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 the following note:
Summary of Product Characteristics:
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
„Additional monitoring“ does not 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.
“Additional monitoring” has been introduced to strengthen the monitoring of certain medicinal products (as listed below) and to support spontaneous reporting of any suspected adverse reactions. The aim is to gain more information regarding the risk/safety profile in the clinical practice so that any new emerging information on clinical efficacy and safety can be provided.
A very close monitoring is required for some medicinal products because less information is available about them compared with other medicines, for example because they are new on the market. Furthermore, examples of medicinal products under additional monitoring also include products for which regulators require more studies to be carried out, e.g. on long-term use.
Generally additional monitoring status is always applied to a medicinal product in the following cases:
- it contains a new active substance authorised in the EU after 1 January 2011;
- it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), authorised in the EU after 1 January 2011;
- it has been given a conditional authorisation (where the company that markets the medicine must provide more data about it) or authorised under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data);
- the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials.
Other medicines can also be placed under additional monitoring, based on advice from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency.
A list of medicines under additional monitoring can be found on the website of the European Medicines Agency (EMA).
List of nationally authorised medicinal products under additional monitoring (available only in german):
Information regarding product information (Summary of Product Characteristics and package leaflet – national translations) can be found in the Austrian medicinal product index.
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).
Information on how to do this can be found in the package leaflet of all medicinal products.
For more information see:
Electronic national reporting system Vigiweb of the BASG (available only in german).
Website of the European Medicines Agency (EMA):