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'. The concept of additional monitoring was introduced by the new EU laws on the safety-monitoring of medicines, the pharmacovigilance legislation, which started to come into effect in July 2012.
Medicines under additional monitoring have a black inverted triangle displayed in the package leaflet and in the information for healthcare professionals (called the summary of product characteristics) together with a short text explaining what it means.
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. Please note that it will not be displayed on the outer packaging 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 dangerous.
Additional monitoring status is always applied to a medicine in the following cases:
- it contains a new active substance;
- it is a biological medicine, such as vaccines or medicines derived from plasma (blood);
- it has been given a conditional approval (where the company that markets the medicine must provide more study data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of study 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.
The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) can also decide to place any other medicine under additional monitoring, in cooperation with EU Member States.