Medicinal products under additional monitoring: a comparative analysis of market access

In 2010, the European Union (EU) introduced new pharmacovigilance legislation that established an additional monitoring (AM) measure for certain medicines following their marketing authorization. Since 2013, a black inverted triangle (▼), accompanied by a brief explanatory sentence, has been displayed on their leaflet and in the summary of product characteristics. This symbol is uniformly used across all EU member states to indicate medicines subject to AM.