Black Triangle

What does the black triangle ▼ mean?


The European Union has introduced a new way of identifying medicines that are being monitored particularly closely.          

These medicines have a black inverted triangle ▼ displayed in their package leaflet, together with a short sentence that reads: "This medicinal product is subject to additional monitoring."


„Additional monitoring“ doesn’t mean that the medicinal product is unsafe.

Before a medicinal product is introduced to the market efficacy and safety of the medicinal product have to be proven through clinical studies and laboratory tests. Medicinal products are only authorized by the authorities if the benefits outweigh the risks.  

All medicinal products are carefully monitored after they are placed on the market, because some less common side effects may only be apparent when a medicine has been used in a real-life setting for a long time by a larger and more diverse group of patients.


However, a very close monitoring is required for some medicinal products because less information available about them compared with other medicines, for example because they are new on the market.

Examples of medicinal products under additional monitoring include products for which regulators require more studies to be carried out, e.g. on long-term use or on rare side effects seen in clinical trials.

A list of medicines under additional monitoring can be found on the website of the European Medicines Agency (EMA).

Through reports of side effects important information regarding the safety of medicinal products can be gained. Patients and relatives as well as physicians, pharmacists and healthcare professionals can report side effects directly. In Austria reporting can be done by post, fax or directly via the website of the BASG (Austrian Federal Office for Safety in Health Care)/AGES Austrian Medicines and Medical Devices Agency. 

Information on how to do this can be found in the package leaflet of all medicinal products.


Further Information is provided on the website of the European Medicines Agency (EMA), a general information site, a fact sheet as well as a video.


For more information see:

> Electronic national reporting system Vigiweb of the BASG (available only in german):


> Website of the European Medicines Agency (EMA):

Medicines under additional monitoring




Created: 19.02.2015 | Page last modified: 19.08.2015

© Austrian Federal Office for Safety in Health Care
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