Sunday 10 March 2013

Inverted black triangle

Tonio Borg, European Commissioner for Health and Consumer Policy, announced that as of September 2013 on the inside leaflet of certain medicinal products an inverted, black triangle will appear. This will be the result of the adoption of the regulation implementing further EU pharmacovigilance legislation (pharmacovigiliance system allows for the monitoring of the medicine's safety throughout its lifespan). If consumers see such a symbol:



they should realize that this particular medication is subject to additional monitoring. The text of the leaflet will encourage consumers to report unexpected adverse reactions and direct them to the national reporting system. (Q&A)