The Journal The Authority on Global Business in Japan


March 2014
Simplify the Procedures for Importing Cosmetics (Including Medicated Cosmetics)
Toiletries, Cosmetics and Fragrances Committee
Valid Through March 2014

­The American Chamber of Commerce in Japan (ACCJ) urges the Ministry of Health, Labour and Welfare (MHLW) to simplify both the Import Notification procedures for importing foreign-manufactured cosmetics (including medicated cosmetics), as well as the Foreign Manufacturer Accreditation process for the manufacturers of those cosmetics.

Import Procedures
All entities that wish to sell foreign-manufactured cosmetics, must submit an Import Notification to MHLW. To ensure fair competition with domestic cosmetics manufacturers, the ACCJ calls for improvements to the current procedures involved with the import notification process which is complex and requires much time and effort.

Specifically, the ACCJ requests that the submission of a “Change in Import Notification” document not be required when the only change in the Import Notification is the approval date of a marketing approval holder’s license or foreign manufacturer’s accreditation. In addition, the ACCJ recommends a review of the requirements for the documents to be attached to Import Notifications with a view to simplifying them. We request in particular that the re-submission of previously submitted notifications not be required.

An electronic system to carry out the Import Notification process for pharmaceutical products including quasi-drugs and cosmetics has yet to be introduced in Japan, though the MHLW is now considering promoting such a system. The ACCJ urges that an electronic system be established in such a way that not only will the current burdensome paper-based notification process no longer be required, but that changes in the approval date of a manufacturing license or accreditation will also be able to be confirmed on-line. This will facilitate the fulfillment of the recommendation above that no “Change in Import Notification” document will be required in cases of a simple approval date change.

Foreign Manufacturer Accreditation
The ACCJ recommends that MHLW simplify the Foreign Manufacturer Accreditation process required for medicated cosmetics by adopting one of the following approaches:

Redefine the scope of Foreign Manufacturer Accreditation mandate for quasi-drug manufacturers. An exemption has been provided in the case of manufacturers of cosmetics, and we urge the MHLW to create a similar exception for the manufacturers of such quasi-drugs as medicated cosmetics, to which the standards of Good Manufacturing Practices do not apply, so that accreditation will no longer be required; or
Simplify the documents that must be attached to the Foreign Manufacturer Accreditation application, specifically those for the buildings and facilities, and manufacturing processes.