日本化妝品登記法規問題集
Email：tyo4ww@evershinecpa.com
或
日本永輝BPO有限公司Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
接洽人:
丘玲恵（Kyu Reike）日本籍来自台灣
王礼芳（Lily Wang）日本永居来自福建
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
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linkedin address:Dale Chen Linkedin
HLF-JP-10
請問日本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 Japan? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of cosmetics? Website?
Evershine RD：
日本化妝品受《藥品和醫療器材法》（PMDL）規範，並由主管當局厚生勞動省 (MHLW) 監管，藥品和醫療器械局 (PMDA)負責現場檢查、文件審核、審核外國製造商和進口商的申請，以及不良反應報告。
日本將化妝品分為兩類：
1. 化妝品：定義為對人體有溫和作用，以擦、灑等方法塗抹於人體，以達到清潔、美化、增色、改變容貌或保持皮膚或頭髮的良好狀態。可分為6大類：
．香水和古龍水。
．化妝品：例如面霜、口紅、粉底霜、眼妝等。
．護膚化妝品，如潔面乳、乳液、精華、護膚乳等。
．護髮產品，例如洗髮水、染髮劑、護髮素等。
．特殊用途化妝品，例如防曬霜、剃須膏等。
．化妝品肥皂。
2. 準藥品：或稱醫藥部外品，準藥品與化妝品的不同之處在於準藥品不能是器具或裝置，其對人體的影響是輕微的，由厚生勞動省指定。除臭劑、美白產品或抗衰老或痤瘡治療產品等常用物品也屬於準藥品。
準藥物通常具有以下功能：
．防止噁心和其他不適。
．預防皮疹、疼痛等。
．刺激毛髮生長，去除毛髮
．滅鼠、滅蠅、滅蚊等。
一般來說，準藥品包括：
．除臭劑，
．脫毛劑
．頭髮生長治療，
．沐浴產品
．牙膏
．燙髮和矯直產品
．藥用化妝品。
屬於準藥品的化妝品包括
．美白產品
．抗衰老產品
．油性皮膚或痤瘡治療產品
．去頭屑或止癢產品
．祛斑產品
．剃須產品
．抗曬傷或“雪燒”產品
．抗菌產品
Japanese cosmetics are regulated by the Pharmaceuticals and Medical Devices Law (PMDL) and are regulated by the competent authority, the Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for on-site inspections, document audits, and audits of foreign manufacturers and importers. application, and a bad reflection report.
Japan divides cosmetics into two categories:
1. Cosmetics: It is defined as having a mild effect on the human body, and it is applied to the human body by rubbing, sprinkling, etc. to achieve cleaning, beautification, color enhancement, change appearance or maintain good skin or hair condition.
Can be divided into 6 major categories:
． Perfume and cologne.
． Cosmetics: such as creams, lipsticks, foundation creams, eye makeup, etc.
． Skin care cosmetics, such as cleansers, lotions, essences, skin care lotions, etc.
． Hair care products such as shampoos, dyes, conditioners, etc.
． Special-purpose cosmetics, such as sunscreen, shaving cream, etc.
． Cosmetic soap.
2. Quasi-drugs: or quasi-drugs, the difference between quasi-drugs and cosmetics is that quasi-drugs cannot be appliances or devices, and their effects on the human body are slight, and are designated by the Ministry of Health, Labour and Welfare.
Commonly used items such as deodorants, whitening products, or anti-aging or acne treatment products are also quasi-drugs.
Quasi-drugs typically have the following functions:
． Prevent nausea and other discomfort.
． Prevent rashes, pains, etc.
． Stimulates hair growth, removes hair
． Rats, flies, mosquitoes, etc.
In general, quasi-drugs include:
． Deodorant,
． Hair remover
． Hair growth treatment,
． Bath products
． Toothpaste
． Perm and Straightening Products
． Medicinal Cosmetics.
Cosmetics that fall under the category of quasi-drugs include
． Whitening products
． Anti-aging products
． Products for oily skin or acne
． Anti-dandruff or anti-itch products
． Freckle removal products
． Shaving Products
． Anti-sunburn or “snow burn” products
． Antibacterial products
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/keshouhin/index.html
https://www.mhlw.go.jp/english/index.html
HLF-JP-20
外國公司要到日本銷售化妝品，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 Japan, 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：
於公司登記時需要設有規定人員，並於銷售前取得製造販賣業許可證方可銷售該化妝品。
欲取得化妝品製造販賣業許可證之企業需要設有規定之人員
1. 製造販賣負責人1名：負責監管品質保證負責人及安全管理負責人的工作，應符合以下條件之一
．藥劑師
．高中或以上學校內完成藥學或化學的專業課程人士
．高中或以上學校內完成藥學或化學的相關課程，並從事化妝品的品質管理或安全管理之業務已滿3年之人士
．其他由厚生勞動大臣視為具有與上述人士同等知識水平之人士。
2. 品質保證負責人1名：主要負責管理化妝品的商品上市、製造管理及品質管理實施的確保、品質管理信息及不良問題的處理、回收處理、文件記錄與管理等， 應符合以下條件
．必須為全職員工
．具備妥善處理化妝品品質保證業務能力
．具有3年以上從事品質保證的相關經驗
．必須是企業的品質保證統籌部門負責人
．涉及化妝品銷售相關部門的員工不得擔任品質保證負責人
3. 安全管理負責人1名：負責蒐集並處理安全管理信息，建立安全確保措施、實施措施，應符合以下條件
．必須為全職員工
．具備妥善處理化妝品安全管理業務能力
．具有3年以上從事安全管理的相關經驗
．必須是企業的安全管理統籌部門負責人
．涉及化妝品銷售相關部門的員工不得擔任安全管理負責人
4. 須符合良好質量規範 (GQP) 和良好警戒規範 (GVP)
化妝品製造販賣業許可證申請資料：
1.申請書
．公司名稱
．公司地址
．負責人資料
2. 法人登記證
．法人組織架構圖
3. 業務分配表
．業務人員診斷書(確認是否毒品成癮)
4. 統籌製造販賣負責人相關資料
．勞動合同
．相關資格證書
5. 品質保證部門相關資料
．GQP體制圖
6. 安全管理部門相關資料
．GVP體制圖
7. 配置圖(明確標有公司所在建築物、地皮等內部的索在具體方位)
8. 公司的平面圖
9. 保管設備相關圖紙
10. 公司的指引圖(從附近車站到公司位置)
At the time of company registration, it is necessary to have specified personnel, and to obtain a manufacturing and sales license before sales can sell the cosmetics.
Companies that want to obtain a cosmetic manufacturing and sales license need to have specified personnel
1. 1 person in charge of manufacturing and sales: Responsible for supervising the work of the person in charge of quality assurance and the person in charge of safety management, and one of the following conditions should be met
．Pharmacist
．Professionals who have completed pharmacy or chemistry in high school or above
．Those who have completed pharmacy or chemistry-related courses in high school or above, and have been engaged in the quality management or safety management of cosmetics for 3 years or more
．Other persons who are deemed by the Minister of Health, Labour and Welfare to have the same level of knowledge as those mentioned above.
2. 1 person in charge of quality assurance: mainly responsible for managing the product launch of cosmetics, manufacturing management and ensuring quality management implementation, quality management information and handling of defective issues, recycling, document recording and management, etc. The following conditions should be met
．Must be full-time employee
．Possess the ability to properly handle cosmetic quality assurance business
．Have more than 3 years of relevant experience in quality assurance
．Must be the person in charge of the quality assurance coordination department of the company
．Employees involved in cosmetic sales related departments are not allowed to serve as the person in charge of quality assurance
3. 1 person in charge of safety management: responsible for collecting and processing safety management information, establishing safety assurance measures and implementing measures, which should meet the following conditions
．Must be full-time employee
．Possess the ability to properly handle cosmetics safety management business
．More than 3 years of relevant experience in safety management
．Must be the head of the safety management coordinating department of the company
．Employees involved in cosmetics sales related departments are not allowed to serve as the person in charge of safety management.
4. Must comply with Good Quality Practice (GQP) and Good Vigilance Practice (GVP)
Application materials for cosmetics manufacturing and sales license:
1. Application form
．Company
．Business address
．Responsible Person Information
2. Legal person registration certificate
．Corporate organization chart
3. Business Allocation Table
．Business Person’s Medical Certificate (Confirmation of Drug Addiction)
4. Coordinate the relevant information of the person in charge of manufacturing and selling
5. Information about quality assurance department
．Labor Contract
．Relevant qualification certificate
．GQP institutional chart
6. Information about the safety management department
．GVP institutional chart
7. Configuration diagram (clearly marked the specific orientation of the cables inside the building, land, etc. where the company is located)
8. Floor plan of the company
9. Keep the drawings related to the equipment
10. Guide map of the company (from the nearby station to the company location)
【參考連結】
https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4
HLF-JP-25
假如需要辦理，請問日本有專業服務公司可以協助辦理化妝品公司營業許可證？
HLF-JP-30
外國公司要到日本銷售化妝品，可以指派日本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 Japan, can it assign a Japan 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：
於公司登記時需要設有規定人員，並於銷售前取得製造販賣業許可證方可銷售該化妝品。
欲取得化妝品製造販賣業許可證之企業需要設有規定之人員
1. 製造販賣負責人1名：負責監管品質保證負責人及安全管理負責人的工作，應符合以下條件之一
．藥劑師
．高中或以上學校內完成藥學或化學的專業課程人士
．高中或以上學校內完成藥學或化學的相關課程，並從事化妝品的品質管理或安全管理之業務已滿3年之人士
．其他由厚生勞動大臣視為具有與上述人士同等知識水平之人士。
2. 品質保證負責人1名：主要負責管理化妝品的商品上市、製造管理及品質管理實施的確保、品質管理信息及不良問題的處理、回收處理、文件記錄與管理等， 應符合以下條件
．必須為全職員工
．具備妥善處理化妝品品質保證業務能力
．具有3年以上從事品質保證的相關經驗
．必須是企業的品質保證統籌部門負責人
．涉及化妝品銷售相關部門的員工不得擔任品質保證負責人
3. 安全管理負責人1名：負責蒐集並處理安全管理信息，建立安全確保措施、實施措施，應符合以下條件
．必須為全職員工
．具備妥善處理化妝品安全管理業務能力
．具有3年以上從事安全管理的相關經驗
．必須是企業的安全管理統籌部門負責人
．涉及化妝品銷售相關部門的員工不得擔任安全管理負責人
4. 須符合良好質量規範 (GQP) 和良好警戒規範 (GVP)
化妝品製造販賣業許可證申請資料：
1.申請書
．公司名稱
．公司地址
．負責人資料
2. 法人登記證
．法人組織架構圖
3. 業務分配表
．業務人員診斷書(確認是否毒品成癮)
4. 統籌製造販賣負責人相關資料
．勞動合同
．相關資格證書
5. 品質保證部門相關資料
．GQP體制圖
6. 安全管理部門相關資料
．GVP體制圖
7. 配置圖(明確標有公司所在建築物、地皮等內部的索在具體方位)
8. 公司的平面圖
9. 保管設備相關圖紙
10. 公司的指引圖(從附近車站到公司位置)
化妝品製造販賣業許可證持有人必須符合良好質量規範 (GQP) 和良好警戒規範 (GVP)，落實上市化妝品的產品交付登記、產品質量信息收集、缺陷產品處理、產品從市場召回等，維護銷售的產品質量。
如果認為有必要（產品可能造成有害影響，對於例如），化妝品製造販賣業許可證持有人可以採取糾正措施，例如從市場上召回產品或修改包裝警告和注意事項標籤。
At the time of company registration, it is necessary to have specified personnel, and to obtain a manufacturing and sales license before sales can sell the cosmetics.
Companies that want to obtain a cosmetic manufacturing and sales license need to have specified personnel
1. 1 person in charge of manufacturing and sales: Responsible for supervising the work of the person in charge of quality assurance and the person in charge of safety management, and one of the following conditions should be met
．Pharmacist
．Professionals who have completed pharmacy or chemistry in high school or above
．Those who have completed pharmacy or chemistry-related courses in high school or above, and have been engaged in the quality management or safety management of cosmetics for 3 years or more
．Other persons who are deemed by the Minister of Health, Labour and Welfare to have the same level of knowledge as those mentioned above.
2. 1 person in charge of quality assurance: mainly responsible for managing the product launch of cosmetics, manufacturing management and ensuring quality management implementation, quality management information and handling of defective issues, recycling, document recording and management, etc. The following conditions should be met
．Must be full-time employee
．Possess the ability to properly handle cosmetic quality assurance business
．Have more than 3 years of relevant experience in quality assurance
．Must be the person in charge of the quality assurance coordination department of the company
．Employees involved in cosmetic sales related departments are not allowed to serve as the person in charge of quality assurance
3. 1 person in charge of safety management: responsible for collecting and processing safety management information, establishing safety assurance measures and implementing measures, which should meet the following conditions
．Must be full-time employee
．Possess the ability to properly handle cosmetics safety management business
．More than 3 years of relevant experience in safety management
．Must be the head of the safety management coordinating department of the company
．Employees involved in cosmetics sales related departments are not allowed to serve as the person in charge of safety management.
4. Must comply with Good Quality Practice (GQP) and Good Vigilance Practice (GVP)
Application materials for cosmetics manufacturing and sales license:
1. Application form
．Company
．Business address
．Responsible Person Information
2. Legal person registration certificate
．Corporate organization chart
3. Business Allocation Table
4. Coordinate the relevant information of the person in charge of manufacturing and selling
．Labor Contract
．Business Person’s Medical Certificate (Confirmation of Drug Addiction)
．Relevant qualification certificate
5. Information about quality assurance department
．GQP institutional chart
6. Information about the safety management department
．GVP institutional chart
7. Configuration diagram (clearly marked the specific orientation of the cables inside the building, land, etc. where the company is located)
8. Floor plan of the company
9. Keep the drawings related to the equipment
10. Guide map of the company (from the nearby station to the company location)
Cosmetics manufacturing and sales license holders must comply with Good Quality Practices (GQP) and Good Vigilance Practices (GVP), implement product delivery registration, product quality information collection, defective product handling, product recall from the market, etc. product quality. If deemed necessary (the product may cause harmful effects, for example), the cosmetic manufacturing and vending industry licensee may take corrective action, such as recalling the product from the market or modifying the packaging warning and precautions labeling.
【參考連結】
https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4
HLF-JP-35
假如需要辦理指派日本公司擔任營業代理人，請問日本有專業服務公司可以協助？
HLF-JP-40
外國公司銷售到日本化妝品本身，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？
可允許的語文除了日文外，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 Japan?
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 Japanese, which other languages are allowed? Website?
Evershine RD：
產品需要先取得生產許可證，外國化妝品的製造商需要委託日本當地公司向藥品醫療器材局（PMDA）申請製造商認可，亦或由製造販賣業許可持有者代為申請，製造商需符合GMP（良好生產規範）。
厚生勞動省 (MHLW)有權向外國製造商授予認證，而 PMDA 負責申請文件處理以及檢查製造機構的建築物和設施以獲得認證。
申請所需文件：
1. 製造商名稱
2. 廠名、工廠位置
3. 生產基地名稱、地址
4. 國內聯繫公司名稱、聯繫人
5. 日本負責人、電話、電子郵件
6. 員工人數（包括兼職員工）
7. 製造部人員數、質檢部人員數
8. 廠長、現場負責人（歐盟合格人員，或其他國家質量部門負責人）
9. 工廠生產的所有產品數量
10. 受檢產品信息
11. 項目名稱（英文名稱）
12. 產品名稱（英文名稱）
13. 生產開始時間
14. 商業製造從（MM / YY）開始
15. 生產現場信息
．廠址面積
．場地面積、倉庫面積
．倉庫面積
．生產設施區
．生產設施面積
．檢測實驗室面積
16. 產品成分、原料、活性
17. 製造方法
18. 包裝/標籤
19. 儲存
20. 過去 5 年是否有政府機構的檢查
．政府機構名稱
．監管機構名稱
．檢查日期 對象項目名稱
．被檢產品名稱 結果
．檢查類型（現場/桌面）
．檢查結果 演示或書面
21. 過去 5 年監管機構的 GMP 檢查歷史。
22. 過去 5 年是否存在 GMP 不符合（如果是，請概述）
23. 過去 5 年是否產品召回或 GMP 不合規歷史（請詳細說明。）
24. 外國製造商在其國家獲得的與製造和銷售製造商有關的許可證或證書的副本
在日本，化妝品、準藥品的標籤需要於申請化妝品生產許可證(製造商或由製造販賣業許可證持有人代為申請)時獲得許可，方可標識。
化妝品標籤的所有信息必須用日語表達，並且必須清楚明確地列出。
禁止使用虛假或可能具有誤導性的表達進行標籤，以及未經批准的標籤效果聲明。
化妝品應註明的項目如下：
1.進口商的名稱和地址
2.營銷主管所在辦公室的地址
（如果該辦公室是日本以外需註明：外國批准持有人的姓名和國家；姓名和指定進口商的地址）。
3.生產國家
4.品牌名稱：註冊日本產品名稱。
5.製造編號或批號
6.全部成分列表（按數量降序）
7.保質期
8.警告，禁止使用事項
9.厚生勞動省部令規定的其他項目
全成分標籤
化妝品外包裝上必須使用日語全成分標籤。除了全成分標籤外，外包裝和初級包裝的信息必須相同。
1.所有非顏色成分按優勢降序排列。
2.依次為含量在1%以下的所有顏色和非顏色成分，以隨機順序排列。
3.無需註明附帶成分。
4.混合成分必須標明每種單獨的成分。
5.萃取物被指示為將提取物和溶劑或稀釋溶液分開。
6.香水可以表示為“香水”。
注意：日本化妝品工業協會 (JCIA) 編制了日文版的化妝品成分標籤名稱列表，以配合 PMDL 的要求在標籤上列出所有成分名稱。
企業可以參考該文件來規範日本成分的名稱。
準藥品的標籤信息：
1.營銷許可證持有人姓名和地址
2.產品名稱
3.製造編號或批號
4.重量、體積或含量
5.有效成分名稱和濃度
6.對於含有厚生勞動省規定的特定成分的準藥品，請註明成分名稱
7.保質期
8.警告，禁止使用事項
9.準藥品註記：須按照厚生勞動省的要求標註準藥品字樣
10.厚生勞動省需要標註的其他信息
注意：
1.準藥品的聲稱是基於所含的活性成分，只有在獲得批准後才能標註。
(美白功效：產品必須含有美白活性成分；抗痘功效：產品必須含有抗痘活性成分。)
2. 日本化妝品工業協會製作關於準藥品成分標籤的基本方針，以配合 PMDL 的要求在標籤上列出所有成分名稱。
企業可以參考該文件來規範日本成分的名稱。
The product needs to obtain a production license first. The manufacturer of foreign cosmetics needs to entrust a local company in Japan to apply for the manufacturer’s approval to the Pharmaceuticals and Medical Devices Agency (PMDA), or the holder of the manufacturing and sales license should apply for it. good manufacturing practice).
The Ministry of Health, Labour and Welfare (MHLW) has the authority to grant certification to foreign manufacturers, while the PMDA is responsible for application document processing and inspection of the buildings and facilities of the manufacturing facility to obtain certification.
Required Documents for Application:
1. Manufacturer Name
2. Factory name, factory location
3. Production base name and address
4. Domestic contact company name and contact person
5. Person in charge in Japan, telephone, email
6. Number of employees (including part-time employees)
7. Number of personnel in manufacturing department and number of personnel in quality inspection department
8. Factory director, on-site person in charge (EU qualified personnel, or the person in charge of the quality department of other countries)
9. Quantity of all products produced by the factory
10. Information of the inspected product
11. Project name (in English)
12. Product name (in English)
13. Start of production
14. Commercial manufacturing starts from (MM/YY)
15. Information on production site
． Factory site area
． Site area, storage area
． Warehouse area
． Production facility area
． Production facility area
． Testing lab area
16. Product ingredients, raw materials, activities
17. Manufacturing method
18. Packaging/labelling
19. Storage
20. Has there been any inspection by government agencies in the past 5 years?
． Government agency name
． Regulator name
． Inspection date Subject item name
． Tested product name Result
． Examination results presentation or written
． Exam Type (Live/Desktop)
21. History of GMP inspections by regulatory agencies over the past 5 years.
22. Has there been any GMP non-compliance in the past 5 years (if yes, please outline)
23. Is there a history of product recalls or GMP noncompliance in the past 5 years (please specify.)
24. Copies of licenses or certificates obtained by the foreign manufacturer in his country in relation to the manufacture and sale of the manufacturer
In Japan, the labels of cosmetics and quasi-drugs need to be approved when applying for a cosmetic production license (manufacturer or the holder of a manufacturing and sales license) before they can be identified.
All information on cosmetic labels must be expressed in Japanese and must be clearly and clearly listed. Labeling with false or potentially misleading expressions, as well as unapproved claims of labeling effect, is prohibited.
Cosmetics should be marked as follows:
1. Importer’s name and address
2. The address of the marketing executive’s office(If the office is outside Japan, specify: name and country of foreign approval holder; name and address of designated importer).
3. Country of manufacture
4. Brand name: registered Japanese product name.
5. Manufacturing number or batch number
6. Full list of ingredients (in descending order of quantity)
7. Shelf Life
8. Warnings and Prohibited Uses
9. Other items prescribed by the order of the Ministry of Health, Labour and Welfare
Full Ingredient Labels
Japanese full-ingredient labels must be used on the outer packaging of cosmetic products. In addition to the full ingredients label, the information on the outer and primary packaging must be identical.
1. All non-color components are in descending order of dominance.
2. All color and non-color components with content below 1% are listed in random order.
3. There is no need to indicate the accompanying ingredients.
4. Mixed ingredients must be labeled with each individual ingredient.
5. The extract is indicated to separate the extract from the solvent or diluent solution.
6. Fragrance can be expressed as “perfume”.
Note: The Japan Cosmetic Industry Association (JCIA) has compiled a Japanese version of the List of Cosmetic Ingredient Labeling Names to list all ingredient names on the label in compliance with PMDL requirements.
Companies can refer to this document to regulate the names of Japanese ingredients.
Quasi-drug labeling information:
1. Marketing License Holder Name and Address
2. Product name
3. Manufacturing number or batch number
4. Weight, volume or content
5. Name and concentration of active ingredients
6. For quasi-drugs containing specific ingredients specified by the Ministry of Health, Labour and Welfare, please indicate the ingredient name
7. Shelf life
8. Warning, Prohibited Use
9. Quasi-drug marking: The wording of quasi-drug must be marked in accordance with the requirements of the Ministry of Health, Labour and Welfare
10. Other information that the Ministry of Health, Labour and Welfare needs to label
Note:
1. The claim of a quasi-drug is based on the active ingredient contained and can only be labelled after approval.
(Whitening effect: The product must contain whitening active ingredients; Anti-acne effect: The product must contain anti-acne active ingredients.)
2. The Japan Cosmetic Industry Association has formulated a basic policy on the labeling of quasi-drug ingredients, and listed all ingredient names on the label in accordance with the PMDL requirements.
Companies can refer to this document to regulate the names of Japanese ingredients.
【參考連結】
https://www.jcia.org/user/business/ingredients/drugexplain
https://www.jcia.org/user/business/ingredients/namelist
https://www.pmda.go.jp/english/review-services/glp-gcp-gpsp/0002.html
HLF-JP-45
請問在日本有哪些專業服務機構，可以協助辦理化妝品產品許可證？
HLF-JP-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？
可允許的語文除了日文外，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 Japanese, which other languages are allowed? Website?
Evershine RD：
產品需要先取得生產許可證，外國化妝品的製造商需要委託日本當地公司向藥品醫療器材局（PMDA）申請製造商認可，亦或由製造販賣業許可持有者代為申請，製造商需符合GMP（良好生產規範）。
厚生勞動省 (MHLW)有權向外國製造商授予認證，而 PMDA 負責申請文件處理以及檢查製造機構的建築物和設施以獲得認證。
申請所需文件：
1. 製造商名稱
2. 廠名、工廠位置
3. 生產基地名稱、地址
4. 國內聯繫公司名稱、聯繫人
5. 日本負責人、電話、電子郵件
6. 員工人數（包括兼職員工）
7. 製造部人員數、質檢部人員數
8. 廠長、現場負責人（歐盟合格人員，或其他國家質量部門負責人）
9. 工廠生產的所有產品數量
10. 受檢產品信息
11. 項目名稱（英文名稱）
12. 產品名稱（英文名稱）
13. 生產開始時間
14. 商業製造從（MM / YY）開始
15. 生產現場信息
．廠址面積
．場地面積、倉庫面積
．倉庫面積
．生產設施區
．生產設施面積
．檢測實驗室面積
16. 產品成分、原料、活性
17. 製造方法
18. 包裝/標籤
19. 儲存
20. 過去 5 年是否有政府機構的檢查
．政府機構名稱
．監管機構名稱
．檢查日期 對象項目名稱
．被檢產品名稱 結果
．檢查結果 演示或書面
．檢查類型（現場/桌面）
21. 過去 5 年監管機構的 GMP 檢查歷史。
22. 過去 5 年是否存在 GMP 不符合（如果是，請概述）
23. 過去 5 年是否產品召回或 GMP 不合規歷史（請詳細說明。）
24. 外國製造商在其國家獲得的與製造和銷售製造商有關的許可證或證書的副本
在日本，化妝品、準藥品的標籤需要於申請化妝品生產許可證(製造商或由製造販賣業許可證持有人代為申請)時獲得許可，方可標識。
化妝品標籤的所有信息必須用日語表達，並且必須清楚明確地列出。
禁止使用虛假或可能具有誤導性的表達進行標籤，以及未經批准的標籤效果聲明。
化妝品應註明的項目如下：
1.進口商的名稱和地址
2.營銷主管所在辦公室的地址
（如果該辦公室是日本以外需註明：外國批准持有人的姓名和國家；姓名和指定進口商的地址）。
3.生產國家
4.品牌名稱：註冊日本產品名稱。
5.製造編號或批號
6.全部成分列表（按數量降序）
7.保質期
8.警告，禁止使用事項
9.厚生勞動省部令規定的其他項目
全成分標籤
化妝品外包裝上必須使用日語全成分標籤。除了全成分標籤外，外包裝和初級包裝的信息必須相同。
1.所有非顏色成分按優勢降序排列。
2.依次為含量在1%以下的所有顏色和非顏色成分，以隨機順序排列。
3.無需註明附帶成分。
4.混合成分必須標明每種單獨的成分。
5.萃取物被指示為將提取物和溶劑或稀釋溶液分開。
6.香水可以表示為“香水”。
注意：日本化妝品工業協會 (JCIA) 編制了日文版的化妝品成分標籤名稱列表，以配合 PMDL 的要求在標籤上列出所有成分名稱。
企業可以參考該文件來規範日本成分的名稱。
準藥品的標籤信息：
1.營銷許可證持有人姓名和地址
2.產品名稱
3.製造編號或批號
4.重量、體積或含量
5.有效成分名稱和濃度
6.對於含有厚生勞動省規定的特定成分的準藥品，請註明成分名稱
7.保質期
8.警告，禁止使用事項
9.準藥品註記：須按照厚生勞動省的要求標註準藥品字樣
10.厚生勞動省需要標註的其他信息
注意：
1.準藥品的聲稱是基於所含的活性成分，只有在獲得批准後才能標註。
(美白功效：產品必須含有美白活性成分；抗痘功效：產品必須含有抗痘活性成分。)
2. 日本化妝品工業協會製作關於準藥品成分標籤的基本方針，以配合 PMDL 的要求在標籤上列出所有成分名稱。
企業可以參考該文件來規範日本成分的名稱。
The product needs to obtain a production license first. The manufacturer of foreign cosmetics needs to entrust a local company in Japan to apply for the manufacturer’s approval to the Pharmaceuticals and Medical Devices Agency (PMDA), or the holder of the manufacturing and sales license should apply for it. good manufacturing practice).
The Ministry of Health, Labour and Welfare (MHLW) has the authority to grant certification to foreign manufacturers, while the PMDA is responsible for application document processing and inspection of the buildings and facilities of the manufacturing facility to obtain certification.
Required Documents for Application:
1. Manufacturer Name
2. Factory name, factory location
3. Production base name and address
4. Domestic contact company name and contact person
5. Person in charge in Japan, telephone, email
6. Number of employees (including part-time employees)
7. Number of personnel in manufacturing department and number of personnel in quality inspection department
8. Factory director, on-site person in charge (EU qualified personnel, or the person in charge of the quality department of other countries)
9. Quantity of all products produced by the factory
10. Information of the inspected product
11. Project name (in English)
12. Product name (in English)
13. Start of production
14. Commercial manufacturing starts from (MM/YY)
15. Information on production site
． Factory site area
． Site area, storage area
． Warehouse area
． Production facility area
． Production facility area
． Testing lab area
16. Product ingredients, raw materials, activities
17. Manufacturing method
18. Packaging/labelling
19. Storage
20. Has there been any inspection by government agencies in the past 5 years?
． Government agency name
． Regulator name
． Inspection date Subject item name
． Tested product name Result
． Examination results presentation or written
． Exam Type (Live/Desktop)
21. History of GMP inspections by regulatory agencies over the past 5 years.
22. Has there been any GMP non-compliance in the past 5 years (if yes, please outline)
23. Is there a history of product recalls or GMP noncompliance in the past 5 years (please specify.)
24. Copies of licenses or certificates obtained by the foreign manufacturer in his country in relation to the manufacture and sale of the manufacturer
In Japan, the labels of cosmetics and quasi-drugs need to be approved when applying for a cosmetic production license (manufacturer or the holder of a manufacturing and sales license) before they can be identified.
All information on cosmetic labels must be expressed in Japanese and must be clearly and clearly listed. Labeling with false or potentially misleading expressions, as well as unapproved claims of labeling effect, is prohibited.
Cosmetics should be marked as follows:
1. Importer’s name and address
2. The address of the marketing executive’s office(If the office is outside Japan, specify: name and country of foreign approval holder; name and address of designated importer).
3. Country of manufacture
4. Brand name: registered Japanese product name.
5. Manufacturing number or batch number
6. Full list of ingredients (in descending order of quantity)
7. Shelf Life
8. Warnings and Prohibited Uses
9. Other items prescribed by the order of the Ministry of Health, Labour and Welfare
Full Ingredient Labels
Japanese full-ingredient labels must be used on the outer packaging of cosmetic products. In addition to the full ingredients label, the information on the outer and primary packaging must be identical.
1. All non-color components are in descending order of dominance.
2. All color and non-color components with content below 1% are listed in random order.
3. There is no need to indicate the accompanying ingredients.
4. Mixed ingredients must be labeled with each individual ingredient.
5. The extract is indicated to separate the extract from the solvent or diluent solution.
6. Fragrance can be expressed as “perfume”.
Note: The Japan Cosmetic Industry Association (JCIA) has compiled a Japanese version of the List of Cosmetic Ingredient Labeling Names to list all ingredient names on the label in compliance with PMDL requirements.
Companies can refer to this document to regulate the names of Japanese ingredients.
Quasi-drug labeling information:
1. Marketing License Holder Name and Address
2. Product name
3. Manufacturing number or batch number
4. Weight, volume or content
5. Name and concentration of active ingredients
6. For quasi-drugs containing specific ingredients specified by the Ministry of Health, Labour and Welfare, please indicate the ingredient name
7. Shelf life
8. Warning, Prohibited Use
9. Quasi-drug marking: The wording of quasi-drug must be marked in accordance with the requirements of the Ministry of Health, Labour and Welfare
10. Other information that the Ministry of Health, Labour and Welfare needs to label
Note:
1. The claim of a quasi-drug is based on the active ingredient contained and can only be labelled after approval.
(Whitening effect: The product must contain whitening active ingredients; Anti-acne effect: The product must contain anti-acne active ingredients.)
2. The Japan Cosmetic Industry Association has formulated a basic policy on the labeling of quasi-drug ingredients, and listed all ingredient names on the label in accordance with the PMDL requirements. Companies can refer to this document to regulate the names of Japanese ingredients.
【參考連結】
https://www.jcia.org/user/business/ingredients/drugexplain
https://www.jcia.org/user/business/ingredients/namelist
https://www.pmda.go.jp/english/review-services/glp-gcp-gpsp/0002.html
HLF-JP-55
請問在日本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-JP-60
經過核准登記的化妝品，進口到日本要檢附什麼文件？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 Japan? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
銷售前進口商需要提交營銷通知、化妝品（外國製造商、進口商）通知，兩份通知必須附有進口商或製造商的完整成分清單，如果無法獲得此清單，則必須提供確認產品不包含任何違禁成分組合的測試和檢查結果記錄。
1. 化妝品營銷通知
．製造和銷售許可證編號日期
．品牌、成分和數量
．生產方式
．用法用量
．功效或作用
．儲存方式及有效期
．標準和測試方法
．製造名稱、地點、許可證、註冊分類
．原料藥生產場所、名稱、地點 許可證、註冊分類
．製造和銷售項目的
注意
．紙張尺寸應為 A4。
．提交一式兩份。
．用墨水、墨水等寫字，寫在楷書上。
2. 化妝品（外國製造商、進口商）通知
．外國製造商名稱
．外國製造商辦公室或工廠的位置
．銷售化妝品的人的辦事處
注意
．紙張尺寸應為日本工業標準 A4。
．提交一份正本和兩份副本。
．用墨水、墨水等寫字，寫在楷書上。
外國化妝品進口日本規定：
1. 進口化妝品需先取得生產許可證、製造販賣業許可
2. 外國製造者需經由PMDA認可
3. 每個項目的生產和販售批准(如果含有厚生勞動大臣指定成分的化妝品必須得到厚生勞動大臣的批准)
4. 標籤與包裝符合規定
上述條件符合後，可向海關報關進口化妝品
海關
1. 海關分類號（HS編碼）
．美容/化妝/防曬化妝品（HS3304）
．護髮產品（HS 3305）
．剃須類產品（HS 3307）
．肥皂（HS3401）等
．其他產品可以向海關顧問辦公室諮詢
2. 生產許可證、製造販賣業許可證副本
3. 報關單內容：
．採購表格（發票）
．提貨單或海運單（空運單）
．票價說明
．保險費報表
．其他法律的許可/批准證明書（如果貨物需要根據海關相關法律（如植物保護法）以外的法律許可/批准）
．優惠原產地證書（適用優惠關稅時）
．免稅聲明（申請免稅時）
Before sale the importer is required to submit a Marketing Notice, a Cosmetic (Foreign Manufacturer, Importer) Notice, both notices must be accompanied by the importer’s or manufacturer’s full list of ingredients, and if this list is not available, confirmation that the product does not contain any Records of test and inspection results for prohibited ingredient combinations.
1. Cosmetics Marketing Notice
． Manufacture and Sales License Number Date
． Brand, Ingredients and Quantity
． ways to produce
． Dosage
． efficacy or action
． Storage method and expiration date
． Standards and Test Methods
． Manufacturing name, place, license, registration classification
． API production site, name, location License, registration classification
． Manufacture and sale of items
Notice
． The paper size should be A4.
． Submit in duplicate.
． Write with ink, etc., and write in regular script.
2. Cosmetics (Foreign Manufacturer, Importer) Notification
． Foreign manufacturer’s name
． Location of foreign manufacturer’s office or factory
． Office of the person who sells cosmetics
Notice
． The paper size should be JIS A4.
． Submit one original and two copies.
． Write with ink, etc., and write in regular script.
Regulations for foreign cosmetics imported into Japan:
1. To import cosmetics, a production license and manufacturing and sales license must be obtained first.
2. Foreign manufacturers are required to be approved by PMDA
3. Approval for production and sale of each item(Cosmetics containing ingredients designated by the Minister of Health, Labour and Welfare must be approved by the Minister of Health, Labour and Welfare)
4. Labels and packaging comply with the regulations
After the above conditions are met, the imported cosmetics can be declared to the customs.
Customs
1. Customs classification number (HS code)
． Beauty/Makeup/Sunscreen Cosmetics (HS3304)
． Hair Care Products (HS 3305)
． Shaving products (HS 3307)
． Soap (HS3401) etc.
． For other products, please consult the Customs Consultant Office
2. Copy of production license, manufacturing and sales license
3. Contents of customs declaration:
． Purchase Form (Invoice)
． Bill of Lading or Sea Waybill (Air Waybill)
． Fare Description
． Premium Statement
． Certificate of license/approval from other laws (if the goods need to be licensed/approved under laws other than customs-related laws (e.g. plant protection law))
． Preferential Certificate of Origin (when preferential tariffs apply)
． Tax exemption declaration (when applying for tax exemption)
【參考連結】
https://www.pmda.go.jp/PmdaSearch/yoshikiDownload/
https://www.customs.go.jp/zeikan/seido/index.htm
https://www.customs.go.jp/tetsuzuki/c-answer/imtsukan/1805_jr.htm
HLF-JP-70
日本化妝品審核機構，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：
GMP（良好生產規範）申請所需文件：
1. 製造商名稱
2. 廠名、工廠位置
3. 生產基地名稱、地址
4. 國內聯繫公司名稱、聯繫人
5. 日本負責人、電話、電子郵件
6. 員工人數（包括兼職員工）
7. 製造部人員數、質檢部人員數
8. 廠長、現場負責人（歐盟合格人員，或其他國家質量部門負責人）
9. 工廠生產的所有產品數量
10. 受檢產品信息
11. 項目名稱（英文名稱）
12. 產品名稱（英文名稱）
13. 生產開始時間
14. 商業製造從（MM / YY）開始
15. 生產現場信息
．廠址面積
．場地面積、倉庫面積
．倉庫面積
．生產設施區
．生產設施面積
．檢測實驗室面積
16. 產品成分、原料、活性
17. 製造方法
18. 包裝/標籤
19. 儲存
20. 過去 5 年是否有政府機構的檢查
．政府機構名稱
．監管機構名稱
．檢查日期 對象項目名稱
．被檢產品名稱 結果
．檢查結果 演示或書面
．檢查類型（現場/桌面）
21. 過去 5 年監管機構的 GMP 檢查歷史。
22. 過去 5 年是否存在 GMP 不符合（如果是，請概述）
23. 過去 5 年是否產品召回或 GMP 不合規歷史（請詳細說明。）
24. 外國製造商在其國家獲得的與製造和銷售製造商有關的許可證或證書的副本
Documents required for GMP (Good Manufacturing Practice) application:
1. Manufacturer Name
2. Factory name, factory location
3. Production base name and address
4. Domestic contact company name and contact person
5. Person in charge in Japan, telephone, email
6. Number of employees (including part-time employees)
7. Number of personnel in manufacturing department and number of personnel in quality inspection department
8. Factory director, on-site person in charge (EU qualified personnel, or the person in charge of the quality department of other countries)
9. Quantity of all products produced by the factory
10. Information of the inspected product
11. Project name (in English)
12. Product name (in English)
13. Start of production
14. Commercial manufacturing starts from (MM/YY)
15. Information on production site
． Factory site area
． Site area, storage area
． Warehouse area
． Production facility area
． Production facility area
． Testing lab area
16. Product ingredients, raw materials, activities
17. Manufacturing method
18. Packaging/labelling
19. Storage
20. Has there been any inspection by government agencies in the past 5 years?
． Government agency name
． Regulator name
． Inspection date Subject item name
． Tested product name Result
． Examination results presentation or written
． Exam Type (Live/Desktop)
21. History of GMP inspections by regulatory agencies over the past 5 years.
22. Has there been any GMP non-compliance in the past 5 years (if yes, please outline)
23. Is there a history of product recalls or GMP noncompliance in the past 5 years (please specify.)
24. Copies of licenses or certificates obtained by the foreign manufacturer in his country in relation to the manufacture and sale of the manufacturer
【參考連結】
https://www.pmda.go.jp/english/review-services/glp-gcp-gpsp/0002.html
HLF-JP-75
日本化妝品審核機構，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？
由PMDA對外國製造商進行GMP審核。
HLF-JP-77
請問在日本有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？
由PMDA對外國製造商進行GMP審核。
HLF-JP-80
外國子公司進口化妝品後，如果委託日本的經銷商銷售，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 Japan 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：
於公司登記時需要設有規定人員，並於銷售前取得製造販賣業許可證方可銷售該化妝品。
欲取得化妝品製造販賣業許可證之企業需要設有規定之人員
1. 製造販賣負責人1名：負責監管品質保證負責人及安全管理負責人的工作，應符合以下條件之一
．藥劑師
．高中或以上學校內完成藥學或化學的專業課程人士
．高中或以上學校內完成藥學或化學的相關課程，並從事化妝品的品質管理或安全管理之業務已滿3年之人士
．其他由厚生勞動大臣視為具有與上述人士同等知識水平之人士。
2. 品質保證負責人1名：主要負責管理化妝品的商品上市、製造管理及品質管理實施的確保、品質管理信息及不良問題的處理、回收處理、文件記錄與管理等， 應符合以下條件
．必須為全職員工
．具備妥善處理化妝品品質保證業務能力
．具有3年以上從事品質保證的相關經驗
．必須是企業的品質保證統籌部門負責人
．涉及化妝品銷售相關部門的員工不得擔任品質保證負責人
3. 安全管理負責人1名：負責蒐集並處理安全管理信息，建立安全確保措施、實施措施，應符合以下條件
．必須為全職員工
．具備妥善處理化妝品安全管理業務能力
．具有3年以上從事安全管理的相關經驗
．必須是企業的安全管理統籌部門負責人
．涉及化妝品銷售相關部門的員工不得擔任安全管理負責人
4. 須符合良好質量規範 (GQP) 和良好警戒規範 (GVP)
化妝品製造販賣業許可證申請資料：
1.申請書
．公司名稱
．公司地址
．負責人資料
2. 法人登記證
．法人組織架構圖
3. 業務分配表
．業務人員診斷書(確認是否毒品成癮)
4. 統籌製造販賣負責人相關資料
．勞動合同
．相關資格證書
5. 品質保證部門相關資料
．GQP體制圖
6. 安全管理部門相關資料
．GVP體制圖
7. 配置圖(明確標有公司所在建築物、地皮等內部的索在具體方位)
8. 公司的平面圖
9. 保管設備相關圖紙
10. 公司的指引圖(從附近車站到公司位置)
化妝品製造販賣業許可證持有人必須符合良好質量規範 (GQP) 和良好警戒規範 (GVP)，落實上市化妝品的產品交付登記、產品質量信息收集、缺陷產品處理、產品從市場召回等，維護銷售的產品質量。
如果認為有必要（產品可能造成有害影響，對於例如），化妝品製造販賣業許可證持有人可以採取糾正措施，例如從市場上召回產品或修改包裝警告和注意事項標籤。
At the time of company registration, it is necessary to have specified personnel, and to obtain a manufacturing and sales license before sales can sell the cosmetics.
Companies that want to obtain a cosmetic manufacturing and sales license need to have specified personnel
1. 1 person in charge of manufacturing and sales: Responsible for supervising the work of the person in charge of quality assurance and the person in charge of safety management, and one of the following conditions should be met
．Pharmacist
．Professionals who have completed pharmacy or chemistry in high school or above
．Those who have completed pharmacy or chemistry-related courses in high school or above, and have been engaged in the quality management or safety management of cosmetics for 3 years or more
．Other persons who are deemed by the Minister of Health, Labour and Welfare to have the same level of knowledge as those mentioned above.
2. 1 person in charge of quality assurance: mainly responsible for managing the product launch of cosmetics, manufacturing management and ensuring quality management implementation, quality management information and handling of defective issues, recycling, document recording and management, etc. The following conditions should be met
．Must be full-time employee
．Possess the ability to properly handle cosmetic quality assurance business
．Have more than 3 years of relevant experience in quality assurance
．Must be the person in charge of the quality assurance coordination department of the company
．Employees involved in cosmetic sales related departments are not allowed to serve as the person in charge of quality assurance
3. 1 person in charge of safety management: responsible for collecting and processing safety management information, establishing safety assurance measures and implementing measures, which should meet the following conditions
．Must be full-time employee
．Possess the ability to properly handle cosmetics safety management business
．More than 3 years of relevant experience in safety management
．Must be the head of the safety management coordinating department of the company
．Employees involved in cosmetics sales related departments are not allowed to serve as the person in charge of safety management.
4. Must comply with Good Quality Practice (GQP) and Good Vigilance Practice (GVP)
Application materials for cosmetics manufacturing and sales license:
1. Application form
．Company
．Business address
．Responsible Person Information
2. Legal person registration certificate
．Corporate organization chart
3. Business Allocation Table
．Business Person’s Medical Certificate (Confirmation of Drug Addiction)
4. Coordinate the relevant information of the person in charge of manufacturing and selling
．Labor Contract
．Relevant qualification certificate
5. Information about quality assurance department
．GQP institutional chart
6. Information about the safety management department
．GVP institutional chart
7. Configuration diagram (clearly marked the specific orientation of the cables inside the building, land, etc. where the company is located)
8. Floor plan of the company
9. Keep the drawings related to the equipment
10. Guide map of the company (from the nearby station to the company location)
Application process for a cosmetic manufacturing and sales license:
1. Confirm whether the cosmetics comply with Japanese regulations
2. Have a physical company address
3. Have the required personnel (manufacturing and sales person in charge, quality assurance person in charge, safety management person in charge)
4. Prepare application form and related materials
5. Submit application to local county government and pay processing fee
6. On-site inspection by the county government
7. Postcards will be issued after approval, and the applicant company will go to the county government to collect the certificate after receiving the postcard
8. Start business (all manufactured, imported and sold cosmetics need to be declared to the prefectural government)
Cosmetics manufacturing and sales license holders must comply with Good Quality Practices (GQP) and Good Vigilance Practices (GVP), implement product delivery registration, product quality information collection, defective product handling, product recall from the market, etc. product quality.
If deemed necessary (the product may cause harmful effects, for example), the cosmetic manufacturing and vending industry licensee may take corrective action, such as recalling the product from the market or modifying the packaging warning and precautions labeling.
【參考連結】
https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4
HLF-JP-85
請問在日本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？
Email：tyo4ww@evershinecpa.com
或
日本永輝BPO有限公司 -Evershine.jp
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
丘玲恵（Kyu Reike）日本籍来自台灣
王礼芳（Lily Wang）日本永居来自福建
或
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
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