What does the “black triangle” mean?

The European Union has introduced a new symbol for medicines that are subject to special monitoring. These medicines can be identified by the following sign on the package leaflet: an upright black triangle (▼) and a warning text in the package leaflet:

"▼ This medicine is subject to additional monitoring. This allows new safety information to be identified quickly. You can help by reporting any side effects you experience. For information on reporting side effects, see the end of section 4”.

What does “additional monitoring” mean?

If a medicine is marked with a black triangle, this does not mean that it is unsafe, but that it is monitored additionally.

Effective and safe medicines have already been tested before they are approved – only those that pass the tests are allowed on the market.

Nevertheless, medicines marked with a black triangle are monitored particularly thoroughly and closely – especially after many people have started using the medicine in everyday life. This is because some side effects only occur when many people use the medicine under ‘real’ conditions.

The aim of the additional monitoring is to gather new safety information as early as possible, thereby enabling the use of the medicine to be  made safer.

When is a medicine labelled with the black triangle?

A medicine receives this symbol if:

• it contains a new active substance that was authorised in the EU after 1 January 2011;
• or it is a biological medicine (e.g. vaccines or medicines derived from blood/plasma) and was authorised after 1 January 2011;
• or it has received conditional authorisation which means that the company must provide further data at a later date, or has been authorised under exceptional circumstances (e.g. because not all data was available yet);
• or the company must conduct further studies after authorisation, e.g. on long-term use or rare side effects;
• The European Medicines Agency (EMA) website has a list of all medicines that are subject to additional monitoring.

What does this mean for you as a patient?

• If you are given a medicine labelled with the black triangle, you know that it was tested and authorised and also closely monitored so that new safety information can be obtained as early as possible.
• You can help making medicines safer by reporting any side effects you observe. This is helpful and important.
• If you have any questions or feel uncertain – e.g. about a side effect – talk to your doctor or pharmacist.