Table 1 Recent legislative/non-legislative changes related to OTCs in Japan

2002

An online chain OTC pharmacy initiated online sales of OTCs

2009

OTCs were classified into 3 categories, according to their risk levels: first-class OTCs (especially high risk), second-class OTCs (relatively high risk), and third-class OTCs (others)

The online sale of first- and second-class OTCs was prohibited

The registered distributor qualification system was enforced

Two online chain OTC pharmacies filed a lawsuit against the government, arguing for the ban on online OTC sales to be lifted

2013

The Supreme Court ruled that the ban on online OTC sales was illegal and, thus, invalid

2014

A new risk category (OTCs requiring guidance [post-marketing safety evaluation is incomplete]) was added to the OTC classification

The online sale of all OTCs, except those requiring guidance, was officially permitted