泰國化妝品登記法規問題集

泰國永輝BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰國籍說中文
Pay Xiao 泰國籍說英文

或
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin
或
Email：bkk4ww@evershinecpa.com

各國化妝品登記法規問答集

HLF-TH-10
請問泰國對於化妝品的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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：

泰國公共衛生部轄下的食品藥品監督管理局為現行泰國化妝品主管機關，針對化妝品、進出口查驗、藥品、食品、麻醉品和醫療器材分設六個單位。
其中，化妝品管理部單獨負責控制、規範並確保化妝品中的標準符合現行標準和法規。
在泰國，化妝品的定義是指接觸於人體各外部器官或口腔內的牙齒和口腔黏膜，以清潔、發出香味、改善外觀、改善身體氣味或保護身體使之保持良好狀態為主要目的之物質和製劑，但不包括人體外的飾品和服裝。
高風險化妝品產品包含：酒精類、片狀清潔身體（濕紙巾）、隱藏清潔劑成分、玻璃安瓶/玻璃瓶/注射器、包含大麻、口腔噴霧/漱口水等，需要依照各項的規定進行標註及附上資料。
化妝品中包含大麻和大麻萃取物須提出物質清單通報，必須通報食品藥品監督管理局，化妝品中的大麻籽油/提取物屬於哪個類別(大麻籽油/大麻籽提取物/大麻籽水/氫化大麻籽油/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).

【參考連結】

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
外國公司要到泰國銷售化妝品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：

任何生產、進口銷售或分包生產、銷售化妝品者，必須提出申報，並在開具申報回執後，方可從事化妝品的生產或進口。
通知、通知收據的簽發應符合規定之規則、程序和條件:

1. 生產者、進口者或生產銷售合同者必須具備以下條件：

．自然人：必須具有泰國國籍，最低年齡為二十歲。
．法人：必須在泰國營業登記。

2. 營業登記須向泰國商務部進行電子登記。

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.

【參考連結】

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

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

HLF-TH-25

假如需要辦理，請問泰國有專業服務公司可以協助辦理化妝品公司營業許可證？

HLF-TH-30
外國公司要到泰國銷售化妝品，可以指派泰國公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？
外國公司與營業代理人的產品責任為何?網頁？

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。任何生產、進口銷售或分包生產、銷售化妝品的人，必須提出申報，並在開具申報回執後，方可從事化妝品的生產或進口。
通知、通知收據的簽發應符合規定之規則、程序和條件。

申請化妝品許可證

1.流程：通過服務中心提交文件/電子文件→繳交相關手續費→工作人員審核→文件審核→批准結果(三個工作日)
2.方式：

• 食品藥品監督管理局的健康產品一站式服務中心(OSSC)
• 衛生局
• 網路

3.申請表：

• 商品名稱和化妝品名稱(泰文和英文)
• 化妝品的使用方式
• 化妝品種類(使用區域、目的)
• 化妝品的物理特性
• 容器的物理特性
• 化妝品的款式(單品或者其他)
• 生產商的詳細資料
• 合同製造的詳細資料(承包商、製造商)
• 進口銷售的詳細資料(進口商、外國製造商)
• 化妝品成分清單、詳細內容等

4.注意事項

• 任何與化妝品產品有關的聲明均應附上製造商(包含國內外)出具的書面聲明，並由公司董事簽字。
• 如果附件是英語以外的其他語言請附上翻譯成泰文的文件，或由語言學院/大學等可信賴機構認證的英語。
• 國內市場銷售負責人如果不是公司或是與生產者相同的人，需附上授權書影本。
• 如果產品的名稱、類型或特性表明防曬，製造商或進口商必須將上述防曬能力測試結果的證明文件保存備查。
• 申請進口化妝品必須附上製造商的授權書、製造商或產品所有者的產品品牌名稱，並說明發行人與進口產品者的關係(製造商/產品所有者/經銷商)。

根據東盟化妝品指令，發生不良事件時，無論報告的來源（消費者、醫療保健專業人員等），負責將化妝品投放市場的公司或個人應向泰國食品藥品監督管理局報告:

1.每當有合理懷疑化妝品可能是引起反應的原因時，應報告所有嚴重的不良事件，沒有強制要求報告非嚴重不良事件。

2.不良事件發生率高（非嚴重/嚴重反應）
非嚴重不良事件發生率高，需要與食品藥品監督管理局快速溝通（由事件與售出的比率定義），應以醫學和科學方式對情況進行判斷後，再進行報告。

3.不良事件報告

• 公司資料：公司名稱及地址、申報人姓名、電話、傳真、郵箱
• 產品詳情：產品名稱、成分列表和包裝尺寸（請附上單獨的列表）、產品類型/預期用途
• 製造商名稱、製造國、到期或生產日期、批號。
• 不良事件詳情

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

【參考連結】

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

假如需要辦理指派泰國公司擔任營業代理人，請問泰國有專業服務公司可以協助？

HLF-TH-40
外國公司銷售到泰國化妝品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？化妝品包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了泰文外，其他哪種語文也可以？網頁？

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：

任何生產、進口銷售或分包生產、銷售化妝品的人，必須提出申報，並在開具申報回執後，方可從事化妝品的生產或進口。通知、通知收據的簽發應符合規定之規則、程序和條件。

申請化妝品許可證

1. 流程：通過服務中心提交文件/電子文件→繳交相關手續費→工作人員審核→文件審核→批准結果(三個工作日)
2. 方式：

• 食品藥品監督管理局的健康產品一站式服務中心(OSSC)
• 衛生局
• 網路

3. 申請表：

• 商品名稱和化妝品名稱(泰文和英文)
• 化妝品的使用方式
• 化妝品種類(使用區域、目的)
• 化妝品的物理特性
• 容器的物理特性
• 化妝品的款式(單品或者其他)
• 生產商的詳細資料
• 合同製造的詳細資料(承包商、製造商)
• 進口銷售的詳細資料(進口商、外國製造商)
• 化妝品成分清單、詳細內容等

4.注意事項

• 任何與化妝品產品有關的聲明均應附上製造商(包含國內外)出具的書面聲明，並由公司董事簽字。
• 如果附件是英語以外的其他語言請附上翻譯成泰文的文件，或由語言學院/大學等可信賴機構認證的英語。
• 國內市場銷售負責人如果不是公司或是與生產者相同的人，需附上授權書影本。
• 如果產品的名稱、類型或特性表明防曬，製造商或進口商必須將上述防曬能力測試結果的證明文件保存備查。
• 申請進口化妝品必須附上製造商的授權書、製造商或產品所有者的產品品牌名稱，並說明發行人與進口產品者的關係(製造商/產品所有者/經銷商)。

製造和銷售化妝品的製造商、進口商和分包商必須確保所有化妝品的標籤必須符合以下要求：

1. 標籤上包含的所有訊息必須準確無誤，不得包含任何可能導致嚴重誤解的訊息；所有訊息必須符合道德並符合泰國文化規範。
2. 必須用泰語書寫，且大小易於閱讀；也可以用外語提供訊息。進口到泰國銷售的化妝品在海關檢查時無需在包裝或包裹物上貼有泰文標籤，但必須在銷售前貼上泰文標籤。
3. 標籤必須包含以下信息：

• 化妝品的名稱和商品名稱。
• 如果產品是在國內製造的，須註明製造商的名稱和位置；進口化妝品需註明進口商名稱、所在地以及製造商名稱和原產國。
• 數量、使用說明、注意事項、警告、製造和到期日期的月份和年份、批號，以及產品製造中使用的所有成分名稱。
• 根據委員會在泰國皇家政府公報中規定的規則和條件，以及保護消費者安全的任何其他訊息。

如果標籤不符合規定的條件，經委員會批准，秘書長有權責令終止使用該標籤或修改該標籤。

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.

【參考連結】

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

請問在泰國有哪些專業服務機構，可以協助辦理化妝品產品許可證？

HLF-TH-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？
化妝品包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了泰文外，其他哪種語文也可以？網頁？

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：

外國公司需在泰國有設立公司再提出申請。任何生產、進口銷售或分包生產、銷售化妝品的人，必須提出申報，並在開具申報回執後，方可從事化妝品的生產或進口。通知、通知收據的簽發應符合規定之規則、程序和條件。

申請化妝品許可證

1. 流程：通過服務中心提交文件/電子文件→繳交相關手續費→工作人員審核→文件審核→批准結果(三個工作日)
2. 方式：

• 食品藥品監督管理局的健康產品一站式服務中心(OSSC)
• 衛生局
• 網路

3. 申請表：

• 商品名稱和化妝品名稱(泰文和英文)
• 化妝品的使用方式
• 化妝品種類(使用區域、目的)
• 化妝品的物理特性
• 容器的物理特性
• 化妝品的款式(單品或者其他)
• 生產商的詳細資料
• 合同製造的詳細資料(承包商、製造商)
• 進口銷售的詳細資料(進口商、外國製造商)
• 化妝品成分清單、詳細內容等

4.注意事項

• 任何與化妝品產品有關的聲明均應附上製造商(包含國內外)出具的書面聲明，並由公司董事簽字。
• 如果附件是英語以外的其他語言請附上翻譯成泰文的文件，或由語言學院/大學等可信賴機構認證的英語。
• 國內市場銷售負責人如果不是公司或是與生產者相同的人，需附上授權書影本。
• 如果產品的名稱、類型或特性表明防曬，製造商或進口商必須將上述防曬能力測試結果的證明文件保存備查。
• 申請進口化妝品必須附上製造商的授權書、製造商或產品所有者的產品品牌名稱，並說明發行人與進口產品者的關係(製造商/產品所有者/經銷商)。

製造和銷售化妝品的製造商、進口商和分包商必須確保所有化妝品的標籤必須符合以下要求：

1. 標籤上包含的所有訊息必須準確無誤，不得包含任何可能導致嚴重誤解的訊息；所有訊息必須符合道德並符合泰國文化規範。
2. 必須用泰語書寫，且大小易於閱讀；也可以用外語提供訊息。進口到泰國銷售的化妝品在海關檢查時無需在包裝或包裹物上貼有泰文標籤，但必須在銷售前貼上泰文標籤。
3. 標籤必須包含以下信息：

• 化妝品的名稱和商品名稱。
• 如果產品是在國內製造的，須註明製造商的名稱和位置；進口化妝品需註明進口商名稱、所在地以及製造商名稱和原產國。
• 數量、使用說明、注意事項、警告、製造和到期日期的月份和年份、批號，以及產品製造中使用的所有成分名稱。
• 根據委員會在泰國皇家政府公報中規定的規則和條件，以及保護消費者安全的任何其他訊息。

如果標籤不符合規定的條件，經委員會批准，秘書長有權責令終止使用該標籤或修改該標籤。

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.

【參考連結】

https://aseancosmetics.org/

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

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

HLF-TH-55

請問在泰國有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？

HLF-TH-60
經過核准登記的化妝品，進口到泰國要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：

根據化妝品法規，化妝品在泰國生產或進口前需要向食品藥品監督管理局通報產品，並上市前需通過優良生產規範認證。
化妝品優良生產規範認證申請資料：

1.申請人、生產基地編號

2.公司名稱、化妝品生產基地位置

3.實驗室(有/無)

4.總公司/辦事處地址、電話

5.生產的化妝品類型(固體/液體/氣體)

6.員工人數、工作天數和小時數

7.其他證明文件

．生產現場位置圖

．總公司/辦事處位置圖

．法人登記證/商業登記證

．組織結構圖

．工作流程圖

．工廠平面圖

．機器生產現場、周圍、各種房間和與生產相關區域的照片

．建築物的立面圖

．員工培訓SOP

．健康檢查SOP

．員工著裝SOP

．原料接收和包裝材料SOP

．原料或不符合要求的包裝材料處理SOP

．清潔SOP

．原料/生產中化妝品/待包裝化妝品/成品化妝品品質控制SOP

．原料/待包裝化妝品/成品化妝品取樣SOP

．原材料規格、一次包裝的示例以及每次檢查的結果2 件

．SOP 內部審核

．召回化妝品的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.

【參考連結】

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
泰國化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

公司或負責配售化妝品的人員應向化妝品監管機構提供下列文件：

1.製造商用於檢查化妝品成分的方法與產品分析對應的證書。
2.用於化妝品成分中微生物控制和化學純度的檢查標準。

成分安全性資料：可自供應商、東盟化粧品科學會、歐盟消費品科學委員會或美國化粧品成分評估委員會等機構取得。

1. 產品配方之定性及定量(以國際化粧品成分名稱 INCI 或東協化粧品指令 ACD認可的命名法，以及成分含量)：說明配方中每一成分的功能。
2. 製造資訊：包含製造廠、組裝廠或包裝廠之名稱、國家、地址及電話。

．簡述產品製造流程。

．詳細製程資訊或品質管制等相關資料必要時主管機關得要求提供。

3. 產品檢驗規格及方法：

．產品的微生物及成分之化學純度的標準。

．可確認符合規格之分析方法。

4. 產品安定性報告(產品儲存時間純低於三十個月者)：

．支持保存有效期限的安定性試驗結果或安定性評估。

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.

【參考連結】

https://aseancosmetics.org/

HLF-TH-75

泰國化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

HLF-TH-77

請問在泰國有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？

HLF-TH-80
外國子公司進口化妝品後，如果委託泰國的經銷商銷售，經銷商需要化妝品營業許可證嗎？
假如化妝品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？
是連帶責任嗎？還是可以規範由外國子公司負責？

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。任何生產、進口銷售或分包生產、銷售化妝品的人，必須提出申報，並在開具申報回執後，方可從事化妝品的生產或進口。
通知、通知收據的簽發應符合規定之規則、程序和條件。
根據東盟化妝品指令，發生不良事件時，無論報告的來源（消費者、醫療保健專業人員等），負責將化妝品投放市場的公司或個人應向泰國食品藥品監督管理局報告:

1.每當有合理懷疑化妝品可能是引起反應的原因時，應報告所有嚴重的不良事件，沒有強制要求報告非嚴重不良事件。

2.不良事件發生率高（非嚴重/嚴重反應）
非嚴重不良事件發生率高，需要與食品藥品監督管理局快速溝通（由事件與售出的比率定義），應以醫學和科學方式對情況進行判斷後，再進行報告。

3.不良事件報告

．公司資料：公司名稱及地址、申報人姓名、電話、傳真、郵箱

．產品詳情：產品名稱、成分列表和包裝尺寸（請附上單獨的列表）、產品類型/預期用途

．製造商名稱、製造國、到期或生產日期、批號。

．不良事件詳情

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

【參考連結】

https://aseancosmetics.org/

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

HLF-TH-85

請問在泰國有哪些專精於化妝品銷售與消費權益相關法律服務的業者？

各國化妝品登記法規問答集

泰國永輝BPO有限公司
1108/31 Sukhumvit Road, Phrakanong, Klongtoey, Bangkok, Thailand 10110
接洽人:
Ploy Lee 泰國籍說中文
Pay Xiao 泰國籍說英文

或
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199 in Taiwan; Mobile: +86-139-1048-6278 in China
TEL: +886-2-27170515 E100 ;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen ;
linkedin address:Dale Chen Linkedin
或
Email：bkk4ww@evershinecpa.com

永輝關係企業: 泰國永輝服務有限公司
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

全球永輝服務據點參考資料:
永輝100%關係企業
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其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
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永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

請用下列電郵與我們聯繫: HQ4TPE@evershinecpa.com

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