The European Medicines Agency has published today the initial list of medicines subject to additional monitoring. This represents an important deliverable of the new European pharmacovigilance legislation. These medicines will have to display an inverted back triangle in their package leaflet and in the information for healthcare professionals called the summary of product characteristics (SmPC), together with a short sentence explaining what the triangle means.
All medicines on the European Union market are carefully monitored. If a medicine is labelled with the inverted black triangle, it does not mean that it is unsafe; the purpose of the symbol is to actively encourage healthcare professionals and patients to report any suspected adverse reactions observed with the medicine, either because the medicine is new to the market or because there is a limitation to the data available on its safety.
Reporting suspected adverse reactions is an important way to gather more information on medicines on the market. Regulatory authorities look at reports of adverse reactions alongside all the information they already have to make sure that the benefits of medicines remain greater than their risks and to take any necessary action to optimise safe and effective use.
Medicines that are subject to additional monitoring are:
- medicines authorised after 1 January 2011 that contain a new active substance;
- biological medicines, for which there is limited post-marketing experience;
- medicines with a conditional approval or approved under exceptional circumstances;
- medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS).
To access the list, click here.
For more information, visit the European Medicines Agency website.