6. Registration Processes

Cosmetics
Japan

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

When importing cosmetics from overseas, two notifications should be submitted by the Marketing Authorization Holder (MAH):

1. Foreign manufacturer notification 外国製造業者届書: the Pharmaceuticals and Medical Devices Agency (PMDA) is in charge.
2. Cosmetics sales notification 化粧品製造販売届書: the Prefectural pharmaceutical affairs division is in charge.

For both notifications, the local government usually accepts the application within one week. Both written and electronic applications are accepted.

Changes in formulation, packaging, labeling, cosmetic labeling, or marketing claims do not require the submission of a Cosmetics sales notification. 

Only a change in the marketing name would trigger a new Cosmetics sales notification.

Authorities portal to do notification

1. https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0004.html
2. https://www.tmiph.metro.tokyo.lg.jp/k_yakuji/i-sinsa/cosmetics/todokede/

Information required to submit a notification

1. Marketing name
2. Place of manufacture
3. Manufacturing process for:
   1. Foreign manufacturers: weighing, mixing, filling, packaging, labeling, storage, inspection
   2. Japanese manufacturers: packaging, labeling, storage, inspection

Notification outcome as given by Authorities

Go to the prefectural pharmaceutical affairs division to apply. If there are no problems, the application will be accepted on the spot and the stamped duplicate will be returned.

An electronic application is also acceptable.

The notification is valid forever. However, if a change in the marketing name occurs, this would trigger a new Cosmetics sales notification.

Mandatory dossier to be elaborated by manufacturer (see PIF in EU) to be kept at manufacturer's site (not to be submitted to Authorities)

There is no cosmetics dossier to provide to the authorities. The importer is responsible for the safety of the product by making documents of the Quality standards available in case of inspection (marketing name, efficacy and effects, method of use, name and location of manufacturing facility, formulation, manufacturing method, container/packaging form, contents of labeling, precautions for storage and use, product specifications and test methods, name and location of testing laboratory, shipping standards, arrangements with manufacturers).

6.2 References

1. https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0004.html

2. https://www.tmiph.metro.tokyo.lg.jp/k_yakuji/i-sinsa/cosmetics/todokede/