Procedures after obtaining cosmetics approval
Updated: July 2025, 7
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Obligations of cosmetics manufacturers and distributors
After obtaining permission to manufacture and sell cosmetics, the following points must be kept in mind in order to properly operate and manage the business.
1: Obligation to present a permit
The original manufacturing/sales license must be displayed in a conspicuous place at the licensed business premises.
The manufacturing license (original) must also be displayed in a conspicuous place at the manufacturing facility.
2: Creating a quality control and safety management system for manufacturers and distributors
Manufacturers and distributors have the following obligations in order to maintain the quality control and safety management system stipulated by the GVP Ministerial Ordinance and GQP Ministerial Ordinance.
1) Providing information to consumers
A system must be in place to provide accurate information in response to inquiries from consumers.
Specifically, the following system is required.
- Announcement of contact details
- Setting up a consultation desk
- Managing product information
②Report of recall
When a voluntary recall of a cosmetic product that has been manufactured or sold is initiated, the company must promptly report the statutory details to the governor of the prefecture having jurisdiction.
③Reporting side effects, etc.
If a company becomes aware of a research report indicating that a cosmetic product it has manufactured or sold may have harmful effects, it must report this to the Minister of Health, Labour and Welfare within 30 days.
3: Manufacturer's obligations
Manufacturers are required to comply with the following obligations when manufacturing cosmetics:
① Regarding record keeping, etc.
Manufacturing records, testing records, and other records related to the management of the manufacturing facility must be prepared and kept for three years.
② Regarding facilities and equipment
The structure and equipment of a manufacturing facility must comply with the "Rules for Structures and Facilities of Pharmacies, etc." If changes are made to the manufacturing facility or equipment, the equipment requirements must be cleared, and depending on the changes, new manufacturing facilities may be required. You may need to apply for a business license or submit a change notification.
4: Changes to permissions for marketing and marketing businesses/manufacturers
5: Business audit and compliance support services
