Cosmetics manufacturing and sales business, manufacturing business license, manufacturing and sales notification
Updated: July 2025, 12
For those of you considering entering the cosmetics business, are you worried about the complexity of license applications and the cumbersome procedures?
Support Administrative Scriveners Corporation provides comprehensive support, from prior consultation with the Pharmaceutical Affairs Division to document preparation and FD application on your behalf.
In addition to obtaining permission, we also provide comprehensive support after permission is granted, including application for changes and renewals, internal audits, support for establishing systems, and consulting.
Our team of experienced, specialized consultants will fully support your cosmetics business.
table of contents
- 1 Please contact our support administrative scrivener corporation for cosmetics permits!
- 2 Support menu
- 3 Benefits of requesting
- 4 The process for obtaining permission
- 5 Guests’ Feedback
- 6 Partnership information
- 7 We also handle contracts with testing and analysis centers.
- 8 If you don't respond appropriately, this could happen...
- 9 We are providing the latest information on cosmetics approvals!
- 10 Related page
- 11 Video explanation
- 12 Nationwide support
Please contact our support administrative scrivener corporation for cosmetics permits!
Frequently asked questions from people considering new applications
- I don't understand the procedure for applying for a permit.
- I want to sell cosmetics under my own name
- I want to import and sell newly released cosmetics from overseas.
- I don't know what the requirements are for a person in charge, so I can't hire someone.
We support new license applications for those who are planning to enter the cosmetics business.
You can request everything from prior consultation with the Pharmaceutical Affairs Division to document preparation and FD application on your behalf.
Frequently asked questions from existing cosmetic licensees
- I would like support for procedures to change when there are changes to officers or responsible persons.
- The deadline for cosmetics license renewal is approaching, but how should I prepare?
- I got a sudden call from the Pharmaceutical Affairs Division. They said they were going to do a regular inspection, but what should I do?
- Apparently, a site inspection will be conducted again when applying for renewal. Is there anything I should do to prepare?
- I haven't been able to create the documents that are required to be created and recorded in the procedure manual...is this okay?
- The procedure manual (GVP, GQP) has never been opened since it was established...
- I have no idea what to write in the procedure manual format...
- We have reviewed the distribution flow of cosmetics, but is the current procedure manual okay?
- We keep records in the company, but they are not kept in line with the procedure manual...
- I'm not entirely sure whether the cosmetics business methods and management conditions in my company are appropriate...
When you renew your permit, your records for the past five years will be checked.
We check for omissions in five-year records, omissions in records of administrative announcements, and forgetting to keep a history of revisions, and we ask you to report on improvements.
In addition, cosmetics licensees are subject to irregular on-site inspections and collection of cosmetics by the Pharmaceutical Affairs Division.
Investigations and collections may be carried out without prior notice.
In these cases, it is best to seek the help of a professional.
Frequently asked questions from companies starting up cosmetics businesses
- The work has become highly personalized, and I am worried about whether the new person in charge will be able to handle it (or I am already having trouble handling it).
- They do not understand the laws on which the procedure manuals are based, such as the Pharmaceuticals and Medical Devices Act and the Medical Device Act, and are unable to effectively lecture on the procedure manuals to on-site staff.
- I am worried about whether I am currently able to handle the paperwork that needs to be prepared before the next license renewal.
- It is a hassle to submit the periodic "Cosmetics Manufacturing and Sales Notification" to the prefectural government office.
- Due to the large number of products and notifications, it is not possible to grasp and organize the contents of the notifications.
- I am worried that the product descriptions on my EC site may violate the Pharmaceuticals and Medical Devices Act, the Standards for Proper Advertising of Pharmaceuticals, etc.
- I am unable to choose the appropriate words to use when making a sales pitch.
- I am importing new cosmetics from overseas, but I am worried about restrictions on ingredients.
When starting a cosmetics business, we are receiving an increasing number of inquiries from customers who would like to request after-sales support after approval, such as "We handle so many products that we don't have the time to prepare notification documents each time," or "We think we can somehow obtain new approval, but we don't think we can get through the renewal process."
When starting a cosmetics business, we recommend that you hire an administrative scrivener who handles administrative procedures on your behalf and is familiar with relevant laws and regulations, such as the Pharmaceutical and Medical Device Act and Standards for Appropriate Advertising of Pharmaceutical Products.
Frequently asked questions from pharmaceutical companies
- We would like to hold practical training on cosmetics in-house.
- Participate in regular in-house training.
- I would like to attend a seminar on regulations in the cosmetics industry.
- We would like to provide basic pharmaceutical knowledge training to new employees.
- As part of the lecture on the Internet mail order business, I would like to discuss points to be careful about when selling cosmetics.
SupportMenu
Applications for cosmetics permits require the use of specialized software and the establishment of procedural manuals, and the application process is often accompanied by experts.
① New application support
We will prepare all the necessary documents and submit the registration application to the relevant government office on your behalf.
We provide total support for various operations up until the start of business, focusing on the following areas:
- Preparation of FD application forms and various attachments
- Preparation of necessary documents such as procedure manuals (GVP, GQP)
- Obtaining various certificates on your behalf
- Pre-consultation with pharmaceutical affairs departments and public health centers, etc. & application agency
- Advice on necessary facilities and internal structure
- Lecture before on-site inspection
- Attending on-site inspections
- Corrective action after on-site inspection
② Application for change/renewal of license
If there are any changes to your registered information, we will make the necessary changes on your behalf.
We also accept renewal applications for the five-year validity period.
③ Product notification and export certificate preparation
We handle the necessary product-specific notifications prior to import and sales, as well as the preparation of export certificates that are often required by export destinations when exporting cosmetics overseas.
④ Pharmaceutical affairs specialist lecturer dispatch service
We dispatch specialized lecturers with extensive knowledge of pharmaceutical affairs to in-house training for cosmetics manufacturers, various pharmaceutical affairs seminars and lectures, etc.
⑤ Cosmetics business audit services
Permits and licenses do not end once a permit is obtained.
In order to continue business operations, it is necessary to properly comply with laws and regulations.
At Support Administrative Scrivener Corporation, we not only help you obtain permission, but alsoWe also provide thorough support after approval through audits..
Main audit contents
- Confirmation and proposal of internal system for handling cosmetics
- Check and review the contents of procedures (GQP, GVP),Drafting revised procedures to suit the actual situation
We will check whether legal changes etc. are properly reflected and whether there are any discrepancies with your company's system, and then create a revision proposal. - Check whether there are any missing or incomplete documents that should be recorded and stored
We will check whether any documents are missing or if there are any points that may be questionable and will provide you with advice. - Lecture on how to create records
- Cosmetics permit training
Training will be conducted when there is a handover of personnel, at the end of a fiscal year, etc.
Case study
Case 1: ``Existing customer'' Due to sudden retirement, I was assigned to be in charge of cosmetics instead of taking over from my predecessor.
[Solution] Training, confirmation of recorded documents, sharing of information that was withheld by our company, support for system development
We provide training on what cosmetics licenses are, explain the process so far, send copies of application forms, etc., and have established a system so that you can carry out your cosmetics business with peace of mind.
Case 2: Only the easy-to-understand parts of the procedure manual were kept, and the renewal deadline approached without making any revisions for five years.
[Solution] Checking the contents of procedure manuals and creating revision plans / ② Checking recorded documents
We provided advice on where to look and create the missing documents. We were able to reflect the legal revisions to the procedure manual and propose revisions that matched the company's current structure, and we were able to successfully complete the renewal application without any issues.
Through consultation and listening, we will identify the compliance support your company needs.
⑥ Pharmaceutical affairs consulting
Our pharmaceutical consulting services provide a one-stop service for all aspects of cosmetic pharmaceutical affairs.
Main support content
| Pharmaceutical advertisement check | We check for any expressions that violate regulations regarding pharmaceutical advertising, regardless of whether they are printed or online (e.g. product descriptions on e-commerce sites, product advertising text, in-store posters and POP, etc.). We can also propose expressions that are appealing while still adhering to the rules. |
| Submission to government offices, etc. on your behalf | We handle everything from document creation to submission for cosmetic manufacturing and sales notifications, notifications of changes thereto, and foreign notifications (to PMDA) that are required in the case of import. |
| Checking the wording of legal product labeling | Violation of legal product labeling is the most common recall case. By carefully checking the display contents in advance, you can minimize such future collection risks. |
| Document maintenance for business permit maintenance/continuation | Cosmetics manufacturing and sales businesses must continuously manage documents related to market release judgment, quality control, self-inspection, etc. based on the contents of the procedure manual (GQP, GVP) prepared in advance at the time of obtaining permission. However, the reality is that there are quite a few companies that prioritize sales, marketing, and advertising and neglect this operating procedure. By involving our office, we will provide full support in this field of document management and propose a system for smooth continuous management. |
Laws and regulations/administrative procedures
| Change notification application agency | We will act on your behalf to apply for changes. |
| Manufacturing and sales notification agency | We will handle everything from inquiring about brand names to creating application forms and filing notifications on your behalf. We will also tell you things to keep in mind when naming your product. |
| export certificate | This document is often required by the export destination when exporting cosmetics overseas. |
Procedure Manual Related
| Confirmation and scrutiny of the contents of procedure manuals (GQP, GVP) | We provide GQP/GVP procedure manuals that cover legal compliance matters, such as proposing revisions of procedure manuals to suit actual conditions and creating revision plans for procedure manuals. We also support appropriate revisions if there are changes to the internal structure. |
| Collection of safety management information | According to the GVP Ministerial Ordinance, safety management officers are required to collect safety management information at least once a month. We support in-house processing in accordance with GVP ministerial ordinances when safety management information is acquired. |
| Item management/quality standard document operation support | We track various notifications and change history, organize the notification status, and support the maintenance of quality standard documents. |
| Self-inspection follow-up | We support the implementation of once-a-year self-inspections that are often forgotten, leading to effective inspections. |
| Education and training follow-up | We provide training tailored to your goals. Please inform the person in charge of your wishes, such as QMS/GVP training, public notice expression training, legal display training, etc. Plans that provide training at the time of a handover of a person in charge or at the timing of a new fiscal year are also popular. |
Sales, business and compliance related
| Pharmaceutical advertisement check | We will check to see if there are any legal issues with the advertising text on POPs and e-commerce sites during sales, and if there are any issues, we will provide you with proposed changes. |
| Checking the wording of legal product labeling | Check for any legal issues with product labeling. |
| Examination of brand name | There have been cases where there were no problems at the time of obtaining the permit, but before you know it you are in violation of the law, so we recommend comprehensive risk management by experts. If a violation is discovered, there is a risk of product recall in the worst case, so we support strengthening internal compliance. |
| Internal compliance training | |
| Regular meeting regarding cosmetics license | We conduct MTG once every 1 to 1 months to provide collection cases and the latest information, and provide opportunities to check records. |
| Internal audit | We provide internal audit methods, actual internal audits, records of internal audits, and follow-up for improvements after internal audits. |
annual contract
| Pharmaceutical consulting (1 year contract and up) | We will regularly check the procedure manual and provide advice. It can also be used as part of self-inspection and educational training. We also handle product notifications and change notifications at a lower cost than applying individually. The service content can be customized according to your company's wishes. We also distribute email newsletters containing administrative information, etc. |
⑦ Comprehensive outsourcing of legal management
List of Services
- GQP/GVP procedure manual (creation, operation, revision, application of legal changes)
- Item management/quality standard document operation support
- Self-examination
- Education Training
- Collection of safety management information
- Examination of brand name
- Advertising review
- Internal audit
- Regular meetings (once every 1-3 months)
Laws regarding cosmetics licensing are frequently updated, and compliance awareness has particularly increased in recent years.
If a violation is discovered, there is a risk of product recall or fines in the worst case, so continuous vigilance is essential.
There have been cases where there were no problems at the time of obtaining the permit, but before you know it you are in violation of the law, so we recommend comprehensive risk management by experts.
This content is especially recommended for "business operators who are about to renew their licenses" and "business operators who have lost their predecessor and are not yet able to keep up with training a successor."
Learn more about bulk outsourcing
We can also assist you in obtaining a Certificate of Origin.
For those who need to obtain a Certificate of Origin when exporting.
Are you having trouble because the procedures are so complicated and you don't know where to start?
We provide support for obtaining a specific certificate of origin based on the EPA.
Why not leave the complicated procedures, from requesting origin determination to issuing certificates, to our experts?
Benefits of requesting
Start your business smoothlyCanThat
By entrusting the application process to an administrative scrivener who specializes in new cosmetics license applications, you can smoothly prepare everything from establishing an organizational structure to preparing the necessary documents.
We will not only collect certificates and prepare documents, but also visit pharmaceutical affairs departments and public health centers on your behalf.
In addition, after the application for permission is submitted, there will be an on-site inspection by the Pharmaceutical Affairs Division. Since our company has accumulated a lot of know-how, we can provide advice based on past data.
Our specialized licensing team responds quickly and accurately
We areRanked 2nd in the administrative scrivener office rankingsIt is a major player in the industry (Teikoku Databank, 2020).
We handle more than 200 consultations a year, and have the know-how to create procedure manuals (GVP, GQP) in a way that suits the actual situation, so we can provide support for business operations after obtaining permission.Build an appropriate compliance systemAvailable
"Change procedure"Leave it to mereceive
We will handle all the administrative procedures for licenses and permits, such as change procedures when there are changes in officers, and renewal procedures when licenses are about to expire.Reducing work for in-house personnelWe can help you.
You can build an internal management system that takes into account the post-approval period.
Licensed cosmetics businesses are subject to occasional inspections and collection of cosmetics by the Pharmaceutical Affairs Division.
OurRegulatory Consulting ServicesFor companies that have signed a contract withTo be able to respond to sudden investigations, etc., as a fixed-term project, tailored to your styleWe will proceed with the construction of an internal management system in a planned manner.
By establishing an appropriate internal system in preparation for after permission is granted and after the start of business, and thoroughly understanding the contents of the procedure manual and how to create it, you can eliminate unnecessary hassle, make your work easier, and enable smooth application without having to report improvements during on-site inspections at the time of renewal.
[Free management system diagnosis now available!]
The process for obtaining permission
General procedure for obtaining a cosmetics manufacturing and sales license
General procedure for cosmetics manufacturing and sales notification
Guests’ Feedback
Partnership information
① Proposals for import agents (OEM)
We often hear from many companies that they have trouble managing each item as they act as an import agency.
The time and effort required to apply for manufacturing and sales notification each time, confirmation of changes, and preparation of quality standard documents are extremely complicated.
By partnering with us, you can centrally manage your information and reduce the hassle of filing applications.
② Proposals for EC site operators
If you are a seller who is having trouble renewing your cosmetics license, or if you would like to start selling cosmetics but don't have a license, please let us know.
③ Proposals for trading companies and retailers
Cosmetics already have certain effects and efficacy that they can claim.
We check to make sure that the advertising expressions do not deviate from this.
If you use deviant advertising expressions, you may be subject to penalties or recall, so please consult us before importing or selling.
We also handle contracts with testing and analysis centers.
We areWe also have partnerships with testing and analysis centers.
Even if you do not have the facilities to test drugs on your own, you can leave the contract with a testing and analysis center to us.
①Receive a request from the customer.
②We will support the contract between the customer and the test analysis center.
③A contract is established between the customer and the testing and analysis center, and the drug can be tested.
If you don't respond appropriately, this could happen...
① When importing cosmetics
Ukari found some very good cosmetics in Korea and was convinced that they would be a big hit if they were sold in Japan.
Sell this in Japan and make a lot of money...Ushishishishishi♪
The activist Ukari immediately negotiated with a local Korean cosmetics company, KOREAN COSME, and signed an exclusive sales contract for the cosmetics, which he was sure would be a big hit.
Going well, going well♪
- The day the product arrives from Korea to Japan.
Thanks to Ukari's efforts, the product finally arrived at the Japanese airport (customs).
However····
The customs official simply said, "We can't pass through customs."
When asked why,"A license is required to import cosmetics."And that.
Ukari, who didn't know anything about permission, was surprised!
Wow, that's a lie! ?
Ukari-kun has worked hard so far.
There's no way I can give up at a place like this.
Ukari hurriedly started researching about ``cosmetics permission.''
Get permission and make your dream cosmetics business a hit!
ApparentlyCosmetics manufacturing/manufacturing/sales industryIt seems that there are two permissions, but to obtain permissionPlaces and peopleThe requirements for, it cannot be prepared in just a few days.
While Ukari was conducting his research, the products arriving at Japanese airports were:Customs paid warehouseIt is stored in
Days passed by without being able to sell the product, and the high cost of storing it in the warehouse was mounting.
In the end, I decided to send the product back to Korea without any prospect of obtaining permission...
Also, I had to pay for shipping the product back.
Sales aren't going up, but costs are going up...
Furthermore, KOREAN COSME, which received the product back, was furious and said, "What's going on? The contract is broken!!"
The contract I had worked so hard to secure was now up for grabs.
My dream cosmetics business ended just like a dream...(;-;)
To prevent this from happening!
Support AdministrationLeave it to the legal professionals corporation!!!
② "What? Isn't that a cosmetic?"
Miko, a beauty enthusiast, was looking for cosmetics with high beauty effects in Korea.
The products that caught the eye of fashion-conscious Yoshiko were A Gel and B Cream, which are huge hits in Korea.
I actually bought it and used it myself, and within just one day, my skin was as smooth as a different person's...
This is perfect for Japanese skin! It will definitely be a hit!!
Convinced of this, Yoshiko immediately began preparations to sell the product in Japan.
I'm glad I got permission to use cosmetics for times like this.
Yoshiko used the cosmetics permit she had already obtained to complete the import procedures for these two products at Japanese customs.
I submitted the necessary documents and the procedure was perfect.
All that is left to do is wait to receive the imported cosmetics♪
However···
One day, Yoshiko received a call from customs.
The customs official said something shocking to me: "A Gel cannot pass through customs."
When I asked Yoshiko the reason, it turned out that the product she was trying to import wasNot recognized as cosmeticsTherefore, they say that they cannot pass through customs.
However, due to the ingredients, "A gel" is not popular in Japan.Quasi-drug, so it cannot be imported with a cosmetics permit."
Wow, no matter how you look at it, this is a cosmetic! !
Furthermore, the next day. Also, you will be contacted by customs.
A customs official told me, ``Even B Cream cannot pass through customs as it is now.''
When I asked him why, he said, ``According to the XXX Convention, it contains ingredients that must go through different procedures.''
...What on earth did I do? . . . tears
To prevent this from happening!
Please consult with the support administrative scrivener corporation! ! !
*Our corporation is an administrative scrivener corporation and is not a government agency (government agency).
We are providing the latest information on cosmetics approvals!
[Expert explains]
Latest Topics on Cosmetics Approvals
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