Medicines under additional monitoring must be clearly marked

At the end of April the European Medicines Agency published the initial list of medicines subject to additional monitoring, showing ‘an important deliverable of the new European pharmacovigilance legislation’.

Listed medicines must 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.

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.

The inverted black triangle will start appearing in the package leaflet and SmPC of the medicines concerned in the second half of 2013. Marketing-authorisation holders of medicines on the list should start to include new information in the product information during the course of 2013.

Medicines 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; and medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS).

Other medicines can also be placed under additional monitoring, based on a recommendation from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

A medicine can be included on this list when it is approved for the first time or at any time during its lifecycle. It remains under additional monitoring for five years, or until the PRAC decides to remove it from the list – usually because studies have further established the safety profile of the product concerned. The complete additional-monitoring list will be reviewed every month by the PRAC.


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