The European Medicines Agency (EMA) has published a list of medicines that are subject to additional monitoring. From the autumn of 2013, these medicines will display an inverted black triangle in their package leaflet and the summary of product characteristics with information for patients and healthcare professionals.
This medicinal product is subject to additional monitoring.
Holders of marketing authorisations granted before 1 September 2013 of medicines on the list must update the package leaflet and summary of product characteristics to include the new black symbol and explanatory text by 31 December 2013. This time limit may be extended in special circumstances.
What does the list and the black triangle mean?
All medicines are carefully monitored after they are placed on the EU market. Only medicines whose benefits have been shown to be greater than their risks can be granted a marketing authorisation. Obviously, the benefits of medicines must remain greater than their risks after they have been put on the market. Medicine could give side effects, and medicine could cause harm.
If a medicine is labelled with the inverted black triangle, it does not mean that it is unsafe compared to other medicines. When a medicine has the inverted black triangle, it means that it is monitored more intensely than other medicines. This is generally because there is less information available on it than on other medicines, for example because it is new to the market or there is limited data on its long-term use.
The black triangle is also intended to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, because this is an important way to gather important information about medicines on the market.
A medicine becomes subject to additional monitoring 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), for which there is limited post-marketing experience,
- it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved 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 a recommendation from the European Commission or a national competent authority in the EU/EEA after consultation in the EU Pharmacovigilance Risk Assessment Committee (PRAC).
The list is updated monthly and published on the EMA website: List of medicinal products under additional monitoring
Further information about medicines subject to additional monitoring is available from EMA. Medicines under additional monitoring