“We want to source popular Korean skincare and sell it in Japan” is a request we receive often. Choosing the products goes smoothly enough. Many people then stop when they learn that before the product itself, the company needs a licence in order to sell domestically. Here is the overall picture.

What comes first is not product registration but company licensing

To import cosmetics and ship them domestically as your own products, two licences are required in principle.

  • Cosmetics marketing authorization — to bear responsibility for placing products on the market
  • Cosmetics manufacturing licence — to package, label and store imported cosmetics

Applying labels to products arriving from overseas, preparing outer packaging, storing them in a warehouse — these fall within “manufacturing” under the law. So even if you intend only to pass imported goods straight through, a manufacturing licence is required in most cases. Applications go to the pharmaceutical affairs division of the prefecture where the premises are located.

The personnel requirement is the usual bottleneck

What gets overlooked is the requirement for qualified personnel. The law requires a general marketing supervisor for the marketing authorization and a responsible engineer for the manufacturing licence. Both must be a licensed pharmacist, or someone who has completed specialised coursework in pharmacy or chemistry at high school or university level.

In other words, there is a condition sitting entirely outside the question of whether the product is good. If no one in the company qualifies, the decision to hire, or to work with a company that already holds the licences, comes first.

A label is not a translation

Cosmetics distributed in Japan must carry a full ingredient listing. The problem here is that translating a Korean or English ingredient list directly does not work. In Japan, ingredients must be rendered into the display names established by the Japan Cosmetic Industry Association. These frequently do not correspond one-to-one with the country-of-origin notation, and reconciling them takes effort.

There are also limits on how efficacy may be expressed. Claims used on overseas packaging and websites not uncommonly fall outside what the PMD Act permits in Japan. It is closer to reality to think of this as “rebuilding to Japanese standards” rather than “translating”.

A working order

  • Establish first whether the product is a cosmetic, a quasi-drug or general merchandise (the classification changes the procedures required)
  • Confirm whether licences are needed, and whether the personnel requirement can be met internally
  • Obtain the full ingredient list and check it can be mapped to Japanese display names
  • Draft the label and review the efficacy expressions against the PMD Act
  • Only then settle quantities and lead times

Reverse the order and the goods arrive, then stop at labelling. We place ingredient checking and labelling work at the early stage of sourcing consideration. We can advise from licence acquisition onward, or work alongside companies that already hold the licences and are looking for products.

Primary sources referenced

※ This article summarises the outline of the system. Individual determinations rest with the competent pharmaceutical affairs division. Please confirm current primary sources when acting on any specific case.