Japan Cosmetics Registration QA
Email: tyo4ww@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
HLF-JP-10
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：
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
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：
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？
Evershine RD：
Yakujihou
https://www.yakujihou.com/globalconsulting/
SME
HLF-JP-30
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：
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？
Evershine RD：
OHYAMA
KASEI
https://www.toakasei.com/english/region/cosmetic/
HLF-JP-40
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：
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？
Evershine RD：
Yakujihou
https://www.yakujihou.com/globalconsulting/
SME
HLF-JP-50
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：
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？
Evershine RD：
Yakujihou
https://www.yakujihou.com/globalconsulting/
SME
HLF-JP-60
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：
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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？
Evershine RD：
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？
Evershine RD：
由PMDA對外國製造商進行GMP審核。
HLF-JP-80
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：
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？
Evershine RD：
Atsumi & Sakai
Matsuo&Kosugi
Mori Hamada & Matsumoto
Contact Us
Tokyo Evershine BPO Service Limited Corp.
E-mail: tyo4ww@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4tyo@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
Linkedin address: Dale Chen
Additional Information
Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico
Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.
Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
Please send email to HQ4tyo@evershinecpa.com
More Cities and More Services please click Sitemap
*Labor Law Regulation compliance audit.
*Evershine use online payroll relevant 5-in-1 System support our services:
-GPS-Clocking ; Staff Scheduling;
-Leave system ; Overtime System;
-Payroll Parameter Collection System;
-payroll gross to net calculation
*Pay salary through internet Banking Function
We act as your in-house accountant supported by cloud accounting and payroll system.
We are a member of LEA and IAPA.
Our affiliated companies are located at major cities in Eastern China area.
We are featured in providing services to the overseas entities of MNC (Multi-National-Companies) parent companies.
Read more
Company registration,
Work Permit and Visa application;
Online Accounting Services,
Payment Services,
Tax Compliance Services;
Payroll compliance Services,
Trademark Registration;
Due Diligence for M&A project.
Read more
*International Tax Planning
*Company Registration
*Work Permit Application
*Import and Export Permit and License Application
*Food and Drink Business Permit and License Application
*Medical Devise Business Permit and License Application
Read more