New black triangle scheme

on the 2 June 2013

The MHRA black triangle list, which identifies medicines subject to intense safety scrutiny, has been replaced by an EU-wide 'additional monitoring' list.

Adverse drug reactions can be reported using the Yellow Card at the back of MIMS in print or online on the MHRA website | SCIENCE PHOTO LIBRARY

Medicines included on the new list, maintained by the European Medicines Agency, will continue to be denoted by a black triangle (▼) and monitoring requirements remain the same, with prescribers still required to report any adverse events via the Yellow Card scheme.

The list includes the following:

new active substances authorised in the EU after 1 January 2011;
biological medicines, such as vaccines or medicines derived from plasma, for which there is limited post-marketing experience;
medicines with conditional approval (where more data are required) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data);
medicines for which additional studies are required (for instance, to provide more data on long-term use of the medicine or on a rare side-effect seen during clinical trials).

The black triangle symbol and information about additional monitoring will be included on Summaries of Product Characteristics and Patient Information Leaflets from September 2013.

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