Medicines under enhanced surveillance will now be marked with a black triangle in their leaflet. The legislation will be imposed on Europe from September.
A black triangle in the leaflet, it is with this symbol that patients will be able to identify at the start of the 2013 school year.Medicines subject to enhanced surveillance. The new system unveiled by the European Medicines Agency (EMA) will be implemented throughout the European Union (EU).
All drugs are monitored as soon as they are placed on the market. Reinforced surveillance concerns drugs for which the authorities have less experience, due to their recent marketing or a lack of data on their long-term use. The status of “drug under enhanced surveillance” applies in certain cases. For example, when the product contains a new active substance authorized in the EU since 1e January 2011, or when the manufacturing company was requested to conduct additional studies, in order to collect data on a rare adverse reaction observed during clinical trials.
The use of this symbol will be imposed on companies marketing medicinal products in all EU Member States from autumn 2013 and will be accompanied by a short explanatory sentence: ” 
This medicinal product is subject to reinforced surveillance ”. In addition, the legislation will also apply to medicinal products authorized in the EU after 1e January 2011. They will benefit from a transition period to gradually adapt the notices to the new regulations.
But the Medicines Safety Agency (Ansm) recalls in a press release that “this is not a list of dangerous drugs or even presenting a particular safety problem. Therefore, under no circumstances should treatment be interrupted without seeking the advice of your doctor or pharmacist, ”concludes the Agency.
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