▼: the inverted black triangle symbol for medicines under additional monitoring

The European Union (EU) provides for a procedure for indicating which medicines competent authorities in Europe are monitoring more closely. All European member states use a black inverted equilateral triangle to mark medicines under extra surveillance.

Patient information leaflets and summaries of product characteristics (SPC) of medicines under extra monitoring state:

▼ This medicine is subject to additional monitoring.

When should additional monitoring take place?
Additional monitoring is appropriate when there is fewer information on the medicine than on other medicines: a newly marketed medicine, a medicine for which there is not enough information on long-term use... This does not mean the medicine is not safe, however.

  • For medicines with an active substance approved in the EU after January 1, 2011.
  • For biological substances such as vaccines or medicines derived from plasma (blood), for which there has been only limited experience since they were brought to market.
  • For medicines approved under certain conditions (if the company marketing a medicine must provide more information on the medicine), or when a medicine is approved under extraordinary conditions (if there are specific reasons why the company cannot provide an extensive data set).
  • The company marketing a medicine is obliged to perform additional clinical testing (such as providing more information on long-term use of the medicine or a rare side effect found during clinical testing).
  • For a medicine for which the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) provides additional monitoring.

European list of medicines with additional monitoring
The European list of medicines under additional monitoring is updated by the PRAC on a monthly basis.

Medicines can be added to the list when the first marketing authorisation is granted or when they have already been brought to market. Additional monitoring is performed for five years or until the PRAC decides to stop additional monitoring.

There may be a delay between the decision to add or remove a medicine to the list, and the update of the patient information leaflet and SPC. This is until the inventory of medicines on the market with the old version of the package insert.

Belgian list of medicines under additional monitoring

The Belgian list of medicines with additional monitoring is available on the FAMHP’s website and is updated every month in parallel with the European list.

Why are medicines monitored after approval?
Regulatory authorities decide to approve a medicine after having weighed up the risk/benefit balance, based on the results of the clinical research.
Only medicines that have proven to have benefits that outweigh the risks may be brought to market. This ensures patients’ access to treatments they need without being exposed to unacceptable side effects.
A relatively small number of patients are involved in clinical trials for a limited period of time. Patients in clinical trials are selected carefully and are monitored very closely in controlled conditions.

In daily life, however, a larger and more diverse group of patients will use the medicine. They may also have other diseases and use other medicines. Side effects that are more rare may only come to light when a medicine has been used for a long time by a large number of people.

It is therefore of great importance that the safety of all medicines is monitored for as long as they are on the market.
As soon as a medicine is brought to market, information is collected continuously in order to monitor experiences with the medicine in real-life. Regulatory authorities in Europe monitor these closely to ensure the benefits of the medicine continue to outweigh the risks.

The same monitoring methods are used throughout the EU, so regulatory authorities in various EU countries can share the information collected. This gives them institutions a treasure trove of knowledge on which they can base their decisions. It also allows them to quickly take corrective action in the interest of patient safety, if necessary, such as warning patients and health care providers, or revising medicines’ instructions for use.

Last updated on 31/01/2020