Black triangle on medicines under additional monitoring

The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals. A short sentence explains what the triangle means:

 This medicinal product is subject to additional monitoring.

The black triangle appeared on 1 October 2013 in all EU Member States to identify medicines under additional monitoring.

All medicines are carefully monitored after they are placed on the EU market. If a medicine is labeled with the black triangle, this means that it is being monitored even more intensively than other medicines.

This is generally because there is less information available on it than on other medicines. The reason is, for example, that it is new to the market or there is limited data on its long-term use. It does not mean that the medicine is unsafe.

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.