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Fisiko supports the import and sale of cosmetics from overseas to Japan!
☑ I know attractive cosmetics sold overseas but not launched in Japan yet
☑ The ingredients (formula) and package of such cosmetics conform to the laws and regulations of Japan *
* Fisiko can also support you with conformance checking of the foreign products to Japanese regulations. (※to be subject to fees)
☑ looking for a sole sales agent in Japan *
* Fisiko supports the business as a sole sales agent of foreign products in the Japanese market. (Fisiko will hold exclusive lights of selling the products in Japan and Fisiko Co Ltd.'s name will be printed as "Seller" on the products.)
Please introduce the "attractive foreign cosmetics that have not been released in Japan yet" to Fisiko. Based on the successful check result of conformance to Japanese regulations and information including product quality and usability (cost performance), and market competitiveness, we Fisiko will consider their marketability and determine to be the sole sales agent (the "Seller" printed on the products) who will sell the products in Japan on behalf of your company.
If you are interested in, please contact Fisiko (infoOfisico.biz Please replace O with @) and provide us with necessary information such as information of product(s), brand holder* (your company) and original manufacturer (if different from the brand holder).
*Your company must be the brand holder. For conformance check of the foreign products to Japanese regulations, we require you to submit detailed information such as formulation including ingredient list with % and MSDS, package quality test results including material description provided by the manufacturer as well as the copy of their national license.
To proceed the conformance check of the foreign products to Japanese regulations, we will also require the brand holder to provide us with at least 5 sets of actual product samples for each product. As for the cost estimation and duration of the product quality test which will take about 1-3 months normally, we will inform you after checking the samples.
Based on the check result of conformance to Japanese regulations, the case will be proceeded in two directions.
PASS After the careful consideration of market acceptance, if Fisiko determines the brand will be "salable" in Japan, we will consult with the brand holder about marketing strategies such as channel, estimated sales amount and RRP.
And based on the expected sales volume, firstly, we will give a quotation of product manufacturing cost per unit in Japan (the price you will pay to the Japanese cosmetics manufacturing and distribution license holder *Japanese national qualification required. See below for details). Then, we will discuss the wholesale price (purchase price which Fisiko will pay to the brand holder) based on the product cost.
As a result of the examination, if the two companies came out satisfactory conclusion, the deal will be made and the two parties will be entered into a sole sales agent agreement in the Japanese market.
FAILURE When either product container and/or holding carton failed the check of conformance to Japanese regulations, we will examine the possibility to use alternative container/carton to meet the Japanese regulations. In case of the failure of the formulation (ingredients), we will consider the possibility of changing formulation or development of Japanese specification either by the brand holder or the Japanese cosmetics manufacturing and distribution license holder* (TBD). *The products will be "Overseas brand yet made in Japan (Japanese quality)".
However, if we come up with the conclusion that there won't be any possibility of alternative, we are afraid that the project that launching the brand into the Japanese market won't go further.
The business flow when importing and selling foreign-made cosmetics in Japanese market
Prior to proceed the steps, you need to understand and accept the following two conditions if you want to import and sell your products in Japanese market.
■Processing overseas products to conform the Japanese legal requirements, confirming and certifying their quality are only allowed to the Japanese cosmetics manufacturing and distribution license holder*.
*Sticking Japanese labels in foreign countries by original brand holder prior to importing and selling cosmetics is an illegal act in Japan. It must be done by the Japanese cosmetics manufacturing and distribution license holder which name would be printed on the products. Even if the product quality is approved in foreign countries, it is required to be inspected and certified by the Japanese license holder, too.
■The names printed in the Japanese label stuck on the product must be the name of the Japanese cosmetics manufacturing and distribution license holder as "Manufacturer and distributor (seizou-hanbai-moto)" and Fisiko Co., Ltd. as "Seller (hatsubai-moto)", NOT the original brand holder. Original brand holder's name won't exist on the Japanese version unless they use own name as the brand name. Instead, all legal responsibility in Japan regarding product quality in distribution process would be taken by the Japanese license holder instead of the original holder though they will negotiate with the original brand holder in case of defective products.
In Japan, cosmetics are strictly ordained under "the Pharmaceutical Affairs Law (the PA law hereinafter)" and relative laws same as medicines and medical devices, and it is prohibited to import and sell them without following the full procedure prescribed in the PA law even if the product is authorized and sold in foreign countries.
It is not just the matter of product quality but also the legality including WHO will do the designated procedures correctly.
You must follow the necessary steps (flow) as follows:
Cosmetics: "foreign manufacturer (original brand holder)" → "Japanese cosmetics manufacturing license holder (factory)" ) → "Japanese cosmetics manufacturing and distribution license holder (company *There are the companies which have both manufacturing license and manufacturing and distribution license) → "Seller (e.g. Fisiko Co., Ltd.) → retailers/consumers
In addition, in the process from importing to selling cosmetics, preparing application materials including registration of products at concerned governmental office are needed and most of them should be done by aforementioned Japanese cosmetics manufacturing and distribution license holder.
1. Officially-sanctioned route (flow) when importing and selling foreign-made cosmetics in Japanese market
A) Overseas manufacturer (original brand holder) + B) Japanese cosmetics manufacturing license holder + C) Japanese cosmetics manufacturing and distribution license holder* * If the company holds licenses of both B & C, the company can act concurrently. The company name will be printed as “Manufacturer and distributor (seizou-hanbai-moto)”.
+ D) Selling agency* *The company name will be printed as “Seller (hatsubai-moto)”
A) Overseas manufacturer (original brand holder) *national qualification and/ or GMP required
↓ Quality inspection and importing process
・Requirements: Invoice, copy of national qualification, Verification of importing products with the application for import submitted to Department of Human Services by Japanese cosmetics manufacturing and distribution license holder is required for customs clearing
B) Japanese cosmetics manufacturing license holder *Japanese national qualification required
*Labeling, packaging and quality inspection which meet Japanese legal standard shall be deemed as the part of “manufacturing process” in Japan.
↓ Deliver the processed cosmetics to C) Japanese cosmetics manufacturing and distribution license holder.
C) Japanese cosmetics manufacturing and distribution license holder *Japanese national qualification required
In charge of manufacturing and distribution process based on the Japanese regulations (Based on the inspection report prepared by B), C) is required to do appearance check and check the product quality information, etc., prior to wholesale/distribute the products. Implementation and operation of GQP and GVP systems required by the PA law, etc., and C) is legally responsible to overall product quality in Japan.)
↓ Deliver the processed cosmetics to wholesaler and/or consumers
D) Selling agent* (Fisiko Co., Ltd. = a sole sales agent in Japan)
↓
E) Retailer and/or consumer (end-user)
2. Permitting and notification system in Japan
1. As for above B), cosmetics manufacturing license (Keshouhin Seizougyou Kyoka)* is required.
Q. Where to apply? A. Apply to the governor of prefectural government in Japan where the company (factory) registered
2. As for above C), cosmetics manufacturing and distribution license (Keshouhin Seizouhanbaigyou Kyoka)* is required.
Q. Where to apply? A. Apply to the governor of prefectural government in Japan where the company (factory) registered
3. As for above A), application for Accreditation of Overseas Manufacturer (Gaikoku Seizougyou (seizouhanbaigyou) kyoka) is required.
Q. Where to apply? A. Apply to Pharmaceuticals and Medical Devices Agency (PMDA), an Independent Administrative Legal Entity of Japan
4. Registration of cosmetics to be sold in Japan (1 item each)
Q. Where to apply? A. Apply to the governor of prefectural government in Japan where the company (factory) registered
In case either directly dealing with the original brand holder (a foreign company) or through the Japanese company (a Japanese subsidiary of the brand holder) , Fisiko can assist the client with all arrangements relating to the flow of the above, from looking for the appropriate Japanese license holder(s), to let them conduct the conformance check of the foreign products to Japanese regulations, and proceed to obtain estimation of necessary works (incl. manufacturing process as Japanese specification, quality check, etc.) when your products pass the check in case you regard that to handle these procedure by yourself is difficult. (※to be subject to fees)
In addition, not only buying the products (Japanese specification) from your company as your sole sales agent in Japan, Fisiko can also provide you with various services such as preparing/creating the contents of information requiring legality (e.g. conform to the P.A. law) such as product information printed on the products and/or promotion tools, website, etc. (※to be subject to fees)
NOTE: If you just translate the original label in Japanese, it won't meet the Japanese legal requirement. In addition, how to appeal the product efficacy via media also need to be modified to conform Japanese regulations. Legality is quite important.
With Fisiko, a professional of cosmetics business in Japan, selling your cosmetics in Japan, which used to be "I want to do it, but I am not sure what to do.", will become possible!
If you are interested in, please contact Fisiko (infoOfisiko.biz Please replace O with @)