Post-marketing safety measures
Description on the package inserts
The package inserts (instructions, etc.), container or capsule of a quasi-drug products and cosmetics must contain instructions, dosages, and other necessary precautions for use and handling (Articles 60 and 62 of the PMD Act). Other necessary precautions for use and handling are for the purpose of ensuring proper use and storage, etc. Some precautions are determined by official notifications, mainly for products containing specific ingredients such as scrubbing agents and cochineal. For cosmetics for which labeling precautions have not yet been determined, JCIA has established the Voluntary Standards for Labeling Precautions for Use of Cosmetics and requests member companies for conformity.
Reporting of adverse reactions, etc.
When a marketing holder, etc. of quasi-drug products or cosmetics becomes aware of a matter described in Article 228-20 (5) of the Ordinance for Enforcement of the PMD Act with respect to quasi-drugs or cosmetics that have been marketed or approved, it must report to the Minister of Health, Labour and Welfare within the period specified in each item (15 or 30 days).
