In Japan, local labeling is listed on package inserts, ‘tempu bunsho’. The package inserts should contain the information presented in the Instructions for Use (IFU) in Japanese. The Market Authorization Holder (MAH) or Manufacturer of Pharmaceuticals must affix packaging inserts as a Clearance Release Judgement requirement. Packaging inserts can be affixed in the factory of origin or done in Japan by the warehousing manufacturer. Notification is required before the medical device or IVD device can be marketed in Japan (or at the time of new approval) and when revising the package insert.
General Device Labeling Requirements
Pharmacy/Ethical drugs (not including IVD, pharmacy-compounded drugs or over-the-counter drugs), Class IV medical devices and all regenerative medical products are subject to the package insert notification system. Exemptions to be specified through ordinances of the Ministry of Health, Labor and Welfare (MHLW).
Package inserts must include:
Date of preparation/revision
Japan Standard Commodity Classification Number
Dosage and administration
Use during pregnancy, delivery or lactation
Effects of laboratory tests
Precautions concerning use
Precautions for handling
Conditions for approval
Name and address of manufacturer or importer
“References and request for literature should be make to:”
IVD Specific Requirements
Standards for package inserts for IVD devices are specified in Article 41-3.
IVDs are exempt from packaging requirements given:
Package insert and other information is provided using electronic data processing systems of other information-communication technologies approved by the MHLW ordinance
When the intended seller of an IVD device receives approval from the intended purchaser to not include a package insert
Pharmaceutical Specific Requirements
For pharmaceutical products listed in the Japanese Pharmacopoeia (JP), information specific in the JP must be included in the package insert. Marketing designated for pharmaceuticals must be immediately published using the electronic data processing system or other information-communication technologies.
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