What is a cosmetics manufacturing and sales license?
Legal basis and type of permission (manufacturing and sales business)
To manufacture and sell cosmetics in Japan, a "manufacturing license" and a "manufacturing and sales license" are required under the Pharmaceutical and Medical Device Act (formerly the Pharmaceutical Affairs Act). A manufacturing and sales license is a license that must be obtained by a "seller" who distributes products under their own brand.
Although cosmetics are originally made to have "mild effects on the human body," as long as they are applied to human skin, there is the possibility that they can lead to various health hazards, such as "skin redness," "skin rash," and "persistent itching." Manufacturers and distributors, as the people responsible for shipping and distributing products to the market, must obtain licenses and conduct their business appropriately.
Manufacturing and sales license: For sellers who are responsible for product quality assurance and market management
Why is permission required? (Legal obligations/Safety management responsibility)
In order to protect the health and safety of consumers, the Pharmaceuticals and Medical Devices Act requires manufacturers and distributors to manage the quality and safety of their products. Selling products without a license is considered unlicensed business and subject to administrative and criminal penalties. Licensed businesses must also establish a GQP (quality control) and GVP (safety control) system and manage products responsibly.
Permission requirements
Personnel requirements (responsible person qualifications, etc.)
The manufacturing and sales license requires the appointment of a "general manufacturing and sales manager." As a requirement, the person in charge must have one of the following qualifications and experience:
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)
Preparation of GQP/GVP system and procedure manual
In order to properly manage the quality and safety of cosmetics, it is necessary to prepare operational manuals called "GQP" and "GVP."
GQP (quality control rules)：These are procedures to ensure that products are made with the proper quality. For example, they define how to check products and how to check them before shipping.
GVP (Safety Management Rules)This determines how to respond if complaints or reports of problems are received from consumers, etc.
Based on these rules, you should prepare a procedure like this:
Quality control procedures (inspection, shipping decisions, etc.)
Safety management procedures (dealing with complaints and defects, etc.)
Product recall manual
Management rules for entrusting work to external companies
Permit application process
General flow of the cosmetics manufacturing and sales industry
List of documents to be submitted
Below are the typical documents to be submitted (may vary slightly depending on the prefecture).
Manufacturing and sales business license application form
Certificate of use and qualifications of the general manufacturing and sales manager
Organization
Complete set of GQP/GVP procedures
Office floor plan
Certificate of entry
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
Product notification and foreign manufacturer notification
After obtaining permission, a "Manufacturer's and Sales Notification (Item Notification)" must be submitted for each cosmetic product. For imported products, a separate "Foreign Manufacturer Notification" is required.
Notification for each product: This is a procedure for notifying the prefecture where the license was obtained for each cosmetic product to be sold (name of cosmetic product, name and address of manufacturer, etc.).
Imported cosmetics: This is a procedure to notify PMDA when importing and selling cosmetics manufactured overseas in Japan, separate from the product notification. (Name and address of overseas manufacturer, etc.)
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 the general manager of manufacturing and sales
In addition, the permit has an expiration date.Renewal procedure every 5 years is required. When renewing, five years' worth of records prepared based on the GQP/GVP procedures mentioned above will be checked on-site.
Benefits of Choosing Support Gyoseishoshi Law Firm
Preparation and submission of various procedures
We will create and organize complicated and specialized procedure manuals, as well as provide lectures on the contents.
Provision of GQP/GVP manual template
Customization and content verification
Checking and creating documents to be submitted
We provide long-term support, including operational support after obtaining permission (item notification and change notification).
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.
