日本化妆品登记法规问题集

Email：tyo4ww@evershinecpa.com

或
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接洽人:
丘玲恵（Kyu Reike）日本籍来自台湾
王礼芳（Lily Wang）日本永居来自福建
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skype: annylin8008
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各国化妆品登记法规问答集

HLF-JP-10
请问日本对于化妆品的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of cosmetics in 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：

日本化妆品受《药品和医疗器材法》（PMDL）规范，并由主管当局厚生劳动省 (MHLW) 监管，药品和医疗器械局 (PMDA)负责现场检查、文件审核、审核外国製造商和进口商的申请，以及不良反应报告。

日本将化妆品分为两类：

1. 化妆品：定义为对人体有温和作用，以擦、洒等方法涂抹于人体，以达到清洁、美化、增色、改变容貌或保持皮肤或头发的良好状态。可分为6大类：

．香水和古龙水。

．化妆品：例如面霜、口红、粉底霜、眼妆等。

．护肤化妆品，如洁面乳、乳液、精华、护肤乳等。

．护发产品，例如洗发水、染发剂、护发素等。

．特殊用途化妆品，例如防晒霜、剃须膏等。

．化妆品肥皂。

2. 准药品：或称医药部外品，准药品与化妆品的不同之处在于准药品不能是器具或装置，其对人体的影响是轻微的，由厚生劳动省指定。除臭剂、美白产品或抗衰老或痤疮治疗产品等常用物品也属于准药品。

准药物通常具有以下功能：

．防止噁心和其他不适。

．预防皮疹、疼痛等。

．刺激毛发生长，去除毛发

．灭鼠、灭蝇、灭蚊等。

一般来说，准药品包括：

．除臭剂，

．脱毛剂

．头发生长治疗，

．沐浴产品

．牙膏

．烫发和矫直产品

．药用化妆品。

属于准药品的化妆品包括

．美白产品

．抗衰老产品

．油性皮肤或痤疮治疗产品

．去头屑或止痒产品

．祛斑产品

．剃须产品

．抗晒伤或“雪烧”产品

．抗菌产品

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

【参考连结】

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
外国公司要到日本销售化妆品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell cosmetics in 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：

于公司登记时需要设有规定人员，并于销售前取得製造贩卖业许可证方可销售该化妆品。
欲取得化妆品製造贩卖业许可证之企业需要设有规定之人员

1. 製造贩卖负责人1名：负责监管品质保证负责人及安全管理负责人的工作，应符合以下条件之一

．药剂师

．高中或以上学校内完成药学或化学的专业课程人士

．高中或以上学校内完成药学或化学的相关课程，并从事化妆品的品质管理或安全管理之业务已满3年之人士

．其他由厚生劳动大臣视为具有与上述人士同等知识水平之人士。

2. 品质保证负责人1名：主要负责管理化妆品的商品上市、製造管理及品质管理实施的确保、品质管理信息及不良问题的处理、回收处理、文件记录与管理等， 应符合以下条件

．必须为全职员工

．具备妥善处理化妆品品质保证业务能力

．具有3年以上从事品质保证的相关经验

．必须是企业的品质保证统筹部门负责人

．涉及化妆品销售相关部门的员工不得担任品质保证负责人

3. 安全管理负责人1名：负责蒐集并处理安全管理信息，建立安全确保措施、实施措施，应符合以下条件

．必须为全职员工

．具备妥善处理化妆品安全管理业务能力

．具有3年以上从事安全管理的相关经验

．必须是企业的安全管理统筹部门负责人

．涉及化妆品销售相关部门的员工不得担任安全管理负责人

4. 须符合良好质量规范 (GQP) 和良好警戒规范 (GVP)

化妆品製造贩卖业许可证申请资料：

1.申请书

．公司名称

．公司地址

．负责人资料

2. 法人登记证

．法人组织架构图

3. 业务分配表

．业务人员诊断书(确认是否毒品成瘾)

4. 统筹製造贩卖负责人相关资料

．劳动合同

．相关资格证书

5. 品质保证部门相关资料

．GQP体制图

6. 安全管理部门相关资料

．GVP体制图

7. 配置图(明确标有公司所在建筑物、地皮等内部的索在具体方位)

8. 公司的平面图

9. 保管设备相关图纸

10. 公司的指引图(从附近车站到公司位置)

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)

【参考连结】

https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4

HLF-JP-25
假如需要办理，请问日本有专业服务公司可以协助办理化妆品公司营业许可证？

HLF-JP-30
外国公司要到日本销售化妆品，可以指派日本公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？
外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell cosmetics in 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：

于公司登记时需要设有规定人员，并于销售前取得製造贩卖业许可证方可销售该化妆品。
欲取得化妆品製造贩卖业许可证之企业需要设有规定之人员

1. 製造贩卖负责人1名：负责监管品质保证负责人及安全管理负责人的工作，应符合以下条件之一

．药剂师

．高中或以上学校内完成药学或化学的专业课程人士

．高中或以上学校内完成药学或化学的相关课程，并从事化妆品的品质管理或安全管理之业务已满3年之人士

．其他由厚生劳动大臣视为具有与上述人士同等知识水平之人士。

2. 品质保证负责人1名：主要负责管理化妆品的商品上市、製造管理及品质管理实施的确保、品质管理信息及不良问题的处理、回收处理、文件记录与管理等， 应符合以下条件

．必须为全职员工

．具备妥善处理化妆品品质保证业务能力

．具有3年以上从事品质保证的相关经验

．必须是企业的品质保证统筹部门负责人

．涉及化妆品销售相关部门的员工不得担任品质保证负责人

3. 安全管理负责人1名：负责蒐集并处理安全管理信息，建立安全确保措施、实施措施，应符合以下条件

．必须为全职员工

．具备妥善处理化妆品安全管理业务能力

．具有3年以上从事安全管理的相关经验

．必须是企业的安全管理统筹部门负责人

．涉及化妆品销售相关部门的员工不得担任安全管理负责人

4. 须符合良好质量规范 (GQP) 和良好警戒规范 (GVP)

化妆品製造贩卖业许可证申请资料：

1.申请书

．公司名称

．公司地址

．负责人资料

2. 法人登记证

．法人组织架构图

3. 业务分配表

．业务人员诊断书(确认是否毒品成瘾)

4. 统筹製造贩卖负责人相关资料

．劳动合同

．相关资格证书

5. 品质保证部门相关资料

．GQP体制图

6. 安全管理部门相关资料

．GVP体制图

7. 配置图(明确标有公司所在建筑物、地皮等内部的索在具体方位)

8. 公司的平面图

9. 保管设备相关图纸

10. 公司的指引图(从附近车站到公司位置)

化妆品製造贩卖业许可证持有人必须符合良好质量规范 (GQP) 和良好警戒规范 (GVP)，落实上市化妆品的产品交付登记、产品质量信息收集、缺陷产品处理、产品从市场召回等，维护销售的产品质量。
如果认为有必要（产品可能造成有害影响，对于例如），化妆品製造贩卖业许可证持有人可以採取纠正措施，例如从市场上召回产品或修改包装警告和注意事项标籤。

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.

【参考连结】

https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4

HLF-JP-35
假如需要办理指派日本公司担任营业代理人，请问日本有专业服务公司可以协助？

HLF-JP-40
外国公司销售到日本化妆品本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
化妆品包装内容及各种标示，需要事先核准吗？
可允许的语文除了日文外，其他哪种语文也可以？网页？

Do foreign companies need to apply for an approval before importing cosmetics sold to 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：

产品需要先取得生产许可证，外国化妆品的製造商需要委託日本当地公司向药品医疗器材局（PMDA）申请製造商认可，亦或由製造贩卖业许可持有者代为申请，製造商需符合GMP（良好生产规范）。

厚生劳动省 (MHLW)有权向外国製造商授予认证，而 PMDA 负责申请文件处理以及检查製造机构的建筑物和设施以获得认证。

申请所需文件：

1. 製造商名称

2. 厂名、工厂位置

3. 生产基地名称、地址

4. 国内联繫公司名称、联繫人

5. 日本负责人、电话、电子邮件

6. 员工人数（包括兼职员工）

7. 製造部人员数、质检部人员数

8. 厂长、现场负责人（欧盟合格人员，或其他国家质量部门负责人）

9. 工厂生产的所有产品数量

10. 受检产品信息

11. 项目名称（英文名称）

12. 产品名称（英文名称）

13. 生产开始时间

14. 商业製造从（MM / YY）开始

15. 生产现场信息

．厂址面积

．场地面积、仓库面积

．仓库面积

．生产设施区

．生产设施面积

．检测实验室面积

16. 产品成分、原料、活性

17. 製造方法

18. 包装/标籤

19. 储存

20. 过去 5 年是否有政府机构的检查

．政府机构名称

．监管机构名称

．检查日期 对象项目名称

．被检产品名称 结果

．检查类型（现场/桌面）

．检查结果 演示或书面

21. 过去 5 年监管机构的 GMP 检查历史。

22. 过去 5 年是否存在 GMP 不符合（如果是，请概述）

23. 过去 5 年是否产品召回或 GMP 不合规历史（请详细说明。）

24. 外国製造商在其国家获得的与製造和销售製造商有关的许可证或证书的副本

在日本，化妆品、准药品的标籤需要于申请化妆品生产许可证(製造商或由製造贩卖业许可证持有人代为申请)时获得许可，方可标识。

化妆品标籤的所有信息必须用日语表达，并且必须清楚明确地列出。
禁止使用虚假或可能具有误导性的表达进行标籤，以及未经批准的标籤效果声明。

化妆品应註明的项目如下：

1.进口商的名称和地址

2.营销主管所在办公室的地址

（如果该办公室是日本以外需註明：外国批准持有人的姓名和国家；姓名和指定进口商的地址）。

3.生产国家

4.品牌名称：註册日本产品名称。

5.製造编号或批号

6.全部成分列表（按数量降序）

7.保质期

8.警告，禁止使用事项

9.厚生劳动省部令规定的其他项目

全成分标籤

化妆品外包装上必须使用日语全成分标籤。除了全成分标籤外，外包装和初级包装的信息必须相同。

1.所有非颜色成分按优势降序排列。

2.依次为含量在1%以下的所有颜色和非颜色成分，以随机顺序排列。

3.无需註明附带成分。

4.混合成分必须标明每种单独的成分。

5.萃取物被指示为将提取物和溶剂或稀释溶液分开。

6.香水可以表示为“香水”。

注意：日本化妆品工业协会 (JCIA) 编制了日文版的化妆品成分标籤名称列表，以配合 PMDL 的要求在标籤上列出所有成分名称。
企业可以参考该文件来规范日本成分的名称。

准药品的标籤信息：

1.营销许可证持有人姓名和地址

2.产品名称

3.製造编号或批号

4.重量、体积或含量

5.有效成分名称和浓度

6.对于含有厚生劳动省规定的特定成分的准药品，请註明成分名称

7.保质期

8.警告，禁止使用事项

9.准药品註记：须按照厚生劳动省的要求标註准药品字样

10.厚生劳动省需要标註的其他信息

注意：

1.准药品的声称是基于所含的活性成分，只有在获得批准后才能标註。
(美白功效：产品必须含有美白活性成分；抗痘功效：产品必须含有抗痘活性成分。)

2. 日本化妆品工业协会製作关于准药品成分标籤的基本方针，以配合 PMDL 的要求在标籤上列出所有成分名称。
企业可以参考该文件来规范日本成分的名称。

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.

【参考连结】

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
请问在日本有哪些专业服务机构，可以协助办理化妆品产品许可证？

HLF-JP-50
外国公司可以用自己名义申请办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
化妆品包装内容及各种标示，需要事先核准吗？
可允许的语文除了日文外，其他哪种语文也可以？网页？

Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetics packaging and labeling require prior approval?
In addition to Japanese, which other languages ​​are allowed? Website?

Evershine RD：

产品需要先取得生产许可证，外国化妆品的製造商需要委託日本当地公司向药品医疗器材局（PMDA）申请製造商认可，亦或由製造贩卖业许可持有者代为申请，製造商需符合GMP（良好生产规范）。
厚生劳动省 (MHLW)有权向外国製造商授予认证，而 PMDA 负责申请文件处理以及检查製造机构的建筑物和设施以获得认证。

申请所需文件：

1. 製造商名称

2. 厂名、工厂位置

3. 生产基地名称、地址

4. 国内联繫公司名称、联繫人

5. 日本负责人、电话、电子邮件

6. 员工人数（包括兼职员工）

7. 製造部人员数、质检部人员数

8. 厂长、现场负责人（欧盟合格人员，或其他国家质量部门负责人）

9. 工厂生产的所有产品数量

10. 受检产品信息

11. 项目名称（英文名称）

12. 产品名称（英文名称）

13. 生产开始时间

14. 商业製造从（MM / YY）开始

15. 生产现场信息

．厂址面积

．场地面积、仓库面积

．仓库面积

．生产设施区

．生产设施面积

．检测实验室面积

16. 产品成分、原料、活性

17. 製造方法

18. 包装/标籤

19. 储存

20. 过去 5 年是否有政府机构的检查

．政府机构名称

．监管机构名称

．检查日期 对象项目名称

．被检产品名称 结果

．检查结果 演示或书面

．检查类型（现场/桌面）

21. 过去 5 年监管机构的 GMP 检查历史。

22. 过去 5 年是否存在 GMP 不符合（如果是，请概述）

23. 过去 5 年是否产品召回或 GMP 不合规历史（请详细说明。）

24. 外国製造商在其国家获得的与製造和销售製造商有关的许可证或证书的副本

在日本，化妆品、准药品的标籤需要于申请化妆品生产许可证(製造商或由製造贩卖业许可证持有人代为申请)时获得许可，方可标识。

化妆品标籤的所有信息必须用日语表达，并且必须清楚明确地列出。
禁止使用虚假或可能具有误导性的表达进行标籤，以及未经批准的标籤效果声明。

化妆品应註明的项目如下：

1.进口商的名称和地址

2.营销主管所在办公室的地址

（如果该办公室是日本以外需註明：外国批准持有人的姓名和国家；姓名和指定进口商的地址）。

3.生产国家

4.品牌名称：註册日本产品名称。

5.製造编号或批号

6.全部成分列表（按数量降序）

7.保质期

8.警告，禁止使用事项

9.厚生劳动省部令规定的其他项目

全成分标籤

化妆品外包装上必须使用日语全成分标籤。除了全成分标籤外，外包装和初级包装的信息必须相同。

1.所有非颜色成分按优势降序排列。

2.依次为含量在1%以下的所有颜色和非颜色成分，以随机顺序排列。

3.无需註明附带成分。

4.混合成分必须标明每种单独的成分。

5.萃取物被指示为将提取物和溶剂或稀释溶液分开。

6.香水可以表示为“香水”。

注意：日本化妆品工业协会 (JCIA) 编制了日文版的化妆品成分标籤名称列表，以配合 PMDL 的要求在标籤上列出所有成分名称。
企业可以参考该文件来规范日本成分的名称。

准药品的标籤信息：

1.营销许可证持有人姓名和地址

2.产品名称

3.製造编号或批号

4.重量、体积或含量

5.有效成分名称和浓度

6.对于含有厚生劳动省规定的特定成分的准药品，请註明成分名称

7.保质期

8.警告，禁止使用事项

9.准药品註记：须按照厚生劳动省的要求标註准药品字样

10.厚生劳动省需要标註的其他信息

注意：

1.准药品的声称是基于所含的活性成分，只有在获得批准后才能标註。
(美白功效：产品必须含有美白活性成分；抗痘功效：产品必须含有抗痘活性成分。)

2. 日本化妆品工业协会製作关于准药品成分标籤的基本方针，以配合 PMDL 的要求在标籤上列出所有成分名称。
企业可以参考该文件来规范日本成分的名称。

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.

【参考连结】

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
请问在日本有哪些专业服务机构，可以协助以外国公司名义办理化妆品产品许可证？

HLF-JP-60
经过核准登记的化妆品，进口到日本要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved cosmetics into Japan? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：                      

销售前进口商需要提交营销通知、化妆品（外国製造商、进口商）通知，两份通知必须附有进口商或製造商的完整成分清单，如果无法获得此清单，则必须提供确认产品不包含任何违禁成分组合的测试和检查结果记录。

1. 化妆品营销通知

．製造和销售许可证编号日期

．品牌、成分和数量

．生产方式

．用法用量

．功效或作用

．储存方式及有效期

．标准和测试方法

．製造名称、地点、许可证、註册分类

．原料药生产场所、名称、地点 许可证、註册分类

．製造和销售项目的

注意

．纸张尺寸应为 A4。

．提交一式两份。

．用墨水、墨水等写字，写在楷书上。

2. 化妆品（外国製造商、进口商）通知

．外国製造商名称

．外国製造商办公室或工厂的位置

．销售化妆品的人的办事处

注意

．纸张尺寸应为日本工业标准 A4。

．提交一份正本和两份副本。

．用墨水、墨水等写字，写在楷书上。

外国化妆品进口日本规定：

1. 进口化妆品需先取得生产许可证、製造贩卖业许可

2. 外国製造者需经由PMDA认可

3. 每个项目的生产和贩售批准(如果含有厚生劳动大臣指定成分的化妆品必须得到厚生劳动大臣的批准)

4. 标籤与包装符合规定

上述条件符合后，可向海关报关进口化妆品

海关

1. 海关分类号（HS编码）

．美容/化妆/防晒化妆品（HS3304）

．护发产品（HS 3305）

．剃须类产品（HS 3307）

．肥皂（HS3401）等

．其他产品可以向海关顾问办公室谘询

2. 生产许可证、製造贩卖业许可证副本

3. 报关单内容：

．採购表格（发票）

．提货单或海运单（空运单）

．票价说明

．保险费报表

．其他法律的许可/批准证明书（如果货物需要根据海关相关法律（如植物保护法）以外的法律许可/批准）

．优惠原产地证书（适用优惠关税时）

．免税声明（申请免税时）

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)

【参考连结】

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
日本化妆品审核机构，需要附上的实验室检验资料有哪些? 网页？

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

Evershine RD：

GMP（良好生产规范）申请所需文件：

1. 製造商名称

2. 厂名、工厂位置

3. 生产基地名称、地址

4. 国内联繫公司名称、联繫人

5. 日本负责人、电话、电子邮件

6. 员工人数（包括兼职员工）

7. 製造部人员数、质检部人员数

8. 厂长、现场负责人（欧盟合格人员，或其他国家质量部门负责人）

9. 工厂生产的所有产品数量

10. 受检产品信息

11. 项目名称（英文名称）

12. 产品名称（英文名称）

13. 生产开始时间

14. 商业製造从（MM / YY）开始

15. 生产现场信息

．厂址面积

．场地面积、仓库面积

．仓库面积

．生产设施区

．生产设施面积

．检测实验室面积

16. 产品成分、原料、活性

17. 製造方法

18. 包装/标籤

19. 储存

20. 过去 5 年是否有政府机构的检查

．政府机构名称

．监管机构名称

．检查日期 对象项目名称

．被检产品名称 结果

．检查结果 演示或书面

．检查类型（现场/桌面）

21. 过去 5 年监管机构的 GMP 检查历史。

22. 过去 5 年是否存在 GMP 不符合（如果是，请概述）

23. 过去 5 年是否产品召回或 GMP 不合规历史（请详细说明。）

24. 外国製造商在其国家获得的与製造和销售製造商有关的许可证或证书的副本

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

【参考连结】

https://www.pmda.go.jp/english/review-services/glp-gcp-gpsp/0002.html

HLF-JP-75
日本化妆品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？

由PMDA对外国製造商进行GMP审核。

HLF-JP-77
请问在日本有哪些化妆品检验机构可以提供化妆品检验服务？网页？

由PMDA对外国製造商进行GMP审核。

HLF-JP-80
外国子公司进口化妆品后，如果委託日本的经销商销售，经销商需要化妆品营业许可证吗？
假如化妆品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports cosmetics and entrusts a distributor in 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：

于公司登记时需要设有规定人员，并于销售前取得製造贩卖业许可证方可销售该化妆品。
欲取得化妆品製造贩卖业许可证之企业需要设有规定之人员

1. 製造贩卖负责人1名：负责监管品质保证负责人及安全管理负责人的工作，应符合以下条件之一

．药剂师

．高中或以上学校内完成药学或化学的专业课程人士

．高中或以上学校内完成药学或化学的相关课程，并从事化妆品的品质管理或安全管理之业务已满3年之人士

．其他由厚生劳动大臣视为具有与上述人士同等知识水平之人士。

2. 品质保证负责人1名：主要负责管理化妆品的商品上市、製造管理及品质管理实施的确保、品质管理信息及不良问题的处理、回收处理、文件记录与管理等， 应符合以下条件

．必须为全职员工

．具备妥善处理化妆品品质保证业务能力

．具有3年以上从事品质保证的相关经验

．必须是企业的品质保证统筹部门负责人

．涉及化妆品销售相关部门的员工不得担任品质保证负责人

3. 安全管理负责人1名：负责蒐集并处理安全管理信息，建立安全确保措施、实施措施，应符合以下条件

．必须为全职员工

．具备妥善处理化妆品安全管理业务能力

．具有3年以上从事安全管理的相关经验

．必须是企业的安全管理统筹部门负责人

．涉及化妆品销售相关部门的员工不得担任安全管理负责人

4. 须符合良好质量规范 (GQP) 和良好警戒规范 (GVP)

化妆品製造贩卖业许可证申请资料：

1.申请书

．公司名称

．公司地址

．负责人资料

2. 法人登记证

．法人组织架构图

3. 业务分配表

．业务人员诊断书(确认是否毒品成瘾)

4. 统筹製造贩卖负责人相关资料

．劳动合同

．相关资格证书

5. 品质保证部门相关资料

．GQP体制图

6. 安全管理部门相关资料

．GVP体制图

7. 配置图(明确标有公司所在建筑物、地皮等内部的索在具体方位)

8. 公司的平面图

9. 保管设备相关图纸

10. 公司的指引图(从附近车站到公司位置)

化妆品製造贩卖业许可证持有人必须符合良好质量规范 (GQP) 和良好警戒规范 (GVP)，落实上市化妆品的产品交付登记、产品质量信息收集、缺陷产品处理、产品从市场召回等，维护销售的产品质量。
如果认为有必要（产品可能造成有害影响，对于例如），化妆品製造贩卖业许可证持有人可以採取纠正措施，例如从市场上召回产品或修改包装警告和注意事项标籤。

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.

【参考连结】

https://shinsei.e-gov.go.jp/

https://www.japaneselawtranslation.go.jp/en/laws/view/3213#je_ch4

HLF-JP-85
请问在日本有哪些专精于化妆品销售与消费权益相关法律服务的业者？

各国化妆品登记法规问答集

Email：tyo4ww@evershinecpa.com
或
日本永辉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）日本籍来自台湾
王礼芳（Lily Wang）日本永居来自福建
或
林幸穗  Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110

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