The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. These medicines are described as being under 'additional monitoring'.
Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence explaining what the triangle means:
This medicinal product is subject to additional monitoring.
The black triangle will be used in all EU Member States to identify medicines under additional monitoring. It will start appearing in the package leaflets of the medicines concerned from the autumn of 2013. It will not appear on the outer packaging or labelling of medicines.
What does the black triangle mean?
All medicines are carefully monitored after they are placed on the EU market. If a medicine is labelled with the black triangle, this means that it is being monitored even more intensively 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. It does not mean that the medicine is unsafe.
Additional monitoring status is always applied to a medicine 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 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.
For more information and for a complete list of medicines under additional monitoring, click here.