proposed to be used in the preparation of food;(c) particulars of any investigation carried out by or to the knowledge of the person carrying on the business in question, for the purpose of determining whether and to what extent the substance, or any product formed when the substance is used as aforesaid, is injurious to, or in any other way affects, health;(d) particulars of any investigation or enquiries carried out by or to the knowledge of the person carrying on the business in question, for the purposes of determining the cumulative effect on the health of a person consuming the substance in ordinary quantities.(3) No particulars furnished in accordance with a direction under this section and no information relating to any individual business obtained by means of such particulars shall, without the previous consent in writing of the person carrying on the business in question, be disclosed except in due discharge of his duties under this Act, and any person who discloses any such particulars of information in contravention of this subsection commits an offence and is liable on conviction to imprisonment for a term not exceeding five years or to fine or to both.10 Director May Order Food Premises or Appliances Be Put Into Hygienic And Sanitary Condition(1) Where the Director or an officer authorised by him in this particular respect is satisfied, by his own inspection or the report of an authorised officer, that any food premises, or any food appliance used for or in connection with the preparation, preservation, packaging, storage, conveyance, distribution or sale of food, is in a condition that fails to comply with any hygiene and sanitary requirements specified in regulations made under this Act, he may, by instrument in writing served on the proprietor, owner or occupier of such premises, or the proprietor or owner of such appliance, order that the premises or appliance be put into a hygienic and sanitary condition to the satisfaction of an authorised officer within a period specified in the instrument.(2) If after the expiration of that period, the Director or an officer authorized by him in this particular respect is not satisfied that the food premises or appliance to which the order relates has been put into a condition that complies with the hygienic and sanitary requirements the Director or the officer may, by instrument in writing, served on the proprietor, owner or occupier of the food premises or the proprietor or owner of the appliance, as the case may be, order that -(a) the food premises shall not be kept for the preparation, preservation, packaging, storage or sale or, in the case of a vehicle, for the conveyance, distribution or sale of any food; and(b) the appliance shall not be used in or for the preparation, preservation, packaging, handling, supplying, or serving of any food, until an authorized officer has given or otherwise deemed to have given to the proprietor, owner or occupier of the food premises or the proprietor or owner of the appliance, as the case may be, a certificate in writing that the food premises or appliance has been put into a condition which complies with the hygienic and sanitary requirements.(3) The proprietor, owner or occupier of any food premises or the proprietor or owner of any appliance on whom an order under subsection (2) is served may at any time after the order has been served request, in writing, the Director or an officer authorized by him in this particular respect to cause the food premises or appliance to be inspected by an authorized officer at a place specified in the request.(4) Where a request is so made, an authorized officer shall inspect the food premises or appliance to which the request relates within a period of seven days after the receipt of the request by the Director or the officer authorized by him in this particular respect, and the authorized officer making the inspection shall if he is satisfiedthat the food premises or appliance has been put in a condition that complies with the hygienic and sanitary requirements, give to the proprietor, owner or occupier of the premises or the proprietor or owner of the appliance,a certificate to that effect.(5) Where a request is so made and the premises or appliance is not inspected by an authorized officer within a period of 'seven days after that receipt of the request by the Director or the officer authorized by him in this particular respect, a certificate in respect of the food premises or appliance shall be deemed to have been given to the proprietor, owner or occupier of the food premises or the proprietor or owner of the appliance.(6) Where an order under subsection (2) has been served on the proprietor, owner or occupier of any food premises, or the proprietor or owner of any appliance and a certificate in respect thereof has not subsequently been given or has not otherwise been deemed to have been given any person who -(a) keeps or uses the food premises or any part of the food premises for the preparation, preservation, packaging, storage or sale or in the case of a vehicle, for the conveyance, distribution or sale of any food; or(b) uses the appliance in or for the preparation, preservation, packaging, handling, supplying or serving of any food, commits an offence and is liable on conviction to imprisonment for a term not exceeding five years or to fine or to both.11 Closure Of Insanitary PremisesThe Director or an officer authorized by him in this particular respect may in writing order the closure forthwith not exceeding fourteen days of any premises preparing or selling food where the Director or the officer authorized by him in this particular respect is of the opinion that such premises is in a condition that fails to comply with the sanitary and hygienic requirements and such that it is likely to be hazardous to health, and the proprietor, owner or occupier of the premises who fails to comply with the order commits an offence and is liable on conviction to imprisonment for a term not exceeding five years or to fine or to both.12 Conviction Published In NewspapersA notification of the name and occupation of any person who has been convicted of any offence against this Act or any regulation made thereunder together with his place or places of business, the nature of the offence and the fine, forfeiture, or other penalty inflicted shall, if the court so orders, be published in any newspaper circulating in Malaysia or in any part thereof, and the court shall further order the person convicted to pay the cost of such publication and such cost shall be treated as if it was a fine imposed by such court.Part III Offences And Evidence(1) For the purposes of this part, the term "owner of the rights of the manufacturer or packer" means -(a) in the case of foreign manufactured or packed food, any person who owns the exclusive rights to distribute or sell the food in Malaysia by way of license, agreement or franchise from the foreign manufacturer; or(b) in the case of locally manufactured or packed food , any person who not being the manufacturer or packer , has proprietary rights over the distribution and sale of the food, or who, being the manufacturer or packer, distributes or sells the food through and in the name of a marketing agent.(2) The term "owner of the rights of the manufacturer or packer" in subsection (1) extends also to any person who, in relation to food, claims or holds himself out as one, whether the food is imported or locally manufactured or packed.13 Food Containing Substances Injurious To Health(1) Any person who prepares or sells any food that has in or upon it any substance which is poisonous, harmful or otherwise injurious to health commits an offence and shall be liable, on conviction, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding ten years or to both.(2) In determining whether any food is injurious to health for the purpose of subsection (1), regard shall be had not only to the probable effect of that food on the health of a person consuming it, but also to the probable。
东南亚药包材法规
东南亚药包材法规【原创版】目录1.东南亚药包材法规概述2.东南亚各国药包材法规简介3.中国药包材企业在东南亚市场的机遇与挑战4.结论正文一、东南亚药包材法规概述东南亚地区作为一个地理范围较为广泛的区域，包含了越南、老挝、柬埔寨、缅甸、泰国、马来西亚、新加坡、印度尼西亚（以下简称印尼）、菲律宾、文莱和东帝汶等 11 个国家。
这些国家的药包材法规因各自政治、经济和社会发展状况的差异而存在一定的差异性。
然而，总体上，东南亚各国的药包材法规都在不断完善和加强，以保障药品的安全性和有效性。
二、东南亚各国药包材法规简介1.越南：越南的药包材法规主要遵循《药品管理法》和《药品注册办法》等相关法规，对药包材的生产、经营、使用和进出口等方面进行管理。
2.老挝：老挝的药包材法规主要包括《药品法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
3.柬埔寨：柬埔寨的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
4.缅甸：缅甸的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
5.泰国：泰国的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
6.马来西亚：马来西亚的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
7.新加坡：新加坡的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
8.印尼：印尼的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
9.菲律宾：菲律宾的药包材法规主要包括《药品管理法》和《药品注册办法》等法规，对药包材的生产、经营、使用和进出口等方面进行管理。
新马泰药品注册
一、管理机构：泰国: 卫生部属下的国家药物食品管理局（Food and Drug Administration）,简称：FDA THAILAND。
新加坡：新加坡卫生科学局（Health Sciencse Authority），简称：HAS。
马来西亚：卫生部属下的国家药物管制局(National Pharmaceutical Control Bureau)。
二、注册全部须网上作业：泰国国家药物食品管理局网址：http://www.fda.moph.go.th新加坡卫生科学局网址:.sg马来西亚国家药物管制局：http:.my三、注册的要点：泰国:泰国采用美国FDA管理体系，中药制剂药必须在进口国进行临床试验（在1999年以前已经在销售的除外，比如：云南白药）。
泰国药品分类比较复杂，找准分类是注册成功的关键。
泰国没有保健品的分类，只分为：食品、药品两大类。
药品又进行分类，比如处方药、普通药（OTC）、传统药等等。
要搞清楚有关药物是在哪一种分类下申请，以免搞错方向，白忙一场！西药中归为“普通用药”的药品注册符合“国际标准”可免临床。
但，泰国的国际标准就是美国药典及欧洲药典标准。
（中国的药企花了很大的精力、资金进行的GMP认证在很多国家不被认可，标准成为中国药品出口的一大障碍。
这样的障碍只要通过政府间的沟通才能消除）。
中药制剂药进入泰国的主流市场由于门槛较高，到目前只有10多个产品在泰获准注册，主要是一些经典验方药（在泰国市场已经销售15年以上）。
1999年中医药在泰国合法化，由于没有可以借鉴的经验，完全采用西药的监管方式。
由于有临床验证的要求，注册时间会比较长，取决于临床完成情况。
须以泰文书写。
新加坡：必须有当地的代理商参与。
新加坡对中药进口目前只作安全性评估，对疗效的评估采用中国SDA的评估结论。
中药分成两类：原生药、中成药；注册全程在网上公布。
在资料完备的情况下，2-3月可以获准。
须以英文书写。
马来西亚：中药制剂药不需在进口国进行临床试验。
东南亚药包材法规
东南亚药包材法规【原创版】目录1.东南亚药包材法规的背景和重要性2.东南亚各国药包材法规的概述3.东南亚药包材法规的挑战和机遇4.我国药包材企业如何应对东南亚药包材法规正文一、东南亚药包材法规的背景和重要性随着经济的发展，东南亚国家的医药行业逐渐崛起，对于药品包装材料的需求也越来越大。
因此，药包材法规在东南亚地区显得尤为重要，它不仅关系到药品的质量和安全，还关系到企业的生存和发展。
对于我国药包材企业而言，了解和掌握东南亚药包材法规，是开拓东南亚市场的关键。
二、东南亚各国药包材法规的概述1.越南：越南对药包材的管理主要依据《药品管理法》和《药品包装材料管理规定》。
其中规定，药品包装材料必须符合国家药品标准，并经过检验合格后方可使用。
2.老挝：老挝的药包材法规主要依据《药品管理法》和《药品包装材料注册管理办法》。
药品包装材料在注册时，需提交相关技术资料和样品，经审批后才能生产和销售。
3.柬埔寨：柬埔寨对药包材的管理主要依据《药品管理法》和《药品包装材料质量标准》。
药品包装材料应符合国家标准，并经检验合格后方可使用。
4.缅甸：缅甸的药包材法规主要依据《药品管理法》和《药品包装材料质量控制办法》。
药品包装材料在生产、经营和使用过程中，需符合国家标准和相关规定。
5.泰国：泰国对药包材的管理主要依据《药品管理法》和《药品包装材料注册管理办法》。
药品包装材料在注册时，需提交相关技术资料和样品，经审批后才能生产和销售。
6.马来西亚：马来西亚的药包材法规主要依据《药品管理法》和《药品包装材料注册管理办法》。
药品包装材料在注册时，需提交相关技术资料和样品，经审批后才能生产和销售。
7.新加坡：新加坡对药包材的管理主要依据《药品管理法》和《药品包装材料注册管理办法》。
药品包装材料在注册时，需提交相关技术资料和样品，经审批后才能生产和销售。
8.印度尼西亚：印尼对药包材的管理主要依据《药品管理法》和《药品包装材料注册管理办法》。
马来西亚进口动植物食品要求
• 1.4、人力资源 • 1.4.1、员工培训 • 1.4.2、员工卫生及健康要求 • 1.5、卫生和虫害控制 • 1.5.1、卫生控制（包括车间、员工卫生和
化学药品使用）
• 1.5.2、虫害控制 • 1.5、产品召回 • 1.6、HACCP要求
• 1.4, human resources 1.4.1, staff training 1.4.2, staff hygiene and health requirements
• 2, "Malaysia, the provisions of beef imports from China" Particular emphasis on: 2.1, bovine: all cattle for slaughter must come from the competent veterinary authority of the Chinese Government recognized health free of the disease, aphthae epizootic and cattle plague/ rinderpest , anthracnose anthrax farms, cattle for slaughter to stay in the farms raise at least two weeks. 2.2, HALA requirements: all the slaughter, cooling, processing, transportation and other handling and shipping the Muslim manner
• （二）信息通报 • 出口工厂需要通过出口国主管当局向DVS及
马来西亚医疗器械监管制度
马来西亚医疗器械监管制度马来西亚是我国重要的医疗器械进出口市场之一，由于历史等原因，马来西亚与文莱、新加坡的国家关系比较紧密，三国药械产品流通频繁。
外国厂商的药械产品想要进入东南亚地区大市场，可优先考虑进入马来西亚。
马来西亚国会在2012年正式通过了该国第一部《医疗器械管理法》(即第737号法案)，并从2013年7月起开始施行。
马来西亚《医疗器械管理法》的基本框架与美国的医疗器械法规相似，其中规定：所有在马来西亚生产、进口的医疗器械产品都必须在医疗器械管理部门注册;医疗器械生产商、进口商、分销商(不含零售商)等均属于医疗器械市场主体。
因此，本文简要介绍马来西亚医疗器械注册要求，供有意进入马来西亚市场的医械厂家参考。
马来西亚医疗器械分类马来西亚也是按照医疗器械的风险进行分类，分为A,B,C,D类。
分别举例如下：A类简单–低风险，如：手术器械、压舌器、玻璃温度计中的液体、检查灯、简单伤口敷料、氧气罩、听诊器和辅助行走器。
B类低–中等风险，如：皮下注射针头、抽吸设备、麻醉呼吸回路、吸引器、外部骨骼生长刺激设备、助听器、水凝胶敷料、患者控制的疼痛缓解、光疗机和X光片。
C类中度–高风险，如：肺呼吸机、矫形外科植入物、婴儿保育箱、血液氧合器、血袋、深度创伤敷料、除颤器、放射性治疗设备和呼吸机。
D类高风险，如：起搏器及导线、植入式除颤器、植入式输液泵、心脏瓣膜、神经导管、人造血管和支架。
马来西亚医疗器械注册流程1.指定马来西亚本地的授权代理人来管理公司的医疗器械注册事宜;2.确定产品属于马来西亚法规定义的医疗器械,然后根据分类规则来确定其类别;3.为其产品生产建立一套适当/经核准的质量体系，准备产品注册申报资料：4.向符合资质的合规性评估机构(CAB)申请符合性评审,通过CAB的审核后，可获发评审报告和证书。
CAB评审证书的有效期为5年;5.将CAB审核报告和证书及相关资料向MDA;MDA对在90天内回复给申请人，必要时可能会要求对附加信息进行回复。