马来西亚保健食品登记法规问题集
Email:kul4ww@evershinecpa.com
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马来西亚永辉BPO有限公司
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CA Aaron Yap, 马来西亚籍说马来西亚文中文和英文
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手机:+886-937-606-272
skype: annylin8008
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电话:+886-2-2717-0515 分机:110
HLF-TW-10
请问马来西亚对于保健食品的归类方式为何?它的正式名称为何?
不同归类管理强度有何差异?它的政府管辖机构为何?网页?
What are the categories of health food in Malaysia? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD:
保健品(Health Supplement)是指任何用于补充饮食和维持、增强及改善人体健康功能的产品。
它以胶囊、片剂、粉剂、液体等小单位剂型形式提供(须被管理),不应包括任何无菌製剂(即注射剂、滴眼剂)。
它可能包含一个/多个,或以下组合:
1. 维生素、矿物质、氨基酸、脂肪酸、酶、益生菌等生物活性物质。
2. 源自天然来源的物质,包括萃取物、分离物、浓缩物、代谢物形式的动物、矿物和植物材料。
3. 1 和 2 中提到成分的合成,只能在已证明其安全性的情况下使用。
保健品不应包括:
1. 任何以膳食作为唯一项目的产品。
2. 任何可注射的无菌製剂。
3. 任何源自人体的细胞、组织、器官或任何物质。
4. 《毒物法》附表中列出的任何物质。
2. 除口服途径外的任何其他给药途径。
马来西亚卫生部 (MOH) 辖下的国家药品监管机构 (NPRA) 成立于 1978 年,是马来西亚监管保健品註册、许可、监督和质量控制以及良好生产规范的机构,所有在马来西亚销售的保健品都必须经过卫生部的註册和批准。
Health Supplement (HS) refers to any product used to supplement a diet and to maintain, enhance and improve the health function of human body.
It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, liquids and shall not include any sterile preparations (i.e. injectable, eye drops). It may contain one or more, or the following combinations:
1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
2. Substances derived from *natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite;
3. Synthetic sources of ingredients mentioned in 1 and 2 may only be used where the safety of these has been proven.
Health Supplements shall NOT include:
1. Any product as a sole item of a meal;
2. Any injectable and sterile preparation;
3. Any cells, tissues, organs or any substance derived from the human body;
4. Any substance listed in the Schedule of the Poison Act;
5. Any other route of administration other than the oral route.
Established in 1978, the National Medicines Regulatory Agency (NPRA) under the Ministry of Health (MOH) of Malaysia is the body that regulates the registration, licensing, supervision and quality control and good manufacturing practices of healthcare products in Malaysia. All healthcare products sold in Malaysia must be It has been registered and approved by the Ministry of Health.
【参考连结】
https://www.npra.gov.my/index.php/en/
HLF-TW-20
外国公司要到马来西亚销售保健食品,无论设100%子公司或分公司,需要在公司登记时取得营业特许证?
假如要,其必要条件是什麽?所需文件及申请程序为何?网页?
If a foreign company wants to sell health food in Malaysia, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD:
需要在马来西亚当地註册公司,业务范围为健康/医药产品领域。
批发商必须申请批发商许可证才能通过批发销售或从其场所供应註册产品,许可证有效期为1年。
在马来西亚註册所有企业(包括外国公司),马来西亚公司委员会(SSM)的企业註册处管理。
所有公司必须在成立后 30 天内任命一名公司秘书(需要在马来西亚拥有主要居住地)。
秘书必须获得马来西亚公司委员会( SSM )的许可,或者是国内贸易和消费者事务部规定的专业组织的成员。
商业註册需要以下资料:
1.公司名称
2.私人或上市公司
3.建议的业务类型(业务范围为健康/医药产品领域)
4.註册办事处地址
5.营业地址
6.缴足资本(最低 RM1)
7.董事和发起人的详细信息
8.董事和发起人的声明
9.负责註册成立的个人的合规声明
10.附加文件(如有)
It is necessary to register a company locally in Malaysia, and its business scope is in the field of health/pharmaceutical products.
A local health/cosmetic company in Malaysia is required to apply in the name of a Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.
Register all businesses (including foreign companies) in Malaysia, managed by the Companies Commission of Malaysia (SSM)’s Business Registry. All companies must appoint a company secretary within 30 days of incorporation (primary residence in Malaysia is required).
The secretary must be licensed by the Companies Commission of Malaysia (SSM) or be a member of a professional body as specified by the Ministry of Domestic Trade and Consumer Affairs.
Business registration requires the following information:
1. Company name
2. Private or public companies
3. Suggested business type (The business scope is in the field of health/pharmaceutical products.)
4. Registered Office Address
5. Business address
6. Paid-up capital (minimum RM1)
7. Details of directors and promoters
8. Statement of Directors and Promoters
9. Compliance Statement for the Individual Responsible for Incorporation
10. Additional documents (if available)
【参考连结】
https://www.ssm.com.my/Pages/Home.aspx
HLF-TW-25
HLF-TW-30
外国公司要到马来西亚销售保健食品,可以指派马来西亚公司担任营业代理人销售吗?
担任营业代理人,其必要条件是什麽?所需文件及申请程序为何?外国公司与营业代理人的产品责任为何?网页?
If a foreign company wants to sell health food in Malaysia, can it assign a Malaysian company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD:
必须指定当地代理人(在马来西亚註册的公司)作为註册证书的持有人。
指定的代理人须负责与产品註册有关的所有事项。
在註册过程中需要填写特定的表格,并且根据在药品监督管理局註册的产品的标籤要求,在标籤上註明实际製造商的名称和地址。
经过药物管制局 (DCA) 批准在马来西亚销售/使用。
每个註册保健品都有一个註册号,必须印在其标籤或包装上。这些数字以MAL开头。註册号示例为:MAL19976399X。
登记程序:
1. 于NPRA 网站(www.npra.gov.my) 申请Quest会员资格,需要资料:
.註册表
.公司授权书
.身份证複本
2. 获得 Quest 会员资格后,登录Quest提交产品註册申请。
3. 提交要求的数据、资料。
4. 提交给DCA 会议的产品。
A local agent (a company registered in Malaysia) must be appointed as the holder of the certificate of incorporation.
The appointed agent is then responsible for all matters related to product registration.
Specific forms are required to be filled out during the registration process, and the actual manufacturer’s name and address are indicated on the label according to the labeling requirements for products registered with the Drug Administration.
Approved by the Drug Enforcement Agency (DCA) for sale/use in Malaysia.
Every registered health product has a registration number that must be printed on its label or packaging.
The numbers begin with MAL. An example registration number is: MAL19976399X.
Product registration process:
1. To apply for Quest membership on the NPRA website (www.npra.gov.my), the required information:
. Registration form
. Company Power of Attorney
. Copy of ID
2. After obtaining the Quest membership, log in to Quest to submit a product registration application.
3. Submit the required data and information.
4. Products submitted to the DCA meeting.
The product registration holder is responsible for reporting any adverse reactions to the Pharmacy Service arising from the use of the registered product, must ensure that the company has a pharmacovigilance system and take appropriate action if necessary.
Product registration holders must monitor any product safety issues that arise locally or internationally, as well as report to NPRA, and comply with all safety-related directives issued by the agency.
The product registration status may be affected if the product registration holder fails to notify the Authority of any serious adverse reaction after receiving such reports.
【参考连结】
https://www.npra.gov.my/index.php/en/post-registration-process/4-4-post-marketing-activities.html
HLF-TW-35
HLF-TW-40
外国公司销售到马来西亚保健食品本身,进口前需要办理产品许可吗?
如需要,哪个单位在管理?需要什麽文件?申请程序为何?
保健食品包装内容及各种标示,需要事先核准吗?
可允许的语文除了马来文外,其他哪种语文也可以?网页?
Do foreign companies need to apply for an approval before importing health food sold to Malaysia? If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Malaysian, which other languages are allowed? Website?
Evershine RD:
需要马来西亚当地健康/医药公司担任产品註册持有人的名义申请。
指定的代理商需负责与产品註册有关的所有事项。
在註册过程中需要填写特定的表格,并且根据在药品监督管理局註册的产品的标籤要求,在标籤上註明实际製造商的名称和地址。
经过药物管制局 (DCA) 批准在马来西亚销售/使用。每个註册保健品都有一个註册号,必须印在其标籤或包装上。这些数字以MAL开头。註册号示例为:MAL19976399X。
产品登记程序:
1. 于NPRA 网站(www.npra.gov.my) 申请Quest会员资格,需要资料:
.註册表
.公司授权书
.身份证複本
2. 获得 Quest 会员资格后,登录Quest提交产品註册申请。
3. 提交要求的数据、资料。
4. 提交给DCA 会议的产品。
产品登记需要文件、资料:
1. 产品名称
2. 剂型
(1) 片剂:锭剂、咀嚼片、分散片、发泡锭、膜衣锭、肠溶片、糖衣片、未包膜衣片、缓释锭
(2) 胶囊:软胶囊、硬胶囊、肠溶胶囊、咀嚼软胶囊、缓释胶囊
(3) 粉剂/颗粒剂
(4) 液体:乳液、糖浆、喷雾、悬浮液
(5) 注意事项:
.禁止使用动物剂型的产品。
.新剂型需要有既定参考文献(例如标准药典)的支持。
.应选择正确描述其产品质量控制规范和性能的形式。
(6) 在提交缓释/缓释/定时释放剂型的产品档案时需要以下文件:
.分析协议
.过程质量控制 (IPQC)
.成品规格(FPQC)
.分析证书 (COA)
3. 活性成分
(1) 活性成分名称
(2) 有效成分强度
(3) 活性成分来源
(4) 有效成分备註(如果具备)
(5) 受保护/濒危成分的使用
(6) 保健品活性成分的额外支持数据
.标准/既定参考文献:Martindale、药典、专论等。
.来自参考国家主管部门的信息:保健品註册状态及最大註册剂量、GRAS状态。
.临床研究或科学证据
.已发表的完整文章
.未发表的数据
.支持长期使用的非临床研究
.确定 NOAEL 的毒理学研究(未观察到不良反应水平)
.药理研究
.使用新活性成分作为保健品的理由
.全球註册状态和上市日期
4. 製造商:
(1) 製造商需符合良好生产规范 (GMP) ,须符合下列其中一项
.马来西亚传统医药和保健品良好生产规范指南最新版。
.可接受的 GMP 标准将由产品在原产国分类的类别决定。
例如,如果产品在原产国被归类为食品,则在标准与马来西亚的做法相似的情况下,将接受相关国家当局颁发的食品标准 GMP 证书。
.如果产品在原产国不受监管并且不需要 GMP 认证,製造商必须出示由权威机构认可的独立机构颁发的 GMP 证书。
必须提及包括检查所依据的标准/法规/立法在内的信息。
(2) 降低疾病风险,须符合下列其中一项
. 马来西亚传统医药和保健品良好生产规范指南最新版。
. 药品检验公约和药品检验合作计划 (PIC/S) 标准。
. 接受国家有关部门颁发的GMP证书,其标准与PIC/S标准相似。
5. 合同製造商:当产品所有者不是产品製造商时,合同製造商适用。
6. 第二源信息:如果认为有必要,可以考虑申请第二个来源。该第二个来源产品应在所有方面与第一个产品相同,但製造地点除外。
7. 其他製造商:任何涉及组装、填充和完成、活性成分、包装、标籤等的製造商。
8. 进口产品:进口产品需要报关。
9. 含有预混料的产品:预混活性成分是由不同製造商先前生产的两种或多种活性成分的组合。配方中的预混成分需要製造商/供应商的 GMP 证书。
10. 替换产品:证书持有人在任何时候均不得註册/持有两种或两种以上具有相似配方(原料活性成分、强度和剂型相同)的产品,产品变体除外。
11. 产品详情
(1) 产品说明
(2) 指示/用途
(3) 推荐剂量(剂量/使用说明)和给药途径
(4) 禁忌症
(5) 警告和注意事项
(6) 药物相互作用
(7) 对怀孕和哺乳是否影响
(8) 副作用/不良反应
(9) 过量和治疗的体徵和症状
(10) 储存条件
(11)保质期。
(12)治疗代码(如果有)
(13) 产品配方
(14) 批量製造公式(BMF)
.说明批量大小和实际批量製造主配方。
.根据物质名称、类型(活性成分或赋形剂)、功能和每单位剂量的数量来验证数据。
.如果需要输入其他信息,必须提供批量製造配方文件的附件。
.文件必须由授权人员核实。
12. 包装细节
(1) 片剂、药丸或胶囊允许的最大包装尺寸基于每日剂量,用量不超过 6 个月。
(2) 除非有正当理由,否则具有降低疾病风险声明的产品允许的最大包装尺寸为1个月的产品供应量。
(3) 带尾软凝胶剂型的产品(扭曲和挤压)应配有儿童防护帽。
(4) 包装清单的包装细节如下:
.C1:按重量、体积或数量计算的包装尺寸和填充细节
.C2:容器类型
.C3:条形码/序列号(可选)
.C4:推荐经销商价格(可选)
.C5:建议零售价(可选)
13. 标籤要求:标籤上所有要求的信息应按要求使用马来语或英语。
(1)保健品的标准标籤
.活性物质的名称和强度
. RDA(可选)
. 防腐剂(如有)
. 酒精(如有)
. 指示
. 剂量/使用说明
. 功能声明(如果适用)
. 警告(如果适用)
. 储存条件
. 放在儿童接触不到的地方
. 产品註册持有人的姓名和地址
. 製造商的名称和地址
. 来源(动物来源)
. 胶囊壳的来源(如适用)
. 批号
. 生产日期
. 有效期
. 包装尺寸
. 剂型
(2) 注意事项
.产品标籤应遵循保健品的标准标籤。
.左右面板上的信息可以互换。
.标籤上的所有信息必须真实,不得误导消费者。
.批号、生产日期、有效期可在标籤、瓶盖顶部或瓶底註明。
.前面板必须包含上述信息。但是,侧面板上的信息是可以互换的。可能会施加与产品安全相关的额外警示标籤。
(3) 标籤上禁止使用的视觉/图形
.标籤不应包含任何直接或暗示可能误导消费者对任何产品的陈述或视觉呈现。
.印在外标籤和内标籤上的图形必须标准化,以免给客户造成混淆。
14. 包装说明书:包装插页中需要包含以下信息
(1) 品牌或产品名称
(2) 活性物质的名称和强度
(3) 产品说明
(4) 指示
(5) 剂量/使用说明
(6) 禁忌症
(7) 警告和注意事项
(8) 与其他药物的相互作用
(9) 孕期和哺乳期使用说明
(10)不利影响/不良影响
(11) 用药过量和治疗
(12) 储存条件(如果信息在标籤或外箱标籤上註明,可省略)
(13) 可用的剂型和包装
(14) 製造商/产品註册持有人的名称和地址
(15) 说明书的修订日期
15. 产品负责人:请选择产品所有者是产品持有者、製造商还是两者接有。如果产品所有者既不是产品持有者也不是製造商,请选择产品所有者的名称和地址(仅适用于进口产品)。其他详细信息,如产品所有者、製造商、重新包装商、製造过程中涉及的其他製造商、商店地址和进口商(如果有)都需要填写。重新包装商必须获得GMP证书。
16. 产品负责人授权书:适用于产品所有者指定产品持有人(在马来西亚)作为其在马来西亚的产品持有人的进口产品。
17. 合同製造商和/或重新包装商的任命书:适用于产品由非产品所有者的製造商合同製造的情况。
18. 合同製造商和/或重新包装商的接受函:适用于产品由不是产品所有者的製造商的合同製造的。
19. 药品证书 (CPP)、自由销售证书 (CFS) 和良好生产规范 (GMP) 。如果产品在原产国归类为药品,则可以提交 CPP 代替 CFS 和 GMP 证书。
20. 协议分析附件
21. 成品分析证书
(1) 必须包含产品规格和结果。
(2) 测试和规格清单必须与成品规格文件相同。
(3) 产品註册必须提交两2份成品分析证书。
22. 保健品质量控制测试
(1) 重金属限量测试
(2) 崩解试验(片剂、胶囊剂和丸剂)
(3) 重量均匀度测试(仅限片剂和胶囊剂)
(4) 微生物汙染测试
(5) 特定成分的质量检测
23. 稳定性数据
24. 容器密闭系统类型的储存条件/稳定性研究
25. 药物物质的有效成分的规格和分析证书
An application in the name of a local health/pharmaceutical company in Malaysia as the product registration holder is required.The appointed agent is then responsible for all matters related to product registration. Specific forms are required to be filled out during the registration process, and the actual manufacturer’s name and address are indicated on the label according to the labeling requirements for products registered with the Drug Administration.
Approved by the Drug Enforcement Agency (DCA) for sale/use in Malaysia. Every registered health product has a registration number that must be printed on its label or packaging. The numbers begin with MAL. An example registration number is: MAL19976399X.
Product registration process:
1. To apply for Quest membership on the NPRA website (www.npra.gov.my), the required information:
. Registration form
. Company Power of Attorney
. Copy of ID
2. After obtaining the Quest membership, log in to Quest to submit a product registration application.
3. Submit the required data and information.
4. Products submitted to the DCA meeting.
Product registration requires documents and materials:
1. The product
2. Formulation
(1) Tablets: Lozenges, Chewable Tablets, Dispersible Tablets, Foaming Tablets, Film-Coated Tablets, Enteric-Coated Tablets, Sugar-Coated Tablets, Uncoated Tablets, Sustained-Release Tablets
(2) Capsules: soft capsules, hard capsules, enteric-coated capsules, chewable soft capsules, slow-release capsules
(3) Powder / Granules
(4) Liquids: emulsions, syrups, sprays, suspensions
(5) Notes:
. Animal dosage forms are prohibited.
. New dosage forms need to be supported by established references such as standard pharmacopeias.
. Forms that correctly describe the quality control specifications and performance of their products should be selected.
(6) The following documents are required when submitting a product dossier for an extended release/sustained release/timed release dosage form:
. Analysis Protocol
. In-process Quality Control (IPQC)
. Finished product specifications (FPQC)
. Certificate of Analysis (COA)
3. Active Ingredient
(1) Name of the active ingredient
(2) Strength of active ingredient
(3) Active ingredient source
(4) Remarks on active ingredients (if applicable)
(5) Use of Protected/Endangered Ingredient
(6) Additional Supporting Data for Active Ingredient of Nutraceutical Products
. Standard/Established References: Martindale, Pharmacopoeia, Monographs, etc.
. Information from the competent authorities of the reference country: health product registration status, maximum registered dose, GRAS status.
. Clinical studies or scientific evidence
. Full article published
. unpublished data
. Nonclinical research supporting long-term use
. Toxicology studies to determine NOAEL (no adverse reaction levels)
. pharmacological research
. Reasons to use new active ingredients as supplements
. Global registration status and listing date
4. Manufacturer:
(1) Manufacturers are required to comply with Good Manufacturing Practices (GMP), which must comply with one of the following
. The latest edition of the Good Manufacturing Practice Guidelines for Traditional Medicines and Health Products in Malaysia.
. Acceptable GMP standards will be determined by the category the product is classified into in the country of origin. For example, if a product is classified as food in the country of origin, a GMP certificate for food standards issued by the relevant national authorities will be accepted, provided the standards are similar to what is done in Malaysia.
. If the product is not regulated in the country of origin and does not require a GMP certification, the manufacturer must present a GMP certificate issued by an independent body accredited by an authority. Information including the standard/regulation/legislation on which the inspection is based must be mentioned.
(2) Reduce the risk of disease, subject to one of the following
. The latest edition of the Good Manufacturing Practice Guidelines for Traditional Medicine and Nutraceuticals in Malaysia.
. The Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S) Standard.
. Accept the GMP certificate issued by the relevant state departments, and its standard is similar to the PIC/S standard.
5. Contract Manufacturer: A Contract Manufacturer applies when the Product Owner is not the Product Manufacturer.
6. Second source information: If deemed necessary, a second source may be considered. This second source product shall be identical to the first product in all respects except where it is manufactured.
7. Other Manufacturers: Any manufacturer involved in assembly, filling and finishing, active ingredient, packaging, labeling, etc.
8. Imported products: Imported products need to be declared at customs.
9. Products containing a premix: A premix active ingredient is a combination of two or more active ingredients previously produced by different manufacturers. The premixed ingredients in the formulation require a GMP certificate from the manufacturer/supplier.
10. Substitute Products: The certificate holder shall not at any time register/hold two or more products with similar formulations (same raw material active ingredients, strength and dosage form), except for product variants.
11. Product Details
(1) Product Description
(2) Instructions/Uses
(3) Recommended dosage (dose/instructions for use) and route of administration
(4) Contraindications
(5) Warnings and Cautions
(6) Drug Interactions
(7) Effects on pregnancy and breastfeeding
(8) Side effects/adverse reactions
(9) Signs and symptoms of overdose and treatment
(10) Storage conditions
(11) Shelf life.
(12) Treatment code (if any)
(13) Product formula
(14) Batch Manufacturing Formula (BMF)
. Indicate batch size and actual batch manufacturing master recipe.
. Data are validated according to substance name, type (active ingredient or excipient), function and quantity per unit dose.
. If additional information needs to be entered, an attachment to the batch manufacturing recipe file must be provided.
. Documents must be verified by authorized personnel.
12. Package Details
(1) The maximum permissible package size for tablets, pills or capsules is based on a daily dose not to exceed 6 months of use.
(2) Unless justified, the maximum allowable package size for a product with a reduced disease risk claim is a 1 month supply of product.
(3) Products in soft gel dosage forms with tails (twist and squeeze) should be fitted with a child-resistant cap.
(4) Packing details of the packing list are as follows:
. C1: Package Dimensions and Filling Details by Weight, Volume or Quantity
. C2: Container Type
. C3: Barcode/Serial Number (optional)
. C4: Recommended dealer price (optional)
. C5: suggested retail price (optional)
13. Labelling requirements: The requested information should be in Malay or English as required.
(1) Standard labeling of health products
. Name and strength of active substance
. RDA (optional)
. Preservatives (if any)
. Alcohol (if any)
. Instruction
. Dosage/Instructions for Use
. Feature declaration (if applicable)
. Warning (if applicable)
. Storage conditions
. Keep out of reach of children
. Name and address of product registration holder
. Manufacturer’s name and address
. Origin (animal origin)
. Source of capsule shell (if applicable)
. Batch number
. Production Date
. Validity period
. Package dimensions
. Dosage Form
(2) Precautions
. Product labelling should follow standard labelling for nutraceuticals.
. The information on the left and right panels is interchangeable.
. All information on the label must be truthful and must not mislead consumers.
. The batch number, date of manufacture, and expiration date can be indicated on the label, on the top of the cap or on the bottom of the bottle.
. The front panel must contain the above information. However, the information on the side panels is interchangeable. Additional warning labels related to product safety may be applied.
(3) Prohibited visuals/graphics on the label
. Labels should not contain any direct or implied statement or visual representation of any product that may mislead consumers.
. Graphics printed on outer and inner labels must be standardized to avoid confusion for customers.
14. Package insert: The following information needs to be included in the package insert
(1) The brand or product name
(2) Name and strength of active substance
(3) Product Description
(4) Instructions
(5) Dosage / Instructions for Use
(6) Contraindications
(7) Warnings and Cautions
(8) Interaction with other medicines
(9) Instructions for use during pregnancy and lactation
(10) Adverse effects/adverse effects
(11) Overdose and Treatment
(12) Storage conditions (if the information is stated on the label or outer box label, it can be omitted)
(13) Dosage Forms and Packaging Available
(14) Name and Address of Manufacturer/Product Registration Holder
(15) Date of revision of the specification
15. Product Owner: Please select whether the product owner is the product owner, the manufacturer, or both. If the product owner is neither the product holder nor the manufacturer, select the product owner’s name and address (for imported products only). Additional details such as product owner, manufacturer, repacker, other manufacturers involved in the manufacturing process, store address and importer (if any) will need to be filled in. Repackers must obtain a GMP certificate.
16. Product Owner Power of Attorney: Applicable to imported products where the product owner designates the product holder (in Malaysia) as his product holder in Malaysia.
17. Contract Manufacturer and/or Repacker Appointment: Applies where the product is contract-manufactured by a manufacturer who is not the product owner.
18. Acceptance Letters from Contract Manufacturers and/or Repackers: Applies to products that are contract manufactured by a manufacturer who is not the owner of the product.
19. Certificate of Pharmaceutical Product (CPP), Certificate of Free Sale (CFS) and Good Manufacturing Practice (GMP). If the product is classified as a drug in the country of origin, a CPP can be submitted in lieu of the CFS and GMP certificates.
20. Protocol Analysis Annex
21. Finished Product Certificate of Analysis
(1) Product specifications and results must be included.
(2) The list of tests and specifications must be identical to the finished product specification file.
(3) Product registration must submit two 2 Certificates of Analysis of the Finished Product.
22. Nutraceutical Quality Control Testing
(1) Heavy metal limit test
(2) Disintegration test (tablet, capsule and pill)
(3) Weight uniformity test (tablets and capsules only)
(4) Microbial contamination test
(5) Quality testing of specific components
23. Stability data
24. Storage conditions/stability studies of container closure system types
25. Specifications and certificates of analysis for the active ingredients of the drug substance
【参考连结】
https://www.npra.gov.my/index.php/en/industry
HLF-TW-45
HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗?如需要,哪个单位在管理?需要什麽文件?申请程序为何?保健食品包装内容及各种标示,需要事先核准吗?可允许的语文除了马来文外,其他哪种语文也可以?网页?
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? In addition to Malaysian, which other languages are allowed? Website?
Evershine RD:
需要马来西亚当地健康/医药公司担任产品註册持有人的名义申请。
指定的代理商需负责与产品註册有关的所有事项。在註册过程中需要填写特定的表格,并且根据在药品监督管理局註册的产品的标籤要求,在标籤上註明实际製造商的名称和地址。
经过药物管制局 (DCA) 批准在马来西亚销售/使用。每个註册保健品都有一个註册号,必须印在其标籤或包装上。这些数字以MAL开头。註册号示例为:MAL19976399X。
产品登记程序:
1. 于NPRA 网站(www.npra.gov.my) 申请Quest会员资格,需要资料:
.註册表
.公司授权书
.身份证複本
2. 获得 Quest 会员资格后,登录Quest提交产品註册申请。
3. 提交要求的数据、资料。
4. 提交给DCA 会议的产品。
产品登记需要文件、资料:
1. 产品名称
2. 剂型
(1) 片剂:锭剂、咀嚼片、分散片、发泡锭、膜衣锭、肠溶片、糖衣片、未包膜衣片、缓释锭
(2) 胶囊:软胶囊、硬胶囊、肠溶胶囊、咀嚼软胶囊、缓释胶囊
(3) 粉剂/颗粒剂
(4) 液体:乳液、糖浆、喷雾、悬浮液
(5) 注意事项:
.禁止使用动物剂型的产品。
.新剂型需要有既定参考文献(例如标准药典)的支持。
.应选择正确描述其产品质量控制规范和性能的形式。
(6) 在提交缓释/缓释/定时释放剂型的产品档案时需要以下文件:
.分析协议
.过程质量控制 (IPQC)
.成品规格(FPQC)
.分析证书 (COA)
3. 活性成分
(1) 活性成分名称
(2) 有效成分强度
(3) 活性成分来源
(4) 有效成分备註(如果具备)
(5) 受保护/濒危成分的使用
(6) 保健品活性成分的额外支持数据
.标准/既定参考文献:Martindale、药典、专论等。
.来自参考国家主管部门的信息:保健品註册状态及最大註册剂量、GRAS状态。
.临床研究或科学证据
.已发表的完整文章
.未发表的数据
.支持长期使用的非临床研究
.确定 NOAEL 的毒理学研究(未观察到不良反应水平)
.药理研究
.使用新活性成分作为保健品的理由
.全球註册状态和上市日期
4. 製造商:
(1) 製造商需符合良好生产规范 (GMP) ,须符合下列其中一项
.马来西亚传统医药和保健品良好生产规范指南最新版。
.可接受的 GMP 标准将由产品在原产国分类的类别决定。 例如,如果产品在原产国被归类为食品,则在标准与马来西亚的做法相似的情况下,将接受相关国家当局颁发的食品标准 GMP 证书。
.如果产品在原产国不受监管并且不需要 GMP 认证,製造商必须出示由权威机构认可的独立机构颁发的 GMP 证书。 必须提及包括检查所依据的标准/法规/立法在内的信息。
(2) 降低疾病风险,须符合下列其中一项
. 马来西亚传统医药和保健品良好生产规范指南最新版。
. 药品检验公约和药品检验合作计划 (PIC/S) 标准。
. 接受国家有关部门颁发的GMP证书,其标准与PIC/S标准相似。
5. 合同製造商:当产品所有者不是产品製造商时,合同製造商适用。
6. 第二源信息:如果认为有必要,可以考虑申请第二个来源。该第二个来源产品应在所有方面与第一个产品相同,但製造地点除外。
7. 其他製造商:任何涉及组装、填充和完成、活性成分、包装、标籤等的製造商。
8. 进口产品:进口产品需要报关。
9. 含有预混料的产品:预混活性成分是由不同製造商先前生产的两种或多种活性成分的组合。配方中的预混成分需要製造商/供应商的 GMP 证书。
10. 替换产品:证书持有人在任何时候均不得註册/持有两种或两种以上具有相似配方(原料活性成分、强度和剂型相同)的产品,产品变体除外。
11. 产品详情
(1) 产品说明
(2) 指示/用途
(3) 推荐剂量(剂量/使用说明)和给药途径
(4) 禁忌症
(5) 警告和注意事项
(6) 药物相互作用
(7) 对怀孕和哺乳是否影响
(8) 副作用/不良反应
(9) 过量和治疗的体徵和症状
(10) 储存条件
(11)保质期。
(12)治疗代码(如果有)
(13) 产品配方
(14) 批量製造公式(BMF)
.说明批量大小和实际批量製造主配方。
.根据物质名称、类型(活性成分或赋形剂)、功能和每单位剂量的数量来验证数据。
.如果需要输入其他信息,必须提供批量製造配方文件的附件。
.文件必须由授权人员核实。
12. 包装细节
(1) 片剂、药丸或胶囊允许的最大包装尺寸基于每日剂量,用量不超过 6 个月。
(2) 除非有正当理由,否则具有降低疾病风险声明的产品允许的最大包装尺寸为1个月的产品供应量。
(3) 带尾软凝胶剂型的产品(扭曲和挤压)应配有儿童防护帽。
(4) 包装清单的包装细节如下:
.C1:按重量、体积或数量计算的包装尺寸和填充细节
.C2:容器类型
.C3:条形码/序列号(可选)
.C4:推荐经销商价格(可选)
.C5:建议零售价(可选)
13. 标籤要求:标籤上所有要求的信息应按要求使用马来语或英语。
(1)保健品的标准标籤
.活性物质的名称和强度
. RDA(可选)
. 防腐剂(如有)
. 酒精(如有)
. 指示
. 剂量/使用说明
. 功能声明(如果适用)
. 警告(如果适用)
. 储存条件
. 放在儿童接触不到的地方
. 产品註册持有人的姓名和地址
. 製造商的名称和地址
. 来源(动物来源)
. 胶囊壳的来源(如适用)
. 批号
. 生产日期
. 有效期
. 包装尺寸
. 剂型
(2) 注意事项
.产品标籤应遵循保健品的标准标籤。
.左右面板上的信息可以互换。
.标籤上的所有信息必须真实,不得误导消费者。
.批号、生产日期、有效期可在标籤、瓶盖顶部或瓶底註明。
.前面板必须包含上述信息。但是,侧面板上的信息是可以互换的。可能会施加与产品安全相关的额外警示标籤。
(3) 标籤上禁止使用的视觉/图形
.标籤不应包含任何直接或暗示可能误导消费者对任何产品的陈述或视觉呈现。
.印在外标籤和内标籤上的图形必须标准化,以免给客户造成混淆。
14. 包装说明书:包装插页中需要包含以下信息
(1) 品牌或产品名称
(2) 活性物质的名称和强度
(3) 产品说明
(4) 指示
(5) 剂量/使用说明
(6) 禁忌症
(7) 警告和注意事项
(8) 与其他药物的相互作用
(9) 孕期和哺乳期使用说明
(10)不利影响/不良影响
(11) 用药过量和治疗
(12) 储存条件(如果信息在标籤或外箱标籤上註明,可省略)
(13) 可用的剂型和包装
(14) 製造商/产品註册持有人的名称和地址
(15) 说明书的修订日期
15. 产品负责人:请选择产品所有者是产品持有者、製造商还是两者接有。如果产品所有者既不是产品持有者也不是製造商,请选择产品所有者的名称和地址(仅适用于进口产品)。其他详细信息,如产品所有者、製造商、重新包装商、製造过程中涉及的其他製造商、商店地址和进口商(如果有)都需要填写。重新包装商必须获得GMP证书。
16. 产品负责人授权书:适用于产品所有者指定产品持有人(在马来西亚)作为其在马来西亚的产品持有人的进口产品。
17. 合同製造商和/或重新包装商的任命书:适用于产品由非产品所有者的製造商合同製造的情况。
18. 合同製造商和/或重新包装商的接受函:适用于产品由不是产品所有者的製造商的合同製造的。
19. 药品证书 (CPP)、自由销售证书 (CFS) 和良好生产规范 (GMP) 。如果产品在原产国归类为药品,则可以提交 CPP 代替 CFS 和 GMP 证书。
20. 协议分析附件
21. 成品分析证书
(1) 必须包含产品规格和结果。
(2) 测试和规格清单必须与成品规格文件相同。
(3) 产品註册必须提交两2份成品分析证书。
22. 保健品质量控制测试
(1) 重金属限量测试
(2) 崩解试验(片剂、胶囊剂和丸剂)
(3) 重量均匀度测试(仅限片剂和胶囊剂)
(4) 微生物汙染测试
(5) 特定成分的质量检测
23. 稳定性数据
24. 容器密闭系统类型的储存条件/稳定性研究
25. 药物物质的有效成分的规格和分析证书
网页:https://www.npra.gov.my/index.php/en/industry
An application in the name of a local health/pharmaceutical company in Malaysia as the product registration holder is required.The appointed agent is then responsible for all matters related to product registration. Specific forms are required to be filled out during the registration process, and the actual manufacturer’s name and address are indicated on the label according to the labeling requirements for products registered with the Drug Administration.
Approved by the Drug Enforcement Agency (DCA) for sale/use in Malaysia. Every registered health product has a registration number that must be printed on its label or packaging. The numbers begin with MAL. An example registration number is: MAL19976399X.
Product registration process:
1. To apply for Quest membership on the NPRA website (www.npra.gov.my), the required information:
. Registration form
. Company Power of Attorney
. Copy of ID
2. After obtaining the Quest membership, log in to Quest to submit a product registration application.
3. Submit the required data and information.
4. Products submitted to the DCA meeting.
Product registration requires documents and materials:
1. The product
2. Formulation
(1) Tablets: Lozenges, Chewable Tablets, Dispersible Tablets, Foaming Tablets, Film-Coated Tablets, Enteric-Coated Tablets, Sugar-Coated Tablets, Uncoated Tablets, Sustained-Release Tablets
(2) Capsules: soft capsules, hard capsules, enteric-coated capsules, chewable soft capsules, slow-release capsules
(3) Powder / Granules
(4) Liquids: emulsions, syrups, sprays, suspensions
(5) Notes:
. Animal dosage forms are prohibited.
. New dosage forms need to be supported by established references such as standard pharmacopeias.
. Forms that correctly describe the quality control specifications and performance of their products should be selected.
(6) The following documents are required when submitting a product dossier for an extended release/sustained release/timed release dosage form:
. Analysis Protocol
. In-process Quality Control (IPQC)
. Finished product specifications (FPQC)
. Certificate of Analysis (COA)
3. Active Ingredient
(1) Name of the active ingredient
(2) Strength of active ingredient
(3) Active ingredient source
(4) Remarks on active ingredients (if applicable)
(5) Use of Protected/Endangered Ingredient
(6) Additional Supporting Data for Active Ingredient of Nutraceutical Products
. Standard/Established References: Martindale, Pharmacopoeia, Monographs, etc.
. Information from the competent authorities of the reference country: health product registration status, maximum registered dose, GRAS status.
. Clinical studies or scientific evidence
. Full article published
. unpublished data
. Nonclinical research supporting long-term use
. Toxicology studies to determine NOAEL (no adverse reaction levels)
. pharmacological research
. Reasons to use new active ingredients as supplements
. Global registration status and listing date
4. Manufacturer:
(1) Manufacturers are required to comply with Good Manufacturing Practices (GMP), which must comply with one of the following
. The latest edition of the Good Manufacturing Practice Guidelines for Traditional Medicines and Health Products in Malaysia.
. Acceptable GMP standards will be determined by the category the product is classified into in the country of origin. For example, if a product is classified as food in the country of origin, a GMP certificate for food standards issued by the relevant national authorities will be accepted, provided the standards are similar to what is done in Malaysia.
. If the product is not regulated in the country of origin and does not require a GMP certification, the manufacturer must present a GMP certificate issued by an independent body accredited by an authority. Information including the standard/regulation/legislation on which the inspection is based must be mentioned.
(2) Reduce the risk of disease, subject to one of the following
. The latest edition of the Good Manufacturing Practice Guidelines for Traditional Medicine and Nutraceuticals in Malaysia.
. The Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S) Standard.
. Accept the GMP certificate issued by the relevant state departments, and its standard is similar to the PIC/S standard.
5. Contract Manufacturer: A Contract Manufacturer applies when the Product Owner is not the Product Manufacturer.
6. Second source information: If deemed necessary, a second source may be considered. This second source product shall be identical to the first product in all respects except where it is manufactured.
7. Other Manufacturers: Any manufacturer involved in assembly, filling and finishing, active ingredient, packaging, labeling, etc.
8. Imported products: Imported products need to be declared at customs.
9. Products containing a premix: A premix active ingredient is a combination of two or more active ingredients previously produced by different manufacturers. The premixed ingredients in the formulation require a GMP certificate from the manufacturer/supplier.
10. Substitute Products: The certificate holder shall not at any time register/hold two or more products with similar formulations (same raw material active ingredients, strength and dosage form), except for product variants.
11. Product Details
(1) Product Description
(2) Instructions/Uses
(3) Recommended dosage (dose/instructions for use) and route of administration
(4) Contraindications
(5) Warnings and Cautions
(6) Drug Interactions
(7) Effects on pregnancy and breastfeeding
(8) Side effects/adverse reactions
(9) Signs and symptoms of overdose and treatment
(10) Storage conditions
(11) Shelf life.
(12) Treatment code (if any)
(13) Product formula
(14) Batch Manufacturing Formula (BMF)
. Indicate batch size and actual batch manufacturing master recipe.
. Data are validated according to substance name, type (active ingredient or excipient), function and quantity per unit dose.
. If additional information needs to be entered, an attachment to the batch manufacturing recipe file must be provided.
. Documents must be verified by authorized personnel.
12. Package Details
(1) The maximum permissible package size for tablets, pills or capsules is based on a daily dose not to exceed 6 months of use.
(2) Unless justified, the maximum allowable package size for a product with a reduced disease risk claim is a 1 month supply of product.
(3) Products in soft gel dosage forms with tails (twist and squeeze) should be fitted with a child-resistant cap.
(4) Packing details of the packing list are as follows:
. C1: Package Dimensions and Filling Details by Weight, Volume or Quantity
. C2: Container Type
. C3: Barcode/Serial Number (optional)
. C4: Recommended dealer price (optional)
. C5: suggested retail price (optional)
13. Labelling requirements: The requested information should be in Malay or English as required.
(1) Standard labeling of health products
. Name and strength of active substance
. RDA (optional)
. Preservatives (if any)
. Alcohol (if any)
. Instruction
. Dosage/Instructions for Use
. Feature declaration (if applicable)
. Warning (if applicable)
. Storage conditions
. Keep out of reach of children
. Name and address of product registration holder
. Manufacturer’s name and address
. Origin (animal origin)
. Source of capsule shell (if applicable)
. Batch number
. Production Date
. Validity period
. Package dimensions
. Dosage Form
(2) Precautions
. Product labelling should follow standard labelling for nutraceuticals.
. The information on the left and right panels is interchangeable.
. All information on the label must be truthful and must not mislead consumers.
. The batch number, date of manufacture, and expiration date can be indicated on the label, on the top of the cap or on the bottom of the bottle.
. The front panel must contain the above information. However, the information on the side panels is interchangeable. Additional warning labels related to product safety may be applied.
(3) Prohibited visuals/graphics on the label
. Labels should not contain any direct or implied statement or visual representation of any product that may mislead consumers.
. Graphics printed on outer and inner labels must be standardized to avoid confusion for customers.
14. Package insert: The following information needs to be included in the package insert
(1) The brand or product name
(2) Name and strength of active substance
(3) Product Description
(4) Instructions
(5) Dosage / Instructions for Use
(6) Contraindications
(7) Warnings and Cautions
(8) Interaction with other medicines
(9) Instructions for use during pregnancy and lactation
(10) Adverse effects/adverse effects
(11) Overdose and Treatment
(12) Storage conditions (if the information is stated on the label or outer box label, it can be omitted)
(13) Dosage Forms and Packaging Available
(14) Name and Address of Manufacturer/Product Registration Holder
(15) Date of revision of the specification
15. Product Owner: Please select whether the product owner is the product owner, the manufacturer, or both. If the product owner is neither the product holder nor the manufacturer, select the product owner’s name and address (for imported products only). Additional details such as product owner, manufacturer, repacker, other manufacturers involved in the manufacturing process, store address and importer (if any) will need to be filled in. Repackers must obtain a GMP certificate.
16. Product Owner Power of Attorney: Applicable to imported products where the product owner designates the product holder (in Malaysia) as his product holder in Malaysia.
17. Contract Manufacturer and/or Repacker Appointment: Applies where the product is contract-manufactured by a manufacturer who is not the product owner.
18. Acceptance Letters from Contract Manufacturers and/or Repackers: Applies to products that are contract manufactured by a manufacturer who is not the owner of the product.
19. Certificate of Pharmaceutical Product (CPP), Certificate of Free Sale (CFS) and Good Manufacturing Practice (GMP). If the product is classified as a drug in the country of origin, a CPP can be submitted in lieu of the CFS and GMP certificates.
20. Protocol Analysis Annex
21. Finished Product Certificate of Analysis
(1) Product specifications and results must be included.
(2) The list of tests and specifications must be identical to the finished product specification file.
(3) Product registration must submit two 2 Certificates of Analysis of the Finished Product.
22. Nutraceutical Quality Control Testing
(1) Heavy metal limit test
(2) Disintegration test (tablet, capsule and pill)
(3) Weight uniformity test (tablets and capsules only)
(4) Microbial contamination test
(5) Quality testing of specific components
23. Stability data
24. Storage conditions/stability studies of container closure system types
25. Specifications and certificates of analysis for the active ingredients of the drug substance
【参考连结】
HLF-TW-55
HLF-TW-60
经过核准登记的保健食品,进口到马来西亚要检附什麽文件?经过什麽手续?
在销售时要向各地的卫生福利部相关机构事先或事后准备吗?网页?
What documents are required when importing approved health food into Malaysia? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD:
要将货物进口到马来西亚,需要向马来西亚皇家海关署(JKDM)申报、缴纳关税/税款的进口税、消费税、销售税。
1.海关申报:所有进口到马来西亚的货物必须通过以下方式择一申报
.指定报关员
.自我声明(AEO 计划 – AEO 门户)
.直接用户
2. 商品分类:进口商需要获得对要进口到马来西亚的商品的确认通过获取货物的正确关税代码是否需要缴纳任何关税/税款。
3. 检查物品是否为受控商品或进口违禁品:
.检查拟进口的货物是否为管制货物或受当局禁止或限制进口的货物。
.确认进口之前获得许可/批准。
4. 申报和准备海关放行文件:每个进口商应在货物抵达或抵达马来西亚时,亲自或由其代理人对进口货物进行完整和真实的申报。
.电子报关单
.提交进口许可证(电子档案或副本)
.提单/空运单
.发票(採购订单或信用证)
.装箱单
.原产国证明
.其他相关文件(检验证书、分析证书、成分证书、清真证书、产品规格证书等)
5. 货物检验:JKDM保留检查货物以确保进口符合法律法规的权利。
6. 缴纳关税/税款进口:货物的应付关税/税款必须由进口商在货物到达时支付。可以通过柜檯或电子支付。
7. 海关批准
8. 海关放行
9. 保存文档:进口记录在马来西亚保存七年
To import goods into Malaysia, import duty, excise duty, sales tax is required to be declared to the Royal Malaysian Customs Department (JKDM) and paid for duties/taxes.
1. Customs declaration: All goods imported into Malaysia must be declared through one of the following methods
.Designated Customs Broker
.Self Declaration (AEO Programme – AEO Portal)
.Direct users
2. Commodity classification: The importer needs to obtain confirmation of the goods to be imported into Malaysia by obtaining the correct tariff code of the goods if any duties/taxes are to be paid.
3. Check if the item is a controlled commodity or an imported contraband:
.Check whether the goods to be imported are regulated goods or goods whose importation is prohibited or restricted by the authorities.
.Confirm permission/approval prior to import.
4. Declaration and preparation of customs release documents: Each importer shall make a complete and true declaration of the imported goods in person or by his agent upon arrival or arrival in Malaysia.
. Electronic customs declaration
. Submit import license (electronic file or copy)
.Bill of Lading / Air Waybill
.Invoice (Purchase Order or Letter of Credit)
.Packing List
.Certificate of country of origin
.Other relevant documents (inspection certificate, analysis certificate, composition certificate, halal certificate, product specification certificate, etc.)
5. Goods inspection: JKDM reserves the right to inspect the goods to ensure that the imports comply with laws and regulations.
6. Pay Duties/Taxes Import: Duties/taxes payable on the goods must be paid by the importer upon arrival of the goods. Payment can be made over the counter or electronically.
7. Customs Approval
8. Customs release
9. Preservation of documents: Import records are kept in Malaysia for seven years
【参考连结】
http://www.customs.gov.my/en/pages/main.aspx
HLF-TW-70
马来西亚保健食品审核机构,需要附上的实验室检验资料有哪些? 网页?
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD:
需要具备自由销售证书 (CFS) 和良好生产规范 (GMP):
1. 自由销售证书(CFS)表明该产品可以在马来西亚自由销售。CFS 申请只能由产品註册持有人通过 Quest 系统在线提交。
(1)申请人的详细信息
(2)製造商的详细信息
(3)产品清单上的文件
2. 製造商需符合良好生产规范 (GMP) 。
(1) 依照马来西亚传统医药和保健品良好生产规范指南最新版。
质量控制文件:任何与批次记录相关的质量控製文件应
批次到期后保留一年。
.规格
.抽样程序
.测试程序和记录
.工作表和/或实验室笔记本
.分析报告和/或证书
.来自环境监测的数据
.仪器校准的程序、记录和设备的维护
天然来源材料的规格
.植物的学名或植物学名
.植物来源的详细信息(原产国或地区,以及栽培、收穫时间、收集程序、可能使用的杀虫剂等)
.是使用整个植物/动物还是仅使用一部分
.购买乾燥的植物/动物时,应安装指定的乾燥系统
.宏观和/或微观植物材料的描述
产品测试
.对于已知的活性成分或标记物识别测试
.对已知和未知的成分进行化验
. 极限测试
.确定农药汙染和可接受的限度
.测试有毒金属和可能的汙染物、异物
.放射性、微生物汙染测试
.任何用于减少真菌/微生物汙染的处理或其他感染应记录在案
.经批准的供应商、原始供应商
.印刷品样本
.抽样和测试说明或程序参考
.定性和定量要求以及接受限度
.储存条件和注意事项
.複检前的最长储存期限
成品规格
.微生物和有毒金属汙染
.重量均匀性(片剂和胶囊),崩解(用于片剂、胶囊剂和丸剂)、硬度和脆性(用于片剂),以及粘度(用于内部和外部流体)
.颜色味道和大小等物理外观
.产品的指定名称和代码参考
.公式或参考.
.剂型和包装细节的描述
.取样和测试说明或程序参考
.定性和定量要求,与验收限制
.储存条件和任何特殊处理注意事项
.保质期
生产文件
.製造配方及加工说明:每个产品和批次大小都应该有製造的说明
.製造配方应包括:产品名称、产品参考代码、对产品强度和批次的描述、起始材料列表、每种材料的数量、可接受限度的预期最终产量的声明、相关的中间产量等
.处理说明应包括:加工地点和主要设备、製备的方法、详细逐步加工说明、任何过程控制的说明及其限制、产品的散装储存要求、需要遵守的特殊预防措施、浓缩阶段和使用的方法的详细信息。
(2) 可接受的 GMP 标准将由产品在原产国分类的类别决定。 例如,如果产品在原产国被归类为食品,则在标准与马来西亚的做法相似的情况下,将接受相关国家当局颁发的食品标准 GMP 证书。
(3) 如果产品在原产国不受监管并且不需要 GMP 认证,製造商必须出示由权威机构认可的独立机构颁发的 GMP 证书。 必须提及包括检查所依据的标准/法规/立法在内的信息。
(4) 如果产品在原产国归类为药品,则可以提交 CPP 代替 CFS 和 GMP 证书。
Certificate of Free Sale (CFS) and Good Manufacturing Practice (GMP):
1. The Certificate of Free Sale (CFS) indicates that the product can be freely sold in Malaysia. CFS applications can only be submitted online through the Quest system by product registration holders.
(1) Details of the applicant
(2) Manufacturer’s details
(3) Documents on the product list
2. Manufacturers are subject to Good Manufacturing Practice (GMP).
(1) In accordance with the latest edition of the Guidelines for the Good Manufacturing Practice of Traditional Medicine and Health Products in Malaysia.
Quality Control Documentation: Any quality control documentation related to batch records should be keep for one year after expiration.
. Specification
. Sampling procedure
. Test Procedures and Records
. Worksheets and/or lab notebooks
. Analysis report and/or certificate
. Data from Environmental Monitoring
. Instrument calibration procedures, records and maintenance of equipment
Specifications for materials of natural origin
. Scientific name or botanical name of the plant
. Details of the plant’s origin (country or region of origin, as well as cultivation, time of harvest, collection procedures, pesticides that may be used, etc.)
. Whether to use the whole plant/animal or just a part
. When purchasing dried plants/animals, the specified drying system should be installed
. Description of macro and/or micro plant material
Product testing
. Identification tests for known active ingredients or markers
. Assay for known and unknown components
. Limit testing
. Determination of pesticide contamination and acceptable limits
. Testing for toxic metals and possible contaminants, foreign objects
. Radioactive, microbial contamination testing
. Any treatments or other infections used to reduce fungal/microbial contamination should be documented
. Approved Supplier, Original Supplier
. Print samples
. Sampling and testing instructions or procedure reference
. Qualitative and quantitative requirements and acceptance limits
. Storage Conditions and Notes
. Maximum shelf life before re-inspection
Finished product specification
. Microbial and Toxic Metal Contamination
. Weight uniformity (tablets and capsules), disintegration (for tablets, capsules, and pills), hardness and friability (for tablets), and viscosity (for internal and external fluids)
. Physical appearance such as color, taste and size
. Designated name and code reference of the product
. Formula or reference.
. Description of dosage form and packaging details
. Sampling and Testing Instructions or Procedure Reference
. Qualitative and quantitative requirements, and acceptance limits
. Storage conditions and any special handling precautions
. Shelf life
Production file
. Manufacturing Recipe and Processing Instructions: Manufacturing instructions should be available for each product and batch size
. The manufacturing formula should include: product name, product reference code, description of product strength and batch, list of starting materials, quantity of each material, statement of expected final yield of acceptable limits, associated intermediate yield, etc.
. Handling instructions should include: processing location and major equipment, method of preparation, detailed step-by-step processing instructions, description of any process controls and their limitations, bulk storage requirements for the product, special precautions to be followed, details of the concentration stage and method used information.
(2) Acceptable GMP standards will be determined by the category the product is classified into in the country of origin. For example, if a product is classified as food in the country of origin, a GMP certificate for food standards issued by the relevant national authorities will be accepted, provided the standards are similar to those in Malaysia.
(3) If the product is not regulated in the country of origin and does not require GMP certification, the manufacturer must present a GMP certificate issued by an independent body recognized by an authoritative body. Information including the standard/regulation/legislation on which the inspection is based must be mentioned.
(4) If the product is classified as a pharmaceutical product in the country of origin, a CPP may be submitted in lieu of the CFS and GMP certificates.
【参考连结】
https://npra.gov.my/index.php/en/
HLF-TW-75
马来西亚保健食品审核机构,能够接受海外检验机构的检验资料吗?假如是的话,有些被认可的机构?网页?
Evershine RD:
1. 可接受的 GMP 标准将由产品在原产国分类的类别决定。
例如,如果产品在原产国被归类为食品,则在标准与马来西亚的做法相似的情况下,将接受相关国家当局颁发的食品标准 GMP 证书。
2. 如果产品在原产国不受监管并且不需要 GMP 认证,製造商必须出示由权威机构认可的独立机构颁发的 GMP 证书。
必须提及包括检查所依据的标准/法规/立法在内的信息。
3. 如果产品在原产国归类为药品,则可以提交 CPP 代替 CFS 和 GMP 证书。
3. 如果产品在原产国归类为药品,则可以提交 CPP 代替 CFS 和 GMP 证书。
1. Acceptable GMP standards will be determined by the category the product is classified into in the country of origin.
For example, if a product is classified as food in the country of origin, a GMP certificate for food standards issued by the relevant national authorities will be accepted, provided the standards are similar to those in Malaysia.
2. If the product is not regulated in the country of origin and does not require GMP certification, the manufacturer must present a GMP certificate issued by an independent body recognized by an authoritative body.
Information including the standard/regulation/legislation on which the inspection is based must be mentioned.
3. If the product is classified as a pharmaceutical product in the country of origin, a CPP may be submitted in lieu of the CFS and GMP certificates.
HLF-TW-77
HLF-TW-80
外国子公司进口保健食品后,如果委託马来西亚的经销商销售,经销商需要保健食品营业许可证吗?
假如保健食品有品质瑕疵的话,外国子公司和经销商各自的责任为何?
是连带责任吗?还是可以规范由外国子公司负责?
After a foreign subsidiary imports health food and entrusts a distributor in Malaysia to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD:
代理商/批发商需负责与产品註册有关的所有事项。代理商/批发商必须申请批发商许可证才能通过批发销售或从其场所供应註册产品,许可证有效期为1年。
产品登记程序:
1. 于NPRA 网站(www.npra.gov.my) 申请Quest会员资格,需要资料:
.註册表
.公司授权书
.身份证複本
2. 获得 Quest 会员资格后,登录Quest提交产品註册申请。
3. 提交要求的数据、资料。
4. 提交给DCA 会议的产品。
产品註册持有人负责报告药物服务署因使用註册产品而引起的任何不良反应、必须确保公司有药物警戒系统并在必要时採取适当的行动。产品註册持有人必须监控本地或国际上出现的任何产品安全问题,以及向 NPRA 报告,并遵守管理局发布的所有与安全相关的指令。
如产品註册持有人收到该等报告后未能将任何严重不良反应通知管理局,产品註册状态可能会受到影响。
It is necessary to register a company locally in Malaysia, and its business scope is in the field of health/pharmaceutical products.
A local health/cosmetic company in Malaysia is required to apply in the name of Cosmetic Notification Holder (CNH), and wholesalers must apply for a wholesaler license to sell or supply registered products through wholesale or from their premises, and the license is valid for 1 year.
Product registration process:
1. To apply for Quest membership on the NPRA website (www.npra.gov.my), the required information:
. Registration form
. Company Power of Attorney
. Copy of ID
2. After obtaining the Quest membership, log in to Quest to submit a product registration application.
3. Submit the required data and information.
4. Products submitted to the DCA meeting.
The product registration holder is responsible for reporting any adverse reactions to the Pharmacy Service arising from the use of the registered product, must ensure that the company has a pharmacovigilance system and take appropriate action if necessary.
Product registration holders must monitor any product safety issues that arise locally or internationally, as well as report to NPRA, and comply with all safety-related directives issued by the agency.
The product registration status may be affected if the product registration holder fails to notify the Authority of any serious adverse reaction after receiving such reports.
【参考连结】
URL:https://www.npra.gov.my/index.php/en/post-registration-process/4-4-post-marketing-activities.html
HLF-TW-85
接洽我们:
Email:kul4ww@evershinecpa.com
或
马来西亚永辉BPO有限公司
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