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.