Import & Regulatory BasicsFive Points to Settle Before Signing with a Japanese Distribution Partner — From Licence Scope to Recall Responsibility
Once a Japanese distribution partner is chosen and terms move …
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Import & Regulatory BasicsIf It Says “Medicated”, It Is Not a Cosmetic — The Quasi-Drug Boundary and What Crossing It Requires
Products sold in Korea or the West as “functional cosmet…
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Import & Regulatory BasicsDistributing Medical Devices in Japan — Licence, Notification or Nothing, Depending on Class
When you set out to distribute a medical device in Japan, the …
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Import & Regulatory BasicsReading a Japanese Pharmaceutical License — Category, Scope of Products and Validity
Requesting a copy of the counterparty’s licence before s…
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Import & Regulatory BasicsAn Overseas Company Cannot Hold a Japanese Marketing Authorization — How the Designated MAH System Works
Every overseas manufacturer considering the Japanese market ev…
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Import & Regulatory BasicsWho Needs a License to Sell Medicines in Japan — Marketing Authorization and Distribution License Are Different Systems
When a prospective partner in Japan tells you “we hold a…
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Import & Regulatory BasicsIs Parallel Import Lawful in Japan — The Three Requirements Set Out by the Supreme Court
“Can we buy abroad without going through the authorised …
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Import & Regulatory BasicsNutrient Function Claims, FOSHU and Foods with Function Claims — Three Systems and How to Choose
“We want to sell it as a food with function claims”…
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Import & Regulatory BasicsWhat Cosmetics Advertising May and May Not Say in Japan — The 56 Permitted Claims
What most often trips up imported cosmetics is the wording of …
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