泰國保健食品登記法規問題集

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

各國健康食品登記法規問題集

• 泰國保健食品登記法規問題集
• 在泰國申請食品經營許可證-QA
• 進口國外食品到泰國銷售-QA

HLF-TH-10
請問泰國對於保健食品的歸類方式為何？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 health food in Thailand?
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：

在泰國的食品管理機關是食品藥物管理局。其主要職責為進行食品上市前到上市後的管制，包含建立食品標準、管理食品生產和進口、規範食品衛生和標示要求、核發認證(如自由銷售證明、衛生證明、優良作業規範認證、HACCP認證等)、食品抽查稽核，以及廣告管理等，以確保消費者安全。
在食品法分類中，膳食補充劑屬於標準化食品。

膳食補充劑是指除常規食品外，具有營養或其他物質成分可供食用的產品，呈片劑、膠囊劑、粉劑、片劑、液體或其他形式，對於希望促進健康的消費者來說，與傳統食品不同。營養物質或其他物質是指：

1. 從植物或動物中取得的維生素、氨基酸、脂肪酸、礦物質之產品。
2. 第1項物質的濃縮、代謝、組合或萃取物。
3. 第1項或第2項物質的人造物質。
4. 第1、2 或 3 項物質其中一種或多種的混合物。
5. 食品藥品監督管理局規定且經食品委員會批准的其他物質。

The Food and Drug Administration of Thailand under the Ministry of Public Health. Its main responsibilities are to control food from pre-market to post-market, including establishing food standards, managing food production and import, regulating food hygiene and labeling requirements, and issuing certifications (such as free sales certificates, hygiene certificates, GMP certification, HACCP certification, etc.) , food spot inspection and audit, and advertising management, etc., to ensure consumer safety. In the food law classification, dietary supplements are standardized foods.

Food supplement means products taken for consume other than conventional foods which contain nutrients or other substances as ingredients, are in forms of tablets, capsules, powders, flakes, liquids or others ; which are not conventional foods for consumers who expect for benefit of health promotion. Nutrients or other substances mean :

1. Vitamins, amino acids, fatty acids, minerals and produces obtained from plants or animals.
2. Concentrates, metabolites composition or extracts of substances of 1.
3. Artificial substances imitated like substances of 1 or 2.
4. Mixtures of one or more of substances of 1 ,2 or 3.
5. Substances or others as to Food and Drug Administration prescribed according to an approval of the Food Committee.

【參考連結】

http://food.fda.moph.go.th/law/TH/pages/product.html

http://food.fda.moph.go.th/law/act.php

HLF-TH-20
外國公司要到泰國銷售保健食品，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 health food 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：

需取得營業特許證，資格如下：

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。

Yes, it is required to obtain an approval.

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.dbd.go.th/dbdweb_en/index.php#

http://food.fda.moph.go.th/ESub/pages/register.php

HLF-TH-25

HLF-TH-30
外國公司要到泰國銷售保健食品，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 health food in Thailand, can it assign a Thailand 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：

可以指派泰國當地公司/人擔任營業代理人。

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。

許可證持有人或公司須負責產品之相關問題，並配合食品藥物管理局之相關定期、臨時檢查。

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.

The license holder or company shall be responsible for product-related issues and cooperate with relevant periodic and ad hoc inspections by the Food and Drug Administration.

【參考連結】

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

http://food.fda.moph.go.th/ESub/pages/register.php

HLF-TH-35

HLF-TH-40
外國公司銷售到泰國保健食品本身，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？
保健食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 health food sold to Thailand? 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 Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

需要。膳食補充劑屬標準化食品，需經食品藥物管理局審核通過取得製造/進口許可證與優良作業規範認證方可販售。已獲得泰國 FDA 批准的有執照之進口商可以進口各種食品。
指定的倉庫或倉庫必須經過泰國 FDA 的檢查和批准，方可頒發許可證。進口許可證每三年更新一次：

申請進口食品銷售許可證者，應提交申請表和規定的文件。

申請表內容。

1. 申請人姓名、年齡、國籍、身份證號、居住地址、電話。

．戶籍影本或照片。

．經認證的註冊、目標、授權文件影本或照片。

．申請人指定授權人經營該法人實體的業務證明文件。

．貿易登記或商業登記的影本或照片。

．商務部出具的法人國籍證明文件。

2. 繳交下列規定文件一式兩份：

．用於保持或保存食品質量的必要設備清單（如適用）。

．進口場所、存放場所和場所位置圖鄰近的建築。

．內部收容場所的佈局，其比例與其尺寸相對應，並註明以下項目：( 持有房舍的鄰近區域、收容處所空間的分隔及通風、必要時安裝用於保持或保存食品質量的設備。)

銷售給消費者的膳食補充劑產品應以泰文標示，也可以使用外文。需包含以下內容：

1. 食品名稱，「膳食補充劑」應當作為名稱的一部分顯示，或者附註。
2. 食品序號。
3. 生產商或進口商的名稱和地址（視情況而定）如下：

．在國內生產的，應標明生產者或者分包商的名稱、地址以供銷售，也可以標明生產者或者分包商的總公司名稱和地址。

．進口商品的進口商名稱、地址和生產國。

4. 膳食補充劑的數量應視情況而定，如下：

．片劑或膠囊形式的膳食補充劑以包為單位標示。

．液體形式的膳食補充劑以體積為標示。

．固體或其他形式的膳食補充劑以淨重標示。

5. 膳食補充劑的主要成分和聲稱有用的成分的名稱和數量。
6. 使用防腐劑聲明（如有）。
7. 添加天然顏色或添加人造顏色聲明（視情況而定）。
8. 天然香料、仿天然香料、合成香料的聲明（視情況而定）。
9. 包含任何營養素應通過五類主要食物規範並按適當比例的聲明。

10.使用說明。

11.儲存說明（如有）。

12. 視情況應於包裝上標示生產、到期日:食用期限或者食品質量合格的日/月/年；膳食補充劑的最低保質期不超過90天的日/月/年；食用期限的月/年；食品質量優良或膳食補充劑標準的最低保質期超過 90 天的月/年。
13. 膳食補充劑應遵循公告衛生部規範的健康聲明和食用警告。

Dietary supplements are standardized foods and need to pass the manufacturing/import license, GMP certification and FDA review before they can be sold. Licensed importers can import a variety of food products, provided they are approved by the Thai FDA. The designated warehouse or warehouse must be inspected and approved by the Thai FDA before a license can be issued. Import licenses are also renewed every three years:

1. Those who intend to apply for a license of importation of food to sell, An Application Form attached with the regulation shall be submitted together with documents specified in Application.

Application form content

． Applicant’s name, age, nationality, ID number, residential address, telephone

． Family register copy or photo.

． Certified copy or photograph of registration, objective, authorization documents.

． Documents proving that the applicant has appointed an authorized person to operate the legal entity.

． Copy or photograph of trade registration or business registration.

．Legal person nationality certificate issued by the Ministry of Commerce.

2. The Applicants, according to clause 1, shall attach two copies of the following documents to apply for the license:

．List of equipments used for keeping or preserving of food quality as necessary (if applicable).

．Map of locations of import premises, holding premises and neighboring constructions.

． Layout of inside holding premises which having ratio corresponded to their dimensions and indicates the following items:( Neighboring area of holding premises, Separation of spaces of the holding premises, ventilation including installation of equipments use for keeping or preserving of food quality as necessary.)

Labeling of food supplement products for sale to consumers shall be expressed in Thai language text but foreign language text may also be presented; and shall have texts to express as follows:

1. Names of food, “food supplements” shall be displayed as a part of the name, or accompanied with.
2. Food serial number.
3. Name and address of producers or importers, as the case may be, as follows:

．For food produced within country, name and address of producers or re-packers for sale shall be displayed, or name and address of head office of producers or re-packers may be displayed instead.

．For imported food, name and address of importer and country of producer.

4. Food supplement quantities shall be expressed as the case may be, as follows:

．Food supplement in form of tablets or capsules expressed as the number per pack.

．Food supplement in form of liquid expressed as net volume.

．Food supplement in form of solid or others expressed as net weight.

5. Name and quantity of main ingredients of food supplement and constituents which claims for usefulness, on the label of food supplement .
6. Declaration of “ utilizing preservatives” (if any)
7. Declaration of “natural colour added” or “artificial colour added” if utilizing, as case may be
8. Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”, “natural flavour”, or “imitate natural flavour” if any, as case may be.
9. Clear statement of “Receiving any nutrients should intake by consuming five categories of principal foods and in appropriate proportion.

10.Instruction for use.

11. Instruction for food storage. (if any)
12. Date, month, and year of expiration for consumption or date, moth, and year in which food is in good qualities or standards for food supplement with minimum durability of not more than 90 days; or month, and year of expiration for consumption or , moth, and year in which food is in good qualities or standards for food supplement with minimum durability of more than 90 days; and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before” , as the case may be; and date, month, and year shall be respectively expressed. The declarations, according to (12) under the packaging, on the label shall present statement which indicate the position of that declaration.
13. Warning of food supplement consuming shall be followed the Notification of the Ministry of Public Health, Re : Health claim and Warning of food consuming.

【參考連結】

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

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-45

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？保健食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 health food packaging and labeling require prior approval?
In addition to the Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

須符合以下資格者方能申請:

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。

膳食補充劑屬標準化食品，需經食品藥物管理局審核通過取得製造/進口許可證與優良作業規範認證方可販售。
已獲得泰國 FDA 批准的有執照之進口商可以進口各種食品。
指定的倉庫或倉庫必須經過泰國 FDA 的檢查和批准，方可頒發許可證。進口許可證每三年更新一次：

1.申請進口食品銷售許可證者，應提交申請表和規定的文件。

申請表內容

．申請人姓名、年齡、國籍、身份證號、居住地址、電話。

．戶籍影本或照片。

．經認證的註冊、目標、授權文件影本或照片。

．申請人指定授權人經營該法人實體的業務證明文件。

．貿易登記或商業登記的影本或照片。

．商務部出具的法人國籍證明文件。

2.繳交下列規定文件一式兩份：

．用於保持或保存食品質量的必要設備清單（如適用）。

．進口場所、存放場所和場所位置圖鄰近的建築。

．內部收容場所的佈局，其比例與其尺寸相對應，並註明以下項目：( 持有房舍的鄰近區域、收容處所空間的分隔及通風、必要時安裝用於保持或保存食品質量的設備。)

銷售給消費者的膳食補充劑產品應以泰文標示，也可以使用外文。需包含以下內容：

1. 食品名稱，「膳食補充劑」應當作為名稱的一部分顯示，或者附註。
2. 食品序號。
3. 生產商或進口商的名稱和地址（視情況而定）如下：

．在國內生產的，應標明生產者或者分包商的名稱、地址以供銷售，也可以標明生產者或者分包商的總公司名稱和地址。

．進口商品的進口商名稱、地址和生產國。

4. 膳食補充劑的數量應視情況而定，如下：

．片劑或膠囊形式的膳食補充劑以包為單位標示。

．液體形式的膳食補充劑以體積為標示。

．固體或其他形式的膳食補充劑以淨重標示。

5. 膳食補充劑的主要成分和聲稱有用的成分的名稱和數量。
6. 使用防腐劑聲明（如有）。
7. 添加天然顏色或添加人造顏色聲明（視情況而定）。
8. 天然香料、仿天然香料、合成香料的聲明（視情況而定）。
9. 包含任何營養素應通過五類主要食物規範並按適當比例的聲明。

10.使用說明。

11.儲存說明（如有）。

12. 視情況應於包裝上標示生產、到期日:食用期限或者食品質量合格的日/月/年；膳食補充劑的最低保質期不超過90天的日/月/年；食用期限的月/年；食品質量優良或膳食補充劑標準的最低保質期超過 90 天的月/年。
13. 膳食補充劑應遵循公告衛生部規範的健康聲明和食用警告。

Application of license should meet the following requirements:

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.

Dietary supplements are standardized foods and need to pass the manufacturing/import license, GMP certification and FDA review before they can be sold.  Licensed importers can import a variety of food products, provided they are approved by the Thai FDA. The designated warehouse or warehouse must be inspected and approved by the Thai FDA before a license can be issued. Import licenses are also renewed every three years:

1. Those who intend to apply for a license of importation of food to sell, An Application Form attached with the regulation shall be submitted together with documents specified in Application.

Application form content

． Applicant’s name, age, nationality, ID number, residential address, telephone

． Family register copy or photo.

． Certified copy or photograph of registration, objective, authorization documents.

． Documents proving that the applicant has appointed an authorized person to operate the legal entity.

． Copy or photograph of trade registration or business registration.

．Legal person nationality certificate issued by the Ministry of Commerce.

2. The Applicants, according to clause 1, shall attach two copies of the following documents to apply for the license:

．List of equipments used for keeping or preserving of food quality as necessary (if applicable).

．Map of locations of import premises, holding premises and neighboring constructions.

． Layout of inside holding premises which having ratio corresponded to their dimensions and indicates the following items:( Neighboring area of holding premises, Separation of spaces of the holding premises, ventilation including installation of equipments use for keeping or preserving of food quality as necessary.)

Labeling of food supplement products for sale to consumers shall be expressed in Thai language text but foreign language text may also be presented; and shall have texts to express as follows:

1. Names of food, “food supplements” shall be displayed as a part of the name, or accompanied with.
2. Food serial number.
3. Name and address of producers or importers, as the case may be, as follows:

．For food produced within country, name and address of producers or re-packers for sale shall be displayed, or name and address of head office of producers or re-packers may be displayed instead.

．For imported food, name and address of importer and country of producer.

4. Food supplement quantities shall be expressed as the case may be, as follows:

．Food supplement in form of tablets or capsules expressed as the number per pack.

．Food supplement in form of liquid expressed as net volume.

．Food supplement in form of solid or others expressed as net weight.

5. Name and quantity of main ingredients of food supplement and constituents which claims for usefulness, on the label of food supplement .
6. Declaration of “ utilizing preservatives” (if any)
7. Declaration of “natural colour added” or “artificial colour added” if utilizing, as case may be
8. Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”, “natural flavour”, or “imitate natural flavour” if any, as case may be.
9. Clear statement of “Receiving any nutrients should intake by consuming five categories of principal foods and in appropriate proportion.

10.Instruction for use.

11. Instruction for food storage. (if any)
12. Date, month, and year of expiration for consumption or date, moth, and year in which food is in good qualities or standards for food supplement with minimum durability of not more than 90 days; or month, and year of expiration for consumption or , moth, and year in which food is in good qualities or standards for food supplement with minimum durability of more than 90 days; and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before” , as the case may be; and date, month, and year shall be respectively expressed. The declarations, according to (12) under the packaging, on the label shall present statement which indicate the position of that declaration.
13. Warning of food supplement consuming shall be followed the Notification of the Ministry of Public Health, Re : Health claim and Warning of food consuming.

【參考連結】

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

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

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-55

HLF-TH-60
經過核准登記的保健食品，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 health food 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：

在泰國境內膳食補充劑須遵守食品優良作業規範，泰國食品藥物管理局接受的優良作業規範可以是以下任一種形式：

1. 泰國法律規定的優良生產規範(GMP)。
2. Codex的GMP。
3. HACCP。
4. ISO 9000。
5. 其他等效或者更高階的衛生標準（例如ISO 22000，BRC，IFS等）。

泰國法律規定的膳食補充劑優良生產規範(GMP)認證申請資料：

1.申請人、生產基地編號

2.公司名稱、膳食補充劑基地位置

3.實驗室(有/無)

4.運營商名稱、總公司/辦事處地址、電話

5.已申請許可/許可的食品種類

6.其他證明文件

．食品生產場所/計劃及機器清單

．食物儲藏室（如果存儲地點與生產現場不在同一地點）

．食物儲存位置

．監控系統設備

．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

．機器或設備的馬力和員工人數

．SOP 內部審核

．召回化妝品的SOP等

Dietary supplements in Thailand must comply with food GMP regulations, and GMP certificates must also be attached when importing products for sale in Thailand.
GMP accepted by the Thai FDA can be in any of the following forms:

1. GMP under Thai law.
2. GMP by Codex.
3. HACCP.
4. ISO 9000.
5. Other equivalent or higher sanitary standards (eg ISO 22000, BRC, IFS, etc.).

Application materials for GMP certification for dietary supplements:

1. Applicant, production base number
2. Company name, location of dietary supplement base
3. Laboratory (with/without)
4. Operator name, head office/office address, telephone
5. Types of food for which permit/licensing has been applied
6. Other documents:

． List of food production sites/plans and machines

． Food pantry (if the storage location is not co-located with the production site)

． food storage location

． Monitoring system equipment

． Legal person registration certificate / business registration certificate

． Organizational 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

． Machine or equipment horsepower and number of employees

【參考連結】

https://www.fda.moph.go.th/sites/food/SitePages/gmp.aspx

HLF-TH-70
泰國保健食品審核機構，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：

向食品藥品監督管理局申請食品許可證需提供以下佐證文件

1. 物理、化學的質量標準，以及原材料的微生素規格(視情況)

．各植物原料的學名和特性。

．每種原料的份數、原材料的獨特性、質量控制的檢驗方法、檢驗方法的一致性。

．藥劑種類及萃取溶液的種類與其濃度、原料量每1克可萃取的活性物質比例。

．原料中該物質的主要成分/物質/標誌物的分析方法。

2. 製造商提供的原材料詳細配方資料及所有成分、數量之細節文件，特別是配方中的必需和非必需成分(以百分比及重量表示)。
3. 製造商提供的膳食補充劑的實際詳細製造過程。
4. 製造商提供的微生素之物理、化學的產品資料(產品規格)
5. 膳食補充劑分析結果：必須是國內外政府指定的機構或組織或由該國政府機構認可實驗室、機構的分析結果。

The following supporting documents are required to apply for a food license to the Food and Drug Administration

1. Physical and chemical quality standards, and microbiological specifications of raw materials (as the case may be)

. The scientific name and characteristics of each plant material.

. The number of servings of each raw material, the uniqueness of the raw material, the inspection method for quality control, the consistency of the inspection method.

. The type of drug and the type of extraction solution, its concentration, and the ratio of raw materials to extractable active substances per 1 gram.

. Analysis method of the main component/substance/marker of the substance in the raw material.

2. The detailed formula information of raw materials and detailed documents of all ingredients and quantities provided by the manufacturer, especially the essential and non-essential ingredients in the formula (expressed in percentage and weight).
3. The actual detailed manufacturing process of the dietary supplement provided by the manufacturer.
4. The physical and chemical product information (product specifications) of the micro-organisms provided by the manufacturer
5. Analysis results of dietary supplements: It must be the analysis results of institutions or organizations designated by domestic and foreign governments or laboratories or institutions recognized by the government agencies of the country.

【參考連結】

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-75

泰國保健食品審核機構，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？

Evershine RD：

可以，膳食補充劑分析結果必須是國內外政府指定的機構或組織或由該國政府機構認可實驗室、機構的分析結果。

HLF-TH-77

HLF-TH-80
外國子公司進口保健食品後，如果委託泰國的經銷商銷售，經銷商需要保健食品營業許可證嗎？
假如保健食品有品質瑕疵的話，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 health food and entrusts a distributor in Thailand 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：

食品藥物管理局對上市食品會進行定期、臨時(懷疑/請求)抽查。

上市後控制的目的是確保分配給消費者的食品衛生、質量符合國家食品標準。因此，該措施主要涉及執法活動。
定期對全國所有食品工廠和場所進行檢查，同時對食品進行抽樣分析和化驗，以確保符合法律要求。
如有違規行為，將採取扣押、召回和起訴等措施。一般來說，檢查分成兩種

1. 定期檢查：有計劃的檢查，以確保 FDA 年度食品計劃的成功實施。

．例行檢查：定期檢查，特別是對獲得許可證的場所進行檢查。

．後續檢查：為了確認許可證持有人或公司已按照上次檢查後的指示採取了某些糾正措施。

．檢查點檢查：由駐紮在檢查站(海關)的食品檢查員執行，以確保進入該國的食品安全並符合相關規定。

2. 懷疑或請求檢查：特殊類型的檢查，目的是調查和收集必要的證據以採取法律行動。
   包括檢查進口國投訴或拒絕的原因，從而解決食品製造商和食品產品的問題。

食品和藥物管理局轄下的公共衛生部醫學部負責食品分析。

FDA conducts regular, ad hoc (suspect/request) spot checks of marketed foods.
The purpose of post-market control is to ensure that the food distributed to consumers is hygienic and of a quality that conforms to national food standards.
Therefore, the measure mainly concerns law enforcement activities. Regular inspections of all food factories and establishments across the country are carried out, and food samples are analyzed and tested to ensure compliance with legal requirements.
In the event of violations, measures such as seizures, recalls and prosecutions will be taken. In general, inspections are divided into two

1. Periodic Inspections: Planned inspections to ensure the successful implementation of FDA’s annual food program.

. Routine Inspections: Regular inspections, especially of licensed premises.

. Follow-up Inspections: To confirm that the licensee or company has taken certain corrective actions as indicated after the last inspection.

. Checkpoint Inspections: Performed by food inspectors stationed at checkpoints (customs) to ensure that food entering the country is safe and complies with relevant regulations.

2. The suspect or request inspection: A special type of inspection for the purpose of investigating and collecting the necessary evidence for legal action. This includes examining the reasons for complaints or refusals by the importing country, thereby addressing issues with food manufacturers and food products.

The Food and Drug Administration’s Division of Public Health Medicine is responsible for food analysis.

URL：http://thaihpvc.fda.moph.go.th/thaihvc/index.jsf

【參考連結】

http://thaihpvc.fda.moph.go.th/thaihvc/index.jsf

https://www.fda.moph.go.th/sites/fda_en/SitePages/Food.aspx?IDitem=LawsAndRegulations

HLF-TH-85

HLF-TH-90
目前維生素C(錠狀食品型式)外銷至泰國當地的法規規範，如維生素C劑量每日攝取上限會列為藥品? 劑量多少列為膳食補充品?

目前維生素C(錠狀食品型式)外銷至泰國當地的法規規範如下：
• 泰國將食品分為一般食品、特殊食品和新資源食品三大類，其中特殊食品又細分為保健食品、膳食補充品、醫療食品和嬰幼兒配方奶粉等。
• 維生素C錠屬於膳食補充品，需符合泰國的膳食補充品法規，包括產品註冊、成分規範、標示要求、衛生標準等
• 泰國的膳食補充品法規規定，每日攝取量不得超過1000毫克的維生素C才能被列為膳食補充品，否則將被視為藥品。
• 泰國的膳食補充品法規也規定，產品標示上必須有以下內容：產品名稱、成分表、每日建議攝取量、每份含量、保存方法、注意事項、製造商或進口商名稱和地址、有效日期等

各國健康食品登記法規問題集

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
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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

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永輝100%關係企業
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永輝潛在可服務城市 (2個月籌備期)：
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(版本:2022/03)

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