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 and have a black inverted triangle displayed in their package leaflet and the summary of product characteristics, as follows:
This medicinal product is subject to additional monitoring.
The black triangle 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.
If a medicine is labelled with the black triangle, this means that it is being monitored even more intensively than other medicines. 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), 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.
A European list is available at: list of medicines under additional monitoring.
The Agency first published this list in April 2013, and it is reviewed every month.