“…European legislation that came into effect in July 2012 urges member states to develop tools to facilitate the direct spontaneous reporting of suspected adverse drug reactions (ADR) by patients. Until then, in Spain, spontaneous ADR reporting was based on reports of health professionals to the health authorities . In compliance with the abovementioned European legislation, in 2013, the Spanish Ministry of Health, Social Services and Equality published a new directive, and the Spanish Agency of Medicines and Medical Devices developed an electronic format to collect reports of suspected ADR directly from consumers, through a direct link from its website.…”