Japan's PAL to deregulate OTCs

Japan's revised Pharmaceutical Affairs Law allowing the new adverse reaction to drugs risk-dependent classification of over-the-counter products and the new license system for registered sales personnel at pharmacies and drug stores to sell such products. The new law will come into effect by the summer of 2009.

Although the present PAL requires that all OTC drugs should be sold by qualified pharmacists, the new law permits that those without such staff but with a new license can sell OTC drugs which are classified into three categories depending on their risks in causing side effects.

The new classifications include: drugs with a high risk, such as "switch OTC drugs," whose usage has not been fully experienced as non-prescription agents; relatively high risk, such as cold medicines, analgesics and anti-pyretics which may cause health damages requiring hospitalization in some cases; and relatively low risk, such as vitamin preparations.