To manufacture and sell cosmetics in Japan, a "manufacturing license" and a "manufacturing and sales license" are required under the Pharmaceuticals and Medical Devices Act (formerly the Pharmaceutical Affairs Act). A manufacturing license is required for the factory where the actual manufacturing takes place, while a manufacturing and sales license must be obtained by the "seller" who distributes the product under their own brand.
manufacturing license：For factories that actually manufacture cosmetics (Classification: General, packaging, display, storage, etc.)
Permission requirements
Human requirements (responsible engineer qualifications, etc.)
A manufacturing license requires the appointment of a "chief engineer." As a requirement, one of the following qualifications and experience is required.
pharmacist
Those who have earned credits in chemistry, pharmacy, etc. at a university, etc. *In the case of Tokyo, 12 credits or more
High school graduate or above with 3 years or more experience in safety management/quality control at a company licensed to manufacture and sell cosmetics (practice certificate required)
Permit application process
General procedure for obtaining a cosmetics manufacturing license
List of documents to be submitted
Below are the typical documents to be submitted (may vary slightly depending on the prefecture).
Manufacturing license application form
Certificate of Employment and Qualification of the Chief Engineer
Organization
Office floor plan
Certificate of entry
List of structural and equipment overview
List of equipment
If using other testing and inspection organizations, a copy of the usage summary and contract of the other testing and inspection organization or a certificate of usage
Points to note when obtaining permission
Confirmation of reasons for disqualification
If any of the following apply, you will not be able to obtain permission (Article 12 of the Pharmaceuticals and Medical Devices Act).
Those who have been sentenced to imprisonment or more and have not yet completed the sentence for five years.
Those who have had their license revoked due to a violation of the Pharmaceuticals and Medical Devices Act within the past five years
Organized crime
If applying as a corporation, confirmation from all officers is required.
Post-permission procedures
Permit changes and renewal procedures
If any of the following changes occur, you must promptly notify us or apply for changes.
Company registration information, such as trade name, address, and responsible officer
Name and address of responsible engineer
Benefits of Choosing Support Gyoseishoshi Law Firm
Multilingual Support
We have staff on-site who can speak English, Chinese, and Korean, so we can respond to inquiries in those languages. If you sell cosmetics outside of Japan and would like to import them into Japan, or if you are a foreigner who would like to start a cosmetics manufacturing and sales business in Japan, please feel free to contact us.
One-stop support from company establishment
We can support you from the point of establishing the corporate form necessary to obtain permission. We will support you in creating a system that will enable you to get started smoothly, including the appropriate articles of incorporation and establishment procedures for obtaining permission.
