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New black triangle symbol for medicines subject to additional monitoring

A black inverted triangle '▼' will shortly appear on the package leaflet of certain medicinal products on the EU market. This symbol will flag to patients and health care professionals that a medicinal product is subject to additional monitoring, and its accompanying text will encourage them to report any adverse reaction through national reporting systems.

EPF has been very involved in developing the pharmacovigilance legislation. We believe it is importance to support and monitor its implementation to ensure it works for patients.

Please find here the toolkit we developed with a set of recommendations and guidance on the EU legislative framework.

For more information on the black symbol and pharmacovigilance in the EU, please click here. You can also contact our Senior Policy Adviser Kaisa Immonen-Charalambous for more information.