Japan Cosmetics Regulatory Affairs Application Services

Evershine Japan, together with its foreign affiliates, provides comprehensive Cosmetics Regulatory Affairs application services to support your Japan subsidiary.
Email：tyo4ww.cos@evershinecpa.com

Headhunter Fee of Marketing Supervisor (PRA-PJT-R)

When your Japan subsidiary applies for a Japan Cosmetics Marketing License, it must appoint a qualified pharmacist candidate to serve as the General Marketing Supervisor (GMS).
In other words, a pharmacist (or similarly qualified professional) is required to fulfill the General Marketing Supervisor / responsible person role under the proposed licensing structure.
If your Japan subsidiary does not yet have such a qualified individual, we can assist in identifying and recruiting a suitable candidate.
This fee refers to the General Marketing Supervisor introduction service.

Semiyearly Remuneration of Marketing Responsible Supervisor (PRA-C-RA-H)

Semiannual Remuneration for the Marketing Responsible Supervisor
This amount is based on the preliminary information currently available regarding the candidate and is provided for reference only. The final monthly remuneration will depend on the agreed terms of engagement.
In practice, payments to the Marketing Responsible Supervisor are typically made on a semiannual basis.
All candidate-related arrangements remain subject to the candidate’s continued availability, your confirmation, and final agreement on the engagement terms.

Japan Manual Support of GQP GVP (PRA-C-Manual)

Preparation and/or support for the development of internal GQP and GVP procedure manuals, as well as related compliance documentation, required for the Cosmetics Marketing License structure to be implemented by your Japan subsidiary.
However, as the contemplated structure involves the importation of cosmetics, with packaging, labeling, and storage outsourced to a local third party in Japan, the final fees may be subject to adjustment based on the actual scope of document preparation and compliance system setup.
Accordingly, the final fee will depend on the specific documentation requirements, internal organizational structure, and outsourced operational arrangements.

Japan Cosmetics Marketing Licence (PRA-C-MKL)

Cosmetics Marketing License Application Support (化粧品製造販売業許可申請支援)

We provide support to your Japan subsidiary in applying for and maintaining the Cosmetics Marketing License in Japan, based on the proposed structure in which your Japan subsidiary serves as the license holder, while packaging, labeling, and storage functions are outsourced to a duly licensed third-party facility in Japan.

Japan Cosmetics Packaging Labeling Storage (PRA-C-PLS)

This license is required if your Japan subsidiary physically performs any of the following activities in Japan: filling or bottling, packaging or repackaging, labeling (including affixing Japanese labels), and, in certain regulated cases, storage.
The license is granted on a facility basis, rather than solely at the company level. It typically applies to operations covering the flow of importation, warehousing, labeling, and distribution.
This represents the most common operating model for foreign-owned Japan subsidiaries.

Marketing Notification Filing Support (PRA-CS-CNF)

Marketing Notification Filing Support (製造販売届出)
We provide support for the required marketing notification filings in Japan for the products to be handled by your Japan subsidiary.
Based on the anticipated volume of existing and future SKUs, the final fee will depend on the actual filing structure, product grouping approach, and total number of filings.
Assumption: The current estimate is based on 10 SKUs. Any variance in the number of SKUs may result in a corresponding adjustment to the fees.

Government Fee(PRA-C-GF)

Government filing fee for the Cosmetics Marketing License application (subject to any additional official fees if the final structure or required filings change).

Out-of-Pocket expenses for applying cosmetics RA ( PRA-C-OPE)

1. Out-of-pocket expenses may include local transportation, postage, courier charges, government filing disbursements, and other incidental expenses incurred in connection with the services.
2. Translation fees for company documents are not included unless otherwise agreed.
3. Any notarization, legalization / authentication, courier, transportation, or similar third-party costs, if required, will be recharged to your company at actual cost against supporting receipts or evidence of payment.
4. If any actual disbursement exceeds the amount originally included or estimated, Evershine shall be entitled to recharge the excess amount accordingly.

Non-SOP or out-of-scope Services (PRA-Non-SOP)

*The other services beyond the above-mentioned service items, when you need, we will quote separately based on hourly rate 25000 Yen multiplying estimated spending work-hours.
* When it happens, Evershine will email to you proposal and get your approval in advance before starting the services.

In Japan, for a foreign-owned subsidiary to import and sell cosmetics, the following five key steps are required:

1 Cosmetics Marketing License Application Support.
Please see PRA-C-MKL
We support your Japan subsidiary in applying for and maintaining the Cosmetics Marketing License in Japan under the proposed operating structure.
2.GQP / GVP Procedure Manual Support.
Please see PRA-C-Manual.
We assist in the preparation of GQP / GVP procedure manuals and related compliance documentation required for the intended operating structure.
3.Pharmacist Candidate for the General Marketing Supervisor Function.
Please see PRA-PJT-R and PRA-C-RA-H。
We provide preliminary coordination and support in identifying a qualified pharmacist candidate for the required responsible person (General Marketing Supervisor) role.
4.Japan Cosmetics Manufacture Licence of Packaging Labeling Storage.
Please seePRA-C-PLS
This license is required if your Japan subsidiary physically performs any of the following activities in Japan: filling or bottling, packaging or repackaging, labeling (including Japanese labeling), and, in certain regulated cases, storage.
5.Marketing Notification Filing Support.
Please see PRA-COS-CNF
We provide support for the required marketing notification filings in Japan, with the final scope and fees subject to the actual number of filings and product grouping structure.

Contact Us

Tokyo Evershine BPO Service Limited Corp.

Email：tyo4ww.cos@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin and English
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  

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

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