泰国化妆品登记法规问题集

泰国永辉BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰国籍说中文
Pay Xiao 泰国籍说英文

或
联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
电话：+886-2-2717-0515 分机:104
或
Email：bkk4ww@evershinecpa.com

各国化妆品登记法规问答集

HLF-TH-10
请问泰国对于化妆品的归类方式为何？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 cosmetics in Thailand? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics ? Website?

Evershine RD：

泰国公共卫生部辖下的食品药品监督管理局为现行泰国化妆品主管机关，针对化妆品、进出口查验、药品、食品、麻醉品和医疗器材分设六个单位。
其中，化妆品管理部单独负责控制、规范并确保化妆品中的标准符合现行标准和法规。
在泰国，化妆品的定义是指接触于人体各外部器官或口腔内的牙齿和口腔黏膜，以清洁、发出香味、改善外观、改善身体气味或保护身体使之保持良好状态为主要目的之物质和製剂，但不包括人体外的饰品和服装。
高风险化妆品产品包含：酒精类、片状清洁身体（湿纸巾）、隐藏清洁剂成分、玻璃安瓶/玻璃瓶/注射器、包含大麻、口腔喷雾/漱口水等，需要依照各项的规定进行标註及附上资料。
化妆品中包含大麻和大麻萃取物须提出物质清单通报，必须通报食品药品监督管理局，化妆品中的大麻籽油/提取物属于哪个类别(大麻籽油/大麻籽提取物/大麻籽水/氢化大麻籽油/水解大麻籽提取物/水解大麻籽提取物)。

The Food and Drug Administration Thailand (Thai FDA) under the Ministry of Public Health, MOPH is the current cosmetics authority in Thailand.
Thai FDA has six divisions for cosmetics, import and export inspection, pharmaceuticals, food, narcotics and medical equipment.
Among them, the Cosmetic Control Group is solely responsible for controlling, regulating and ensuring that standards in cosmetics comply with current standards and regulations.

A “cosmetic product” shall mean any substance or preparation intended to be placed in contact (by applying to, massaging or rubbing into, sprinkling or spraying on, dropping onto, introducing into, perfuming, or by any other means,) with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition but shall not include ornaments and clothing which are deemed as accessories outside human body.

High-risk cosmetic products: alcohol, sheet-like body cleaning (wet wipes), hidden detergent ingredients, glass ampoules/glass bottles/syringes, marijuana, oral spray/mouthwash, etc., which need to be labeled according to the regulations of each item and attached information.

Cosmetics containing cannabis and cannabis extracts must submit a Substance List Notification and must notify the Food and Drug Administration of which category the “hemp seed oil/extract” in the cosmetic product belongs to (hemp seed oil/hemp seed extract/hemp seed water / Hydrogenated Hemp Seed Oil / Hydrolyzed Hemp Seed Extract / Hydrolyzed Hemp Seed Extract).

【参考连结】

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Permission.aspx

HLF-TH-20
外国公司要到泰国销售化妆品，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 cosmetics in Thailand, 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：

任何生产、进口销售或分包生产、销售化妆品者，必须提出申报，并在开具申报回执后，方可从事化妆品的生产或进口。
通知、通知收据的签发应符合规定之规则、程序和条件:

1. 生产者、进口者或生产销售合同者必须具备以下条件：

．自然人：必须具有泰国国籍，最低年龄为二十岁。
．法人：必须在泰国营业登记。

2. 营业登记须向泰国商务部进行电子登记。

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister:

1. The producer, importer or production and sales contract must meet the following conditions:

• Natural person: it must have Thai nationality and the minimum age is twenty years old.
• Juridical Person: it must be registered in Thailand.

2. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

【参考连结】

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

https://www.dbd.go.th/dbdweb_en/index.php#

HLF-TH-25

假如需要办理，请问泰国有专业服务公司可以协助办理化妆品公司营业许可证？

HLF-TH-30
外国公司要到泰国销售化妆品，可以指派泰国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 cosmetics in Thailand, can it assign a Thailandn 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：

可以。任何生产、进口销售或分包生产、销售化妆品的人，必须提出申报，并在开具申报回执后，方可从事化妆品的生产或进口。
通知、通知收据的签发应符合规定之规则、程序和条件。

申请化妆品许可证

1.流程：通过服务中心提交文件/电子文件→缴交相关手续费→工作人员审核→文件审核→批准结果(三个工作日)
2.方式：

• 食品药品监督管理局的健康产品一站式服务中心(OSSC)
• 卫生局
• 网路

3.申请表：

• 商品名称和化妆品名称(泰文和英文)
• 化妆品的使用方式
• 化妆品种类(使用区域、目的)
• 化妆品的物理特性
• 容器的物理特性
• 化妆品的款式(单品或者其他)
• 生产商的详细资料
• 合同製造的详细资料(承包商、製造商)
• 进口销售的详细资料(进口商、外国製造商)
• 化妆品成分清单、详细内容等

4.注意事项

• 任何与化妆品产品有关的声明均应附上製造商(包含国内外)出具的书面声明，并由公司董事签字。
• 如果附件是英语以外的其他语言请附上翻译成泰文的文件，或由语言学院/大学等可信赖机构认证的英语。
• 国内市场销售负责人如果不是公司或是与生产者相同的人，需附上授权书影本。
• 如果产品的名称、类型或特性表明防晒，製造商或进口商必须将上述防晒能力测试结果的证明文件保存备查。
• 申请进口化妆品必须附上製造商的授权书、製造商或产品所有者的产品品牌名称，并说明发行人与进口产品者的关係(製造商/产品所有者/经销商)。

根据东盟化妆品指令，发生不良事件时，无论报告的来源（消费者、医疗保健专业人员等），负责将化妆品投放市场的公司或个人应向泰国食品药品监督管理局报告:

1.每当有合理怀疑化妆品可能是引起反应的原因时，应报告所有严重的不良事件，没有强制要求报告非严重不良事件。

2.不良事件发生率高（非严重/严重反应）
非严重不良事件发生率高，需要与食品药品监督管理局快速沟通（由事件与售出的比率定义），应以医学和科学方式对情况进行判断后，再进行报告。

3.不良事件报告

• 公司资料：公司名称及地址、申报人姓名、电话、传真、邮箱
• 产品详情：产品名称、成分列表和包装尺寸（请附上单独的列表）、产品类型/预期用途
• 製造商名称、製造国、到期或生产日期、批号。
• 不良事件详情

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Apply for a cosmetic license

1. Process: Submit documents/electronic documents → pay relevant fees → review → document review → approval results (three working days)
2. Method:

． Food and Drug Administration’s One-Stop Service Center (OSSC) for

Health Products

． Health Center

． Internet

3. Application form:

． Product name and cosmetic name (Thai and English)

． Cosmetics instructions

． Types (range, purpose)

． Physical properties of cosmetics

． Physical properties of the container

． Cosmetics category (single product or other)

． Manufacturer’s details

． Details of contract manufacturing (contractor, manufacturer)

． Details of import sales (importers, foreign manufacturers)

． Cosmetic ingredient list, details, etc.

4. Precautions

．Any statement related to cosmetic products should be accompanied by a written statement issued by the manufacturer (both domestic and foreign) and signed by the company director.

．If the attachment is in a language other than English, please attach the document translated into Thai, or in English certified by a trusted institution such as a language institute/university.

．If the person in charge of sales in the domestic market is not the company or the same person as the producer, a copy of the authorization letter must be attached.

．If the name, type or characteristics of the product indicate sun protection, the manufacturer or importer must keep for future reference documentation of the results of the above-mentioned sun protection ability test.

．The application for imported cosmetics must be accompanied by the manufacturer’s authorization , the product brand of the manufacturer or product owner, and the relationship between the issuer and the importer (manufacturer/product owner/distributor).

Pursuant to the ASEAN Cosmetic Directive, The company or person responsible for placing the cosmetic product in the market shall report to the regulatory authority of the ASEAN Member State where the adverse event occurred, regardless of the source of the report (consumer, healthcare professional, etc).

1.All serious adverse events should be reported. Non-serious adverse events are not required to be reported.

2.High incidence of Adverse Event (Non-serious/severe reactions)

There are “non-serious” adverse events that occur at a high incidence (as defined by the ratio of events to units sold) of a single “severe” reaction type that may necessitate rapid communication to the regulatory authority. However, appropriate medical and scientific judgment should be applied for each situation of non-serious, single “severe”1  adverse reaction that has a high incidence before reporting to the regulatory authority.

3. Adverse Event Reporting

． Company Particulars: Name and address of Company, Name & designation of person reporting, Tel No.,Fax No,Email

．Product Particular: Product Name (as in product notification), Ingredient listing & pack size (Please attach a separate list),Product Type/Intended use

．Name of Manufacturer & country of manufacture, Expiry or manufacturing date, Batch No.

．Details of Adverse Event

【参考连结】

https://www.fda.moph.go.th/

https://aseancosmetics.org/asean-cosmetics-directive/post-marketing-surveillance/

https://www.fda.moph.go.th/sites/Cosmetic/Pages/Main.aspx

HLF-TH-35

假如需要办理指派泰国公司担任营业代理人，请问泰国有专业服务公司可以协助？

HLF-TH-40
外国公司销售到泰国化妆品本身，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？化妆品包装内容及各种标示，需要事先核准吗？
可允许的语文除了泰文外，其他哪种语文也可以？网页？

Do foreign companies need to apply for an approval before importing cosmetics sold to Thailand? If yes, which authority is in charge?
What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval?
In addition to Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

任何生产、进口销售或分包生产、销售化妆品的人，必须提出申报，并在开具申报回执后，方可从事化妆品的生产或进口。通知、通知收据的签发应符合规定之规则、程序和条件。

申请化妆品许可证

1. 流程：通过服务中心提交文件/电子文件→缴交相关手续费→工作人员审核→文件审核→批准结果(三个工作日)
2. 方式：

• 食品药品监督管理局的健康产品一站式服务中心(OSSC)
• 卫生局
• 网路

3. 申请表：

• 商品名称和化妆品名称(泰文和英文)
• 化妆品的使用方式
• 化妆品种类(使用区域、目的)
• 化妆品的物理特性
• 容器的物理特性
• 化妆品的款式(单品或者其他)
• 生产商的详细资料
• 合同製造的详细资料(承包商、製造商)
• 进口销售的详细资料(进口商、外国製造商)
• 化妆品成分清单、详细内容等

4.注意事项

• 任何与化妆品产品有关的声明均应附上製造商(包含国内外)出具的书面声明，并由公司董事签字。
• 如果附件是英语以外的其他语言请附上翻译成泰文的文件，或由语言学院/大学等可信赖机构认证的英语。
• 国内市场销售负责人如果不是公司或是与生产者相同的人，需附上授权书影本。
• 如果产品的名称、类型或特性表明防晒，製造商或进口商必须将上述防晒能力测试结果的证明文件保存备查。
• 申请进口化妆品必须附上製造商的授权书、製造商或产品所有者的产品品牌名称，并说明发行人与进口产品者的关係(製造商/产品所有者/经销商)。

製造和销售化妆品的製造商、进口商和分包商必须确保所有化妆品的标籤必须符合以下要求：

1. 标籤上包含的所有讯息必须准确无误，不得包含任何可能导致严重误解的讯息；所有讯息必须符合道德并符合泰国文化规范。
2. 必须用泰语书写，且大小易于阅读；也可以用外语提供讯息。进口到泰国销售的化妆品在海关检查时无需在包装或包裹物上贴有泰文标籤，但必须在销售前贴上泰文标籤。
3. 标籤必须包含以下信息：

• 化妆品的名称和商品名称。
• 如果产品是在国内製造的，须註明製造商的名称和位置；进口化妆品需註明进口商名称、所在地以及製造商名称和原产国。
• 数量、使用说明、注意事项、警告、製造和到期日期的月份和年份、批号，以及产品製造中使用的所有成分名称。
• 根据委员会在泰国皇家政府公报中规定的规则和条件，以及保护消费者安全的任何其他讯息。

如果标籤不符合规定的条件，经委员会批准，秘书长有权责令终止使用该标籤或修改该标籤。

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Apply cosmetic license

1. Process: Submit documents/electronic documents → pay relevant fees → review → document review → approval results (three working days)
2. Method:

． Food and Drug Administration’s One-Stop Service Center (OSSC) for

Health Products

． Health Center

． Internet

3. Application form:

． Product name and cosmetic name (Thai and English)

． Cosmetics instructions

． Types (range, purpose)

． Physical properties of cosmetics

． Physical properties of the container

． Cosmetics category (single product or other)

． Manufacturer’s details

． Details of contract manufacturing (contractor, manufacturer)

． Details of import sales (importers, foreign manufacturers)

． Cosmetic ingredient list, details, etc.

4. Precautions

．Any statement related to cosmetic products should be accompanied by a written statement issued by the manufacturer (both domestic and foreign) and signed by the company director.

．If the attachment is in a language other than English, please attach the document translated into Thai, or in English certified by a trusted institution such as a language institute/university.

．If the person in charge of sales in the domestic market is not the company or the same person as the producer, a copy of the authorization letter must be attached.

．If the name, type or characteristics of the product indicate sun protection, the manufacturer or importer must keep for future reference documentation of the results of the above-mentioned sun protection ability test.

．The application for imported cosmetics must be accompanied by the manufacturer’s authorization , the product brand of the manufacturer or product owner, and the relationship between the issuer and the importer (manufacturer/product owner/distributor).

Manufacturers, importers and subcontractors for the manufacture and sale of cosmetics must ensure that all cosmetics have labels;

Labels must comply with the following:

1. All information contained on the label must be accurate and must not contain any information which could result in a serious misunderstanding; all information must be ethical and in keeping with Thai cultural norms.
2. Information must be written in the Thai language and must be of a size that is easily legible; information may also be provided in a foreign language. Cosmetics imported for sale in the Kingdom are not required to have a Thai language label on the packaging or wrapping at the time of customs inspection but a Thai-language label must be affixed prior to sale.
3. Labels must bear the following information:

．Name and trade name of the cosmetic.

．Name and location of the manufacturer if the product is manufactured in the Kingdom; name and location of the importer together with the name of the manufacturer and country of origin in the case of imported cosmetics.

．Quantity, directions for use, cautions, warnings, month and year of manufacture and expiry date, batch number or letter, and the names of all ingredients used in the manufacture of the product.

．Any other information intended for the benefit of consumer safety in accordance with the rules and conditions stipulated by the Committee in the Royal Thai Government Gazette.

If a label does not conform to the terms stipulated, the Secretary General, with the approval of the Committee, is authorized to order the Notifying Party to terminate use of the label or to amend said label.

【参考连结】

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

https://www.fda.moph.go.th/sites/Cosmetic/Pages/Main.aspx

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Permission.aspx

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/GMP_CMT.aspx

https://privus.fda.moph.go.th/index.aspx

HLF-TH-45

请问在泰国有哪些专业服务机构，可以协助办理化妆品产品许可证？

HLF-TH-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？
化妆品包装内容及各种标示，需要事先核准吗？
可允许的语文除了泰文外，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 cosmetics packaging and labeling require prior approval?
In addition to Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

外国公司需在泰国有设立公司再提出申请。任何生产、进口销售或分包生产、销售化妆品的人，必须提出申报，并在开具申报回执后，方可从事化妆品的生产或进口。通知、通知收据的签发应符合规定之规则、程序和条件。

申请化妆品许可证

1. 流程：通过服务中心提交文件/电子文件→缴交相关手续费→工作人员审核→文件审核→批准结果(三个工作日)
2. 方式：

• 食品药品监督管理局的健康产品一站式服务中心(OSSC)
• 卫生局
• 网路

3. 申请表：

• 商品名称和化妆品名称(泰文和英文)
• 化妆品的使用方式
• 化妆品种类(使用区域、目的)
• 化妆品的物理特性
• 容器的物理特性
• 化妆品的款式(单品或者其他)
• 生产商的详细资料
• 合同製造的详细资料(承包商、製造商)
• 进口销售的详细资料(进口商、外国製造商)
• 化妆品成分清单、详细内容等

4.注意事项

• 任何与化妆品产品有关的声明均应附上製造商(包含国内外)出具的书面声明，并由公司董事签字。
• 如果附件是英语以外的其他语言请附上翻译成泰文的文件，或由语言学院/大学等可信赖机构认证的英语。
• 国内市场销售负责人如果不是公司或是与生产者相同的人，需附上授权书影本。
• 如果产品的名称、类型或特性表明防晒，製造商或进口商必须将上述防晒能力测试结果的证明文件保存备查。
• 申请进口化妆品必须附上製造商的授权书、製造商或产品所有者的产品品牌名称，并说明发行人与进口产品者的关係(製造商/产品所有者/经销商)。

製造和销售化妆品的製造商、进口商和分包商必须确保所有化妆品的标籤必须符合以下要求：

1. 标籤上包含的所有讯息必须准确无误，不得包含任何可能导致严重误解的讯息；所有讯息必须符合道德并符合泰国文化规范。
2. 必须用泰语书写，且大小易于阅读；也可以用外语提供讯息。进口到泰国销售的化妆品在海关检查时无需在包装或包裹物上贴有泰文标籤，但必须在销售前贴上泰文标籤。
3. 标籤必须包含以下信息：

• 化妆品的名称和商品名称。
• 如果产品是在国内製造的，须註明製造商的名称和位置；进口化妆品需註明进口商名称、所在地以及製造商名称和原产国。
• 数量、使用说明、注意事项、警告、製造和到期日期的月份和年份、批号，以及产品製造中使用的所有成分名称。
• 根据委员会在泰国皇家政府公报中规定的规则和条件，以及保护消费者安全的任何其他讯息。

如果标籤不符合规定的条件，经委员会批准，秘书长有权责令终止使用该标籤或修改该标籤。

The application for a product license is supposed submitted by a company registered in Thailand.
Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Apply cosmetic license

1. Process: Submit documents/electronic documents → pay relevant fees → review → document review → approval results (three working days)
2. Method:

． Food and Drug Administration’s One-Stop Service Center (OSSC) for

Health Products

． Health Center

． Internet

3. Application form:

． Product name and cosmetic name (Thai and English)

． Cosmetics instructions

． Types (range, purpose)

． Physical properties of cosmetics

． Physical properties of the container

． Cosmetics category (single product or other)

． Manufacturer’s details

． Details of contract manufacturing (contractor, manufacturer)

． Details of import sales (importers, foreign manufacturers)

． Cosmetic ingredient list, details, etc.

4. Precautions

．Any statement related to cosmetic products should be accompanied by a written statement issued by the manufacturer (both domestic and foreign) and signed by the company director.

．If the attachment is in a language other than English, please attach the document translated into Thai, or in English certified by a trusted institution such as a language institute/university.

．If the person in charge of sales in the domestic market is not the company or the same person as the producer, a copy of the authorization letter must be attached.

．If the name, type or characteristics of the product indicate sun protection, the manufacturer or importer must keep for future reference documentation of the results of the above-mentioned sun protection ability test.

．The application for imported cosmetics must be accompanied by the manufacturer’s authorization , the product brand of the manufacturer or product owner, and the relationship between the issuer and the importer (manufacturer/product owner/distributor).

Manufacturers, importers and subcontractors for the manufacture and sale of cosmetics must ensure that all cosmetics have labels;

Labels must comply with the following:

1. All information contained on the label must be accurate and must not contain any information which could result in a serious misunderstanding; all information must be ethical and in keeping with Thai cultural norms.
2. Information must be written in the Thai language and must be of a size that is easily legible; information may also be provided in a foreign language. Cosmetics imported for sale in the Kingdom are not required to have a Thai language label on the packaging or wrapping at the time of customs inspection but a Thai-language label must be affixed prior to sale.
3. Labels must bear the following information:

．Name and trade name of the cosmetic.

．Name and location of the manufacturer if the product is manufactured in the Kingdom; name and location of the importer together with the name of the manufacturer and country of origin in the case of imported cosmetics.

．Quantity, directions for use, cautions, warnings, month and year of manufacture and expiry date, batch number or letter, and the names of all ingredients used in the manufacture of the product.

．Any other information intended for the benefit of consumer safety in accordance with the rules and conditions stipulated by the Committee in the Royal Thai Government Gazette.

If a label does not conform to the terms stipulated, the Secretary-General, with the approval of the Committee, is authorized to order the Notifying Party to terminate use of the label or to amend said label.

【参考连结】

https://aseancosmetics.org/

https://www.fda.moph.go.th/

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

HLF-TH-55

请问在泰国有哪些专业服务机构，可以协助以外国公司名义办理化妆品产品许可证？

HLF-TH-60
经过核准登记的化妆品，进口到泰国要检附什麽文件？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 cosmetics into Thailand? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

根据化妆品法规，化妆品在泰国生产或进口前需要向食品药品监督管理局通报产品，并上市前需通过优良生产规范认证。
化妆品优良生产规范认证申请资料：

1.申请人、生产基地编号

2.公司名称、化妆品生产基地位置

3.实验室(有/无)

4.总公司/办事处地址、电话

5.生产的化妆品类型(固体/液体/气体)

6.员工人数、工作天数和小时数

7.其他证明文件

．生产现场位置图

．总公司/办事处位置图

．法人登记证/商业登记证

．组织结构图

．工作流程图

．工厂平面图

．机器生产现场、周围、各种房间和与生产相关区域的照片

．建筑物的立面图

．员工培训SOP

．健康检查SOP

．员工着装SOP

．原料接收和包装材料SOP

．原料或不符合要求的包装材料处理SOP

．清洁SOP

．原料/生产中化妆品/待包装化妆品/成品化妆品品质控制SOP

．原料/待包装化妆品/成品化妆品取样SOP

．原材料规格、一次包装的示例以及每次检查的结果2 件

．SOP 内部审核

．召回化妆品的SOP等

Under current cosmetic regulations, cosmetic products need to be notified to the FDA before being manufactured or imported in Thailand.
Covers description, labeling and declaration of technical ingredients, good manufacturing practice (GMP) pre-marketing.

Cosmetics GMP certification application materials

1. Applicant, production base number
2. Company name, location of cosmetic production base
3. Laboratory
4. Head office/office address and telephone number
5. Type of cosmetic produced (solid/liquid/gas)
6. Number of employees, working days and hours
7. Other supporting documents

. Production site location map

. Head Office/Office Location Map

. Legal person registration certificate / business registration certificate

. Organization Chart

. work flow chart

. Factory floor plan

. Photos of the machine production site, surroundings, various rooms and production-related areas

. Elevation of the building

. Staff training SOP

. Health Check SOP

. Staff Dress SOP

. Raw material receiving and packaging material SOP

. Raw material or non-conforming packaging material handling SOP

. Cleaning SOP

. SOP for Quality Control of Raw Materials / Cosmetics in Production / Cosmetics to Be Packaged / Finished Cosmetics

. Raw material/to-be-packaged cosmetic/finished cosmetic sampling SOP

. Raw material specification, example of one-time packaging and the result of each inspection 2 pieces

. SOP Internal Audit

. SOP for recalling cosmetic products, etc.

【参考连结】

https://www.fda.moph.go.th/

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

https://privus.fda.moph.go.th/index.aspx

HLF-TH-70
泰国化妆品审核机构，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：

公司或负责配售化妆品的人员应向化妆品监管机构提供下列文件：

1.製造商用于检查化妆品成分的方法与产品分析对应的证书。
2.用于化妆品成分中微生物控制和化学纯度的检查标准。

成分安全性资料：可自供应商、东盟化粧品科学会、欧盟消费品科学委员会或美国化粧品成分评估委员会等机构取得。

1. 产品配方之定性及定量(以国际化粧品成分名称 INCI 或东协化粧品指令 ACD认可的命名法，以及成分含量)：说明配方中每一成分的功能。
2. 製造资讯：包含製造厂、组装厂或包装厂之名称、国家、地址及电话。

．简述产品製造流程。

．详细製程资讯或品质管制等相关资料必要时主管机关得要求提供。

3. 产品检验规格及方法：

．产品的微生物及成分之化学纯度的标准。

．可确认符合规格之分析方法。

4. 产品安定性报告(产品储存时间纯低于三十个月者)：

．支持保存有效期限的安定性试验结果或安定性评估。

The following documents shall be made available by the company or person responsible for placing the cosmetic products in the market, to the cosmetic regulatory authority:

1. The available methods used by the manufacturer to check the ingredients of cosmetic products corresponding with the Certificate of Analysis.
2. The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria.

Safety ingredient information: It can be obtained from suppliers, ASEAN Cosmetic Scientific, EU Scientific Committee on Consumer Products, SCCP, US Cosmetic Ingredient Review Board, CIR.

1. Qualitative and quantitative of the product formula (with the international cosmetic ingredient name INCI or the nomenclature approved by the ASEAN Cosmetic Directive ACD, and the ingredient content): Explain the function of each ingredient in the formula.
2. Manufacturing Information: Include the name, country, address and telephone number of the manufacturing plant, assembly plant or packaging plant.

．Briefly describe the product manufacturing process.

．The competent authority may request to provide relevant information such as detailed process information or quality control when necessary.

3. Product inspection specifications and methods:

．Standards for the chemical purity of the microbiological and constituents of a product.

．Analytical methods that can confirm compliance with specifications.

4. Product stability report (product storage time is less than 30 months):

．Stability test results or stability assessments supporting shelf life.

【参考连结】

https://aseancosmetics.org/

HLF-TH-75

泰国化妆品审核机构，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？

HLF-TH-77

请问在泰国有哪些化妆品检验机构可以提供化妆品检验服务？网页？

HLF-TH-80
外国子公司进口化妆品后，如果委託泰国的经销商销售，经销商需要化妆品营业许可证吗？
假如化妆品有品质瑕疵的话，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 cosmetics and entrusts a distributor in Thailand to sell it, does the distributor need a cosmetics 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：

需要。任何生产、进口销售或分包生产、销售化妆品的人，必须提出申报，并在开具申报回执后，方可从事化妆品的生产或进口。
通知、通知收据的签发应符合规定之规则、程序和条件。
根据东盟化妆品指令，发生不良事件时，无论报告的来源（消费者、医疗保健专业人员等），负责将化妆品投放市场的公司或个人应向泰国食品药品监督管理局报告:

1.每当有合理怀疑化妆品可能是引起反应的原因时，应报告所有严重的不良事件，没有强制要求报告非严重不良事件。

2.不良事件发生率高（非严重/严重反应）
非严重不良事件发生率高，需要与食品药品监督管理局快速沟通（由事件与售出的比率定义），应以医学和科学方式对情况进行判断后，再进行报告。

3.不良事件报告

．公司资料：公司名称及地址、申报人姓名、电话、传真、邮箱

．产品详情：产品名称、成分列表和包装尺寸（请附上单独的列表）、产品类型/预期用途

．製造商名称、製造国、到期或生产日期、批号。

．不良事件详情

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Pursuant to the ASEAN Cosmetic Directive, The company or person responsible for placing the cosmetic product in the market shall report to the regulatory authority of the ASEAN Member State where the adverse event occurred, regardless of the source of the report (consumer, healthcare professional, etc).

1.All serious adverse events should be reported. Non-serious adverse events are not required to be reported.

2.High incidence of Adverse Event (Non-serious/severe reactions)

There are “non-serious” adverse events that occur at a high incidence (as defined by the ratio of events to units sold) of a single “severe” reaction type that may necessitate rapid communication to the regulatory authority. However, appropriate medical and scientific judgment should be applied for each situation of non-serious, single “severe”1  adverse reaction that has a high incidence before reporting to the regulatory authority.

3.Adverse Event Reporting

． Company Particulars: Name and address of Company, Name & designation of person reporting, Tel No.,Fax No,Email

．Product Particular: Product Name (as in product notification),Ingredient listing & pack size (Please attach a separate list),Product Type/Intended use

．Name of Manufacturer & country of manufacture, Expiry or manufacturing date, Batch No.

．Details of Adverse Event

【参考连结】

https://aseancosmetics.org/

https://www.fda.moph.go.th/sites/Cosmetic/Pages/Main.asp

HLF-TH-85

请问在泰国有哪些专精于化妆品销售与消费权益相关法律服务的业者？

各国化妆品登记法规问答集

泰国永辉BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰国籍说中文
Pay Xiao 泰国籍说英文

或
联络人：苏 玉 燕  副总经理
手机：+886-928-486-835
电话：+886-2-2717-0515 分机:104
或
Email：bkk4ww@evershinecpa.com

永辉关係企业: 泰国永辉服务有限公司
Evershine Services (Thailand) Co., Ltd
https://bkk.evershinecpa.com
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
Bangkok Manager Paul Xiao, who speaks in both English and Thai.
M: +66-(0)852-222-197

全球永辉服务据点参考资料:
永辉100%关係企业
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其他已提供中文化服务城市：
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永辉潜在可服务城市 (2个月筹备期)：
我们为IAPA会员所,总部在伦敦，全球300个会员所，员工约1万人。
我们为LEA会员所,总部在美国芝加哥，全球600个会员所，员工约2万8千人。
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(版本:2022/03)

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